EE2006_summary of CI and hyp testing

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EN55022-2006

认证之家 EUROPEAN STANDARDEN 55022 NORME EUROPÉENNEEUROPÄISCHE NORM September 2006CENELECEuropean Committee for Electrotechnical StandardizationComité Européen de Normalisation ElectrotechniqueEuropäisches Komitee für Elektrotechnische NormungCentral Secretariat: rue de Stassart 35, B - 1050 Brussels© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.Ref. No. EN 55022:2006 E ICS 33.100.10Supersedes EN 55022:1998 + A1:2000 + A2:2003English versionInformation technology equipment -Radio disturbance characteristics -Limits and methods of measurement(CISPR 22:2005, modified)Appareils de traitement de l'information - Caractéristiques des perturbationsradioélectriques -Limites et méthodes de mesure(CISPR 22:2005, modifiée)Einrichtungen der Informationstechnik - Funkstöreigenschaften - Grenzwerte und Messverfahren (CISPR 22:2005, modifiziert)This European Standard was approved by CENELEC on 2005-09-13. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.EN 55022:2006– 2 –ForewordThe text of the International Standard CISPR 22:2003 as well as A1:2004 and CISPR/I/136/FDIS (Amendment 3) and CISPR/I/128/CDV (Amendment 2, fragment 17), prepared by CISPR SC I "Electromagnetic compatibility of information technology equipment, multimedia equipment and receivers", together with the common modifications prepared by the Technical Committee CENELEC TC 210, Electromagnetic compatibility (EMC), was submitted to the CENELEC Unique Acceptance Procedure for acceptance as a European Standard.In addition, the text of CISPR/I/135A/FDIS (future A2, fragment 1) to CISPR 22:2003, also prepared by CISPR SC I "Electromagnetic compatibility of information technology equipment, multimedia equipment and receivers", was submitted to the CENELEC formal vote as prAD to prEN 55022:2005, with the intention of the two documents being merged and ratified together as a new edition of EN 55022.During the period of voting on these CENELEC drafts, the amendments CISPR/I/135A/FDIS and CISPR/I/136/FDIS (Amendments 2 and 3 respectively) made to CISPR 22:2003, resulted in the publication of a new (fifth) edition of CISPR 22, in accordance with IEC rules. The resulting CISPR 22:2005 was published in April 2005.This resulting version of EN 55022, which was ratified on 2005-09-13, is therefore identical to CISPR 22:2005 except for the common modifications that were included in the document submitted to the CENELEC Unique Acceptance Procedure. The common modifications include CISPR/I/128/CDV, as this draft was not implemented in the unamended CISPR 22:2005.This European Standard supersedes EN 55022:1998 and its amendments A1:2000 and A2:2003.The following dates were fixed:–latest date by which the EN has to be implementedat national level by publication of an identicalnational standard or by endorsement (dop) 2007-04-01–latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2009-10-01This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directives 89/336/EEC, 2004/108/EC and 1999/5/EC. See Annex ZZ.__________– 3 – EN 55022:2006CONTENTS INTRODUCTION (6)1Scope and object (7)2Normative references (7)3Definitions (8)4Classification of ITE (9)4.1Class B ITE (9)4.2Class A ITE (10)5Limits for conducted disturbance at mains terminals and telecommunication ports (10)5.1Limits of mains terminal disturbance voltage (10)5.2Limits of conducted common mode (asymmetric mode) disturbanceat telecommunication ports (11)6Limits for radiated disturbance (11)7Interpretation of CISPR radio disturbance limit (12)7.1Significance of a CISPR limit (12)7.2Application of limits in tests for conformity of equipment in series production (12)8General measurement conditions (13)8.1Ambient noise (13)8.2General arrangement (14)8.3EUT arrangement (16)8.4Operation of the EUT (18)8.5Operation of multifunction equipment (19)9Method of measurement of conducted disturbance at mains terminals and telecommunication ports (20)9.1Measurement detectors (20)9.2Measuring receivers (20)9.3Artificial mains network (AMN) (20)9.4Ground reference plane (21)9.5EUT arrangement (21)9.6Measurement of disturbances at telecommunication ports (23)9.7Recording of measurements (27)10Method of measurement of radiated disturbance (27)10.1Measurement detectors (27)10.2Measuring receivers (27)10.3Antenna (27)10.4Measurement site (28)10.5EUT arrangement (29)10.6Recording of measurements (29)10.7Measurement in the presence of high ambient signals (30)10.8User installation testing (30)11Measurement uncertainty (30)EN 55022:2006– 4 –Annex A (normative) Site attenuation measurements of alternative test sites (41)Annex B (normative) Decision tree for peak detector measurements (47)Annex C (normative) Possible test set-ups for common mode measurements (48)Annex D (informative) Schematic diagrams of examples of impedance stabilization networks (ISN) (55)Annex E (informative) Parameters of signals at telecommunication ports (64)Annex F (informative) Rationale for disturbance measurements and methods (67)Annex ZA (normative) Normative references to international publications with their corresponding European publications (75)Annex ZZ (informative) Coverage of Essential Requirements of EC Directives (76)Bibliography (74)Figure 1 – Test site (31)Figure 2 – Minimum alternative measurement site (32)Figure 3 – Minimum size of metal ground plane (32)Figure 4 – Example test arrangement for tabletop equipment (conducted and radiated emissions) (plan view) (33)Figure 5 – Example test arrangement for tabletop equipment (conducted emission measurement – alternative 1a) (34)Figure 6 – Example test arrangement for tabletop equipment (conducted emission measurement – alternative 1b) (34)Figure 7 – Example test arrangement for tabletop equipment (conducted emission measurement – alternative 2) (35)Figure 8 – Example test arrangement for floor-standing equipment (conductedemission measurement) (36)Figure 9 – Example test arrangement for combinations of equipment (conductedemission measurement) (37)Figure 10 – Example test arrangement for tabletop equipment (radiated emission measurement) (37)Figure 11 – Example test arrangement for floor-standing equipment (radiated emission measurement) (38)Figure 12 – Example test arrangement for floor-standing equipment with vertical riserand overhead cables (radiated and conducted emission measurement) (39)Figure 13 – Example test arrangement for combinations of equipment (radiatedemission measurement) (40)Figure A.1 – Typical antenna positions for alternate site NSA measurements (44)Figure A.2 – Antenna positions for alternate site measurements for minimumrecommended volume (45)Figure B.1 – Decision tree for peak detector measurements (47)Figure C.1 – Using CDNs described in IEC 61000-4-6 as CDN/ISNs (49)Figure C.2 – Using a 150 Ω load to the outside surface of the shield ("in situCDN/ISN") (50)Figure C.3 – Using a combination of current probe and capacitive voltage probe (50)Figure C.4 – Using no shield connection to ground and no ISN (51)Figure C.5 – Calibration fixture (53)Figure C.6 – Flowchart for selecting test method (54)Figure D.1 − ISN for use with unscreened single balanced pairs (55)– 5 – EN 55022:2006 Figure D.2 − ISN with high longitudinal conversion loss (LCL) for use with either oneor two unscreened balanced pairs (56)Figure D.3 − ISN with high longitudinal conversion loss (LCL) for use with one, two,three, or four unscreened balanced pairs (57)Figure D.4 − ISN, including a 50 Ω source matching network at the voltage measuringport, for use with two unscreened balanced pairs (58)Figure D.5 − ISN for use with two unscreened balanced pairs (59)Figure D.6 − ISN, including a 50 Ω source matching network at the voltage measuringport, for use with four unscreened balanced pairs (60)Figure D.7 − ISN for use with four unscreened balanced pairs (61)Figure D.8 − ISN for use with coaxial cables, employing an internal common modechoke created by bifilar winding an insulated centre-conductor wire and an insulatedscreen-conductor wire on a common magnetic core (for example, a ferrite toroid) (61)Figure D.9 − ISN for use with coaxial cables, employing an internal common modechoke created by miniature coaxial cable (miniature semi-rigid solid copper screen or miniature double-braided screen coaxial cable) wound on ferrite toroids (62)Figure D.10 − ISN for use with multi-conductor screened cables, employing an internal common mode choke created by bifilar winding multiple insulated signal wires and an insulated screen-conductor wire on a common magnetic core (for example, a ferrite toroid) (62)Figure D.11 − ISN for use with multi-conductor screened cables, employing an internal common mode choke created by winding a multi-conductor screened cable on ferrite toroids (63)Figure F.1 – Basic circuit for considering the limits with defined TCM impedance of 150 Ω..70 Figure F.2 – Basic circuit for the measurement with unknown TCM impedance (70)Figure F.3 – Impedance layout of the components used in Figure C.2 (72)Figure F.4 – Basic test set-up to measure combined impedance of the 150 Ω and ferrites (73)Table 1 – Limits for conducted disturbance at the mains ports of class A ITE (10)Table 2 – Limits for conducted disturbance at the mains ports of class B ITE (11)Table 3 – Limits of conducted common mode (asymmetric mode) disturbanceat telecommunication ports in the frequency range 0,15 MHz to 30 MHz for class A equipment (11)Table 4 – Limits of conducted common mode (asymmetric mode) disturbance at telecommunication ports in the frequency range 0,15 MHz to 30 MHz for class B equipment (11)Table 5 – Limits for radiated disturbance of class A ITE at a measuring distance of10 m (12)Table 6 – Limits for radiated disturbance of class B ITE at a measuring distance of10 m (12)Table 7 – Acronyms used in figures (31)Table A.1 – Normalized site attenuation (A N (dB)) for recommended geometries with broadband antennas (43)Table F.1 – Summary of advantages and disadvantages of the methods described inAnnex C (68)EN 55022:2006– 6 –INTRODUCTIONThe scope is extended to the whole radio-frequency range from 9 kHz to 400 GHz, but limits are formulated only in restricted frequency bands, which is considered sufficient to reach adequate emission levels to protect radio broadcast and telecommunication services, and to allow other apparatus to operate as intended at reasonable distance.– 7 – EN 55022:2006 INFORMATION TECHNOLOGY EQUIPMENT –RADIO DISTURBANCE CHARACTERISTICS –LIMITS AND METHODS OF MEASUREMENT1 Scope and objectThis International Standard applies to ITE as defined in 3.1.Procedures are given for the measurement of the levels of spurious signals generated by the ITE and limits are specified for the frequency range 9 kHz to 400 GHz for both class A and class B equipment. No measurements need be performed at frequencies where no limits are specified.The intention of this publication is to establish uniform requirements for the radio disturbance level of the equipment contained in the scope, to fix limits of disturbance, to describe methods of measurement and to standardize operating conditions and interpretation of results.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.IEC 60083:1997, Plugs and socket-outlets for domestic and similar general use standardized in member countries of IECIEC 61000-4-6:2003, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fieldsCISPR 11:2003, Industrial, scientific, and medical (ISM) radio-frequency equipment – Electro-magnetic disturbance characteristics – Limits and methods of measurementCISPR 13:2001, Sound and television broadcast receivers and associated equipment – Radio disturbance characteristics – Limits and methods of measurementCISPR 16-1-1:2003, Specification for radio disturbance and immunity measuring apparatus and methods – Part 1-1: Radio disturbance and immunity measuring apparatus – Measuring apparatusCISPR 16-1-2:2003, Specification for radio disturbance and immunity measuring apparatus and methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Ancillary equipment – Conducted disturbances 1Amendment 1 (2004)___________1There exists a consolidated edition 1.1 (2004) including edition 1.0 and its Amendment 1.EN 55022:2006– 8 –CISPR 16-1-4:2004, Specification for radio disturbance and immunity measuring apparatus and methods – Part 1-4: Radio disturbance and immunity measuring apparatus – Ancillary equipment – Radiated disturbancesCISPR 16-4-2:2003, Specification for radio disturbance and immunity measuring apparatus and methods – Part 4-2: Uncertainties, statistics and limit modelling – Uncertainty in EMC measurements3 DefinitionsFor the purposes of this document the following definitions apply:3.1information technology equipment (ITE)any equipment:a) which has a primary function of either (or a combination of) entry, storage, display,retrieval, transmission, processing, switching, or control, of data and of telecommuni-cation messages and which may be equipped with one or more terminal ports typically operated for information transfer;b) with a rated supply voltage not exceeding 600 V.It includes, for example, data processing equipment, office machines, electronic business equipment and telecommunication equipment.Any equipment (or part of the ITE equipment) which has a primary function of radio trans-mission and/or reception according to the ITU Radio Regulations are excluded from the scope of this publication.NOTE Any equipment which has a function of radio transmission and/or reception according to the definitions of the ITU Radio Regulations should fulfil the national radio regulations, whether or not this publication is also valid. Equipment, for which all disturbance requirements in the frequency range are explicitly formulated in other IEC or CISPR publications, are excluded from the scope of this publication.3.2equipment under test (EUT)representative ITE or functionally interactive group of ITE (system) which includes one or more host unit(s) and is used for evaluation purposes3.3host unitpart of an ITE system or unit that provides the mechanical housing for modules, which may contain radio-frequency sources, and may provide power distribution to other ITE. Power distribution may be a.c., d.c., or both between the host unit(s) and modules or other ITE3.4modulepart of an ITE which provides a function and may contain radio-frequency sources3.5identical modules and ITEmodules and ITE produced in quantity and within normal manufacturing tolerances to a given manufacturing specification– 9 – EN 55022:20063.6telecommunications/network portpoint of connection for voice, data and signalling transfers intended to interconnect widely-dispersed systems via such means as direct connection to multi-user telecommunications networks (e.g. public switched telecommunications networks (PSTN) integrated services digital networks (ISDN), x-type digital subscriber lines (xDSL), etc.), local area networks (e.g. Ethernet, Token Ring, etc.) and similar networksNOTE A port generally intended for interconnection of components of an ITE system under test (e.g. RS-232, IEEE Standard 1284 (parallel printer), Universal Serial Bus (USB), IEEE Standard 1394 (“Fire Wire”), etc.) and used in accordance with its functional specifications (e.g. for the maximum length of cable connected to it), is not considered to be a telecommunications/network port under this definition.3.7multifunction equipmentinformation technology equipment in which two or more functions subject to this standard and/or to other standards are provided in the same unitNOTE Examples of information technology equipment include–a personal computer provided with a telecommunication function and/or broadcast reception function; – a personal computer provided with a measuring function, etc.3.8total common mode impedanceTCM impedanceimpedance between the cable attached to the EUT port under test and the reference ground planeNOTE The complete cable is seen as one wire of the circuit, the ground plane as the other wire of the circuit. The TCM wave is the transmission mode of electrical energy, which can lead to radiation of electrical energy if the cable is exposed in the real application. Vice versa, this is also the dominant mode, which results from exposition of the cable to external electromagnetic fields.3.9arrangementphysical layout of the EUT that includes connected peripherals/associated equipment within the test area3.10configurationmode of operation and other operational conditions of the EUT3.11associated equipmentAEequipment needed to maintain the data traffic on the cable attached to the EUT port under test and (or) to maintain the normal operation of the EUT during the test. The associated equipment may be physically located outside the test areaNOTE The AE can be another ITE, a traffic simulator or a connection to a network. The AE can be situated close to the measurement set-up, outside the measurement room or be represented by the connection to a network. AE should not have any appreciable influence on the test results.4 Classification of ITE4.1 Class B ITEClass B ITE is a category of apparatus which satisfies the class B ITE disturbance limits. ITE is subdivided into two categories denoted class A ITE and class B ITE.EN 55022:2006 – 10 – Class B ITE is intended primarily for use in the domestic environment and may include:– equipment with no fixed place of use; for example, portable equipment powered by built-inbatteries;– telecommunication terminal equipment powered by a telecommunication network; – personal computers and auxiliary connected equipment.NOTE The domestic environment is an environment where the use of broadcast radio and television receivers may be expected within a distance of 10 m of the apparatus concerned.4.2 Class A ITE WarningThis is a class A product. In a domestic environment this product may cause radio inter-ference in which case the user may be required to take adequate measures.5 Limits for conducted disturbance at mains terminalsand telecommunication portsThe equipment under test (EUT) shall meet the limits in Tables 1 and 3 or 2 and 4, as appli-cable, including the average limit and the quasi-peak limit when using, respectively, an average detector receiver and quasi-peak detector receiver and measured in accordance with the methods described in Clause 9. Either the voltage limits or the current limits in Table 3 or 4, as applicable, shall be met except for the measurement method of C.1.3 where both limits shall be met. If the average limit is met when using a quasi-peak detector receiver, the EUT shall be deemed to meet both limits and measurement with the average detector receiver is unnecessary.If the reading of the measuring receiver shows fluctuations close to the limit, the reading shall be observed for at least 15 s at each measurement frequency; the higher reading shall be recorded with the exception of any brief isolated high reading which shall be ignored.5.1 Limits of mains terminal disturbance voltageTable 1 – Limits for conducted disturbance at the mains portsof class A ITE Limits dB(μV) Frequency rangeMHzQuasi-peak Average 0,15 to 0,5079 66 0,50 to 30 73 60NOTE The lower limit shall apply at the transition frequency.Class A ITE is a category of all other ITE which satisfies the class A ITE limits but not the class B ITE limits. The following warning shall be included in the instructions for use:Table 2 – Limits for conducted disturbance at the mains portsof class B ITE Limits dB(μV) Frequency rangeMHzQuasi-peak Average 0,15 to 0,5066 to 56 56 to 46 0,50 to 556 46 5 to 30 60 50NOTE 1 The lower limit shall apply at the transition frequencies.NOTE 2 The limit decreases linearly with the logarithm of the frequency in therange 0,15 MHz to 0,50 MHz.5.2 Limits of conducted common mode (asymmetric mode) disturbanceat telecommunication ports 2)Table 3 – Limits of conducted common mode (asymmetric mode) disturbanceat telecommunication ports in the frequency range 0,15 MHz to 30 MHzfor class A equipment Voltage limits dB (μV) Current limits dB (μA) Frequency rangeMHzQuasi-peak Average Quasi-peak Average0,15 to 0,597 to 87 84 to 74 53 to 43 40 to 30 0,5 to 30 87 74 43 30 NOTE 1 The limits decrease linearly with the logarithm of the frequency in the range 0,15 MHz to 0,5 MHz.NOTE 2 The current and voltage disturbance limits are derived for use with an impedance stabilization network (ISN) which presents a common mode (asymmetric mode) impedance of 150 Ω to the telecommunication port under test (conversion factor is 20 log 10 150 / I = 44 dB).Table 4 – Limits of conducted common mode (asymmetric mode) disturbanceat telecommunication ports in the frequency range 0,15 MHz to 30 MHzfor class B equipment Voltage limits dB(μV) Current limits dB(μA) Frequency rangeMHzQuasi-peak Average Quasi-peakAverage 0,15 to 0,584 to 74 74 to 64 40 to 30 30 to 20 0,5 to 30 74 64 30 20 NOTE 1 The limits decrease linearly with the logarithm of the frequency in the range 0,15 MHz to 0,5 MHz.NOTE 2 The current and voltage disturbance limits are derived for use with an impedance stabilization network (ISN) which presents a common mode (asymmetric mode) impedance of 150 Ω to the telecommunication port under test (conversion factor is 20 log 10 150 / I = 44 dB).6 Limits for radiated disturbanceThe EUT shall meet the limits of Table 5 or Table 6 when measured at the measuring distance R in accordance with the methods described in Clause 10. If the reading on the measuring receiver shows fluctuations close to the limit, the reading shall be observed for at least 15 s at each measurement frequency; the highest reading shall be recorded, with the exception of any brief isolated high reading, which shall be ignored.___________2) See 3.6.Table 5 – Limits for radiated disturbance of class A ITE at a measuring distance of 10 mFrequency rangeMHz Quasi-peak limits dB(μV/m)30 to 230 40230 to 1 000 47NOTE 1 The lower limit shall apply at the transition frequency.NOTE 2 Additional provisions may be required for cases where interference occurs.Table 6 – Limits for radiated disturbance of class B ITEat a measuring distance of 10 mFrequency rangeMHz Quasi-peak limits dB(μV/m)30 to 230 30230 to 1 000 37NOTE 1 The lower limit shall apply at the transition frequency.NOTE 2 Additional provisions may be required for cases where interferenceoccurs.7 Interpretation of CISPR radio disturbance limit7.1 Significance of a CISPR limit7.1.1 A CISPR limit is a limit which is recommended to national authorities for incorporation in national publications, relevant legal regulations and official specifications. It is also recom-mended that international organizations use these limits.7.1.2The significance of the limits for equipment shall be that, on a statistical basis, at least 80 % of the mass-produced equipment complies with the limits with at least 80 % confidence.7.2 Application of limits in tests for conformity of equipment in series production7.2.1Tests shall be made:7.2.1.1Either on a sample of equipment of the type using the statistical method of evaluation set out in 7.2.3.7.2.1.2Or, for simplicity's sake, on one equipment only.7.2.2Subsequent tests are necessary from time to time on equipment taken at random from production, especially in the case referred to in 7.2.1.2.7.2.3Statistically assessed compliance with limits shall be made as follows:This test shall be performed on a sample of not less than five and not more than 12 items of the type. If, in exceptional circumstances, five items are not available, a sample of four or three shall be used. Compliance is judged from the following relationship:x kS +≤n L wherex is the arithmetic mean of the measured value of n items in the sample()S n x x n 2n 211=−−∑x n is the value of the individual itemL is the appropriate limitk is the factor derived from tables of the non-central t -distribution which assures with 80 %confidence that 80 % of the type is below the limit; the value of k depends on the sample size n and is stated below.The quantities x n , x , S n and L are expressed logarithmically: dB(μV), dB(μV/m) or dB(pW). n3 4 5 6 7 8 9 10 11 12 k 2,04 1,69 1,52 1,42 1,35 1,30 1,27 1,24 1,21 1,207.2.4 The banning of sales, or the withdrawal of a type approval, as a result of a dispute shall be considered only after tests have been carried out using the statistical method of evaluation in accordance with 7.2.1.1.8 General measurement conditions8.1 Ambient noiseA test site shall permit disturbances from the EUT to be distinguished from ambient noise. The suitability of the site in this respect can be determined by measuring the ambient noise levels with the EUT inoperative and ensuring that the noise level is at least 6 dB below the limits specified in Clauses 5 and 6.If at certain frequency bands the ambient noise is not 6 dB below the specified limit, the methods shown in 10.5 may be used to show compliance of the EUT to the specified limits. It is not necessary that the ambient noise level be 6 dB below the specified limit where both ambient noise and source disturbance combined do not exceed the specified limit. In this case the source emanation is considered to satisfy the specified limit. Where the combined ambient noise and source disturbance exceed the specified limit, the EUT shall not be judged to fail the specified limit unless it is demonstrated that, at any measurement frequency for which the limit is exceeded, two conditions are met:a) the ambient noise level is at least 6 dB below the source disturbance plus ambient noiselevel;b) the ambient noise level is at least 4,8 dB below the specified limit.。

