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EN 10216-2
EUROPEAN STANDARD NORME EUROP ÉENNE EUROP ÄISCHE NORMEN 10216-2May 2002+ A1March 2004ICS 23.040.10; 77.140.75English versionSeamless steel tubes for pressure purposes -Technical delivery conditions - Part 2: Non-alloy and alloy steel tubes with specifiedelevated temperature properties (including amendment A1:2004)Tubes sans soudure en acier pour service sous pression - Conditions techniques de livraison - Partie 2: Tubes en acier non alli é et alli é avec caract éristiques sp écifi ées àtemp érature élev ée(·nclut l amendement A1:2004)Nahtlose Stahlrohre f ür Druckbeanspruchungen - Technische Lieferbedingungen - Teil 2: Rohre aus unlegierten und legierten St ählen mit festgelegtenEigenschaften bei erh öhten Temperaturen(enth ält Änderung A1:2004)This European Standard was approved by CEN on 25 April 2002; amendment A1 was approved by CEN on 2 January 2004.CEN 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 Management Centre or to any CEN 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 CEN member into its own language and notified to the Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T É E U RO P ÉE N D E N O R M A LI S A T I O N E UR O P ÄIS CH E S K O M I T E E F ÜR N O RM U N GManagement Centre: rue de Stassart, 36 B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN 10216-2:2002 + A1:2004 EEN 10216-2:2002 (E)2ContentsForeword.....................................................................................................................................................................3 1 SCOPE............................................................................................................................................................4 2 NORMATIVE REFERENCES.........................................................................................................................4 3 TERMS AND DEFINITIONS...........................................................................................................................5 4 SYMBOLS.......................................................................................................................................................5 5 CLASSIFICATION AND DESIGNATION.......................................................................................................6 5.1 Classification.................................................................................................................................................6 5.2 Designation....................................................................................................................................................6 6 INFORMATION TO BE SUPPLIED BY THE PURCHASER..........................................................................6 6.1 Mandatory information .................................................................................................................................6 6.2 Options...........................................................................................................................................................7 6.3 Examples of an order....................................................................................................................................7 7 MANUFACTURING PROCESS......................................................................................................................8 7.1 Steel making process ...................................................................................................................................8 7.2 Deoxidation process.....................................................................................................................................8 7.3 Tube manufacture and delivery conditions................................................................................................8 8 REQUIREMENTS ...........................................................................................................................................8 8.1 General...........................................................................................................................................................8 8.2 Chemical composition..................................................................................................................................9 8.3 Mechanical properties ................................................................................................................................13 8.4 Appearance and internal soundness........................................................................................................18 8.5 Straightness.................................................................................................................................................18 8.6 Preparation of ends.....................................................................................................................................18 8.7 Dimensions, masses and tolerances........................................................................................................19 9 INSPECTION.................................................................................................................................................24 9.1 Types of inspection.....................................................................................................................................24 9.2 Inspection documents................................................................................................................................24 9.3 Summary of inspection and