香精油中农药残留

Determination of Pesticide Minimum Residue Limits in Essential OilsReport No 3A report for the Rural Industries Research andDevelopment CorporationBy Professor R. C. Menary & Ms S. M. GarlandJune 2004RIRDC Publication No 04/023RIRDC Project No UT-23A© 2004 Rural Industries Research and Development Corporation.All rights reserved.ISBN 0642 58733 7ISSN 1440-6845‘Determination of pesticide minimum residue limits in essential oils’, Report No 3Publication No 04/023Project no.UT-23AThe views expressed and the conclusions reached in this publication are those of the author and not necessarily those of persons consulted. RIRDC shall not be responsible in any way whatsoever to any person who relies in whole or in part on the contents of this report.This publication is copyright. However, RIRDC encourages wide dissemination of its research, providing the Corporation is clearly acknowledged. For any other enquiries concerning reproduction, contact the Publications Manager on phone 02 6272 3186.Researcher Contact DetailsProfessor R. C. Menary & Ms S. M. GarlandSchool of Agricultural ScienceUniversity of TasmaniaGPO Box 252-54HobartTasmania 7001AustraliaPhone: (03) 6226 2723Fax: (03) 6226 7609Email: r.menary@.auIn submitting this report, the researcher has agreed to RIRDC publishing this material in its edited form.RIRDC Contact DetailsRural Industries Research and Development CorporationLevel 1, AMA House42 Macquarie StreetBARTON ACT 2600PO Box 4776KINGSTON ACT 2604Phone: 02 6272 4819Fax: 02 6272 5877Email: rirdc@.auWebsite: .auPublished in June 2004Printed on environmentally friendly paper by Canprint.FOREWORDInternational regulatory authorities are standardising the levels of pesticide residues present in products on the world market which are considered acceptable. The analytical methods to be used to confirm residue levels are also being standardised. To constructively participate in these processes, Australia must have a research base capable of constructively contributing to the establishment of methodologies and must be in a position to assess the levels of contamination within our own products.Methods for the analysis for pesticide residues rarely deal with their detection in the matrix of essential oils. This project is designed to develop and validate analytical methods and apply that methodology to monitor pesticide levels in oils produced from commercial harvests. This will provide an overview of the levels of pesticide residues we can expect in our produce when normal pesticide management programs are adhered to.The proposal to produce a manual which deals with the specific problems associated with detection of pesticide residues in essential oils is intended to benefit the essential oil industry throughout Australia and may prove useful to other horticultural products.This report is the third in a series of four project reports presented to RIRDC on this subject. It is accompanied by a technical manual detailing methodologies appropriate to the analysis for pesticide residues in essential oils.This project was part funded from RIRDC Core Funds which are provided by the Australian Government. Funding was also provided by Essential Oils of Tasmania and Natural Plant Extracts Cooperative Society Ltd.This report, an addition to RIRDC’s diverse range of over 1000 research publications, forms part of our Essential Oils and Plant Extracts R&D program, which aims for an Australian essential oils and plant extracts industry that has established international leadership in production, value adding and marketing.Most of our publications are available for viewing, downloading or purchasing online through our website:•downloads at .au/fullreports/index.html•purchases at .au/eshopSimon HearnManaging DirectorRural Industries Research and Development CorporationAcknowledgementsOur gratitude and recognition is extended to Dr. Noel Davies (Central Science Laboratories, University of Tasmania) who provided considerable expertise in establishing procedures for chromatography mass spectrometry.The contribution to extraction methodologies and experimental work-up of Mr Garth Oliver, Research Assistant, cannot be underestimated and we gratefully acknowledge his enthusiasm and novel approaches.Financial and ‘in kind’ support was provided by Essential Oils Industry of Tasmania, (EOT).AbbreviationsADI Average Daily IntakeAGAL Australian Government Analytical Laboratoriesingredientai activeAPCI Atmospheric Pressure Chemical IonisationBAP Best Agricultural PracticesenergyCE collisionDETA DiethylenetriamineECD Electron Capture DetectorionisationESI ElectrosprayFPD Flame Photometric DetectionChromatographyGC GasResolutionHR HighChromatographyLC LiquidLC MSMS Liquid Chromatography with detection monitoring the fragments of Mass Selected ionsMRL Maximum Residue LimitSpectrometryMS MassNRA National Registration AuthorityR.S.D. Relative Standard DeviationSFE Supercritical Fluid ExtractionSIM Single Ion MonitoringSPE Solid Phase ExtractionTIC Total Ion ChromatogramContents FOREWORD (III)ACKNOWLEDGEMENTS (IV)ABBREVIATIONS (V)CONTENTS (VI)EXECUTIVE SUMMARY (VII)1. INTRODUCTION (1)1.1B ACKGROUND TO THE P ROJECT (1)1.2O BJECTIVES (2)1.3M ETHODOLOGY (2)2. EXPERIMENTAL PROTOCOLS & DETAILED RESULTS (3)2.1M ETHOD D EVELOPMENT (3)2.2M ONITORING OF H ARVESTS (42)2.3P RODUCTION OF M ANUAL (46)3. CONCLUSIONS (47)IMPLICATIONS & RECOMMENDATIONS (50)BIBLIOGRAPHY (50)Executive SummaryThe main objective of this project was to continue method development for the detection of pesticide residues in essential oils, to apply those methodologies to screen oils produced by major growers in the industry and to produce a manual to consolidate and coordinate the results of the research. Method development focussed on the effectiveness of clean-up techniques, validation of existing techniques, the assessment of the application of gas chromatography (GC) with detection using electron capture detectors (ECD), flame photometric detectors (FPD) and high pressure liquid chromatography (HPLC) with ion trap mass selective (MS) detection.The capacity of disposable C18 cartridges to separate components of boronia oil was found to be limited with the majority of boronia components being eluted on the solvent front, with little to no separation achieved. The cartridges were useful, however, in establishing the likely interaction of reverse phases (RP) C18 columns with components of essential oils, using polar mobile phases . The loading of large amounts of oil onto RP HPLC columns presents the risk of permanently contaminating the bonded phases. The lack of retention of components on disposable SPE C18 cartridges, despite the highly polar mobile phase, presented a good indication that essential oils would not accumulate on HPLC RP columns.The removal of non-polar essential oil components by solvent partitioning of distilled oils was minimal, with the recovery of pesticides equivalent to that recorded for the essential oil components. However application of this technique was of advantage in the analysis of solvent extracted essential oils such as those produced from boronia and blackcurrant.ECD was found to be successful in the detection of terbacil, bromacil, haloxyfop ester, propiconazole, tebuconazole and difenaconzole. However, analysis of pesticide residues in essential oils by application of GC ECD is not sufficiently sensitive to allow for a definitive identification of any contaminant. As a screen, ECD will only be effective in establishing that, in the absence of a peak eluting with the correct retention time, no gross contamination of pesticide residues in an essential oil has occurred . In the situation where a peak is recorded with the correct elution characteristics, and which is enhanced when the sample is fortified with the target analyte, a second means of contaminant identification would be required. ECD, then, can only be used to rule out significant contamination and could not in itself be adequate for a positive identification of pesticide contamination.Benchtop GC daughter, daughter mass spectrometry (MSMS) was assessed and was not considered practical for the detection of pesticide residues within the matrix of essential oils without comprehensive clean-up methodologies. The elution of all components into the mass spectrometer would quickly lead to detector contamination.Method validation for the detection of 6 common pesticides in boronia oil using GC high resolution mass spectrometry was completed. An analytical technique for the detection of monocrotophos in essential oils was developed using LC with detection by MSMS. The methodology included an aqueous extraction step which removed many essential oil components from the sample.Further method development of LC MSMS included the assessment of electrospray ionisation (ESI) and atmospheric pressure chemical ionisation (APCI. For the chemicals trialed, ESI has limited application. No response was recorded for some of the most commonly used pesticides in the essential oil industry, such as linuron, oxyflurofen, and bromacil. Overall, there was very little difference between the sensitivity for ESI and APCI. However, APCI was slightly more sensitive for the commonly used pesticides, tebuconazole and propiconazole, and showed a response, though poor, to linuron and oxyflurofen. In addition, APCI was the preferred ionisation method for the following reasons,♦APCI uses less nitrogen gas compared to ESI, making overnight runs less costly;♦APCI does not have the high back pressure associated with ionisation by ESI such that APCI can be run in conjunction with UV-VIS without risk of fracturing the cell, which is pressure sensitive. Analytes that ionised in the negative APCI mode were incorporated into a separate screen which included bromacil, terbacil, and the esters of the fluazifop and haloxyfop acids. Further work using APCI in the positive mode formed the basis for the inclusion of monocrotophos, pirimicarb, propazine and difenaconazole into the standard screen already established. Acephate, carbaryl, dimethoate, ethofumesate and pendimethalin all required further work for enhanced ionisation and / or improved elution profiles. Negative ionisation mode for APCI gave improved characteristics for dicamba, procymidone, MCPA and mecoprop.The thirteen pesticides included in this general screen were monocrotophos, simazine, cyanazine, pirimicarb, propazine, sethoxydim, prometryb, tebuconazole, propiconazole, , difenoconazole and the esters of fluroxypyr, fluazifop and haloxyfop.. Bromacil and terbacil were not included as both require negative ionisation and elute within the same time window as simazine, which requires positive ionisation. Cycling the MS between the two modes was not practical.The method validation was tested against three oils, peppermint, parsley and fennel.Detection limits ranged from 0.1 to 0.5 mgkg-1 within the matrix of the essential oils, with a linear relationship established between pesticide concentration and peak height (r2 greater than 0.997) and repeatabilities, as described by the relative standard deviation (r.s.d), ranging from 3 to 19%. The type of oil analysed had minimal effect on the response function as expressed by slope of the standard curve.The pesticides which have an carboxylic acid moiety such as fluazifop, haloxyfop and fluroxypyr, present several complications in any analytical method development. The commercial preparations usually have the carboxylic acid in the ester form, which is hydrolysed to the active acidic form on contact with soil and vegetation. In addition, the esters may be present in several forms, such as the ethoxy ethyl or butyl esters. Detection using ESI was tested. Preliminary results indicate that ESI is unsuitable for haloxyfop and fluroxypyr ester. Fluazifop possessed good ionisation characteristics using ESI, with responses approximately thirty times that recorded for haxloyfop. Poor chromatography and response necessitated improved mobile phase and the effect of pH on elution characteristics was considered the most critical parameter. The inclusion of acetic acid improved peak resolution.The LC MSMS method for the detection of dicamba, fluroxypyr, MCPA, mecoprop and haloxyfop in peppermint and fennel distilled oils underwent the validation process. Detection limits ranged from 0.01 to 0.1 mgkg-1Extraction protocols and LC MSMS methods for the detection of paraquat and diquat were developed. ESI produced excellent responses for both paraquat and diquat, after some modifications of the mobile phase. Extraction methodology using aqueous phases were developed. Extraction with carbonate buffer proved to be the most effective in terms of recovery and robustness. A total ion chromatogram of the LC run of an aqueous extract of essential oil was recorded and detection using a photodiode array detector confirmed that very little essential oil matrix was co-extracted. The low background noise indicated that samples could be introduced directly into the MS. This presented a most efficient and rapid way for analysis of paraquat and diquat, avoiding the need for specialised columns or modifiers to be included in the mobile phase to instigate ion exchange.The adsorbtion of paraquat and diquat onto glass and other surfaces was reduced by the inclusion of diethylenetriamine (DETA). DETA preferentially accumulates on the surfaces of sample containers, competitively binding to the adsorption sites. All glassware used in the paraquat diquat analysis were washed in a 5% solution of 0.1M DETA, DETA was included in all standard curve preparations, oils were extracted with aqueous DETA and the mobile phase was changed to 50:50 DETA / methanol. The stainless steel tubing on the switching valve was replaced with teflon, further improvingreproducibility. Method validation was undertaken of the analysis of paraquat and diquat using the protocols established. The relationship between analyte concentration and peak area was not linear at low concentrations, with adsorption more pronounced for paraquat, such that the response for this analyte was half that seen for diquat and the 0.1 mgkg-1 level.The development of a method for the detection of the dithiocarbamate, mancozeb was commenced. Disodium N, N'-ethylenebis(dithiocarbamate) was synthesised as a standard for the derivatised final analytical product. An LC method, with detection using MSMS, was successfully completed. The inclusion of a phase transfer reagent, tetrabutylammonium hyrdrogen sulfate, required in the derivatisation step, contaminated the LC MSMS system, such that any signal from the target analyte was masked. Alternatives to the phase transfer reagent are now being investigated.Monitoring of harvests were undertaken for the years spanning 1998 to 2001. Screens were conducted covering a range of solvent extracted and distilled oils. Residues tested for included tebuconazole, simazine, terbacil, bromacil, sethoxydim, prometryn, oxyflurofen, pirimicarb, difenaconazole, the herbicides with acidic moieties and paraquat and diquat. Problems continued for residues of propiconazole in boronia in the 1998 / 1999 year with levels to 1 mgkg-1 still being detected. Prometryn residues were detected in a large number of samples of parsley oil.Finally the information gleaned over years of research was collated into a manual designed to allow intending analysts to determine methodologies and equipment most suited to the type of the pesticide of interest and the applicability of analytical equipment generally available.1. Introduction1.1 Background to the ProjectResearch undertaken by the Horticultural Research Group at the University of Tasmania, into pesticide residues in essential oils has been ongoing for several years and has dealt with the problems specific to the analysis of residues within the matrix of essential oils. Analytical methods for pesticides have been developed exploiting the high degree of specificity and selectivity afforded by high resolution gas chromatography mass spectrometry. Standard curves, reproducibility and detection limits were established for each. Chemicals, otherwise not amenable to gas chromatography, were derivatised and incorporated into a separate screen to cover pesticides with acidic moieties.Research has been conducted into low resolution GC mass selective detectors (MSD and GC ECD. Low resolution GC MSD achieved detection to levels of 1 mgkg-1 in boronia oil, whilst analysis using GC ECD require a clean-up step to effectively detect halogenated chemicals below 1mgkg-1.Dithane (mancozeb) residues were digested using acidified stannous chloride and the carbon disulphide generated from this reaction analysed by GC coupled to FPD in the sulphur mode.Field trials in peppermint crops were established in accordance with the guidelines published by the National Registration Authority (NRA), monitoring the dissipation of Tilt and Folicur residues in peppermint leaves and the co-distillation of these residues with hydro-distilled peppermint oils were assessed.Development of extraction protocols, analytical methods, harvest monitoring and field trials were continued and were detailed in a subsequent report. Solvent-based extractions and supercritical fluid extraction (SFE) was found to have limited application in the clean-up of essential oilsIn conjunction with Essential Oils of Tasmania (EOT), the contamination risk, associated with the introduction of a range of herbicides, was assessed through a series of field trials. This required analytical method development to detect residues in boronia flowers, leaf and oil. The methodology for a further nine pesticides was successful applied. Detection limits for these chemicals ranged from 0.002 mgkg-1 to 0.1 mgkg-1. In addition, methods were developed to analyse for herbicides with active ingredients (ai) whose structure contained acidic functional groups. Two methods of pesticide application were trialed. Directed sprays refer to those directed on the stems and leaves of weeds at the base of boronia trees throughout the trial plot. Cover sprays were applied over the entire canopy. For all herbicides for which significant residues were detected, it was evident that cover sprays resulted in contamination levels ten times those occurring as a result of directed spraying in some instances. Chloropropham, terbacil and simazine presented potentially serious residue problems, with translocation of the chemical from vegetative material to the flower clearly evident.Directed spray applications of diuron and dimethenamid presented only low residue levels in extracted flowers with adequate control of weeds. Oxyflurofen and the mixture of bromacil and diuron (Krovar) presented only low levels of residues when used as a directed spray and were effective as both post and pre-emergent herbicides. Only very low levels of residues of both sethoxydim and norflurazon were detected in boronia oil produced in crops treated with directed spray applications. Sethoxydim was effective as a cover spray for grasses whilst norflurazon showed potential as herbicide to be used in combination with other chemicals such as diuron, paraquat and diquat. Little contamination of boronia oils by herbicides with acidic moieties was found. This advantage, however, appears to be offset by the relatively poor weed control. Both pendimethalin and haloxyfop showed good weed control. Both, however, present problems with chemical residues in boronia oil and should only be used as a directed sprayThe stability of tebuconazole, monocrotophos and propiconazole in boronia under standard storage conditions was investigated. Field trials of tebuconazole and propiconazole were established in commercial boronia crops and the dissipation of both were monitored over time. The amount of pesticide detected in the oils was related to that originally present in the flowers from which the oils were produced.Experiments were conducted to determine whether the accumulation of terbacil residues in peppermint was retarding plant vigour. The level recorded in the peppermint leaves were comparatively low. Itis unlikely that terbacil carry over is the cause for the lack of vigour in young peppermint plants.Boronia oils produced in 1996, 1997 and 1998 were screened for pesticides using the analytical methods developed. High levels of residues of propiconazole were shown to persist in crops harvested up until 1998. Field trials have shown that propiconazole residues should not present problems if the fungicide is used as recommended by the manufacturers.1.2 Objectives♦Provide the industry, including the Standards Association of Australia Committee CH21, with a concise practical reference, immediately relevant to the Australian essential oil industry♦Facilitate the transfer of technology from a research base to practical application in routine monitoring programs♦Continue the development of analytical methods for the detection of metabolites of the active ingredients of pesticide in essential oils.♦Validate the methods developed.♦Provide industry with data supporting assurances of quality for all exported products.♦Provide a benchmark from which Australia may negotiate the setting of a realistic maximum residue limit (MRL)♦Determine whether the rate of uptake is relative to the concentration of active ingredient on the leaf surface may establish the minimum application rates for effective pest control.1.3 MethodologyThree approaches were used to achieve the objectives set out above.♦Continue the development and validation of analytical methods for the detection of pesticide residues in essential oils. Analytical methods were developed using gas chromatography high resolution mass spectrometry (GC HR MS), GC ECD, GC FPD and high pressure liquid chromatography with detection using MSMS.♦Provide industry with data supporting assurances of quality for all exported products.♦Coordinate research results into a comprehensive manual outlining practical approaches to the development of analytical proceduresOne aspect of the commissioning of this project was to provide a cost effective analytical resource to assess the degree of the pesticide contamination already occurring in the essential oils industry using standard pesticide regimens. Oil samples from annual harvests were analysed for the presence of pesticide residues. Data from preceding years were collated to determine the progress or otherwise, in the application of best agricultural practice (BAP).2. Experimental Protocols & Detailed ResultsThe experimental conditions and results are presented under the following headings:♦Method Development♦Monitoring of Commercial Harvests♦Production of a Manual2.1 Method DevelopmentMethod development focussed on the effectiveness of clean-up techniques, validation of existing techniques, the assessment of the application of GC ECD and FPD and high pressure liquid chromatography with ion trap MS, MS detection.2.1.1 Clean-up Methodologies2.1.1.i. Application of Disposable SPE cartridges in the clean-up of pesticide residues in essentialoilsLiterature reviews provided limited information with regards to the separation of contaminants within essential oils. The retention characteristics of disposable C18 cartridges were trialed.Experiment 1;Aim : To assess the capacity of disposable C18 cartridges to the separation of boronia oil components. Experimental : Boronia concrete (49.8 mg) was dissolved in 0.5 mL of acetone and 0.4 mL of chloroform was added. 1mg of octadecane was added as an internal standard. A C18 Sep-Pak Classic cartridge (short body) was pre- conditioned with 1.25 mL of methanol, which was passed through the column at 7.5 mLmin-1, followed by 1.25 mL of acetone, at the same flow rate. The boronia samplewas then applied to the column at 2 mLmin-1 flow and eluted with 1.25 mL of acetone / chloroform (5/ 4) and then eluted with a further 2.5 mL of chloroform. 5 fractions of 25 drops each were collected. The fractions were analysed by GC FID using the following parametersAnalytical parameters6890PackardHewlettGCcolumn: Hewlett Packard 5MS 30m, i.d 0.32µmcarrier gas instrument grade nitrogeninjection volume: 1µL (split)injector temp: 250°Cdetector temp: 280°Cinital temp: 50°C (3 min), 10°Cmin-1 to 270°C (7 mins)head pressure : 10psi.Results : Table 1 record the percentage volatiles detected in the fractions collectedFraction 1 2 3 4 5 % components eluting 18 67 13 2636%monoterpenes 15%sesquiquiterpenes 33 65 2%high M.W components 1 43 47 9Table 1. Percentage volatiles eluting from SPE C18 cartridgesDiscussion : The majority of boronia components eluted on the solvent front, effecting minimal separation. This area of SPE clean-up of essential oils requires a wide ranging investigation, varying parameters such as cartridge type and polarity of mobile phase.Experiment 2.Aim : For the development of methods using LC MSMS without clean-up steps, the potential for oil components to accumulate on the reverse phase (RP) column must be assessed. The retention of essential oil components on SPE C18 cartridges, using the same mobile phase as that to be used in theLC system, would provide a good indication as to the risk of contamination of the LC columns withoil components.Experimental: Parsley oil (20-30 mg) was weighed into a GC vial. 200 µL of a 10 µgmL-1 solution (equivalent to 100mgkg-1 in oil) of each of sethoxydim, simazine, terbacil, prometryn, tebuconazoleand propiconazole were used to spike the oil, which was then dissolved in 1.0 mL of acetonitrile. The solution was then slowly introduced to the C18 cartridge (Waters Sep Pac 'classic' C18 #51910) using a disposable luer lock, 10 mL syringe, under constant manual pressure, and eluted with 9 mLs of acetonitrile. Ten, 1 mL fractions were collected and transferred to GC vials. 1mg of octadecane was added to each vial and the samples were analysed by GC FID under the conditions described in experiment 1.The experiment was repeated using C18 cartridges which had been pre-conditioned with distilled waterfor 15 mins. Again, parsley oil, spiked with pesticides was eluted with acetonitrile and 5 x 1 mL fractions collected.Results: The majority of oil components and pesticides were eluted from the C18 cartridge in the firsttwo fractions. Little to no separation of the target pesticides from the oil matrix was achieved. Table2 lists the distribution of essential oil components in the fractions collected.Fraction 1 2 3 4 5 % components eluting 18 67 13 2663%monoterpenes 15%sesquiquiterpenes 33 65 2%high M.W components 1 43 47 9water conditioned% components eluting 35 56 8 12%monoterpenes 3068%sesquiquiterpenes 60 39 1 0%high M.W components 0 50 42 7Table 2. Percentage volatiles eluting for SPE C18 cartridgesFigure 1 shows a histogram of the percentage distribution of components from the oil in each of the four fractions.Figure 1. Histogram of the percentage of volatiles of distilled oils in each of four fraction elutedon SPE C18 cartridges (non-preconditioned)Figure 2. Histogram of the percentage of volatiles of distilled oils in each of four fraction elutedon SPE C18 cartridges (preconditioned)Discussion : The chemical properties of many of the target pesticides, including polarity, solubility in organic solvents and chromatographic behaviour, are similar to the majority of essential oil components. This precludes the effective separation of analytes from such matrices through the use of standard techniques, where the major focus is pre-concentration of pesticide residues from water or water based vegetative material. However, this experiment served to provide a good indication that under HPLC conditions, where a reverse phase C18 column is used in conjunction with acetonitrile / water based mobile phases, essential oil components do not remain on the column.。

2006[1].692.EC 中英文

COMMISSION DECISION of 12 October 2006 amending, for the purposes of adapting to technical progress, the Annex to Directive 2002/95/EC of the European Parliament and of the Council as regards exemptions for applications of hexavalent chromium (notified under document number C(2006) 4791) (Text with EEA relevance) (2006/692/EC)欧盟委员会于2006年10月12日为了适应技术发展，针对指令2002/95/EC附录关于欧盟议会和欧盟理事会针对六价铬应用的豁免进行修改的决定。

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(b) thereof, Whereas:欧洲共同体委员会，注意到成立欧洲共同体的条约，注意到欧洲议会和欧盟理事会2003年1月27日第2002/95/EC 号关于在电气电子设备（1）中限制使用某些有害物质指令，特别是其中第5(1)(b)条，鉴于：(1) Directive 2002/95/EC requires the Commission to evaluate certain hazardous substances prohibited pursuant to Article 4(1) of that Directive.（1）欧盟委员会按照第2002/95/EC号指令，需要对在此指令中的第4(1)条所禁止的某些有害物质进行评估。

Item-4-IECGuide115-Gryn

IECEE Assessor Training, 2006-2009
IECEE Copyright 2006
IEC Guide 115
Arithmetic mean or average – sum of observations divided by the number of observations (n)
IECEE Assessor Training, 2006-2009
IECEE Copyright 2006
IEC Guide 115
General References and Acknowledgements ISO/IEC GUM – Guide to the expression of uncertainty in measurement NIST Reference on Constants, Units and Uncertainty International Vocabulary of basic and general terms in metrology (VIM) International metrology organizations
IEC Guide 115
True Value (of a quantity) – (idealized) value consistent with a definition of a given particular quantity This is the value that would be obtained by a perfect measurement (which is not possible) Conventional True Value is a value accepted by a convention or agreement, eg. “reference value” Uncertainty (of measurement) - parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.

20623-2006英文

20623-2006英文20623-2006 EnglishIn recent years, the world has seen an unprecedented development in technology and communication. With the increasing integration of global economies, international standards have become essential in ensuring harmonized practices and promoting trade. Standardization plays a crucial role in various industries, providing a framework for quality management and improving overall efficiency. One such standard that has gained significant importance is the 20623-2006 English standard.The 20623-2006 English standard is a comprehensive guideline for effective communication in English. It focuses on the use of language, grammar, and vocabulary in various professional and business contexts. This standard aims to enhance understanding, reduce miscommunication, and facilitate a smooth exchange of information among individuals from diverse cultural backgrounds.One of the key aspects covered in the 20623-2006 English standard is clarity in communication. The standard emphasizes the importance of using plain and simple language to convey messages. By avoiding jargon or complex sentence structures, the standard ensures that the intended meaning is clear to all parties involved. This clarity is especially critical in cross-cultural business negotiations or international conferences, where participants may have different levels of English proficiency.Furthermore, the 20623-2006 English standard addresses the issue of grammar and vocabulary. It provides guidelines for the correct usage oftenses, prepositions, and articles, among other grammatical elements. Additionally, the standard promotes the use of appropriate vocabulary, encouraging individuals to choose words that accurately convey their intended meaning. This attention to grammar and vocabulary helps to minimize misunderstandings and ensures effective communication between parties.In addition to clarity and grammar, the standard also emphasizes cultural sensitivity. It recognizes the diverse cultural backgrounds of individuals involved in international communication and encourages respect for cultural differences. Adhering to this standard means being aware of linguistic nuances, avoiding offensive language or stereotypes, and tailoring communication styles to suit the cultural sensitivities of the audience. This cultural sensitivity fosters better rapport and understanding between individuals, promoting effective collaboration and avoiding potential conflicts.The 20623-2006 English standard also emphasizes the importance of brevity and conciseness in communication. In a fast-paced business environment, time is a valuable resource. The standard encourages individuals to express their ideas and thoughts succinctly, avoiding unnecessary repetition or excessive use of words. By promoting brevity, the standard enables efficient communication, allowing for quicker decision-making and streamlined processes.Overall, the 20623-2006 English standard provides comprehensive guidelines for effective English communication in professional and business contexts. By focusing on clarity, grammar, vocabulary, cultural sensitivity,brevity, and conciseness, the standard ensures that communication is accurate, efficient, and culturally appropriate. Adhering to this standard enables individuals to better navigate the globalized world, promotes understanding among diverse cultures, and supports harmonized practices in the international business arena.In conclusion, the 20623-2006 English standard serves as a vital tool for effective communication in English. As technology continues to advance and global connections strengthen, the importance of standardized communication cannot be overstated. By following the guidelines outlined in this standard, individuals and organizations can ensure that their messages are accurately understood, fostering collaboration, and facilitating successful interactions in the international arena.。

Chapter 4 Syntax

you eat bananas Ultimate constituents you eat banana -s
The segmentation of the sentence up into its immediate constituents by using binary cuttings until its ultimate constituents are obtained is an important approach to the realization of the nature of language, called Immediate Constituent Analysis (IC analysis).
The word “syntax” came originally from Greek and literally meant “a setting out together” or “arrangement”.
Most languages have a finite number of basic words, but those words can be put together to make an infinite number of sentences.
Formal accounts of syntax are based on establishing the basic constituents, namely, categories, from which word strings are formed. Sentences are regarded as hierarchies of interlocking smaller units, or constituents.

2006年GCT入学资格考试外语运用能力试题及参考答案

2006 年GCT 入学资格考试外语运用能力试题（50 题，每题2 分，满分100 分，考试时间45 分钟）Part One Vocabulary and StructureDirections:There are ten incomplete sentences in this part. For each sentence there are four choices marked A, B, C and D. Choose the one that best completes the sentence. Mark your answer on the ANSWER SHEET with a single line through the center.1. Every plant, animal, and human being needs water to ________ alive.A. stayB. makeC. runD. glow2. It ________ commonplace to think of sport as a "leisure industry" now.A. becameB. will becomeC. is becomingD. had become3. Changes in climate ________ slowly through the years.A. make progressB. take placeC. keep paceD. set sail4. Scientists can predict regions ________ new species are most likely to be found.A. whereB. whenC. whyD. how5. You should use ________ and natural language when you write a personal letter.A. formalB. politicalC. magicD. plain6. Radios today seldom need ________ or the attention of a technician.A. to repairB. repairedC. repairingD. to have repaired7. It is a great pity for ________ to be any quarrel in the school board meeting.A. whereB. hereC. thereD. why8. Magicians ________ use techniques from science and the arts to deceive the mind and eye.A. generouslyB. geneticallyC. cleverlyD. subsequently9. To get the best view of Sydney Harbour, take a Sydney Seaplane flight ________ the Harbour and Bondi Beach.1A. aboveB. underC. overD. across10. Chocolate manufacturers blend many types of beans to yield ________ and color desired in the final product.A. the shapeB. the flavorC. the functionD. the brandPart Two Reading ComprehensionDirections:In this part there are three passages and one announcement, each followed by five questionsor unfinished statements. For each of them, there are four choices marked A, B, C and D. Choose the best one and mark your answer on the ANSWER SHEET with a single line through the center.Questions 11-15 are based on the following passage:Jessica Bucknam shouts "tiao!" (tee-ow) and her fourth-grade students jump."Dun!" (doo-wee) she commands, and they crouch（蹲）. They giggle（吃吃地笑）as the commands keep coming in Mandarin Chinese.Half of the 340 students at the K-5 school are enrolled in the program. They can continue studying Chinese in middle and high schools. The goal: to speak like natives.About 24,000 American students are currently learning Chinese. Most are in high schools. But the number of younger students is growing in response to China's emergence as a global superpower."China has become a strong partner of the United States," says Mary Patterson, Woodstock's principal. "Children who learn Chinese at a young age will have more opportunities for jobs in the future."Isabel Weiss, 9, isn't thinking about the future. She thinks learning Chinese is fun. "when you hear people speaking in Chinese, you know what they're saying," she says. "And they don't know that you know."11. What do the fourth-grade students seem to be doing in the first paragraph?A. They are learning how to jump.B. They are learning how to crouch.C. They are learning how to giggle.D. They are learning Chinese.12. The purpose of the program for Jessica's students is to ________.A. enable them to learn how to commandB. get them enrolled in the language programC. help them to speak like a ChineseD. continue enrolling more students to learn Chinese13. In response to the fact that ________ , more American students are learning Chinese.A. the United States is the only superpower in the worldB. international trading is becoming globalizedC. partnership is encouraging business and tradeD. China is emerging as a new superpower in the world14. Why do more and more young students personally choose to learn Chinese in the United States?A. They will have more job opportunities in the future.B. They are more interested in the international trade.C. They will visit China for further education.D. They are curious about the corporate partnership.15. Isabel Weiss has also chosen to learn Chinese because ________ .A. she wants a brighter futureB. she finds it fun to learn the languageC. she likes to do business in ChinaD. she watches people speak the languageQuestions 16-20 are based on the following passage:The National Aeronautics and Space Administration (NASA) has announced plans to return people to the moon by 2018. "And this time," according to a NASA press release, "we're going to stay."NASA wants to make a new spaceship for the missions using parts from the Apollo program, which first took people to the moon in 1969, and the space shuttle. NASA says the new Crew Exploration Vehicle (CEV) will be "affordable, reliable, reliable, and sage."The CEV will be able to hold four astronauts. The plan is to have the CEV dock（对接）in space with the lunar lande—the vehicle astronauts will use to land on the moon—which will be launched separately into space. The CEV will then travel to the moon and all four astronauts will walk on the moon.The first moon missions are expected to last up to seven days. Exploration and construction of a moon base will be the astronauts' top priorities（最优先考虑的事）.NASA hopes to have a minimum of two moon missions a year starting in 2018. This will allow for quick moon base construction, constant scientific study, and training for future missions to Mars.16. What is new in NASA's plan to return to the moon by 2018?A. People will land and remain on the moon.B. Equipment will be carried and installed there.3C. More CEVs will be made regularly.D. A special device will be used in landing.17. How will NASA make its new spaceship?A. It will base its design on that of the Apollo program.B. It will use parts only from the Apollo program.C. It will make use of the Apollo program and the space shuttle.D. It will develop new designs and make new components.18. How will CEV and the moon lander be launched?A. They will be launched separately.B. CEV will dock with the moon lander.C. They will be launched together.D. The moon lander will hold four astronauts.19. What will be the astronauts' top priorities?A. Entering the orbit and landing on the moon.B. Landing and walking on the moon surface.C. Exploration and researches into the moon composition.D. Exploration and construction of a moon base.20. The reason why NASA hopes to carry out at least two moon missions a year starting in 2018 is to ________.A. ensure the moon traveling and the moon base constructionB. speed up the moon base construction and other activitiesC. guarantee the quality of the researchers' scientific studyD. set up new training laboratories for future missions to MarsQuestions 21-25 are based on the following passage:At the end of the U.S. Civil War, about four million slaves were freed. Now, people around the world can hear some of the former slaves' stories for the first time ever, as told in their own voices."That was in slavery time," says Charlie Smith in one interview. "They sold the colored people. And they were bringing them from Africa. They brought me from Africa. I was a child."The Library of Congress released the collection of recordings, Voices from the Days of Slavery, in January. The recordings were made between 1932 and 1975. Speaking at least 60 years after their emancipation（解放）, the storytellers discuss their experiences as slaves. They also tell about their lives as free men and women.Isom Moseley was just a boy at the time of emancipation, but he recalls that things were slow to change. "It was a year before the folks knowed they was free," he says.[黑人说英语有时不合语法，因此，这里他把knew说成了knowed, 把were 说成了was.]Michael Taft, the head of the library's archive of folk culture, says the recordings reveal something that written stories cannot. "The power of hearing someone speak is so much greater than reading something from the page," Taft says. "It's how something is said—the dialect, the low pitches, the pauses—that helps tell the story."21. What is new about the slaves' stories?A. They are told in the slaves' own voices.B. People travel around the world to hear them.C. Colored people were sold.D. They happened in the slavery time.22. What is the title of the collection of recordings?A. The End of the U.S. Civil WarB. The Library of CongressC. Voices from the Days of SlaveryD. The Recordings of Written Stories23. How many years did it take to complete the collection of recordings?A. 26 years.B. 33 years.C. 44 years.D. 57 years.24. What do the storytellers tell us about?A. How they were brought to the United States from Africa.B. The release of the collection of recordings.C. What happened 60 years after their emancipation?D. Their experiences as slaves and their lives as free men and women.25. The recordings differ from written stories in that ________.A. the tellers and the government are contributing togetherB. the dialect, the low pitches, and the pauses are more revealingC. the hearing and reading both help tell the storiesD. the power of watching someone write is more engagingQuestions 26-30 are based on the following announcement:526. In order to be chosen, applicants must send in ________ before Nov. 30, 2006.A. their papers and application formsB. their papers and degree certificatesC. their application forms and diplomasD. their applications and registrations27. The number 92354 is the ________ of Loma Linda University SD.A. fax codeB. phone numberC. zip codeD. street number28. The qualifications for the application for the award include all of the following EXCEPT ________.A. hospital interns, resident or clinical fellowsB. undergraduates, masters or Health Science degree candidatesC. doctorial degree candidates or equivalentsD. Ph. D. supervisors or former student award winners29. Journal of Biomaterials Research will publish ________.A. the abstract of the paper of the applicant chosenB. the presented paper of the applicant chosenC. the abstract and paper of the applicant selectedD. the application form and paper of the applicant30. It can be inferred that the criterion/criteria for the selection of qualified candidates is/are ________.A. the qualification of the applicantsB. the quality of the applicants' papersC. the number of the papers presentedD. the abstract of the papers submittedPart Three ClozeDirections:There are ten blanks in the following passage. For each numbered blank, there are four choices marked A, B, C and D. Choose the best one and mark your answer on the ANSWER SHEET with a single line through the center.The hobby of collecting autographs（亲笔签名）is called philography, from a Greek word meaning love of writing. People 31 many kinds of autographs. Some collect signatures or other handwritten materials of authors, composers, movie stars, or sports heroes. Others focus on certain 32 such as the signing of the Declaration of Independence, a presidential election, or the space program.33 collectors try to acquire a complete set of autographs of Novel Prize winners or Academy Award winners.Collectors may request autographs 34 celebrities either in person or by letter. Most beginning autograph collectors do not have the knowledge to determine 35 an autograph is genuine（真实的）. They may mistake other kinds of signatures for 36 handwritten signatures. For example, some people have secretaries who sign their mail. Some individuals send out mass-produced letters or signed photographs to collectors who 37 their autographs. Many famous people use a mechanical device called an Autopen to sign autographs. The 38 can7sign 3,000 signatures in eight hours. The only way to recognize an Autopen autograph is to compare two of them. All Autopen autographs are 39 , but no two handwritten autographs are 40 alike.31．A．neglect B．arrange C．read D．collect32．A．stories B．events C．actions D．plans33．A．Some B．Any C．No D．Several34．A．from B．in C．for D．to35．A．what B．how C．whether D．where36．A．false B．indirect C．open D．genuine37．A．copy B．request C．write D．mail38．A．actor B．machine C．collector D．secretary 39．A．genuine B．false C．different D．identical 40．A．fluently B．initially C．exactly D．convenientlyPart Four Dialogue CompletionDirections:In this part, there are ten short incomplete dialogues between two speakers, each followed by four choices marked A, B, C and D. Choose the one that most appropriately suits the conversational context and best completes the dialogue. Mark your answer on the ANSWER SHEET with a single line through the center.41. Steve: Hi, my name is Steve. It's nice to meet you.Jack: I'm Jack.A. My name is Jack, you know.B. How are you, Steve?C. It's pleasure to meet you, Steve.D. You're busy, aren't you?42. Jill: Hi, Jane, this is Jill. Do you have time to talk?Jane: Hi, Jill, . I was just watching TV.A. so whatB. no doubtC. sometimeD. sure43. Salesman: Good morning, sir. May I help you?Customer: That's OK. .Salesman: Fine. Please take your time.A. I'm just looking aroundB. I'm just playing aroundC. I'm just sneaking aroundD. I'm just hanging around44. Customer: Could you hold the door open for a moment, please?Salesman: Certainly. .A. please take your timeB. I'm sorry I can'tC. No worry, pleaseD. Never mind it45. Harry: I didn't know you play billiards. Are you having fun?John: I'm having a great time. What are you doing?A. Great!B. How about you?C. I miss it so much.D. Do you know billiards?46. Bob: Why didn't you come to my party last night?Bill: I'm sorry, . I had to visit my grandmother at the hospital.A. I did itB. I still remember itC. I couldn't make itD. I will come47. Cashier: How can I help you, Miss?Nancy:Cashier: Sure. How do you want it?A. Why didn't you say it then?B. No, I don't need your help.C. Could you break a 20 for me?D. No, I can manage it.48. Friend A: This meal is on me. .Friend B: Thanks, but isn't it my turn to treat you?A. It's none of your businessB. I'll treat youC. I invite youD. My pleasure49. Stewardess: Please put your seat up. We'll be serving dinner shortly.Passenger: I'd like to, but there seems to be something wrong with it.A. Can you help with it?B. Can you stay a few minutes?C. It's your duty to fix it.D. Hold on, please.50. Student A: Thanks a lot. I really enjoyed your company.Student B: Don't mention it. .A. Sorry to keep you outB. Many happy returns of the dayC. Same hereD. You're too polite2006 年GCT 入学资格考试外语运用能力试题参考答案与解析Part One Vocabulary and Structure1．【答案】A【解析】“stay … alive”意为“使（某人或某物）活着，维持生命，生存下去”。