testing..........................................................................................................24 10 SAMPLING....................................................................................................................................................25 10.1 Frequency of tests ......................................................................................................................................25 10.2 Preparation of samples and test pieces ...................................................................................................26 11 TEST METHODS..........................................................................................................................................27 11.1 Chemical analysis.......................................................................................................................................27 11.2 Tensile test...................................................................................................................................................27 11.3 Flattening test..............................................................................................................................................28 11.4 Ring tensile test...........................................................................................................................................29 11.5 Drift expanding test.....................................................................................................................................29 11.6 Ring expanding test....................................................................................................................................30 11.7 Impact test....................................................................................................................................................30 11.8 Leak tightness test......................................................................................................................................31 11.9 Dimensional inspection..............................................................................................................................32 11.10 Visual examination......................................................................................................................................32 11.11 Non-destructive testing..............................................................................................................................32 11.12 Material identification .................................................................................................................................32 11.13 Retests, sorting and reprocessing............................................................................................................32 12 MARKING .....................................................................................................................................................33 12.1 Marking to be applied .................................................................................................................................33 12.2 Additional marking......................................................................................................................................33 13PROTECTION (33)Annex A (Informative) Creep rupture strength values........................................................................................34 Annex ZA (informative)............................................................................................................................................39 Bibliography (Informative).......................................................................................................................................40EN 10216-2:2002 (E)3ForewordThis document (EN 10216-2:2002) has been prepared by Technical Committee ECISS/TC 29, "Steel tubes and fittings for steel tubes", the secretariat of which is held by UNI.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2002, and conflicting national standards shall be withdrawn at the latest by November 2002.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document. Other Parts of EN 10216 are:Part 1: Non-alloy steel tubes with specified room temperature properties. Part 3 : Alloy fine grain steel tubesPart 4 : Non-alloy and alloy steel tubes with specified low temperature properties Part 5 : Stainless steel tubesAnother European Standard series covering tubes for pressure purposes is: EN 10217:Welded steel tubes for pressure purposesAccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.Foreword to amendment A1This document (EN 10216-2:2002/A1:2004) has been prepared by Technical Committee ECISS/TC 29 "Steel tubes and fittings for steel tubes", the secretariat of which is held by UNI.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2004, and conflicting national standards shall be withdrawn at the latest by September 2004.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 97/23/EC.For relationship with EU Directive 97/23/EC, see informative annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and UnitedKingdom.EN 10216-2:2002 (E)41 SCOPEThis Part of EN 10216 specifies the technical delivery conditions in two test categories for seamless tubes of circular cross section, with specified elevated temperature properties, made of non-alloy and alloy steel.NOTE This Part of EN 10216 may also be applied for tubes of non-circular cross section; necessary modification should be agreed a the time of enquiry and order.2 NORMATIVE REFERENCESThis European Standard incorporates by date or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For date references, subsequent amendments to or revisions of, any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments).The requirements of this European Standard rule when they differ from those in the standards and documents referred to below:EN 10002-1, Metallic materials - Tensile testing - Part 1: Method of test (at ambient temperature). EN 10002-5, Metallic materials - Tensile testing - Part 5: Method of testing (at elevated temperature). EN 10020, Definitions and classification of grades of steel.EN 10021, General technical delivery requirements for steel and iron products. EN 10027-1, Designation systems for steels - Part 1 : Steel names, principle symbols.. EN 10027-2, Designation systems for steels - Part 2: Numerical systems. EN 10045-1, Metallic materials - Charpy impact test - Part 1: Test method. EN 10052, Vocabulary of heat treatment terms for ferrous products. EN 10204, Metallic products - Types of inspection documents.ENV 10220, Seamless and welded steel tubes - Dimensions and masses per unit length EN 10233, Metallic materials - Tubes - Flattening test. EN 10234, Metallic materials - Tubes - Drift expanding test. EN 10236, Metallic materials - Tubes - Ring expanding test. EN 10237, Metallic materials - Tubes - Ring tensile test.EN 10246-1, Non-Destructive Testing of steel tubes Part 1 : Automatic electromagnetic testing of seamless and welded (except submerged arc welded) ferromagnetic steel tubes for verification of hydraulic leak-tightness. EN 10246-5,Non-Destructive Testing of steel tubes Part 5: Automatic full peripheral magnetic transducer/flux leakage testing of seamless and welded (except submerged arc-welded) ferromagnetic steel tubes for the detection of longitudinal imperfections.EN 10246-6, Non-Destructive Testing of steel tubes - Part 6: Automatic full peripheral ultrasonic testing of seamless steel tubes for the detection of transverse imperfections.EN 10216-2:2002 (E)5EN 10246-7, Non-Destructive Testing of steel tubes - Part 7 : Automatic full peripheral ultrasonic testing of seamless and welded (except submerged arc welded) steel tubes for the detection of longitudinal imperfections. EN 10246-14, Non-Destructive Testing of steel tubes - Part 14:Automatic ultrasonic testing of seamless and welded (except submerged arc welded) steel tubes for the detection of laminar imperfections.EN 10256, Non-Destructive Testing of steel tubes - Qualification and competence of level 1 and level 2 NDT personnel.EN ISO 377, Steel and steel products - Location and preparation of samples and test pieces for mechanical testing (ISO 377:1997)prEN 101681) , Iron and steel products - Inspection documents - List of information and description.prEN 102661), Steel tubes, fittings and structural hollow sections - Symbols and definition of terms for use in product standardsEN ISO 2566-1, Steel - Conversion of elongation values Part 1: Carbon and low-alloy steels (ISO 2566-1:1984) ISO 14284, Steel and iron - Sampling and preparation of samples for the determination of chemical composition CR 10260, Designation systems for steel - Additional symbolsCR 10261, ECISS Information Circular IC 11 - Iron and steel - Review of available methods of chemical analysis.3 TERMS AND DEFINITIONSFor the purposes of this Part of EN 10216, the terms and definitions given in EN 10020, EN 10021, EN 10052 and prEN 10266 and the following apply:3.1test categoryclassification that indicates the extent and level of inspection and testing 3.2employerorganisation for which a person works on a regular basis.NOTE The employer may be either the tube manufacturer or supplier or a third party organisation providing, Non-Destructive Testing (NDT) services.4 SYMBOLSFor the purpose of this Part of EN 10216, the symbols given in prEN 10266 and the following apply:d specified inside diameter;d min specified minimum inside diameter; T min specified minimum wall thickness; D c calculated outside diameter; d ccalculated inside diameter;1) In preparation; until this document is published as a European Standard, the corresponding national standard(s) should be agreed at the time of enquiry and order.EN 10216-2:2002 (E)6T c calculated wall thickness; TCtest category5 CLASSIFICATION AND DESIGNATION5.1 ClassificationIn accordance with the classification system in EN 10020, the steel grades P195GH, P235GH and P265GH are classified as non-alloy quality steels and the other steel grades are classified as alloy special steels.5.2 Designation5.2.1For the tubes covered by this Part of EN 10216 the steel designation consists of:the number of this Part of EN 10216; plus either:the steel name in accordance with EN 10027-1 and CR 10260; or:the steel number allocated in accordance with EN 10027-2. 5.2.2The steel name of non-alloy steel grades is designated by:the capital letter P for pressure purposes;the indication of the specified minimum yield strength at room temperature for wall thickness less than or equal to 16 mm, expressed in MPa (see Table 4): the symbols GH for elevated temperature.5.2.3 The steel name of alloy steel grades is designated by the chemical composition (see Table 2) and the symbols for the heat treatment, where specified in column 3 and footnote 3 of Table 1.6 INFORMATION TO BE SUPPLIED BY THE PURCHASER6.1 Mandatory informationThe following information shall be supplied by the purchaser at the time of enquiry and order: a) the quantity (mass or total length or number); b) the term "tube";c) the dimensions (outside diameter D and wall thickness T or a set of dimensions covered by Option 11) (seeTable 6); d) the designation of the steel grade in accordance with this Part of EN 10216 (see 5.2); e)the test category for non-alloy steel (see 9.3).EN 10216-2:2002 (E)76.2 OptionsA number of options are specified in this Part of EN 10216 and these are listed below. In the event that the purchaser does not indicate a wish to implement any of these options at the time of enquiry and order, the tubes shall be supplied in accordance with the basic specification (see 6.1).1) Cold finishing (see 7.3.2).2) Restriction on copper and tin content (see Table 2). 