Corporate social responsibility communication

Corporate social responsibility communication:stakeholder information,response and involvement strategiesMette Morsing and Majken Schultz nIntroductionMessages about corporate ethical and socially responsible initiatives are likely to evoke strong and often positive reactions among stakeholders. Research has even pointed to the potential business beneﬁts of the internal and external communication of corporate social responsibility (CSR)efforts(Maignan et al.1999).However, while CSR is generally associated with positive corporate virtues(e.g.Johnson&Johnson,The Body Shop,Patagonia)and reﬂects an organiza-tion’s status and activities with respect to its perceived societal obligations(Brown&Dacin 1997),corporate CSR messages have also proven to attract critical attention(e.g.Starbuck,Shell, TDC).In fact,research suggests that the more companies expose their ethical and social ambi-tions,the more likely they are to attract critical stakeholder attention(Ashforth&Gibbs1990, Vallentin2001).Other studies have triggered questions such as‘if a company focuses too intently on communicating CSR associations,is it possible that consumers may believe that the company is trying to hide something?’(Brown& Dacin1997:81).Furthermore,stakeholder ex-pectations regarding CSR are a moving target and must be considered carefully on a frequent basis.While stakeholders previously primarily attribu-ted negative attention to particular industries(i.e.‘sin stocks’,including companies producing to-bacco,alcohol,weapons,pornography,etc.), today CSR issues have become more unpredict-able and changing,and including,for example, child labour,gene-modiﬁed organisms(GMOs), hormones,union assembly rights,sweatshops, etc.,which in practice are concerns across many if not all industries.Furthermore,the number of CSR rankings and CSR surveillance institutions is increasing.Critical stakeholder attention is not restricted to a company’s decisions and actions, but also focuses on the decisions and actions of suppliers,consumers and politicians,which may spur criticism towards a company(e.g.Nike, Cheminova).In that sense,corporate CSR engagement today requires more sophisticated and ongoing stakeholder awareness and calls for more sophisticated CSR communication strate-gies than previously.To increase our understanding of how man-agers can develop and maintain an ongoing awareness towards themselves and their environ-ment,we argue,in line with the editors of this special issue and other research(Craig-Lees2001, Cramer et al.2004),that the theory of sense-making is a fruitful method for better under-standing communication processes.Sensemaking is inherently social(Weick1995),as we ‘make sense of things in organizations while in conversation with others,while reading communi-cations from others,while exchanging ideas withn Respectively:Associate Professor and Director of the Center forCorporate Values and Responsibility;and Professor in the Depart-ment of Intercultural Communication and Management–both atCopenhagen Business School,Frederiksberg,Denmark.r2006The AuthorsJournal compilation r2006Blackwell Publishing Ltd,9600Garsington Road,Oxford,OX42DQ,UK and350Main St,Malden,MA02148,USA323others’(Nijhof et al.2006),implying that no manager or organization makes sense in splendid isolation(Craig-Lees2001).But,the extent to which an individual–or an organization–is able to integrate the sensemaking of others will inﬂuence the individual’s–or the organization’s –ability to enact strategically a productive relationship(Gioia et al.1994).This implies that managers need to develop a sense of the organi-zation’s internal and external environments(Tho-mas&McDaniel1990)and thereafter be willing to deﬁne a revised conception of the organization. This process is what Gioia&Chittipeddi(1991: 434)refer to as‘interpretive work’under the label ‘sensemaking’,i.e.trying toﬁgure out what the others want and ascribe meaning to it.However, Gioia and Chittipeddi expand the notion of sense-making by introducing the concept of‘sense-giving’,putting a special focus on the managerial processes facilitating sensemaking in organiza-tions.According to Gioia&Chittipeddi(1991: 443),sensemaking is followed by action in terms of articulating an abstract vision that is then disseminated and championed by corporate man-agement to stakeholders in a process labelled ‘sensegiving’,i.e.attempts to inﬂuence the way another party understands or makes sense.In contrast to Gioia&Chittipeddi,who have an internal focus on sensegiving and sensemaking processes among managers and employees,we add an external focus as we suggest that by involving external stakeholders in corporate CSR efforts,managers and employees will also engage in the sensegiving and sensemaking processes. Building on Gioia and Chittipeddi’s terminology, we suggest that not only managers but also external stakeholders may more strongly support and contribute to corporate CSR efforts if they engage in progressive iterations of sensemaking and sensegiving processes,as this enhances awareness of mutual expectations.First,this paper outlines stakeholder theory with a focus on communication and,second,it links stakeholder relations to the three CSR communication strategies discussed in this paper: informing,responding and involving.Next,a demonstration of several survey studies illustrat-ing the communication challenge for managers is given.Finally,the implications for managerial practice are discussed because companies want to communicate that they are ethical and socially responsible organizations.This paper concludes by suggesting that communicating CSR intro-duces a new–and often overlooked–complexity to the relationship between sender and receiver of corporate CSR messages,which entails a manage-rial commitment to involving stakeholders in the ongoing sensegiving and sensemaking processes. Stakeholder theoryWhile the stakeholder model was introduced to management theory many years ago by Freeman (1984),stakeholder management has developed into one of current management theory’s most encompassing concepts(e.g.Donaldson&Pres-ton1995,Mitchell et al.1997,Stoney&Win-stanley2001).Freeman’s(1984:25)‘stakeholder view of theﬁrm’instrumentally deﬁnes a stake-holder as‘Any group or individual who can affect or is affected by the achievement of theﬁrm’s objectives’and he suggests that there is a need for ‘integrated approaches for dealing with multiple stakeholders on multiple issues’(1984:26).While Freeman framed and demarcated stakeholders as elements of corporate strategic planning,he most importantly demonstrated the urgency of stake-holders for the mission and purpose of the com-pany,and in doing so,also suggested the positive ﬁnancial implications of better relationships with stakeholders.In line with Freeman’s thinking, many other scholars have pursued exploration of the link between corporate social performance andﬁnancial performance(Wood1991,Pava& Krausz1996),but the conclusions so far paint an unclear picture(Margolis&Walsh2003).In recent years,stakeholder theory has devel-oped a focus on the importance of engaging stakeholders in long-term value creation(Andriof et al.2002).This is a process whose perspective focuses on developing a long-term mutual rela-tionship rather than simply focusing on immedi-ate proﬁt.This does not imply that proﬁt and economic survival are unimportant,but the process argument is that in order to proﬁt and324r2006The Authors Journal compilation r2006Blackwell Publishing Ltd.survive companies need to engage frequently with a variety of stakeholders upon whom dependence is vital.The emphasis is moved from a focus on stakeholders being managed by companies to a focus on the interaction that companies have with their stakeholders based on a relational and process-oriented view(Andriof&Waddock 2002:19).This implies an increased interest in understanding how managers can manage not the stakeholders themselves,but relationships with stakeholders.As a result,this increases the scope of stakeholder relationships from public relations and marketing managers practising their author-ity and communication skills to a strategic potential for all functional managers to relate to multiple stakeholders.Stakeholder relationships in this processual perspective have even been suggested as a source of competitive advantage (Andriof&Waddock2002,Post et al.2002, Johnson-Cramer et al.2003)as those companies with strong relations to other organizations, institutions and partners are in a better position to develop relational rents through relation-speciﬁc assets,knowledge-sharing routines,com-plementary resource endowments and effective governance(Dyer&Singh1998).The stakeholder relationship is assumed to consist of‘interactive,mutually engaged and responsive relationships that establish the very context of doing modern business,and create the groundwork for transparency and accountability’(Andriof et al.2002:9).This brings the notion of participation,dialogue and involvement to the centre of stakeholder theory,with a clear inspira-tion(and aspiration)from democratic ideals. While dialogue is the tool,agreement and consensus are most often regarded as the solution on which to base further decisions and action,and hence to continue the collaboration.As argued by Johnson-Cramer et al.(2003:149)‘The essence of stakeholder dialogue is the co-creation of shared understanding by company and stakeholder’. Today,participation and dialogue have become a natural element of corporate self-presentations. In the following section,three CSR communica-tion strategies are presented that cover the develop-ment from a classical monologue to more mutual and dialogue-based stakeholder relationships.Three CSR communication strategies Based on Grunig&Hunt’s(1984)characteriza-tion of models of public relations,we unfold three types of stakeholder relations in terms of how companies strategically engage in CSR commu-nication vis-a-vis their stakeholders:the stake-holder information strategy;the stakeholder response strategy;and the stakeholder involve-ment strategy.In1984,public relations theory argued(Grunig &Hunt1984)that50%of all companies practised one-way communication(in terms of public information)to their stakeholders,and only 35%practised two-way communication processes (in terms of either two-way asymmetric or two-way symmetric communication).This relates to the theory of sensemaking in terms of public information building on processes of sensegiving, whereas two-way communication builds on pro-cesses of sensemaking and sensegiving.While some would agree that the prevalence of public information(sensegiving)is also a fairly accurate picture of corporate communication processes today,we suggest that there is an increasing need to develop sophisticated two-way communication processes(sensemaking and sensegiving)when companies convey messages about CSR.While one-way information on corporate CSR initiatives is necessary,it is not enough.Grunig&Hunt have also presented a fourth public relations model,i.e.a one-way commu-nication model deﬁned as‘press agentry/publicity’or a propaganda model.We have not elaborated upon this model as one of our strategies for CSR communication,but we mention it to put our three CSR communication strategies into perspec-tive.The press agentry model serves a propaganda function in which practitioners‘spread the faith of the organization involved,often through incomplete,distorted,or half-true information’(Grunig&Hunt1984:21).The question of whe-ther a message is true or not does not play a major role in this model.While the propaganda model may beneﬁt,for example,the delivery of a sports promotion,movie press agentry or generally aes-thetic advertising messages,we contend that this model is inappropriate for CSR communication.r2006The AuthorsJournal compilation r2006Blackwell Publishing Ltd.325While some messages play with pretending to be real,this is not the case for messages about ethics and CSR.In this case,the public expects another type of authenticity and organizational support, i.e.that the company actually means what it says. In fact,we argue that the press agentry model erodes the very ambition of CSR communication, which is to present the company as an ethical and transparent socially responsible organization. Nevertheless,this model highlights one of the assumptions behind contemporary stakeholder expectations regarding corporate CSR communi-cation,that it represents the truth.The following is a presentation of the three CSR communication strategies:a one-way communica-tion strategy,a two-way asymmetric communica-tion strategy and a two-way symmetric communi-cation strategy,each of which we relate to the pro-cesses of sensegiving and sensemaking(Table1). Stakeholder information strategyIn the‘stakeholder information strategy’,similar to Grunig&Hunt’s public information model, communication is always one-way,from the organization to its munication is basically viewed as‘telling,not listening’(Grunig&Hunt1984:23),and therefore the one-way communication of the stakeholder informa-tion strategy has the purpose of disseminating......................................................................................................................................Table1:Three CSR communication strategiesThe stakeholder information strategy The stakeholderresponse strategyThe stakeholderinvolvement strategyCommunication ideal: (Grunig&Hunt1984)Public information,one-way communicationTwo-way asymmetriccommunicationTwo-way symmetriccommunicationCommunication ideal:sense-making and sensegiving:SensegivingSensemakingSensegivingSensemakingegivinginformation,not necessarily with a persuasive intent,but rather to inform the public as objectively as possible about the organization. Companies adopting a stakeholder information model engage in active press relations pro-grammes and concurrently produce information and news for the media,as well as a variety of brochures,pamphlets,magazines,facts,numbers andﬁgures to inform the general ern-ments,non-proﬁt organizations and many busi-nesses primarily use the public information model.The company‘gives sense’to its audiences. The stakeholder information model assumes that stakeholders are inﬂuential as they can either give support in terms of purchasing habits, showing loyalty and praising the company,or they can show opposition in terms of demonstrat-ing,striking or boycotting the company(Smith 2003).Therefore,the company must inform stakeholders about its good intentions,decisions and actions to ensure positive stakeholder sup-port.Quite a few companies engage in CSR initiatives because corporate managers believe that it is morally‘the right thing to do’(Paine 2001),and this often sincere wish to improve social conditions in the local or global community supports their stakeholder information strategy. Top management,conﬁdent the company is doing the right thing,believes the company just needs to inform the general public efﬁciently about what it is doing to build and maintain positive stake-holder support.One strategic task of stakeholder information strategies is to ensure that favourable corporate CSR decisions and actions are commu-nicated effectively to the company’s stakeholders. The task of the corporate communications department is to ensure that a coherent message is conveyed in an appealing way and that the focus is on the design of the concept message(van Riel1995),i.e.that the CSR message conveys,for example,how the CSR initiatives demonstrate a generally shared concern,are linked to the core business and show organizational support(Scott &Lane2000).It is outside the realm of this strategy to consider that external stakeholders,i.e. third-party stakeholders,should endorse corpo-rate CSR initiatives.Trustworthy communication originates from the company itself.Stakeholder response strategyThe stakeholder response strategy is based on a ‘two-way asymmetric’communication model,as opposed to the two-way symmetric model of the stakeholder involvement strategy.In both models, communicationﬂows to and from the public.But there is a conspicuous difference between the two models in that the two-way asymmetric assumes an imbalance from the effects of public relations in favour of the company,as the company does not change as a result of the public relations. Rather,the company attempts to change public attitudes and behaviour.As such,the company needs to engage stakeholders by making the corporate decisions and actions relevant for them because the company needs the external endorse-ment from external stakeholders.The corporate communication department will typically conduct an opinion poll or a market survey to make sense of where the company has–hopefully–improved and can improve its CSR munication is perceived as feedback in terms ofﬁnding out what the public will accept and tolerate.This is an evaluative mode of measuring whether a particular communication initiative has improved stake-holder understanding of the company–and vice versa.Corporate management will champion and ‘give sense’to its decisions according to the market survey results in which managers‘make sense’. Although these communication processes are perceived as two-way methods in Grunig& Hunt’s public relations models,we elaborate on their model as we stress that responding to stakeholders is still rather sender oriented.The stakeholder response strategy is a predominantly one-sided approach,as the company has the sole intention of convincing its stakeholders of its attractiveness.We,therefore,highlight stake-holder responsiveness rather than their pro-active engagement in communication processes.Stake-holders are perceived as being inﬂuential,but as passively responding to corporate initiatives.In a company’s attempts to understand stakeholder concerns in a CSR perspective,it runs the risk of only hearing its own voice being reﬂected back; the company asks its stakeholders questions within a framework that invites predominantlyr2006The AuthorsJournal compilation r2006Blackwell Publishing Ltd.327the answers it wants to hear.What aspires to be a two-way communication mechanism is really a one-way method of supporting and reinforcing corporate actions and identity.As the stakeholder response strategy is a frequently used commu-nication model within CSR communication,and as many CSR initiatives assume stakeholder sensitivity,weﬁnd this latter point important, and return to it in the discussion.Stakeholder involvement strategyThe stakeholder involvement strategy,in contrast, assumes a dialogue with its stakeholders.Persua-sion may occur,but it comes from stakeholders as well as from the organization itself,each trying to persuade the other to change.Ideally,the company as well as its stakeholders will change as a result of engaging in a symmetric communica-tion model,i.e.progressive iterations of sense-making and sensegiving processes.Because the stakeholder involvement strategy takes the notion of the stakeholder relationship to an extreme,companies should not only inﬂuence but also seek to be inﬂuenced by stakeholders, and therefore change when necessary.While this could apply to Freeman’s stakeholder conceptua-lization,it would also challenge his stakeholder concept regarding the extent to which a company should change its(CSR)activities when stake-holders challenge existing(CSR)activities,and the extent to which a company should insist on its own possibly divergent assessment.Rather than imposing a particular CSR initia-tive on stakeholders,the stakeholder involvement strategy invites concurrent negotiation with its stakeholders to explore their concerns vis-a-vis the company,while also accepting changes when they are necessary.By engaging in dialogue with stakeholders,the company ideally ensures that it keeps abreast not only of its stakeholders’concurrent expectations but also of its potential inﬂuence on those expectations,as well as letting those expectations inﬂuence and change the company itself.The stakeholder involvement strategy is in har-mony with the stakeholder information strategy in the assumption that stakeholders are inﬂuential in terms of their support of,or opposition to,the company,and it concurs with the stakeholder response strategy in that stakeholder expectations should be investigated using opinion polls.The involvement strategy,however,further assumes that,while informing and surveying is necessary, it is not sufﬁcient.Stakeholders need to be invol-ved in order to develop and promote positive support as well as for the company to understand and concurrently adapt to their concerns,i.e.to develop its CSR initiatives.Therefore,the stake-holder involvement strategy suggests that compa-nies engage frequently and systematically in dialogue with their stakeholders in order to explore mutually beneﬁcial action–assuming that both parties involved in the dialogue are willing to change.In organizational practice,the primary top managerial task in the stakeholder involvement strategy becomes one of ensuring that the organization is capable of establishing an ongoing and systematic interaction with multiple stake-holders.The communication task becomes one of ensuring a two-way dialogue(Grunig&Hunt 1984)in an almost Habermasian1sense,in which the primary aim is to bring about mutual under-standing,rational agreement or consent.As no top management is capable of engaging in dialogue with multiple stakeholders on a con-current basis,the organizational implication is an ‘integrated form’(Weaver et al.1999)of stake-holder thinking in which the corporate CSR programme depends on its ability to integrate not only organizational members’CSR concerns but also to integrate external stakeholders’CSR concerns in a concurrent dialogue.Corporate policies dictating what organizational units can and cannot do with respect to certain stakeholder groups are‘sure to fail to establish successful transactions with the stakeholder,no matter how well intentioned the policy’(Freeman1984:162), as they neither motivate nor integrate changing expectations.While these three CSR communication strate-gies have been presented to underline the in-creased necessity for managers to incorporate learning and techniques to support more stake-holder involvement,there is only little evidence328r2006The Authors Journal compilation r2006Blackwell Publishing Ltd.that two-way communication processes are the norm currently being practised.In the following, we explore this apparent corporate hesitation to engage in two-way communication processes by presenting empirical observations on the challenges managers face in terms of CSR communication.Empirical illustration of the CSR communication challengeIn the following,we present some empirical observations that serve to demonstrate the man-agerial challenge in communicating corporate CSR efforts.These empirical data originate from national reputation surveys in Denmark,Norway and Sweden,which in further detail demonstrate the CSR communication challenge for companies operating in the Scandinavian countries.The data serve as illustrations of a managerial challenge in practice and not as proof of the validity of our discussion on CSR communication.As a result, no statistical analysis of the data is given.The empirical data consist of part of the results from national reputation surveys in Denmark, Sweden and Norway(annual Reputation Quoti-ent s).The survey is conducted in each country to outline the reputation of the companies most visible among the general public(Fombrun et al. 2000and see Table2for basic information). The reputation survey shows how the general public in the three Scandinavian countries in general agree that it is important that companies are responsible for more than just their share-holders.In all three countries,less than10%of the general publicﬁnd shareholders to be the only prime stakeholder in2005(see Table3).In Denmark,almost half of the general publicﬁnds that companies should take on a broader respon-sibility that exceeds core stakeholders such as employees and customers.In Sweden and Nor-way,this percentage is signiﬁcantly lower,as only one-third of the population believes that compa-nies should engage in broader CSR activities. The reputation surveys also show the general public’s perceptions of how companies should communicate about their social responsibility. Surveyﬁndings from2005suggest that the citizens in all three Scandinavian countries in general hold different perceptions of how companies should communicate their CSR efforts(see Table4). Someﬁnd that companies should publicize proactively and openly,while others prefer more minimal communication based on websites and annual reports.Few peopleﬁnd that companies should not communicate about their CSR efforts at all.There are slight variations between the three countries in that Danes are more reluctant about the use of corporate advertising and press releases than Swedes and Norwegians.The countries are nevertheless similar to the extent that only10%of the publicﬁnds that corpora-tions should not publicize information about their CSR activities.The difference between the coun-tries concerns how companies should publicize......................................................................................................................................Table2:Data for national Reputation Quotient Surveys in2005Country Denmark Sweden NorwayNumber of respondents4178Online interviewsFebruary20052783Online interviewsFebruary20053397Online interviewsFebruary2005Number of companiesincluded in the ranking221620 Highest ranking company Novo Nordisk79.9IKEA81.1IKEA72.7 Lowest ranking company Cheminova48.1Skandia41.5NSB51.5Topﬁve companies in relation to social responsibility GrundfossDanfossLegoOticonCarlsbergIKEAArla FoodsICAVolvoMicrosoftNRKMicrosoftCoopHydroIKEA...................................................................................................................................... r2006The AuthorsJournal compilation r2006Blackwell Publishing Ltd.329information.Danes,for example,are more in favour of more discrete communication channels such as annual reports and corporate websites as compared to advertising and public relations. However,opinions about how companies should communicate may change over time.This is demonstrated by the development of opinions among the general public in Denmark from2002 to2005.Figure1shows that the Danish scepti-cism towards CSR communication has changed from2004to2005.In the period from2002to 2004,approximately20%of the population found that companies should cease to communicate about their good deeds.This perception changed during the last year of the reported data,bringing the level of Danish scepticism more in line with Sweden and Norway.At the same time,however, Danes have also become less accepting of the less discrete and more aggressive types of commu-nication(advertising and public relations),while the attitude towards using annual reports and websites has become much more positive since 2002.Although Danes have become more aligned with the other Scandinavian countries in the period from2002to2005,they are still more sceptical about CSR communication than other Scandinavians.In general,the reputation surveys point to a particular communication challenge for managers operating in the Scandinavian countries,illustrat-ing the sensitive nature of communicating social responsibility for managers in practice.People agree that companies have a responsibility that exceeds shareholders’thinking and as a minimum, should also be concerned with employees and customers.More than a third of the population groupsﬁnd that companies share a broad social responsibility.Half of the Scandinavian popula-tionﬁnds that companies should communicate broadly and openly about these important social efforts via advertising and public relations.How-ever,the other half of the population encourages companies either to communicate in a subtle way or not to communicate about their social respon-sibility at all.While the reputation surveys do not serve to prove the quest for more sophisticated CSR communication,they do suggest a manage-rial challenge in that the general publicﬁnds that CSR is of high importance to companies,while at the same time they have mixed opinions about......................................................................................................................................Table3:For what should companies be responsible?Which of the following statements areclosest to your opinion?Denmark2005(%)Sweden2005(%)Norway2005(%)Only generate proﬁts to shareholders449Responsible towards shareholders andemployees and customers496456 Shareholders,employees,customers PLUSbroad social responsibility452931 ...................................................................................................................................... ......................................................................................................................................Table4:How should companies communicate their CSR efforts?When companies engage in acts ofcorporate citizenship,do you think theyshould publicize their good deeds?Denmark2005(%)Sweden2005(%)Norway2005(%)Yes,publicize through corporate advertisingand press releases304742Yes,minimal releases such as annualreports and on website594649No,should not publicize1189 ......................................................................................................................................330r2006The Authors Journal compilation r2006Blackwell Publishing Ltd.。