3) Product analysis (see 8.2.2). 4) Impact testing (see Table 4).5) Longitudinal impact testing at -10° C for non-alloy steel grades (see Table 4). 6) Tensile testing at elevated temperature (see 8.3.2). 7) Selection of leak-tightness test method (see 8.4.2.1).8) Non-Destructive Testing for test category 2 tubes for detection of transverse imperfections (see 8.4.2.2).9) Non-Destructive Testing for test category 2 tubes for detection of laminar imperfections (see 8.4.2.2). 10) Special ends preparation (see 8.6).11) Set of dimensions other than D and T (see 8.7.1). 12) Exact lengths (see 8.7.3).13) The type of inspection document other than the standard document (see 9.2.1). 14) Test pressure for hydrostatic leak-tightness test (see 11.8.1). 15) Wall thickness measurement away from the ends (see 11.9). 16) Non-Destructive Testing method (see 11.11.1). 17) Additional marking (see 12.2). 18)Protection (see 13).6.3 Examples of an order6.3.1 Example 1100 t of seamless tube with an outside diameter of 168,3 mm, a wall thickness of 4,5 mm, in accordance with EN 10216-2, made of steel grade P265GH, to test category 1 with a 3.1.C inspection certificate in accordance with EN 10204:100 t - Tube - 168,3 x 4,5 - EN 10216-2 - P265GH - TC1 - Option 13: 3.1.C6.3.2 Example 2100 m of seamless tube with a minimum inside diameter of 240 mm, a minimum wall thickness of 40 mm in accordance with Part of EN 10216, made of steel grade 10CrMo9-10, with a 3.1.C inspection certificate in accordance with EN 10204:100 m - Tube - d min 240 x T min40 - EN 10216-2 - 10CrMo9-10 - Option 13: 3.1.CEN 10216-2:2002 (E)87 MANUFACTURING PROCESS7.1 Steel making processThe steel making process is at the discretion of the manufacturer.7.2 Deoxidation processSteels shall be fully killed.7.3 Tube manufacture and delivery conditions7.3.1 All NDT activities shall be carried out by qualified and competent level 1,2 and/or 3 personnel authorised to operate by the employer.The qualification shall be in accordance with EN 10256 or, at least, an equivalent to it.It is recommended that the level 3 personnel be certified in accordance with EN 473 or, at least, an equivalent to it.The operating authorisation issued by the employer shall be in accordance with a written procedure. NDT operations shall be authorised by level 3 NDT individual approved by the employer.NOTEThe definition of level 1, 2 and 3 can be found in appropriate Standards, e.g. EN 473 and prEN 102567.3.2 The tubes shall be manufactured by a seamless process.Unless option 1 is specified, the tubes may be either hot or cold finished at the discretion of the manufacturer. The terms hot finished and cold finished apply to the condition of the tube before it is heat treated in accordance with7.3.3.Option 1: The tubes shall be cold finished before heat treatment. 7.3.3The tubes shall be supplied in the relevant heat treatment conditions as specified in Table 1.8 REQUIREMENTS8.1 GeneralWhen supplied in a delivery condition indicated in clause 7.3 and inspected in accordance with clauses 9, 10 and 11, the tubes shall conform to the requirements of this Part of EN 10216.In addition, the general technical delivery requirements specified in EN 10021 shall apply.Tubes shall be suitable for hot and cold bending provided the bending is carried out in an appropriate manner. When tubes are specified in the order by d, d min or T min the following equations, with all terms in mm, shall apply for the calculation of outside diameter D c , inside diameter d c and wall thickness T c , instead of D, d and T for the relevant requirements in clauses 8.4.1.4, 10.2.2.2, 11.3, 11.8.1, 11.9, 11.11.4, 12.1 and Table 1, footnote c, Tables 4, 5, 8, 10, 13 and 14: D c =T d2(1)D c = T d of tolerance d 22minmin(2)EN 10216-2:2002 (E)9d c = 2minmind of toleranced(3)T c = 2minminT of toleranceT(4)For tolerance see Tables 8, 9 and 10.8.2 Chemical composition8.2.1 Cast analysisThe cast analysis reported by the steel producer shall apply and conform to the requirements of Table 2.NOTE When welding tubes produced in accordance with this Part of this EN 10216, account should be taken of the fact that the behaviour of the steel during and after welding is dependent not only on the steel, but also on the applied heat treatment and the conditions of preparing for and carrying out the welding.8.2.2 Product analysisOption 3 : Product analysis for the tubes shall be supplied.Table 3 specifies the permissible deviations of the product analysis from the specified limits on cast analysisgiven in Table 2.EN 10216-2:2002 (E)10Table 1 Heat treatment conditions Steel grade Heattreatment aAustenizing Tempering SteelnameSteelnumberTemperature°CCoolingMediumTemperature°CCoolingmedium P195GH 1.0348 +N b880 to 940 Air - -P235GH 1.0345 +N b880 to 940 Air - -P265GH 1.0425 +N b880 to 940 Air - - 20MnNb6 1.0471 +N b900 to 960 Air - - 16Mo3 1.5415 +N b890 to 950 Air - -8MoB5-4 1.5450 +N b920 to 960 Air - - 14MoV6-3 1.7715 +NT b c930 to 990 Air 680 to730 air 10CrMo5-5 1.7338 +NT b c900 to 960 Air 650 to 750 air 13CrMo4-5 1.7335 +NT b c900 to 960 Air 660 to 730 air 10CrMo9-10 1.7380 +NT b c900 