journal of testing and evaluation 检索证明

journal of testing and evaluation 检索证明Journal of Testing and Evaluation: A Reliable Source for Evidence-Based Research Introduction:The Journal of Testing and Evaluation (JTE) is a renowned academic journal that serves as a reliable resource for researchers and scholars in the field of testing and evaluation. With its rigorous peer-review process, JTE ensures that only high-quality and evidence-based research is published. This journal provides an excellent platform for researchers to share their findings and contribute to the advancement of testing and evaluation methodologies.Objective and Scope:The primary objective of JTE is to disseminate research that focuses on the development and application of testing and evaluation techniques across various disciplines. The journal covers a wide range of topics, including but not limited to, testing methodologies, evaluation frameworks, psychometric analysis, reliability and validity studies, item response theory, performance assessment, and assessment in educational settings.Peer-Review Process:JTE follows a stringent peer-review process to ensure the quality and validity of research published in the journal. All submissions undergo a double-blind review, where the identities of the authors and reviewers are kept confidential. This unbiased review process helps maintain high academic standards and ensures that the published articles meet the rigorous criteria of sound research methodology and reliable results.Contributions to the Field:The articles published in JTE contribute significantly to the field of testing and evaluation. Researchers often turn to JTE as a primary source for reliable and evidence-based research findings. The journal's wide range of topics ensures that researchers from different disciplines can find relevant research to inform their studies. This cross-disciplinarity is crucial in enhancing the understanding and applicability of testing and evaluation methodologies in various fields.Practical Applications:One of JTE's strengths lies in its focus on practical applications of testing and evaluation research. While theoretical advancements are important, JTE emphasizes the need for research that can be applied in real-world contexts. This ensures that the findings presented in the journal have meaningful implications for practitioners in different sectors, such as education, healthcare, employment testing, and performance evaluation.Access and Availability:JTE is an open-access journal, allowing unrestricted access to its content. This policy promotes the dissemination of knowledge across academia and beyond, ensuring that research findings reach a wide audience. With an electronic platform, the journal provides easy access to articles, ensuring convenient availability for researchers, practitioners, and students.Conclusion:The Journal of Testing and Evaluation is a reputable source for evidence-based research in the field of testing and evaluation. Its rigorous peer-review process, comprehensive scope, and emphasis on practical applications make it a valuable resource for researchers, practitioners, and students alike. By promoting high-quality research, JTE plays a crucial role in advancing testing and evaluation methodologies across various disciplines, contributing to evidence-based decision-making and improved assessment practices.。

ICH-Q Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions

European Medicines Agency7 Westferry Circus, Canary Wharf, London, E14 4HB, UKTel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledgedJune 2006EMEA/CHMP/ICH/222007/2006ICH Topic Q 4 BRegulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)Step 3NOTE FOR GUIDANCE ON REGULATORY ACCEPTANCE OF ANALYTICALPROCEDURES AND/OR ACCEPTANCE CRITERIA (RAAPAC)(EMEA/CHMP/ICH/222007/2006)TRANSMISSION TO CHMPJune 2006TRANSMISSION TO INTERESTED PARTIES June 2006DEADLINE FOR COMMENTS September 20061. INTRODUCTION1.1 Objective(s) of the GuidelineThis document describes a procedure to facilitate acceptance by regulatory authorities of pharmacopoeial analytical procedures and/or acceptance criteria (APAC)1 for use in the three ICH regions.1.2 BackgroundThe ICH Q6A Guideline encourages the development of harmonised texts by the Pharmacopoeial Discussion Group (PDG). However, until now, ICH has not addressed the regulatory acceptability of pharmacopoeial-proposed APAC for the three ICH regions. The Q4B EWG has been formed to address this issue.PDG consists of representatives from the European Directorate for the Quality of Medicines in the Council of Europe; the Ministry of Health, Labour and Welfare, and the United States Pharmacopeial Convention, Inc. PDG is anticipated to be the principal source of APAC proposals to the Q4B EWG. This Guideline is intended to facilitate regulatory acceptance of these proposed APAC and their interchangeability with those APAC contained in the local regional pharmacopoeias, thus avoiding redundant testing and different acceptance criteria in favour of a common testing strategy in each regulatory region. The Q4B process will initially focus on the 11 General Test Chapters (refer to Attachment I). There are many other pharmacopoeial harmonisation proposals being developed (e.g., excipient monographs and other general test chapters), and these could also be considered for Q4B evaluation.This guideline provides a general description of the process to facilitate regulatory acceptance of analytical procedures and/or acceptance criteria (RAAPAC). For each APAC evaluated, the EWG intends to develop a topic-specific annexe to the Q4B Guideline following the ICH process.1.3 Scope of the GuidelineThis Guideline addresses RAAPAC for the three ICH regions, especially for APAC provided by PDG. It also provides flexibility so that the Q4B EWG can evaluate, and regulatory authorities can choose to accept, non-PDG text.Principles1.4 GeneralThe EWG will take scientific evaluations and regulatory impact into consideration when evaluating APAC.The PDG harmonisation process produces APAC which have been through independent public comment/consultation. The Q4B Outcome in the annexe details an interpretation of how APAC should be used. At the regulatory consultation stage for the Q4B topic-specific annexes, regulators intend to focus on comments received relating to the Q4B Outcome. Interested parties are encouraged to focus their comments on the Q4B Outcome in the annexe. Implementation details will be described in the topic-specific annexes which will be available on the ICH website.The EWG will evaluate the proposed APAC and make a recommendation regarding regulatory acceptance. In order to preserve transparency, once the EWG has made a recommendation, any subsequent revisions to the PDG harmonised text should occur only through the PDG process. The EWG should be notified of any revisions to a text that has been submitted to the Q4B process. Any such change will prompt an EWG review in order to1 The term analytical procedures and/or acceptance criteria (APAC) refers to pharmacopoeial monographs, general test chapters, analytical methods, and/or associated acceptance criteria.assess both the merit of the change and the appropriateness of any subsequent Q4B activity related to that APAC. Unilateral changes/revisions by any of the individual pharmacopoeias will void the ICH final status.2. GUIDELINES2.1 Q4B Evaluation ProcessThe Q4B’s goal is to encourage acceptance of APAC by regulatory authorities. The document submission should outline any issues for resolution, and should contain any appropriate supporting data. For PDG submissions, the documentation should be provided after PDG Stage 5B (refer to Attachment II).The Q4B topic-specific annexe process follows the ICH step process as detailed below (see also Figure I).2.1.1Step 1Each Q4B member party independently evaluates the documents for regulatory impact. Additional discussion within the Q4B EWG, and/or communication with the submitting party, might be warranted in order to resolve any issues prior to sign-off.2.1.2Step 2The Q4B EWG signs off on a draft annexe to this Guideline which is presented to the Steering Committee as an ICH Step 2 document.2.1.3 Step 3Regulatory consultation (generally within 3 months) focuses on the Q4B Outcome in the annexe. The annexe can be revised based on comments received.2.1.4Step 4The ICH Steering Committee adopts the annexe and adds it to this guideline.2.1.5Step 5The annexe moves to the regional regulatory implementation step.2.2 Annexe ContentsThe topic-specific annexes will contain the following information. Other information might be incorporated on a case-by-case basis.Topic titleIntroductionQ4B OutcomeAs appropriate, statements, decisions and other information that will assist in the use of the accepted APAC by stakeholdersStatement or implementation timelines indicating regulators' advice on when stakeholders can begin using the APAC (at Step 4)References to methods and acceptance criteria, as appropriate.2.3 Use of the Accepted APACAPAC that have reached Step 5 can be used by stakeholders. When changing to the Step 5 APAC, any change notification and/or prior approval should be handled in accordance with established regional regulatory mechanisms. These regional mechanisms will be described in the topic-specific annexes.3.GLOSSARYAnalytical Procedures and/or Acceptance Criteria (APAC) – pharmacopoeial monographs, general test chapters, analytical methods, and/or associated acceptance criteria.Document Submission – The working documents received from PDG or Non-PDG sources that contain the proposed APAC and any other support documents provided for Q4B evaluation.Non-PDG – One or two of the regional pharmacopoeias, but not all 3 pharmacopoeias acting together as the PDG.PDG – The three-party Pharmacopoeial Discussion Group, comprised of representatives from the European Directorate for the Quality of Medicines in the Council of Europe; the Ministry of Health, Labour and Welfare, and the United States Pharmacopeial Convention, Inc.Q4B Outcome - The Q4B process produces an interpretation of how APAC should be used. The Q4B Outcome is included as part of the topic-specific annexe developed for each APAC. Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) – Acceptance by the ICH member regulatory authorities of APAC that have been evaluated by Q4B.ATTACHMENT IICH Q6A General ChaptersDissolutionDisintegrationUniformity of Content Uniformity of Mass Harmonised to Uniformity of Dosage UnitsExtractable Volume Particulate MatterSterilityMicrobiological Quality Bacterial Endotoxins Sulphated Ash/ROIColour and Clarity(per ICH SC, work will just be on "Colour")ATTACHMENT IIPDG Document Submission Provided for ICH Q4B EWG EvaluationFor the purposes of the process, the Coordinating or Lead Pharmacopoeia, on behalf of PDG, is asked to provide, as soon as possible after PDG Stage 5B sign-off and usually within six months, the following texts and information (termed the "document submission" as defined in the Guideline) to the Q4B EWG, via the ICH secretariat, with a copy to the Q4B EWG Rapporteur (for awareness):The PDG sign-off document containing the PDG-harmonised text (PDG Stage 5B).A Briefing Note dealing in particular with:Residual differences between one or more of the pharmacopoeias, to include a commentary on any difference from the point of view of harmonisation;Any specific issues relating to publication;If any equivalency study was conducted, a summary of the outcome;The projected publication schedule in each pharmacopoeia, with clear indication as to the anticipated final PDG Stage 7 implementation date; andAny additional clarifying or awareness information not covered above.The texts as intended for adoption and publication in each pharmacopoeia together with a statement of any local differences with respect to the sign-off text.Additional clarifying information may be separately incorporated by one or more of the PDG pharmacopoeias in their respective information chapters on pharmacopoeial harmonisation. Therefore, the revised information chapter on harmonisation from each pharmacopoeia incorporating such information (in draft form where this is available) should accompany the provided documents.If any changes occur or additional differences are discovered after submission to Q4B, the Q4B EWG should be informed promptly by the pharmacopoeia concerned.Figure I – Topic-Specific Annexe Process。

Hypothesis_Testing(统计学假设检验)

we might hypothesize that the mean IQ for UIC students is = 110. we might select a random sample of n = 100 UIC students.
2. Next, we obtain a random sample from the population. For example,
批注本地保存成功开通会员云端永久保存去开通
Statistics for Business (ENV)
Chapter 9
INTRODUCTION TO HYPOTHESIS TESTING
1
Hypothesis Testing
9.1
9.2 9.3
Null and Alternative Hypotheses and Errors in Testing z Tests about a Population with known s t Tests about a Population with unknown s
2
Hypothesis testing-1
Researchers usually collect data from a sample and then use the sample data to help answer questions about the population. Hypothesis testing is an inferential statistical process that uses limited information from the sample data as to reach a general conclusion about the population.

OOS调查指南

OOS调查指南1（FDA 2006）注：英文原版请自行查阅FDA官网，中文系部分下载加自行翻译而成，不当之处请留言。

Guidance for Industry 行业指南Investigating Out-of-Specification (OOS)Test Results for Pharmaceutical Production药品生产中OOS结果的调查Additional copies are available from: 本文件可自以下途径得到Office of Training and Communication 培训和交流办公室Division of Drug Information HFD-240 药品信息分部Center for Drug Evaluation and Research 药品审评中心Food and Drug Administration 食品药品管理局5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmU.S. Department of Health and Human Services 美国卫生和福利部Food and Drug Administration 食品药品管理局Center for Drug Evaluation and Research (CDER) 药品审评中心October 2006TABLE OF CONTENTS 目录I. INTRODUCTION 介绍II. BACKGROUND 背景III. IDENTIFYING AND ASSESSING OOS TEST RESULTS界定和评价OOS检验结果—PHASE I: LABORATORY INVESTIGATION第一步：化验室调查A. Responsibility of the Analyst 化验员职责B. Responsibilities of the Laboratory Supervisor化验室主管职责IV. INVESTIGATING OOS TEST RESULTS 对OOS结果的调查—PHASE II: FULL-SCALE OOS INVESTIGATION 第二步：全面OOS调查A. Review of Production 生产情况审核B. Additional Laboratory Testing 附加化验室测试C. Reporting Testing Results 报告测试结果V. CONCLUDING THE INVESTIGATION 调查结论A. Interpretation of Investigation Results 调查结果解释B. Cautions 注意事项C. Field Alert Reports 现场警示报告.GUIDANCE FOR INDUSTRY[1] 行业指南Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production药物生产中不合格结果的调查This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 本指南代表FDA对本专题现行的想法。