to 960 Air 680 to 750 air 11CrMo9-10 1.7383 +QT 900 to 960 Air or Liquid 680 to 750 air 25CrMo4 1.7218 +QT 860 to 900 Air or Liquid 620 to 680 air 20CrMoV13-5-5 1.7779 +QT 980 to 1030 Air or Liquid 680 to 730 air 15NiCuMoNb5-6-4 1.6368 +NT c880 to 980 Air 580 to 680 airX11CrMo5+I 1.7362+I +I 890 to 950 FurnaceAtmosphere- -X11CrMo5+NT1 1.7362+NT1 +NT1 930 to 980 Air 730 to 770 airX11CrMo5+NT2 1.7362+NT2 +NT2 c930 to 980 air 710 to 750 airX11CrMo9-1+I 1.7386+I +I 950 to 980 FurnaceAtmosphere- -X11CrMo9-1+NT 1.7386+NT +NT c890 to 950 air 720 to 800 airX10CrMoVNb9-1 1.4903 +NT c1040 to 1090 air 730 to 780 airX20CrMoV11-1 1.4922 +NT c1020 to 1080 air 730 to 780 aira+N = Normalising, +NT = Normalising + Tempering, +QT = Quenching + Tempering (air or liquid), +I = Isothermal Annealing.b Normalising includes Normalising Forming.c For these steel grades it may be necessary in the case of wall thickness T above 25 mm or T/D > 0,15 to apply quenching and tempering in order to achieve the intended structure and material properties . The decision shall be left to the discretion of the manufacturer but shall be stated to the customer at the time of enquiry and order. Steel tubes treated in such a way shall be designated by the steel name supplemented by the symbol +QT .EN 10216-2:2002 (E)13Table 3 Permissible deviations of the product analysis from specified limits on cast analysis given in Table 2Element Limiting value for the cast analysis in accordance with Table 2 % by massPermissible deviation of the product analysis% by mass C0,29 0,02 0,400,05 Si 0,40 to 1,000,06 1,000,05 Mn 1,00 to 1,500,10 P 0,025+ 0,005 0,010+ 0,003 S 0,010 0,020+ 0,005 Al 0,0600,005 B0,0060,001 1,000,05 1,00 to 10,000,10 Cr 10,00 to 12,500,15 Cu0,80 0,05 0,35 0,03 Mo0,35 to 1,20 0,04 N0,070 0,01 Nb0,10 0,005 0,35 0,05 Ni0,35 to 1,30 0,07 Ti0,060 + 0,010 0,10+ 0,01 V 0,10 to 0,55 0,03 8.3 Mechanical properties8.3.1 Mechanical properties at and below room temperatureThe mechanical properties at and below room temperature of the tubes shall conform to the requirements in Table 4 and in clauses 11.3, 11.4, 11.5 and 11.6.8.3.2 Proof strength at elevated temperatureThe minimum proof strength R p0,2 values at elevated temperature are given in Table 5.Option 6: Proof strength R p0,2 shall be verified. The test temperature shall be specified at the time of enquiry and order.。
粉体颗粒状态与流动性的关系
摘要本文以粉体颗粒状态与流动性的关系为研究重点,采用粉体特性综合测试仪,分别测试了8个粉体样品的休止角、平板角、松装密度、振实密度、分散度等参数,得到样品的Carr流动性指数,评价了8个样品的流动性;通过激光粒度分析仪测了粉体的平均径、中位径、峰值径以及累积百分率处粒子的粒径以及粒径分布;用图形图像分析仪测试分析了样品的粒形。
对样品的流动性与粉体粒形、粒径及其颗粒分布的关系进行了分析。
分析结果表明,8个样品流动性好坏依次为:2号>1号>4号>5号>3号>6号>8号>7号。
粉体的流动性与颗粒的球形度成正比,球形度越大,流动性越好。
8个样品中2号球形度最大、流动性最好,7号球形度最小,流动性最差。
关键词:粉体流动性Carr指数粒形粒径abstractThis paper focuses on the research of the relationship between the powder particles state and liquidity, and respectively tests the angle of repose, flat angle, apparent density, tap density and dispersion and other parameters of eight samples. Carr index table is referred and Carr indexes are obtained. The liquidity performance of the eight samples in sequence is: No.2 > No.1 >No.4 > No.5 > No.3 >No.6 > No.8 > No. 7. The median diameter, the number average diameter and the cumulative percentage of the particle size and size distribution of particles of the powder are measured by laser particle size analyzer. Besides, the particle shape of the sample is tested by image analyzer and analyzed. The results show that the liquidity of powder is in direct proportion to the spherical degree of particle, namely, the greater the spherical degree is, and the better liquidity is. In the eight samples, spherical degree of No. 2 is the largest and its liquidity is the best; spherical degree of No. 7 is the smallest and its liquidity is the worst.Keywords: Powder; Liquidity; Carr Index; Particle Shape; Particle Size目录摘要 (I)abstract (II)0 引言 (1)0.1 研究背景 (1)0.2 粉体流动性的表征方法 (1)0.3 粉体流动性的影响因素 (2)1.实验样品与实验方法 (4)1.1实验样品 (4)1.2实验方案 (4)1.3 试验仪器 (4)1.3.1 BT-1000粉体特性综合测试仪 (4)1.3.1.1测试原理 (4)1.3.1.2测试方法 (5)2.实验结果与分析 (7)2.1粉体carr指数的测定及结果分析 (7)2.1.1流动指数分析 (7)2.1.2压缩度分析 (7)2.2激光粒度分析 (8)2.3粉体的粒形测试及流动性分析 (8)结论 (15)致谢 (16)参考文献 (17)0 引言0.1 研究背景所谓粉体,是由不连续的微粒构成,是一类特殊的固体,同时具有液态和固态的性质。
2007粉末注射成形PIM会议在美国佛罗里达召开
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2007 粉末注射成形( PIM) 会议在美国佛罗里达召开
中图分类号 : TF1241 35 文献标识码 :D 上个月在美国佛罗里达召开了 “PIM2007” 会议 , 美国金属粉末工业联合会金属注射成形协会的主席 Mat2 t hew Bulger 先生在会上发表对北美粉末注射成形市场的评论时说 “虽然北美金属注射成形产业增长的速度慢 : 于亚洲和欧洲 ,不过现在金属注射成形协会会员企业对这一行业的信心在过去的几年里持续增加 ,2006 年北美 金属注射成形产业对新设备的定单增加了 ,金属注射成形产业从业人员的职业信心增强了” 。2006 年北美地区 金属注射成形零件产品的销售额为 11 75 亿美元 , 而 2003 年北美地区的销售额只有约 1 亿美元 , 虽然低于预期 的增长 , 但 Mat thew Bul ger 认为这个增长速度还是可以接受的。北美地区粉末注射成形制品的主要市场在医 疗器械制造领域 ,约占北美地区粉末注射成形制品市场总份额的 36 % 。五金制品 Matt hew Bul ger 先生认为 , 2008 年美国粉末注射成形制品在医疗器械制造领域的市场会进一步增长 ,仍会是北美粉末注射成形制品市场 最盈利 , 并占据市场统治地位的产品 ,他预计 2009 年北美的情况也基本是这样 。 Mat t hew B ulger 先生将导致北美粉末注射成形制品市场增长的因素归结为 : 新材料的开发 , 更严格的 公差控制 ,节约了能源和原材料 , 以及工程师的技术水平普遍得到了提高等 。根据一份对注射成形协会会员 企业的调查 : 现在人们对粉末注射成形技术和其应用的了解更多了。人们对粉末注射成形知识的增加也可 部分归结为粉末注射成形产业的高速增长 。M att hew B ulger 认为还有很长的路要走 ,需要开发新材料 , 进 一步降低生产费用。为了达到公差控制的标准仍有一些问题有待解决 , 为了制订有关标准人们已经忙碌了 多年 ,这项工作仍需要完善 。一份对金属注射成形企业会员的统计材料表明 :所有的回答者均对研究开发的 成果感兴趣 , 但很少有人会投资搞开发 。现在在粉末注射成形领域研究开发的方向主要是 : 钛金属 、 功能梯 度材料 、 低成本金属粉末 、 新型合金及提高粉末注射成形零件产品的质量等 。我们的责任是做一些行业基础 工作 ,这也是美国金属粉末工业联合会支持粉末冶金行业研究开发和市场开拓工作的一部分。 Yoshi yuki Kato 发表了一份关于亚太地区金属注射成形制品生产状况的论文 , Yoshiyuki Kat o 对亚太 地区国家金属注射成形市场分别进行了分析。200 6 年在日本有约 30 个生产金属注射成形制品的公司 , 金 属 注射成形制品的市场规模约为 1 1 3 亿美元 , 产品的主要应用领域集中于汽车制造 。 金属注射成形制品在 (下转第 4 5 页 )
2020年美国芝加哥国际表面处理和涂层展会SurfaceTechnology USA
2020年美国芝加哥国际表面处理和涂层展会SurfaceTechnology USA展会介绍展会时间:2020年09月14日举办周期:两年一届主办单位:德国汉诺威展览公司Deutsche Messe AG , Hannover展会地址:美国-芝加哥-芝加哥迈考密会展中心McCormick Place展会详情美国芝加哥表面处理和涂层展会SurfaceTechnologyUSA是国际上表面处理和涂层技术最专业的展览会。