阪崎肠杆菌检测方法的研究进展

阪崎肠杆菌检测方法的研究进展380?国外医学卫生学分册2006年第33卷第6期[2O][21][22][23]吕相征,刘秀梅.转基因食品的致敏性评估[J].中国食品卫生杂志,2003,1s(3):238—243.SiehererSH,SampsonHA.Foodallergy[J].JAllergyClinImmunol,2006,l17(2):471—475.WarnerJO.EuropeanFoodLabeningLegislation:a nightmareforfoodmanufacturersandallergysufferersalike【J].PediatrAllergyImmunol,2005,16:1-2.TaylorSL,HefleSL,Bindslev—JensenC,eta1.Factors affectingthedeterminationofthresholddosesforallergenicfoods:howmuchistoomuch[J].JAllergyClinImmunol,2002,109:24—30.[24][25][26]TaylorSL,HefleSL,Bindslev—JensenC,eta1.A consensusprotocolforthedeterminationofthethreshold dosesforallergenicfoods:howmuchistoomuch?[J].ClinExpAllergy,2004,34:689—695.HourihaneJO'B,KnulstAC.Thresholdsofallergenic proteinsinfoodsJJ.ToxicolApplPharmacol,2005,207:S152一S156.NationalResearchCouncil.Riskassessmentinthefederalgovernment:managingtheprocess【MJ.WashingtonDC: NationalAcademyPress.1983.183—190.091阪崎肠杆菌检测方法的研究进展裴晓燕综述刘秀梅审校(中国疾病预防控制中心营养与食品安全所,北京100050)摘要:阪崎肠杆菌是食品和环境中广泛存在的一种条件致病菌,该菌能引起严重的新生儿脑膜炎,小肠结肠炎和菌血症.近年来,随着对该菌的日益重视,其检测方法也得到不断的发展和改善.本文对阪崎肠杆菌的非特异性与特异性传统检测方法,PCR检测,探针法和实时PCR等分子生物学检测方法以及其他相关方法进行了综述.关键词:阪崎肠杆菌;检测中图分类号:TS207.4文献标识码:A文章编号:1001—1226(2oo6)06—0380—06阪崎肠杆菌(Enterobactersakazakii)是肠杆菌属的一种条件致病菌,该菌引起的食源性疾病可导致婴儿(尤其是新生儿)的脑膜炎,小肠结肠炎和菌血症,报告病例的死亡率达20%～50%,幸存者常遗留严重的神经系统疾病.近年来对食品(奶粉,巧克力,谷类食品,马铃薯,意大利面等)加工厂原料,生产环境及家庭中阪崎肠杆菌污染率的研究发现,阪崎肠杆菌在自然界中分布广泛.在多起阪崎肠杆菌的暴发事件中发现,新生儿阪崎肠杆菌感染与婴儿配方粉(powderedinfantformula,PIF)密切相关.2004年2月FAO/WHO在日内瓦召开的婴儿配方粉中阪崎肠杆菌专家研讨会上提出,婴儿配方粉中微量的阪崎肠杆菌污染(<3CFU/100g)也能导致感染的发生.即使是婴儿配方粉中大肠菌群污染水平符合相应的微生物学标准,也可能存在阪崎肠杆菌收稿日期:2006.05.15;修回日期:2006-09.27作者简介:裴晓燕,女,博士研究生,研究方向:营养与食品卫生.审者简介:刘秀梅,女,研究员,首席科学家,研究方向:营养与食品卫生. 的污染.PIF中阪崎肠杆菌的污染已经引起国际社会的广泛关注.2002年国际食品微生物标准化委员会(ICMSF)j把阪崎肠杆菌列为"严重危害特定人群,危害生命或慢性实质性后遗症或长期影响"的一种致病菌.因此,PIF和其他食品及其环境中阪崎肠杆菌的检测方法对婴儿配方粉的生产,安全监管以及阪崎肠杆菌所致疾病的临床诊断等尤为重要.1传统检测方法传统的阪崎肠杆菌检测方法都是针对阪崎肠杆菌特有的生化特征,尤其是黄色素的产生和a一葡萄糖苷酶活性等生物学性状进行鉴定,用于实验室检测和流行病学调查.包括前增菌,选择性增菌,选择性分离培养,生化鉴定等4个步骤,定量检测采用100g,10g和1g3个样本量的最可能数(mostprobablenumber,MPN)法,因此产品中数量极少的微生物也可以被检测和定量.1.1非特异性检测方法研究初期,阪崎肠杆菌的检测方法都是在国际国外医学卫生学分册2006年第33卷第6期?381?标准化组织(ISO)肠杆菌科细菌标准检测方法的基础上建立起来的.1982年在对芬兰一起新生儿阪崎肠杆菌脑膜炎暴发事件的调查过程中,Muytjens等从调制好的配方奶中分离到阪崎肠杆菌,但没有从配制该液态配方的水和配方粉中分离到该菌,认为不能从婴儿配方粉中分离到阪崎肠杆菌的原因可能是该菌在配方粉中分布不均或数量太低,无法用传统方法分离出来.而从1988年Uuytjens等的检测结果来看,20种阳性样品的带菌量均在0.36 ～66CFU/100g之间.在该研究中Muytjens等首次详细描述了婴儿配方粉中阪崎肠杆菌的定量检测方法,按"三管"MPN法以无菌操作分别取检样100g, 10g,lg,加入已预热至45℃分别装有900ml,90ml,9ml缓冲蛋白胨水(bufferedpeptonewater,BPW)的锥形瓶中,轻轻振摇使充分溶解,36%孵育过夜.取过夜培养的增菌液lOml,加入装有90ml无菌肠道菌增菌肉汤(enterobacteriaceaeenrichmentbroth,EE broth)中,36℃孵育过夜.取1rnl富集肉汤与20ml的液体结晶紫中性红胆盐葡萄糖琼脂(violetredbile ~ucoseagar,VRBGA)混匀,倾注平板,36℃过夜培养.从VRBGA平板上分离到的可疑菌落划线接种血平板和伊红美蓝琼脂(eosin—methyleneblueagar, EMB),然后用API20E生化鉴定系统进行鉴定.另外,Muytjens等还把a一葡萄糖苷酶阳性,甲苯胺蓝琼脂(toluidineblueagar)上细胞外DNase阳性和营养琼脂(nutritionagar,NA)上25℃培养48h产生黄色菌落作为鉴定阪崎肠杆菌的标准.加拿大对婴儿配方粉的污染情况进行调查时,只对Muytjens等的方法做了少许修改:从VRBGA平板上分离到可疑菌落直接进行API20E生化鉴定.结果从120罐婴儿配方粉中检测到来自5个厂家的8罐检样中含有阪崎肠杆菌(0.36CFU/100g),方法敏感度与Muyqens等的方法相同.2001年在美国田纳西州一新生儿重症监护室发生的阪崎肠杆菌感染事件的调查中,医务人员与州健康与疾病控制中心合作对感染源进行了调查, 从未开罐和开罐的婴儿配方粉中分离到的阪崎肠杆菌脉冲场凝胶电泳(pulsedfieldgelelectmphoresis, PFGE)指纹图谱与从脑膜炎患儿中分离到的完全相同.该事件的调查方法是根据1988年Muytjens等的方法,即将100g配方粉与400ml预热到45℃的磷酸盐缓冲蛋白胨水混合,36℃孵育过夜.取1nll增菌液接种到9ml的煌绿胆盐肉汤,36%孵育过夜后,接种LesEndo琼脂,36%孵育过夜.选择具有绿色金属光泽的菌落接种到添加5%羊血的胰蛋白胨大豆琼脂(trypticasesoyagar,TSA)平板上,36℃孵育过夜后,室温放置24～48h.将黄色菌落再次接种到添加5%羊血的TSA平板,证实黄色素的产生. 疑似阪崎肠杆菌采用API20E证实.2002年美国FDA制定了"婴儿配方粉中阪崎肠杆菌的分离和计数"方法H..,这是国际上颁布的第一个官方方法.该方法的工作原理和步骤与Uuytjens等和加拿大的调查方法基本一致.只是在该方法中根据EE肉汤的含菌量,选择直接涂布法或直接划线法接种VRBGA平板,而不是倾注法.采用API20E生化鉴定系统对TSA平板上的黄色菌落进行鉴定.没有推荐其他附加生化检测项目.阪崎肠杆菌的检测水平与既往报道一致,检测限为0.36CFU/100g.1.2特异性检测方法阪崎肠杆菌早期检测方法的选择性只是针对肠杆菌科细菌,而不是阪崎肠杆菌.EE肉汤适合所有肠道菌群的生长繁殖,这就可能对阪崎肠杆菌的生长产生竞争性抑制作用,降低检出率.VRBGA平板对阪崎肠杆菌的选择性极差,阪崎肠杆菌,阴沟肠杆菌和成团肠杆菌等多种肠道菌都可以在该平板上生长并产生粉紫色菌落,胆汁酸沉淀形成紫色晕圈,阪崎肠杆菌无特征性菌落不能与其他微生物相区别. 这样,由于阪崎肠杆菌在VRBGA平板上菌落形态的多样性,以及TSA平板上黄色素产生的多源性,经VRBGA和TSA平板选择到的黄色菌落很多都不是阪崎肠杆菌.针对上述问题,新发展的检测方法选择对阪崎肠杆菌特异性较强的选择性增菌肉汤和选择性分离平板.在雀巢研究方法…,杜邦Qu~iconBAX系统PCR检测方法和ISO方法中都选用"mKST-Vm"作为阪崎肠杆菌选择性增菌肉汤,即在大肠菌群增菌肉汤月桂基硫酸盐胰蛋白胨肉汤(1aurylsulfatettyptose broth,LST)中另加入NaC1和万古霉素(vancomycin, Vm).研究证明与其他肠杆菌科细菌(如沙门菌属,大肠埃希氏菌,肺炎克雷伯氏菌和费氏柠檬酸杆菌) 相比,阪崎肠杆菌具有较高的耐渗透压能力,另加入0.5mo1/L的NaC1在保证阪崎肠杆菌良好生长的同时,可以有效地抑制上述其他细菌的生长.在LST+382?国外医学卫生学分册2006年第33卷第6期0.5mol/LNaC1中加入Vm可以有效地抑制革兰氏阳性菌的生长.多项研究证明阪崎肠杆菌在46℃或47℃也能良好生长,而较高的生长温度可以进一步抑制其他细菌的生长,所以在上述方法中选用44℃或45℃用于mLST-Vm的选择性增菌培养.阪崎肠杆菌能在VRBGA,TSA,NA,血平板,MacConkey琼脂,伊红美蓝琼脂,脱氧胆酸琼脂等多种培养基上生长繁殖¨,但这些都不是该菌特异性的选择性培养基.Muytjens等"首次鉴定了129株阪崎肠杆菌分离株的a.葡萄糖苷酶活性,结果显示100%为阳性,而检测的97株其它肠杆菌(如阴沟肠杆菌,成团泛菌核产气肠杆菌等)均为阴性,Farmer等¨也证实了Muytjens等的结果.为了便于阪崎肠杆菌的检测,根据阪崎肠杆菌的这一特征在基础培养基中加入5.溴.4.氯一3一吲哚一a,D一吡喃葡糖苷(5一bromo一4一chloro一3一indolyl—a,D—glucopyranoside,XaGlc)或4一甲基伞形酮一a—D一葡糖苷(4-Methylumbelliferyl—a—D—glucoside,a.MUG)作为a.葡萄糖苷酶指示剂,发展了新的阪崎肠杆菌选择性分离培养基,如DFI琼脂(Dmgg~.Forsythe—Iversenagar),阪崎肠杆菌分离琼脂(Enterobactersakazakiiisolationagar,ESIA),R&F阪崎肠杆菌显色培养基,CES琼脂,OK培养基15],NA+a.MUG琼脂(即补充a.MUG的NA)16]等.但是,某些a.葡萄糖苷酶底物如4.邻硝基苯.a.D.吡喃葡糖苷(4-nitropheny1.D.glucopyranoside)或a.MUG的分解产物在琼脂平板上扩散可导致结果难以确定,从而使其应用受到限制n.Manafi和Lang【18]分别比较了3种不同的商品化培养基在2种不同的培养温度下(37℃和45℃)对阪崎肠杆菌的检测效果.试验所用培养基分别为DFI琼脂(Oxoid公司,英国),ESIA(AES实验室,法国)和CES琼脂(Merck公司,德国),阪崎肠杆菌产生的a一葡萄糖苷酶能水解上述培养基中的XaGlc分别产生蓝绿色,蓝色和青绿色菌落.该研究选择了经胰蛋白胨大豆肉汤(trypticasesoybroth,TSB)富集的25株阪崎肠杆菌和55株其他细菌对比3种显色培养基在37℃和45℃下的选择性,结果显示37℃生长的假阳性结果较多,而45℃是鉴别阪崎肠杆菌和抑制其他杂菌的最佳生长条件.Oxoid公司推荐的方法认为,可以利用DFI琼脂把VRBGA和TSA两步选择性分离培养合并成一步,直接对该显色琼脂上的蓝绿色可疑菌落进行生化鉴定,可节省2～3天的时间,采用这种发光培养基可快速鉴定婴儿配方粉和其他食品中的阪崎肠杆菌¨.而且,Oxoid公司的技术报告中指出,与美国FDA的方法相比,该方法可以提高婴儿配方粉和其他食品中阪崎肠杆菌的复苏率.I.euschner和Bew"刮对ISO肠杆菌标准检测方法稍作修改用于阪崎肠杆菌的筛检,并在欧洲8个国家的16个实验室进行实验室间验证.该方法应用NA+a—MUG琼脂.无菌取样25g加入225ml的BPW 中,37℃培养16～20h,取10ml的BPW非选择性增菌肉汤加入90ml的EE选择性富集肉汤.37℃培养18～24h后划线接种VRBGA平板,37~C培养24h;同时划线接种NA+a.MUG平板25℃培养16h,并在室温避光放置24h.阪崎肠杆菌在NA+a—MUG平板上生长,正常光线下形成鲜黄色菌落,紫外线下显示蓝,紫色荧光.疑似菌落采用API20E进行生化鉴定.验证的样本分别为空白对照(无阪崎肠杆菌污染),低污染水平(1～10CFU/25g)和中等污染水平(1～10CFU/g)的婴儿配方粉,且均以绿脓假单胞菌(Pseudomonasaeruginosa)和乳酸菌(LactobaciUus spp.)作为背景杂菌.低污染水平VRBGA和NA+ a—MUG琼脂的敏感度相似.而中等污染水平的敏感性VRBGA为96.7%,NA+a.MUG琼脂为98.3%.此外,2005年0h和Kang报道了一种新的调制婴儿配方奶中阪崎肠杆菌快速监测方法,即96孔板荧光MPN法快速计数.该方法根据阪崎肠杆菌产生的a.葡萄糖苷酶能分解a.MUG(OK培养基)产生荧光,对添加该底物的肉汤进行荧光检测,通过96孔微孔板进行10管MPN法计数.分别采用传统平板法和微量MPN法对蛋白胨水(0.2%)和调制婴儿配方奶中的阪崎肠杆菌进行定量检测,结果发现上述两种方法在检测不同样品时,其相关性存在高度一致性.故认为,与传统平板法相比,微量MPN法所需时间较短(<10h),更为经济适用,可应用于婴儿配方奶中阪崎肠杆菌数量的快速监测.2006年2月ISO和国际乳品联盟(International DairyFederation,IDF)联合公布了"乳和乳制品中阪崎肠杆菌的检测"方法,即ISO/TS229641IDF/RM 210【2.该方法分别选择mLST-Vm和ESIA作为阪崎肠杆菌选择性增菌肉汤和选择性分离培养基替代美国FDA方法中的EE肉汤和VRBGA,且2步选择性培养的温度均为44℃.整个实验需5～6天.国外医学卫生学分册2006年第33卷第6期?383? 2分子生物学检测方法2.1PCR检测2003年Keyser等在评估3种上流式厌氧污泥床技术处理葡萄酒酿造厂废水的能力时,首次报道了阪崎肠杆菌的快速PCR学检测方法.该PCR 方法是根据ATCC29544[GenBank:AB004746]单个16SrRNA基因设计的引物.2004年Lehenr等测定了阪崎肠杆菌ATCC51329和从食品,环境及人体中分离到的l3株阪崎肠杆菌的16SrRNA基因序列.通过对16SrRNA基因序列的系统发育学分析, 发现阪崎肠杆菌存在第二种不同的系统发育种系, 即阪崎肠杆菌ATCC51329与新测序的l3株阪崎肠杆菌及ATCC29544之间存在较大的基因差异.在该研究中,采用大量的目标和非目标菌对Keyser等建立的PCR检测系统进行初步评估,证明该系统存在较大的特异性问题,而且该系统不能检测到阪崎肠杆菌ATCC51329这一分支.Lehenr等根据16SrRNA测序结果建立了特异性的阪崎肠杆菌PCR检测系统,并选择75株目标和非目标菌进行试验,结果证实该PCR检测系统能正确鉴定两类不同的阪崎肠杆菌系统发育种系,并且能正确区分与其亲缘关系较近的其他肠杆菌及其他细菌,具有良好的特异性和可靠性.高旗利等利用细菌16S和23SrDNA保守序列的通用引物,对6株阪崎肠杆菌16S～23SrRNA 基因问区序列(intergenicspacerregion,ISR)进行了扩增和测序,在比较阪崎肠杆菌与其近源株16S～23S rRNA基因间区序列的基础上,设计了11条阪崎肠杆菌PCR引物,组合成30对PCR引物并筛选出一对阪崎肠杆菌PCR检测的特异性引物,建立了奶粉中阪崎肠杆菌PCR检测方法.并选择l0株阪崎肠杆菌和l8株亲缘关系较近的其他菌株进行验证. 奶粉样品中阪崎肠杆菌检测低限为2.2～5.4CFU/lOOg.试验结果证明该PCR方法与美国FDA方法的检测结果完全符合.此外,uu等.针对阪崎肠杆菌16S～23SrDNA间区转录序列(internal transcribedspacer,ITS)也建立了阪崎肠杆菌特异性PCR检测方法.Lehner等在对阪崎肠杆菌a一葡萄糖苷酶活性进行分子分析的基础上,建立了针对阪崎肠杆菌a一葡萄糖苷酶活性的特异性PCR鉴定系统.除阪崎肠杆菌外,还有其他几种细菌可以在ESIA和DFI等根据阪崎肠杆菌a一葡萄糖苷酶活性合成的显色培养基上生长形成假阳性菌落,然而,Lehner等发现其设计的PCR系统只检测具有a一葡萄糖苷酶活性的阪崎肠杆菌.杜邦Qualicon与雀巢公司合作建立了食品和环境样本中阪崎肠杆菌的PCR检测方法,即Dupont QualiconBAX@检测系统].BAX@系统是应用PCR方法进行快速扩增和荧光检测的一种定性扫描工具.BAX系统采用PCR方法特异性地扩增阪崎肠杆菌DNA的某一段序列,然后用荧光检测法分析PCR产物的存在.整个试验包括采样,样品富集,样本制备,进样,读取结果和证实试验.BAX@系统把引物,聚合酶,核苷酸和阳性对照制成成品放入PCR 反应管;另外,自动荧光系统直接对加盖的PCR管进行检测,可以避免DNA扩增的交叉污染.虽然部分过程实现了自动化,并且缩短了试验时间,但所得阳性菌株仍需用生化(API20E)或分子生物学方法做最后证实.2.2探针法德国慕尼黑V ermiconAG公司针对细菌rRNA特殊区域设计了荧光标记的基因探针,并建立了商品化的检测和鉴定系统,即vermicon鉴定技术(vermiconidentificationtechnology,VIT)oLehner等根据VIT操作指南进行阪崎肠杆菌实验,使用落射荧光显微镜可观察到阪崎肠杆菌发出的特异性红光,使其很容易被鉴定.Lehner等同时利用根据a一葡萄糖苷酶设计的PCR系统和VIT原位杂交技术, 比较和验证对阪崎肠杆菌的快速鉴定情况.实验同时选择代表阪崎肠杆菌2种不同系统发育种系的标准株(ATCC29544和ATCC51329)系列稀释,平板计数法确定该方法的检测限.2种菌株的检测限都是1×10CFU/ml.虽然上述2种方法根据完全不同的靶基因和方法学建立,但在鉴定和区分阪崎肠杆菌方面具有良好的一致性,其特异性都为100%.然而,Lehner等认为PCR方法需要DNA提取步骤,而VIT方法更为快速,方便,针对细菌rRNA的探针原则上只能检测到活的阪崎肠杆菌,3h内就可获得实验结果,而且不需要特殊的实验室设备.【ju等针对阪崎肠杆菌16S～23SrDNAITS建立阪崎肠杆菌特异性PCR检测方法的同时,也建立了寡聚核苷酸微阵列检测方法.通过对6株阪崎肠杆菌ITS进行测序,并与GenBank提供的多种rRNA384?国外医学卫生学分册2006年第33卷第6期基因序列进行比较分析,设计了2对特异性PCR引物和10对寡聚核苷酸探针.试验选用23株阪崎肠杆菌和65株其他菌株检测PCR和寡聚核苷酸微阵列检测方法的特异性和敏感性.试验结果显示,本研究中建立的PCR方法和探针法用于阪崎肠杆菌检测时均为阳性,而且与其他细菌没有交叉反应.通过选择性富集,检测的敏感度可达到1.3CFU/.100g.包括富集过程,2种方法均可在48h内完成. 2.3实时PCR检测方法2005年Seo和Brackett报道了针对阪崎肠杆菌局部大分子合成操纵子,即rpsU基因3'末端和primase(dnaG)基因5'末端,设计引物和TaqMan探针的实时定量PCR检测方法.选择68株肠杆菌和55 株非肠杆菌科细菌评估该试验的特异性.未经富集,经50个PCR循环,该方法能检测到磷酸盐缓冲液(phosphate—bufferedsaline,PBS)和调制婴儿配方奶中100CFU/ml的阪崎肠杆菌,经过增菌培养,可检测到婴儿配方粉中1.6CFU/g的阪崎肠杆菌.该方法能特异性地鉴别阪崎肠杆菌和其他肠杆菌及非肠杆菌科细菌,无需平板接种和生化鉴定,能节省5个工作日.Seo和Brackett认为该实时PCR方法是婴儿配方粉中低污染水平阪崎肠杆菌快速,高灵敏度的定性和定量检测方法,可作为食品企业和管理机构婴儿配方样品的快速筛选方法.近来,uu等根据TaqMan和SYBRgreen技术针对16S～23SrRNA间区序列设计引物,建立了2 种实时PCR方法用于检测经mIST和BHI选择性富集的阪崎肠杆菌.采用35株阪崎肠杆菌和88株其他细菌检测了上述两种方法的准确性,结果显示两种方法的试验结果准确率达100%.该试验用于婴儿配方粉检测时,经25h富集,最低检测限可达1.1 CFU/100g.两种方法都可在2个工作日内完成.3其他方法人工神经网络(artificialneuralnetwork,ANN)是以计算机网络系统模拟生物神经网络的智能计算系统.多层感知器(multi—layerpereeptron,MLP)是一种包括多层前馈网络的ANN模型,每一层的节点都通过一系列的加权链接与下一层的每个节点相连接.联合应用反向传播(back—propogation,BP)算法,ANN 采用与人脑学习和处理信息相似的方式处理问题.例如,在人脑,学习是通过神经元之间的突触连接,而ANN的学习是通过更新组成网络拓扑结构的处理单元之间的权重进行的.为了确定能够改善阪崎肠杆菌鉴定的关键特征,Iversen等利用上述技术对282株肠杆菌(包括189株阪崎肠杆菌分离株)的生化特征和16SrDNA序列进行分析.该模型能对盲样(经过鉴定)进行预测,区分阪崎肠杆菌和在表型和基因型方面与其亲缘关系较近的菌种的正确率达99.3%.对阪崎肠杆菌和a一葡萄糖苷酶活性同为阳性的其他菌种进行比较,16SrRNA序列分析鉴别正确率达98.7%,而通过生化特征鉴别分析完全正确.同时确定了16S rDNA序列中鉴别上述菌种的3个重要区域. Iversen等认为以计算机为基础的分析方法可大大降低数据的维数和复杂性,改善菌种鉴定系统的速度和可靠性.相关技术可在菌群结构和单个菌种的分布方面提供有价值的信息,为快速鉴定致病菌的新方法和诊断实验奠定基础,从而降低由假阳性和假阴性结果导致的错误诊断的危险性.参考文献:[1]TheCentersforDiseaseControlandPrevention,us. Enterobactersakazakiiinfectionsassociatedwiththeuseofpowderedinfantfomula=Tennessee,2001[J].MMWR, 2002,51:297—300.[2]KandhaiMC,ReijMW,GorrisLG,eta1.Occurrenceof Enterobactersakazakiiinfoodproductionenviromnen~and households[J].Lancet,2004,363:39—40.[3]FAO/WHO.Enterobactersakazakiiandmicroorganismsin powderedinfantformula[DB/OL].http://www.who.int/ foodsafety/publications/micro/erdes.pal,2006—05—10. [4]ICMSF.Microorganismsinfoodsnumber7. MicrobiologicaltestinginfoodsafetymanagementlRJ. Netherlands:KluwerAcademic/PlenumPubhshers,2002. 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LehnerA,TasaraT,StephanR.16SrRNAgenebased analysisofEnterobactersakazakiistrainsfromdifferent sourcesanddevelopmentofaPCRassayforidentification [J].BMCMicrobiol,2004,25(4):43.高旗利,张霞,罗茂凰,等.奶粉中阪崎肠杆菌PCR检测方法研究[J].检验检疫科学,2005,4(15):4—8. LiuY,GaoQ,ZhangX,eta1.PCRandoligonucleotide arrayfordetectionofEnterobactersakazakiiininfant formula[J].MolCellProbes,2006,20(1):11-17.LehnerA,NitzscheS,BreeuwerP,parisonof twochromogeniemediaandevaluationoftwomolecular basedidentificationsystemsforEnterobactersakazakii detection[J].BMCMicrobiol,2006,23(6):15. Healthproductsandfoodbranch,Ottawa,Governmentof Canada.theDUPONTQUALICONBAX⑩systemmethod forthedetectionofEnterobactersakazakiiinselectedfoods [DB/OL].http://www.hc—se.gc.ca/fn—an/alt—formats/ hptb-dgpsa]pdf/res—rech/mflp27一e.pdf,2006—05—10. SeoKH,BrackettRE.Rapid,specificdetectionof Enterobactersakazakiiininfantformulausing?。