SurfaceTechnologyUSA展览的主要内容是电镀,清洗,预表面涂装技术,工业等离子表面处理,纳米技术,纺织材料,测量,测试和分析设备等。
SurfaceTechnologyUSA展汇集了所有的表面处理技术和方法,是推动表面处理、表面光洁度和表面涂层的发展。
展会展示了广阔的市场覆盖面创造了表面处理技术和应用的所有供应商的理想的营销环境。
此外,美国制造技术展会IMTS、美国集成自动化及动力传动展会IAMD、美国工业零配件与分承包展会、美国空压及真空技术展会和美国表面处理展会同时在美国芝加哥迈考密会展中心McCormickPlace同期举办这样为参展商和观众创造了双赢的平台,将吸引更多专业人士参观,对于参观者来说,他只需要来到一个展览场地,在同一时间获取相关行业的宝贵信息,对于参展商来说,他们获得了更广泛的目标客户资源。
展品范围金属表面的清洁和预处理:表面清洁和预处理设备(铬酸盐处理设备;使用有机溶剂去油和清洁设备;使用水溶剂去油和清洁设备;使用散体单元处理用振动设备;去除薄膜和油漆用流化设备;表面清洁用激光设备;钝化设备;磷化处理设备;酸洗设备;表面清洁用等离子系统;喷砂处理表面硬化用设备;超声波设备;蒸汽喷砂处理设备;表面清洁和预处理设备附件);表面清洁和预处理用辅料(铬酸盐处理剂;清洁和去油剂;去垢剂;湿润剂、清洁剂、添加剂;磷化剂;酸洗剂;蒸汽喷砂用研磨材料;防腐蚀表面保护剂) 金属产品热处理和表面热化学处理:涂层材料、涂层和辅助材料;金属产品深度热处理和热化学表面处理用设备(热处理操作用热炉和装置;冷却用和洗涤变化物用设备(容器、液体容器及其它);电感应加热器;设备用辅助配件);热处理和热化学表面处理技术(非扩散性表面处理;扩散性表面处理;扩散性金属化处理;热喷涂技术与设备;电火花喷涂应用技术;等离子技术;薄膜科技;CVD(化学气相沉积)技术;PVD(物理气相沉积)技术;聚束技术;离子注入技术;电子技术;激光技术;爆炸技术;热处理机械化与自动化生产线) 电镀技术:电解电镀;电解技术用化学品;电解技术设备(离心机;配料设备;空气和排放物净化系统和设备;过滤器;装载和卸载设备;大规模电镀用设备;开路控制系统;再生系统;整流和电极开关系统;其他);电解技术用化学和电解系统上漆及施加塑料和橡胶涂层:涂层和涂层材料(电沉积喷涂用涂料;涂层烧结和上漆颜料;溶剂涂料和油漆;水性涂料和油漆;低溶剂含量的涂料和油漆;粉剂涂料;丙烯酸有机硅涂料;油质清漆;橡胶涂料;塑料涂层);施加涂层用的设备(手持和自动喷枪;喷涂房、密闭室、过滤墙;上漆及施加塑料和橡胶涂层的自动化设备;上漆及施加塑料和橡胶涂层的完整喷涂系统;上漆及干燥台;沉浸式涂漆机器与设备;沉浸式涂漆用电镀设备;镀膜机器;流动涂附设备;施加塑料及橡胶用机器;粉末喷涂设备;丝网印刷机;喷涂机;真空浸渍设备;镀膜烧结设备);提供材料和辅助的设备(上漆准备用设备;过滤器和过滤设备;材料循环设备;辅料配料设备;压力池;辅料泵);吸收、分离和恢复涂层材料和溶剂的设备;干燥设备(离心干燥机;对流干燥机;电子干燥机;上釉炉;辐射干燥机;紫外线干燥机;真空干燥设备;排水装置) 精细表面处理:附件和辅助设备(工艺刷;打磨抛光膏、乳剂、酸保护剂;抛光用技术设备;清洗机械);精细处理设备(光亮设备;氧化设备;擦拭设备;磨钝尖锐边缘、打磨和抛光设备;喷砂机;标志漆涂层用机器;产品表面光化学硬化设备) 表面处理的其他设备:热交换;冷却机器与设备;通风系统;喷丸加工设备;测量和监控设备、研究设备:研究设备;供应实验室产品;测量和监控设备。
粉体的基本性质及功能
粉体的基本性质及功能《营销界•化妆品观察》2011年1月27日作者:裴廷镐【小中大】彩妆按照分散技术不同,可分类为粉体(powder)彩妆、乳化彩妆、油分散彩妆。
粉体的作用是,为化妆品赋予色调,或构成产品的骨骼。
本文欲从粉体的基本特性着手,带大家了解使用在化妆品上的粉体的特性及功能、用于改善粉体的功能的表面处理方法。
1. 粉体的基本特性粉体(powder material)可以视为固体、液体、气体以外的第四性状。
粉体和固体一样拥有结晶性,与液体一样拥有流动性,与气体一样在不同的粒度(grain size/granularity)表现出飞散(free flowing)性。
粉体是多个固体微粒的集合体,粒子之间有一定的相互作用存在。
考虑一种粉体粒子的基本性质时,应区分粒子的大小、表面能量、表面构造、表面物性等因素。
如果按粒子大小分类可分为——广义的粉体:1 nm ~ 1 mm,狭义的粉体:< 50 um,微粉体:1 um ~ 50 um,超微粉体:10 nm ~ 1 um。
粉体以1um粒度为分界线,表现出的物理、化学性质有以下差异(见表1)。
λ粗大粒子(Macro particle)的特征——不凝集、流动性增加。
λ微粒子的特征——粒子的附着力增加,超过重力的影响而出现凝集。
粒子的大小小于1um时大于1um时增加的物理性质表面积,表面活性,反应性,凝集性,吸液量流动性,充填性,纯度增加表1.粒子大小与物理性质粉体粒子的物理性质可分为粒子性质与粉体性质(见表2)。
作为粒子的性质作为粉体的性质结晶质的大小、排向大小和分布外观密度形状充填构造构造流动性密度吸液量附着力表面的性质表2.粉体粒子的物理性质2. 化妆品用粉体的特性化妆品用的粉体可以分为无机颜料(体质颜料、白色颜料、彩色颜料)、有机颜料、天然颜料、珠光颜料等等(详见表3)。
体质颜料:是构成骨骼的原料,以天然的粘土矿物如云母、滑石粉最具有代表性,另外还有高岭土(kaolin)、碳酸钙、碳酸镁等等。
印制电路板(PCB)通用设计规范
电控设计规范印刷电路板(PCB)通用设计规范(发布日期:2009-09-14)目次1 范围 (2)2 规范性引用文件 (2)3 基本原则 (2)3.1电气连接的准确性 (2)3.2可靠性和安全性 (2)3.3工艺性 (2)3.4经济性 (2)4 技术要求 (2)4.1印制板的选用 (2)4.2自动插件和贴片方案的选择 (3)4.3布局 (3)4.4元器件的封装和孔的设计 (10)4.5焊盘设计 (12)4.6布线设计 (15)4.7丝印设计 (17)5 相关管理内容 (18)5.1设计平台 (18)5.2贮存格式 (18)1范围本设计规范规定了空调电子控制器印制电路板设计中的基本原则和技术要求。
本设计规范适用于美的家用空调国际事业部的电子设备用印刷电路板的设计。
2规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。
凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件,其最新版本适用于本标准。
GB 4706.1 家用和类似用途电器的安全第一部分: 通用要求GB/T 4588.3 印刷电路板设计和使用QMG-J29.001 空调器电子控制器QMG-J52.010 印制电路板(PCB)QMG-J33.001 空调器防火设计规范QMG-J85.029 电气间隙、爬电距离和穿通绝缘距离试验评价方法3基本原则在进行印制板设计时,应考虑以下四个基本原则。
3.1电气连接的准确性印制板设计时,应使用电原理图所规定的元器件,印制导线的连接关系应与电原理图导线连接关系相一致,印制板和电路原理图上元件序号必须一一对应,非功能跳线(仅用于布线过程中的电气连接)除外。
注:如因结构、电气性能或其它物理性能要求不宜在印制板上布设的导线,应在相应文件(如电原理图上)上做相应修改。
3.2可靠性和安全性印制板电路设计应符合相应电磁兼容和电器安规标准的要求。
美国Nice-Pak/PDI公司赢得擦布世界国际创新奖
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DNVGL-CP-0346 DNV GL approval of manufacturer scheme
The content of this service document is the subject of intellectual property rights reserved by DNV GL AS ("DNV GL"). The user accepts that it is prohibited by anyone else but DNV GL and/or its licensees to offer and/or perform classification, certification and/or verification services, including the issuance of certificates and/or declarations of conformity, wholly or partly, on the basis of and/or pursuant to this document whether free of charge or chargeable, without DNV GL's prior written consent.DNV GL is not responsible for the consequences arising from any use of this document by others.The electronic pdf version of this document, available free of chargeCLASS PROGRAMME Approval of manufacturersDNVGL-CP-0346Edition May 2016DNV GL approval of manufacturer schemeFOREWORDDNV GL class programmes contain procedural and technical requirements including acceptance criteria for obtaining and retaining certificates for objects and organisations related to classification.© DNV GL AS May 2016Any comments may be sent by e-mail to rules@This service document has been prepared based on available knowledge, technology and/or information at the time of issuance of this document. The use of this document by others than DNV GL is at the user's sole risk. DNV GL does not accept any liability or responsibility for loss or damages resulting from any use of this document.C h a n g e s - c u r r e n tCHANGES - CURRENTThis is a new document.C o n t e n t sCONTENTSChanges - current...................................................................................................3Section 1 General. (6)1 Introduction.........................................................................................62 Objective............................................................................................63 Scope...................................................................................................64 Application...........................................................................................65 Abbreviations (6)Section 2 Approval procedure (8)1 General................................................................................................82 Initial