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国际司法鉴定标准化研究热点探讨——基于文献计量学方法的分析Discussion on the research hotspot ofinternational forensic science standardization —Based on the analysis of bibliometrics methodBy Zhang Xiaochun 1, Yu Haixing 1,2, Shi Gefei 1, He Xiaodan 1,*文/张晓春1 余海星1,2 史格非1 何晓丹1，*(1. Shanghai Key Laboratory of Forensic Medicine, Key Lab of Forensic Science, Ministry of Justice, Academy of Forensic Science; 2. College of Medicine and Forensics, Xi’an Jiaotong University Health Science Center; *Corresponding author)Abstract: In order to study the development of forensic science standardization, this paper, based on the bibliometric method, analyzes the paper database of forensic science standardization. The research shows that the quantity and quality of papers have a stable growth tendency and the hotspot in the field of forensic science is the technical innovation and multidisciplinary research. The standardization construction of forensic science in China is in the forefront of the world in terms of scientific research investment, but there is still a gap in organizational capacity and influence, which is reflected in the lack of international cooperation. China should strengthen the standardization of forensic science and explore new development modes constantly.Keywords: forensic science, standardization, bibliometrics, multidisciplinary1. IntroductionWith the development of the global standardization and the increasing efforts of the International Standardization Organization (ISO), standardization has become an important part of the development of forensic science [1-3]. In 2021, the 45 member states of ISO/TC 272 held the 27th~39th international standardization work conferences on forensic science, which further improve a series of forensic science standardization procedures from the scene to the laboratory testing [4-5]. At the same time, many organizations have carried out a large number of standardization research, aiming to build a more general forensic science standards system to ensure the reliability, scientificity and accuracy, so as to adapt to the development of standard globalization.[1-3]Bibliomet r ic s is a sc ience of dat a a na ly zing w it h mathematical and statistical methods, which can help researchers identify the topic content and research hotspots in this field [6-8]. At present, some scholars have applied bibliometrics to many branches of forensic science, but there is still no research on the standardization of forensic science from a macro perspective [7,8]. Therefore, it is of great significance to analyze the multidisciplinary forensic science, and grasp the development process, theme context and frontier trend of forensic science standardization.This study is based on the bibliometric method of Web of Science (WoS) database from 2000-2021, in order to providereference information for standards development and research work of forensic science.2. Materials and methods2.1 Data collectionThe data were collected from the Web of Science (WoS) database, including Science Citation Index Expanded (SCIE) and Social Sciences Citation Index (SSCI), with the time range set from 2000.01 to 2021.12. Documents were collected with retrieval TS=(forensic) AND TS=(standard or guide or guideline) AND PY=2000-2021 and exported TXT files. Statistical information includes publication years, paper types, journal information, countries/regions and keywords.2.2 AnalysisPython 3.9.2 was used to process and clean information such as country/region and keywords in the literature data obtained in Section 2.1. The processed data were analyzed by Microsoft Office Excel 2019 and Gephi 0.9.2 software. The Betweenness Centrality (BC) and Eigenvector Centrality (EC) of each data was calculated using Gephi 0.9.2. And python 3.9.2 was used to draw the time series heat maps of the top 20 keywords in frequency. Gephi 0.9.2 software was used to analyze the co-occurrence relationship of keywords and cluster them. BC and EC of keywords were calculated, and the co-occurrence network diagram was drawn by ForceAtlas2 composition algorithm.ESEARCH & EXPLORATIONBETTER COMMUNICATION ｜ GREATER VALUE3. Results3.1 Years and types of publicationThe main subjects of this study were 6258 papers on standardization of forensic science from 1230 journals included in WoS from 2000 to 2021. The number of documents showed an increasing trend over the years (Figure 1), the lowest in 2000 (n=65) and the highest in 2021 (n=707). During the 22 years on average 284.45 ± 181.73 articles were published annually. Among the 6258 papers, the largest proportion was Article (n=5285, 84.45%, 240.2/year), followed by Review (n=453, 7.24%, 20.59/year).3.2 SourcesThe WoS published from 2000 to 2021 included 6258 papers of forensic science standardization, which came from 1230 journals. There were 20 journals with more than 50 papers (Figure 2), with 3221 papers, accounting for 51.47% of the total papers. The highest publication volume was journal Forensic Science International (n=652) came from Ireland, accounting for 10.42% of the total publications. It was followed by Journal of Forensic Sciences (n=614), coming from USA, accounting for 9.81% of the total publications.According to JCR information for the top 20 journals, the average impact factor (IF) was 2.5955 ± 1.5283 (median 2.2935, lower quartile 1.5545, upper quartile 3.3505). The highest IF was Analytical Chemistry (IF: 6.986, 5 year IF: 6.755, Q1) and the lowest was Rechtsmedizin (IF: 0.517, 5 year IF: 0.515, Q4). In terms of the journals citation index (JCI), the highest JCI was the Forensic Science International-Genetics (JCI: 1.75, total citation: 6013). The lowest JCI was Forensic Science Medicine and Pathology (JCI: 0.59, total citation: 1501) andFigure 1：Publication trendsDigital Investigation (JCI: 0.59, total ctiation:1346). The highest total citation was Analytical Chemistry (n=156738) and the lowest was Rechtsmedizin (n=407).3.3 Countries/RegionsExcluding papers without specified countries/regions, authors of other papers from 119 countries/regions have a frequency of 8621 (average 72.45). The top 10 countries/regions with high frequency: USA (n=1751), England (n=655), Germany (n=652), China (n=456) and Australia (n=444). European countries and America, led by USA, are in the dominant position in this field, followed by China and other countries in Asia and Australia.Countries/regions cooperation group according to condit ions (cooperat ion f requenc y ≥2 and indiv idua l frequency≥10) is divided into 3 groups, USA collaboration group (24 countries/regions, total frequency 5980), China collaboration group (22 countries/regions, total frequency 1758) and Spain collaboration group (10 countries/regions, total frequency 700). These 3 countries/regions (n=56) accounted for 47.06% of all countries/regions, and the frequency of publication accounted for 97.88% of the total frequency.The collaboration of the 3 countries/regions cooperation groups is shown in Figure 3. There are 13 countries/regions with EC≥0.900, USA (1.000), England (0.986), Italy (0.975), Germany (0.965), Spain (0.961), Netherlands (0.929), Portugal (0.925), Austria (0.917), Switzerland (0.917), Belgium (0.914), China (0.907), Sweden (0.907), Denmark (0.900). The top 10 countries in BC were USA (86.850), England (69.370), Italy (35.090), Spain (34.912), Germany (33.040), SwitzerlandFigure 2：Journal sources of articlesforensics (n=121), and validation (n=118) were followed. In addition, the keywords from scratch in the past 22 years is NGS (Next-generation sequencing), which is a DNA sequencing technology developed based on PCR and gene chips, and has appeared in papers since 2014.For further clustering analysis of key words, which frequency≥10, the relationship of keywords is shown in Figure 5. According to the total frequency of the word group, keywords were divided into 7 groups: STR group (n=30, 1298 times), forensic anthropology group (n=27, 832 times), mass spectrometry group (n=24, 476 times), digital forensics group (n=14, 351 times), autopsy group (n=14, 314 times), forensic psychiatry group (n=11, 280 times), forensic odontology group (n=11, 239 times). These keywords groups correspond to forensic genetics, forensic anthropology, forensic toxicology,(32.637), Canada (31.382), France (30.210), Sweden (28.719),and Australia (27.921). In addition, China ranked 4th in terms of publication frequency, but China still has a large space for development in international cooperation with China’s BC ranking 18th and EC ranking 11th.3.4 KeywordsA total of 5358 papers contained keywords, accounting for 85.62% of all papers (900 papers without keywords). After deleting, replacing and merging the keywords, we screened 131 keywords with frequency≥10, and further analyzed the temporal hotspot dynamics of the top 20 keywords. As can be seen from Figure 4, the keywords with steady growth of frequency in the past decade is forensic anthropology (n=289), which is a hot field of forensic science standardization in the past decade. In addition, STR (n=202), autopsy (n=124),Forensic Science International Number100200300400500600652614325282189133********8482757463595857565151700Journal of Forensic SciencesForensic Science International - Genetics International Journal of Legal Medicine Journal of Forensic and Legal MedicineScience & JusticeJournal of Analytical ToxicologyLegal MedicineAustralian Journal of Forensic Sciences Analytical and Bioanalytical Chemistry Forensic Science Medicine and PathologyDrug Testing and AnalysisDigital Investigation Analytical ChemistryRechtsmedizin ElectrophoresisAmerican Journal of Forensic Medicine andPathologyMedicine Science and the LawRapid Communications in Mass SpectrometryJournal of Chromatography B-analyticalTechnologies in the Biomedical and Life SciencesESEARCH & EXPLORATIONBETTER COMMUNICATION ｜ GREATER VALUEFigure 3: Collaborative network of countries/regions in standardization of forensic science from 2000 to 2021*Different colors represent different modules, the size of points represents frequency, and the thickness of lines represents the tightness of cooperation.dig it al forensics, forensic pat holog y, forensic psychiatry and forensic odontology. There were 7 of the top 10 EC values of keywords belong to the STR group, including DNA (1.000), validation (0.852), STR (0.844), forensics (0.809), forensic genetics (0.691), DNA typing (0.685), likelihood ratio (0.637). It can be seen that forensic genetics is a high-tech research f ield in nearly 20 years, mainly involving DNA identification. At the same time, forensic anthropology is the keyword with the largest BC value (1678.789), wh ich h a s a close r elat ion sh ip w it h for en sic psychiatry, forensic genetics, forensic odontology and other important disciplines, indicating that forensic anthropology plays a very important core role among various disciplines.4. DiscussionThe subjec t s of t his st udy were t he papers of forensic science standardization included in WoS published from 2000 to 2021, including 6258 documents from 1230 journals. The number of changesFigure 4: Temporal thermal situation of keywords in the field offorensic science standardization from 2000 to 2021The research of keywords in each professional direction of forensic science has reference value for discipline construction. Through the analysis of research hotspots and evolution trends in key fields, it provides valuable reference information for researchers in various fields, and can trace the discipline process and clarify the direction of scientific research development according to visual information, so as to enhance the innovation ability of disciplines from the source.To sum up, the analysis of the statistical results can be carried out from three aspects: time dimension, spatial latitude, theory and practice. First of all, during the 22-year period, the documents showed an overall trend of increasing year by year, and the field of forensic science showed more attention to standardization year by year. The reasons for the growth mainly include the development of science and technology, social needs, international cooperation and globalization. Secondly, in terms of international cooperation, countries/regions contacts are particularly important, which affects the scientific and technological exchanges betweenover the years showed the overall trend of increasing year by year. It can be seen that the requirements and construction of the standardization of forensic science in countries are gradually strengthened, and standardization has become the key planning direction in the field of forensic science in the future.In terms of countries/regions, USA topped the list with 1751 (27.98%), and promoted the standardization cooperation of European countries and America. In addition to developed countries, China and Australia are also in a state of rapid development and attach great importance to the theory, technology, operation and quality of forensic science, which drives the standardization research in neighboring countries and plays a leading role in the scientific and technological development.In terms of key words, it can be seen that forensic science involves a wide range of fields. The standardization of forensic science focused on forensic genetics, forensic anthropology, forensic toxicology, digital forensics, forensic pathology, forensic psychiatry and forensic odontology, etc. Figure 5: Collaborative network of keywords in standardization of forensic science from 2000 to 2021*Different colors represent different modules, the size of points represents frequency, and the thickness of lines represents the tightness of cooperation.ESEARCH & EXPLORATIONBETTER COMMUNICATION ｜ GREATER VALUE[1] Wilson-Wilde L. The international development of forensic science standards — A review[J]. Forensic Science International ,2018,288.[2] He X, Li C. Development of forensic standards in China: a review.[J]. Forensic sciences research ,2022,7(1).[3] Brandi J, Wilson-Wilde L. Standard Methods[M]. Encyclopedia of Forensic Sciences , 2013.[4] Guan Y. Preliminary Analysis on the Progresses of Forensic Science International Standardization by ISO/TC 272[J]. Standard Science , 2018.[5] Zhang X, He X. The enlightenment of the standardization practice of ISO/TC 272 on the standardization construction of forensic expertise[J]. Standard Science , 2022, (03): 47-57.[6] Salini S. An Introduction to Bibliometrics[M].John Wiley & Sons , Inc. 2016.[7] Shi G, Liu N, Yu X, et al. Bibliometric Analysis of Medical Malpractice Literature in Legal Medicine from 1975 to 2018: Web of Science Review[J]. Journal of Forensic and Legal Medicine , 2019,66.[8] Lei G, Liu F, Liu P, et al. Worldwide tendency and focused research in forensic anthropology: A bibliometric analysis of decade (2008–2017)[J]. Legal Medicine ,2019,37.ReferencesZhang Xiaochun, Assistant Engineer at Academy of Forensic Science, focuses on the research into the standardization of forensic science.Yu Haixing, postgraduate student at Xi’an Jiaotong University, focuses on the research into bibliometrics.Shi Gefei, Senior Editor and Senior Forensic Expert at Academy of Forensic Science, is engaged in the editing of science articles and the research on bibliometrics.He Xiaodan, Senior Engineer and Vice Director of Standardization Department at Academy of Forensic Science, focuses on the research into the standardization of forensic science.About the authors:organizations and authors. Many factors (geography, politics, language, culture, science and technology, etc.) lead to the regional concentration of international cooperation, such as Europe, North America, Asia and Latin America. In order to further strengthen the construction of international standardization of forensic science and play a leading role in the global standardization ecosystem, it is necessary to take the lead of key standardization organizations (such as ISO/TC 272, OSAC, ENFSI, etc.), to incline international efforts to developing countries and narrow the gap between countries. Finally, theory and practice are inseparable; we should promote the transformation of theory into practice, because practice drives the development and progress of theoretical research, and constantly meet the needs of the international community for forensic science. At the same time, researchers should analyze the development trend of forensic science standardization in statistics, bibliometrics and other disciplines, break the disciplinary barriers, clarify the development path, strengthen professional cooperation, and promote the development of forensic science from speed to quality. Researchers should formulate a forensic sciencestandardization strategy in line with the development of science and technology by combining various factors such as keywords and hot research fields.5. ConclusionStandards are the crux of the progress of civilization and important guarantee for international cooperation among countries. Under the background of globalization development, we should pay attention to promote the popu l a r i z at ion of s t a nd a r d i z at ion a nd s t r eng t hen standardization cooperation between countries. Forensic science standardization has been developing rapidly in recent years, and the research on the development characteristics of various disciplines is helpful to promote the construction of international security system. In the face of the inevitable and severe international environment, we should make use of the digital platform to strengthen the international communication and cooperation, break down the barriers, and explore the road for the development of international forensic science standardization.This study was supported by grants from the National Key Research and Development Plan of China (grant number 2022YFC3302005) and the Shanghai special analysis of technical trade fund (grant number 2022TBT007).Funding。

06年全年雅思阅读考试文章总纲

2006中国考区雅思考试阅读⽂章⽬录考试时间第⼀篇第⼆篇第三篇06/01/07 ⽼龄职⼯⽔利发展因纽特⼈06/01/14 旅游业的发展史节能建筑抓蚂蚁06/01/21 蝙蝠&回声定位语⾔与商业⽣物杀⾍06/02/11 Australian Sporting Success The true cost of food Maternal Education & Child Mortality 06/02/18 农药和产量关于艺术⾮洲修建公路06/02/25 Intensity and Crowding 美国垃圾回收昆⾍飞⾏进化06/03/11 BRAIN TRAINING 英国⼉童缺乏运动欧洲森林保护06/03/18 育⼉观念的改变伦敦⼤雾保存络资料06/03/25 ⼝译 Interpretation Space and Power Nature of genius06/04/08 Single-sex School Vs. Co-education 地图发展史Maps & Atlas因纽特⼈06/04/22 蚂蚁智⼒Ant Intelligence 古代钱币 E-learning06/04/29 Feeding the world（化肥⼟壤）纸币的发展⼩班教学研究06/05/13 法国城堡建筑科学中的欺骗⾏为燃料电池06/05/20 BRAIN TRAINING 乌鸦制造⼯具和⼈类相似之处 English Spelling and its Development 06/05/27 Banana Evolution Art of Change People’s Blind Moments06/06/10 蝴蝶保护⾊美国航空管制沉船保护06/06/17 龙涎⾹和琥珀英国⼉童缺乏锻炼英语发⾳的演变06/07/08 ⽔獭otters ⽣物杀⾍燃料电池06/07/22 BUS的发展⽓候与国家富裕抓蚂蚁06/07/29 Traffic jam 阿拉斯加鲑鱼保护 Facial emotion06/08/05 海底研究电⼦书e-book 氢能源动⼒06/08/12 going nowhere fast交通拥堵、污染Space & Power Texting the TV短信互动电视06/08/12 Banana Evolution Photography and Painting Taste and Smell06/09/02 Japanese Pagoda London Smog Turkey06/09/16 ⼉童后天教育⽔污染处理法国⼯业时代电影06/09/23 美国肥胖症地图制作沙漠植物06/10/14 城市公共交通新陈代谢与寿命美国港湾环境污染06/10/21 农作物的发展⼩提琴 30年代科幻⽚06/10/28 磁场研究俄罗斯考古保存络资料06/11/04 ⽇本⼉童教育业余科学家的数据价值部落基因研究06/11/18 ⼿势的发展电脑控制汽车教学⽅法实验06/11/25 ⽣物钟⾹⽔阅读法06/12/02 恐龙灭绝英国农业拯救濒危语⾔06/12/09 龙涎⾹和琥珀美国垃圾处理⽣物杀⾍剂06/12/16 乐观与⼈类健康澳⼤利亚更新能源雪崩的研究。