approval....................................................................................93 Renewal of the approval....................................................................104 Extension or change of approved range............................................105 Survey report.....................................................................................116 Final approval report by manufacturer..............................................117 Evaluation by DNV GL........................................................................118 Issuance of certificate.......................................................................119 Validity...............................................................................................1210 Suspension or withdrawal of certificates.. (12)Section 3 Documentation requirements (13)1 Introduction.......................................................................................132 Approval report..................................................................................133 Statistics of previous production.......................................................134 General documentation of manufacturing route and equipment.........135 Manufacturing summary....................................................................136 Manufacturer products specification..................................................147 Manufacturers’ own certificate form.. (14)Section 4 Approval testing (15)1 General requirements........................................................................152 Manufacture of test products.............................................................153 Witnessing of approval testing..........................................................154 Testing requirements.........................................................................155 Retesting.. (16)C o n t e n t sAppendix A : Typical procedure to be followed to obtain initial approval ofmanufacturer........................................................................................................17Changes – historic (18)S e c t i o n 1SECTION 1 GENERAL1 IntroductionThe DNV GL approval of manufacturer (AoM) scheme is a procedure by which the Society approves manufacturers for supply of products in accordance with the Society's rules and standards.2 ObjectiveThe objective of AoM is to verify the manufacturers’ ability to consistently manufacture materials and products to the given specification and according to the DNV GL rule requirements.The objective of this program is to provide general requirements for approval of manufacturers of metallic materials. The additional requirements for AoM of specific types of materials and products are further described in individual programs.3 ScopeThis programme covers the procedures for initial approval, renewal of approval and extension or change of approval , and is based on the requirements given by the Society's rules and standards. It gives the general requirements related to the approval process including the manufacturers application, test plan proposal,works survey, manufacture and testing of sample products, and the general documentation requirements.4 ApplicationThis programme gives the general provisions for obtaining a certificate as "approved manufacturer" by the Society. It is applicable for metallic material manufacturers delivering products in accordance with the Society's rules and standards.5 AbbreviationsTable 1 AbbreviationsAbbreviation Full textAoM Approval of Manufacturer AR As rolledBCA Steel grade with qualified brittle crack arrest properties BOC Basic oxygen convertor CC Continuous castingCTS Controlled thermal severity CP Class programmeCOD Steel grade with qualified CTOD properties CTOD Crack tip opening displacement EAF Electric arc furnaceGCHAZ Grain coarsened heat affected zone HAZHeat affected zoneS e c t i o n 1Abbreviation Full textIC Ingot casting LF Ladle furnace N NormalizingNDT Non-destructive testingNDTT Nil ductility transition temperature NR Normalizing rolling TM Thermo-mechanical rolling VAD Vacuum arc degassing VD Vacuum degassingVOD Vacuum oxygen decarburizingWPQR Welding procedure quealification record WPS Welding procedure specification WWA Welding workshop approval QTQuenching and temperingS e c t i o n 2SECTION 2 APPROVAL PROCEDURE1 General 1.1 IntroductionIn order to be certified, the manufacturer shall demonstrate the ability to consistently manufactureproducts according to the Society's requirements and, if relevant, to a given specification. To this effect the manufacturer shall submit documentation showing that the necessary manufacturing, testing andinspection facilities are available and are supervised by qualified personnel. Works surveys by the Society's representative are required, e.g. to confirm compliance with the submitted documentation. The manufacturer shall also carry out a test program witnessed by the Society's representative, and the obtained test results shall be submitted for assessment by the Society.The following are the main steps of the initial approval process (see App.A ):—request for approval. (Manufacturer)—communicate approval requirements, handle quotation/contract. (Manufacturer/DNV GL)—prepare and submit initial documentation and test plan. (Manufacturer)—review of relevant documentation, e.g. product description, manufacturing route, inspection and testing procedures and quality system. (DNV GL)—review and acceptance of ‘test plan’ prepared and provided by the manufacturer in accordance with the applicable individual approval programme. (DNV GL)—manufacturing of test products, survey and reporting by the Society's surveyor . (Manufacturer/DNV GL)—approval testing in accordance with the accepted ‘test plan’, witnessed by the Society's representative.