Summary list of harmonised standards

EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEsGoods in the Single Market and Enforcement StandardisationBrussels, 4.12.2020Summary of references of harmonised standards published in the Official Journal – Regulations (EC) No 765/2008 and (EC) No 1221/2009 of the European Parliament and of the Council, Directive 2006/42/EC of the European Parliament and of the Council and Union acts incorporating the reference provisions of Decision No 768/2008/EC 1 of the European Parliament and of the CouncilThe summary below consolidates the references of harmonised standards published by the Commission in the Official Journal of the European Union (OJ). It reproduces information already published in the L or C series of the OJ as indicated in columns (2), (5) and/or (7). It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.The Commission services provide this summary for information purposes only. Although they take every possible precaution to ensure that the summary is updated regularly and is correct, errors may occur and the summary may not be complete at a certain point in time. The summary does not as such generate legal effects. This summary was generated on 4 December 2020.Legislationreference(A) ESO(B)Reference number of thestandard (C)Title of the standard(D)Date of start of presumption of conformity (1) OJ reference for publication in OJ (2)Restriction(3) Date of start of presumption of conformity with restriction (4) OJ referencefor publicationof a restrictionin OJ(5)Date ofwithdrawalfrom OJ (end of presumption of conformity)(6) OJ reference for withdrawalfrom OJ (7) 765/2008 CEN EN ISO 9000:2005 Quality management systems - Fundamentals andvocabulary (ISO 9000:2005)16/06/2009 OJ C 136 - 16/06/2009 - - 15/09/2018OJ C 412 -11/12/2015 765/2008 CEN EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)11/12/2015OJ C 412 -11/12/2015- - - 765/2008 CENEN ISO 9001:2008, EN ISO 9001:2008/AC:2009 Quality management systems - Requirements (ISO 9001:2008)16/06/2009OJ C 136 -16/06/2009- - 15/09/2018 OJ C 412 - 11/12/2015 765/2008 CEN EN ISO 9001:2015Quality management systems - Requirements (ISO 9001:2015)11/12/2015 OJ C 412 -11/12/2015- - -1OJ L 218, 13.8.2008, p. 82–128Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIËContact : *****************.euLegislationreference(A)ESO(B)Reference number of thestandard (C)Title of the standard(D)Date of start of presumption of conformity (1) OJ reference for publication in OJ (2)Restriction(3) Date of start of presumption of conformity with restriction (4) OJ referencefor publicationof a restrictionin OJ(5)Date ofwithdrawalfrom OJ (end of presumption of conformity)(6) OJ reference for withdrawalfrom OJ (7) 765/2008 CEN EN ISO 14001:2004 Environmental management systems - Requirements withguidance for use (ISO 14001:2004)16/06/2009OJ C 136 -16/06/2009- - 15/09/2018 OJ C 412 - 11/12/2015 765/2008 CENEN ISO 14001:2004, EN ISO 14001:2004/AC:2009 Environmental management systems - Requirements with guidance for use (ISO 14001:2004)16/06/2009 OJ C136 - 16/06/2009 - - 15/09/2018OJ C 412 -11/12/2015 765/2008 CEN EN ISO 14001:2015 Environmental management systems - Requirements with guidance for use (ISO 14001:2015)11/12/2015 OJ C 412 -11/12/2015 - - -765/2008 CEN EN ISO 14004:2010 Environmental management systems - General guidelines on principles, systems and support techniques (ISO 14004:2004)05/10/2011 OJ C 292 - 05/10/2011 - - 30/04/2019OJ C 209 -10/06/2016765/2008 CEN EN ISO 14004:2016 Environmental management systems - General guidelines on implementation (ISO 14004:2016)10/06/2016 OJ C 209 - 10/06/2016 - - -765/2008 CEN EN ISO 14015:2010 Environmental management - Environmental assessment of sites and organizations (EASO) (ISO 14015:2001)05/10/2011 OJ C 292 - 05/10/2011 - - -765/2008 CEN EN ISO 14020:2001 Environmental labels and declarations - General principles (ISO 14020:2000)16/06/2009 OJ C 136 - 16/06/2009 - - - 765/2008 CEN EN ISO 14021:2001 Environmental labels and declarations - Self-declared environmental claims (Type II environmental labelling) (ISO 14021:1999)16/06/2009 OJ C 136 - 16/06/2009 - - 30/06/2012OJ C 149 - 25/05/2012 765/2008 CENEN ISO 14021:2001, EN ISO 14021:2001/A1:2011 Environmental labels and declarations - Self-declared environmental claims (Type II environmental labelling) (ISO 14021:1999)25/05/2012 OJ C 149 - 25/05/2012 - - 31/10/2018OJ C 293 -12/08/2016765/2008 CEN EN ISO 14021:2016 Environmental labels and declarations - Self-declared environmental claims (Type II environmental labelling) (ISO 14021:2016)12/08/2016 OJ C 293 - 12/08/2016 - - - 765/2008 CEN EN ISO 14024:2000 Environmental labels and declarations - Type Ienvironmental labelling - Principles and procedures (ISO 14024:1999)16/06/2009 OJ C 136 - 16/06/2009 - - 31/12/2020OJ C 209 - 15/06/2018765/2008 CEN EN ISO 14024:2018 Environmental labels and declarations - Type Ienvironmental labelling - Principles and procedures (ISO 14024:2018)15/06/2018 OJ C 209 - 15/06/2018 - - - 765/2008 CEN EN ISO 14031:1999 Environmental management - Environmental performance evaluation - Guidelines (ISO 14031:1999)16/06/2009 OJ C 136 - 16/06/2009 - - 28/04/2014OJ C 348 - 28/11/2013765/2008 CEN EN ISO 14031:2013 Environmental management - Environmental performance evaluation - Guidelines (ISO 14031:2013)28/11/2013 OJ C 348 - 28/11/2013 - - -765/2008 CEN EN ISO 14040:2006 Environmental management - Life cycle assessment - Principles and framework (ISO 14040:2006)16/06/2009 OJ C 136 - 16/06/2009 - - - 765/2008 CEN EN ISO 14044:2006 Environmental management - Life cycle assessment - Requirements and guidelines (ISO 14044:2006)16/06/2009 OJ C 136 - 16/06/2009 - - 31/12/2020OJ C 209 - 15/06/2018765/2008 CENEN ISO 14044:2006, EN ISO 14044:2006/A1:2018 Environmental management - Life cycle assessment - Requirements and guidelines (ISO 14044:2006) 15/06/2018 OJ C 209 - 15/06/2018 - - -765/2008 CEN EN ISO 14050:2010Environmental management - Vocabulary (ISO 14050:2009)05/10/2011OJ C 292 - 05/10/2011- - -Legislation reference(A) ESO(B)Reference number of thestandard(C)Title of the standard(D)presumption ofconformity(1)forpublicationin OJ(2)Restriction(3)presumption ofconformity withrestriction(4)for publicationof a restrictionin OJ(5)from OJ (endof presumptionof conformity)(6)forwithdrawalfrom OJ(7)765/2008 CEN ENISO14063:2010 Environmental management - Environmentalcommunication - Guidelines and examples (ISO14063:2006)05/10/2011OJ C 292 -05/10/2011- - -765/2008 CEN ENISO14064-1:2012 Greenhouse gases - Part 1: Specification with guidance atthe organization level for quantification and reporting ofgreenhouse gas emissions and removals (ISO 14064-1:2006)28/11/2013OJ C 348 -28/11/2013- -01/07/2022OJ L 408 -04/12/2020765/2008 CEN ENISO14064-1:2019 Greenhouse gases - Part 1: Specification with guidance atthe organization level for quantification and reporting ofgreenhouse gas emissions and removals (ISO 14064-1:2018)04/12/2020OJ L 408 -04/12/2020- - -765/2008 CEN ENISO14064-2:2012 Greenhouse gases - Part 2: Specification with guidance atthe project level for quantification, monitoring andreporting of greenhouse gas emission reductions orremoval enhancements (ISO 14064-2:2006)28/11/2013OJ C 348 -28/11/2013- -01/07/2022OJ L 408 -04/12/2020765/2008 CEN ENISO14064-2:2019 Greenhouse gases - Part 2: Specification with guidance atthe project level for quantification, monitoring andreporting of greenhouse gas emission reductions orremoval enhancements (ISO 14064-2:2019)04/12/2020OJ L 408 -04/12/2020- - -765/2008 CEN ENISO14064-3:2012 Greenhouse gases - Part 3: Specification with guidance forthe validation and verification of greenhouse gas assertions(ISO 14064-3:2006)28/11/2013OJ C 348 -28/11/2013- -01/07/2022OJ L 408 -04/12/2020765/2008 CEN ENISO14064-3:2019 Greenhouse gases - Part 3: Specification with guidance forthe verification and validation of greenhouse gasstatements (ISO 14064-3:2019)04/12/2020OJ L 408 -04/12/2020- - -765/2008 CEN ENISO14065:2012 Greenhouse gases - Requirements for greenhouse gasvalidation and verification bodies for use in accreditationor other forms of recognition25/05/2012OJ C 149 -25/05/2012- -31/12/2013OJ C 258 -07/09/2013765/2008 CEN ENISO14065:2013 Greenhouse gases - Requirements for greenhouse gasvalidation and verification bodies for use in accreditationor other forms of recognition (ISO 14065:2013)07/09/2013OJ C 258 -07/09/2013- - -765/2008 CEN ENISO15189:2012 Medical laboratories - Requirements for quality andcompetence (ISO 15189:2012, Corrected version 2014-08-15)13/03/2013OJ C 074 -13/03/2013- - -765/2008 CEN ENISO15195:2003 Laboratory medicine - Requirements for referencemeasurement laboratories (ISO 15195:2003)05/10/2011OJ C 292 -05/10/2011- -01/07/2022OJ L 408 -04/12/2020765/2008 CEN ENISO15195:2019 Laboratory medicine - Requirements for the competence ofcalibration laboratories using reference measurementprocedures (ISO 15195:2018)04/12/2020OJ L 408 -04/12/2020- - -765/2008 CEN ENISO/IEC17000:2004 Conformity assessment - Vocabulary and generalprinciples (ISO/IEC 17000:2004)16/06/2009OJ C 136 -16/06/2009- - -765/2008 CEN ENISO/IEC17011:2004 Conformity assessment - General requirements foraccreditation bodies accrediting conformity assessmentbodies (ISO/IEC 17011:2004)16/06/2009OJ C 136 -16/06/2009- -31/12/2020OJ C 092 -09/03/2018Legislationreference(A)ESO(B)Reference number of thestandard (C)Title of the standard(D)presumption of conformity (1) for publicationin OJ(2) Restriction(3) presumption of conformity with restriction (4) for publicationof a restrictionin OJ(5)from OJ (endof presumption of conformity)(6) for withdrawalfrom OJ (7)765/2008 CEN EN ISO/IEC 17011:2017 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017)09/03/2018 OJ C 092 - 09/03/2018 - - -765/2008 CEN EN ISO/IEC 17020:2012 Conformity assessment - Requirements for the operation of various types of bodies performing inspection (ISO/IEC 17020:2012)25/05/2012 OJ C 149 - 25/05/2012 - - - 765/2008 CEN EN ISO/IEC 17021:2011 Conformity assessment - Requirements for bodiesproviding audit and certification of management systems (ISO/IEC 17021:2011)05/10/2011 OJ C 292 - 05/10/2011 - - 08/07/2017OJ C 412 -11/12/2015765/2008 CEN EN ISO/IEC 17021-1:2015 Conformity assessment - Requirements for bodiesproviding audit and certification of management systems - Part 1: Requirements (ISO/IEC 17021-1:2015)11/12/2015 OJ C 412 - 11/12/2015 - - -765/2008 CEN EN ISO/IEC 17024:2012 Conformity assessment - General requirements for bodies operating certification of persons (ISO/IEC 17024:2012) 07/09/2013 OJ C 258 - 07/09/2013 - - - 765/2008 CEN EN ISO/IEC 17025:2005,EN ISO/IEC17025:2005/AC:2006 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)16/06/2009 OJ C 136 - 16/06/2009 - - 01/07/2021OJ L 408 - 04/12/2020765/2008 CEN EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017) 09/03/2018 OJ C 092 - 09/03/2018 - - -765/2008 CEN EN ISO/IEC 17029:2019 Conformity Assessment - General principles and requirements for validation and verification bodies (ISO/IEC 17029:2019)04/12/2020 OJ L 408 - 04/12/2020 - - -765/2008 CEN EN ISO 17034:2016 General requirements for the competence of reference material producers (ISO 17034:2016)08/09/2017 OJ C 298 - 08/09/2017 - - -765/2008 CEN EN ISO/IEC 17040:2005 Conformity assessment - General requirements for peer assessment of conformity assessment bodies and accreditation bodies (ISO/IEC 17040:2005)16/06/2009 OJ C 136 - 16/06/2009 - - -765/2008 CEN EN ISO/IEC 17043:2010 Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010)28/11/2013 OJ C 348 - 28/11/2013 - - -765/2008 CEN EN ISO/IEC 17050-1:2010 Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004, corrected version 2007-06-15) 05/10/2011 OJ C 292 - 05/10/2011 - - -765/2008 CEN EN ISO/IEC 17050-2:2004 Conformity assessment - Supplier's declaration ofconformity - Part 2: Supporting documentation (ISO/IEC 17050-2:2004)16/06/2009 OJ C 136 - 16/06/2009 - - -765/2008 CEN EN ISO/IEC 17065:2012 Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065:2012)07/09/2013 OJ C 258 - 07/09/2013 - - -765/2008 CEN EN ISO/IEC 17067:2013 Conformity assessment - Fundamentals of product certification and guidelines for product certification schemes (ISO/IEC 17067:2013)12/02/2016 OJ C 054 - 12/02/2016 - - - 765/2008 CEN EN ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing (ISO 19011:2002)16/06/2009 OJ C 136 - 16/06/2009 - - 31/05/2012OJ C 149 - 25/05/2012 765/2008 CEN EN ISO 19011:2011Guidelines for auditing management systems (ISO 19011:2011)25/05/2012OJ C 149 - 25/05/2012- - 01/01/2021OJ L 263 -16/10/2019Legislation reference(A) ESO(B)Reference number of thestandard(C)Title of the standard(D)Date of start ofpresumption ofconformity(1)OJreferenceforpublicationin OJ(2)Restriction(3)Date of start ofpresumption ofconformity withrestriction(4)OJ referencefor publicationof a restrictionin OJ(5)Date ofwithdrawalfrom OJ (endof presumptionof conformity)(6)OJreferenceforwithdrawalfrom OJ(7)765/2008 CEN ENISO19011:2018 Guidelines for auditing management systems (ISO19011:2018)16/10/2019OJ L 263 -16/10/2019- - -765/2008 CEN ENISO22870:2006 Point-of-care testing (POCT) - Requirements for qualityand competence (ISO 22870:2006)05/10/2011OJ C 292 -05/10/2011- -30/11/2019OJ C 076 -10/03/2017765/2008 CEN ENISO22870:2016 Point-of-care testing (POCT) - Requirements for qualityand competence (ISO 22870:2016)10/03/2017OJ C 076 -10/03/2017- - -765/2008 CEN ENISO15189:2007 Medical laboratories - Particular requirements for qualityand competence (ISO 15189:2007)05/10/2011OJ C 292 -05/10/2011- -30/11/2015OJ C 074 -13/03/2013765/2008 CEN ENISO/IEC17020:2004 General criteria for the operation of various types of bodiesperforming inspection (ISO/IEC 17020:1998)16/06/2009OJ C 136 -16/06/2009- -01/03/2015OJ C 149 -25/05/2012765/2008 CEN ENISO/IEC17024:2003 Conformity assessment - General requirements for bodiesoperating certification of persons (ISO/IEC 17024:2003)16/06/2009OJ C 136 -16/06/2009- -01/07/2015OJ C 258 -07/09/2013765/2008 CEN EN45011:1998 General requirements for bodies operating productcertification systems (ISO/IEC Guide 65:1996)16/06/2009OJ C 136 -16/06/2009- -15/09/2015OJ C 258 -07/09/2013Column legendReference information on legislation and standards(A) Reference number of a relevant Directive or Regulation under which it was published in the OJ(B) European standardisation organisation that adopted the relevant standard(C) Reference number of a relevant European standard or of a European standard and its amendment(s)(D) Title of a European standardDates and OJ references for establishing a presumption of conformity(1) Date when a presumption of conformity starts or started in cases where a reference was published in the OJ without restriction. This date is usually, but not always, the same as the OJ reference datein column (2)(2) Reference number and date of a relevant publication in the L or C series of the OJ in cases where a reference was published in the OJ without restrictionDates and OJ references for establishing a presumption of conformity with restriction(3) Restriction published in the OJ to restrict a presumption of conformity – this includes restrictions on the basis of formal objections(4) Date when a presumption of conformity with restriction starts or started in cases where a reference was published in the OJ with restriction. This date is usually, but not always, the same as the datein column (5)(5) Reference number and date of a relevant publication in the L or C series of the OJ in cases where a reference was published in the OJ with restrictionDates and OJ references for ending a presumption of conformity(6) Date when a presumption of conformity ends or ended(7) Reference number and date of a relevant publication in the L or C series of the OJ where the date of withdrawal from the OJ (date in column (6)) was published。

特拉华欺负受害量表(学生卷)中文版信、效度研究

欺负行为对受欺负者的身心健康具有很大的伤害性。研究表明校园受欺负对儿童身心健康有着多方面的消极影响。 [2] 例如，受欺负青少年报告了更多的内向性问题行为，如焦虑、抑郁和退缩[3] ；他们还有更多的药物使用问题[4] ，甚至产生自杀念头和行为[5，6] 。受欺负儿童的抑郁、焦虑水平要高于一般儿童（未受欺负的儿童），且受欺负程度正向预测受欺负儿童的抑郁、焦虑水平，受欺负程度越高，抑郁、焦虑水平越高[7]。
中国临床心理学杂志 2015 年第 23 卷第 4 期
表 1 各年级抽样分布情况
年级 6 年级 7 年级 8 年级 9 年级高一高二高三男女样本一 123 204 161 170 189 190 175 570 642 样本二 230 152 196 160 160 171 162 624 607
中图分类号：R395.1
DOI: 10.16128/ki.1005-3611.2015.04.006
Reliability and Validity of the Chinese Version of Delaware Bullying Victimization Scale-student
（1.湖南师范大学教育科学学院，长沙 410081；2.University of Delaware，Newark， DE 19716；3.Middle Tennessee State University，Murfreesboro，TN 37132）
【摘要】目的：检验特拉华欺负受害量表（学生卷）（DBVS-S）中文版在中国青少年中的信度和效度。方法：应用中文版 DBVS-S 对湖南省 4 个地区 10 所学校小学六年级至高三 2443 名学生施测，以流调中心抑郁量表（CES-D）、学生生活满意度量表（SLSS）和 Olweus 儿童欺负问卷（BVQ）为效标，测评效标关联效度，随机抽取其中 2 个班计 117 名被试间隔 4 周后重测。结果：①DBVS-S 中文版维度结构与原量表一致，探索性因素分析和验证性因素分析均支持三因子结构模型；②DVBS-S 中文版总分与 CES-D 和 BVQ 的相关系数分别为 0.360 和 0.766（P<0.001)，与 SLSS 的相关系数为-0.184（P<0.001)；③总量表α系数为 0.839，4 周后的重测相关系数为 0.684。结论：特拉华欺负受害量表（学生卷）中文版具有较好的信效度。【关键词】特拉华欺负受害量表；信度；效度；心理测量学研究

世界健康调查项目中国预调查重测信度分析

情景内容健康状况描述
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m i= 1 m
Ri S2 R
i
1 2 i= 1 S R
( 4)
i i
公式 4 C 值 , S 2 R 是它的方差。
中国公共卫生 2006 年 3 月第 22 卷第 3 期
Chin J Public Health Mar 2006 Vol . 22 No. 3
283
11 3 析。 2 21 1

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