(Manufacturer/DNV GL)—prepare and submit final approval report including all required documentation and test results reports.(Manufacturer)—review and assessment of approval report. (DNV GL)—provided the manufacturer is found to have adequate qualifications, approval report is complete and test results are found to meet the applicable requirements, an AoM certificate will be granted. AoM certificates are published on DNV GL’s “approval-finder ”. (DNV GL).1.2 Request for approvalThe manufacturer requesting approval (including renewal or extension of existing approvals) shall send a formal application to the Society's local office. The Society provides a quotation for the requested service.1.3 Sub-contractingSub-contracting part of the production shall be described in the "approval documentation", see Sec.3.Sub-contracting of relevant production steps shall be entrusted only to those sub-contractors named in the approval documentation, unless the sub-contractor is holding a relevant AoM certificate. (Furtherlimitations may be given on the AoM certificate) The Society may require surveys of relevant sub-contractors in the course of the approval procedure. The manufacturer requesting approval by the Society shall ensure adequate quality of the sub-contracted production steps.1.4 LimitationsApproval is limited to the facilities/production line and premises/plant used for manufacturing of the test products. The manufacturer shall clearly indicate which manufacturing and production facilities that shall be included in the approval, and shall produce the test products accordingly.S e c t i o n 2The Society's scope of surveys, assessments and approval testing is limited to the process and products covered by the application for approval.Significant changes to the manufacturing facilities or processes shall be reported to the Society. The Society may request new surveys and approval testing as found necessary. Relocation of approved manufacturing facilities either in full or part will normally require new initial approval.Where required by the rules Pt.2, the manufacturer shall prepare a product specification for themanufacturing process, material composition, etc. The approval is limited to the process and composition etc., as given by this product specification.2 Initial approval 2.1 Approval processA flowchart illustrating a typical approval process for initial approval is given in App.A .2.2 Request for approvalThe request for approval shall be sent to the local DNV GL office together with the following information:—name and site address of the manufacturer—a table with a list of products for which approval is requested including the range of approval —a description of manufacturing, testing and inspection facilities and equipment.2.3 Documentation requirements for initial approvalThe manufacturer shall prepare the approval documentation as required in Sec.3 and by the relevant individual approval programme.2.4 Test plan proposalThe manufacturer shall prepare a detailed test plan in accordance with Sec.4 [2] and by the relevant individual approval programme.2.5 Works survey for initial approvalThe manufacturer shall organize a works survey together with the Society's surveyor . Focus will normally be given to quality control of critical production steps, and that manufacturing, testing and inspection facilities are available and supervised/operated by qualified personnel.The surveyor will decide the scope of the survey, and may request additional documentation when preparing for the works survey.Manufacture of test products and approval testing may require separate visits. In case of adequatepreparation and agreement with the Society, these steps of the approval process may be combined in one or two visits.2.6 Manufacture of test productsThe manufacturer shall establish a schedule for the production of test products, see Sec.4. The surveyor shall be invited for witnessing of all critical manufacturing steps.2.7 Approval testingApproval testing shall be performed in accordance with Sec.4.S e c t i o n 23 Renewal of the approval 3.1 Request for renewalApplication for renewal should be made not later than three months before the expiry date of the certificate.Applications received after the expiry of the certificate may require new initial approval if deemed necessary by the Society.3.2 Documentation requirements for renewal of AoM certificateFor renewal of the AoM certificate, the manufacturer shall submit an assessment report confirming that original approval conditions are maintained and no significant changes have been made to manufacturing process, equipment and procedures. A brief summary report giving statistical information related to certified products supplied to vessels classed by the Society in the previous validity period shall be included.If no products have been subject to certification by the Society for a period of two years, the Society reserves the right to require additional surveys and approval tests.3.3 Renewal surveyManufacturer shall invite the Society's surveyor for renewal survey in order to revisit the critical manufacturing steps and to verify that the approved conditions are maintained.During the survey the manufacturer shall provide evidence that the applicable versions of relevant rules,standards and approval programs are applied, and that all requirements given therein are implemented.3.4 Approval testing for renewalIf there are no significant changes to the manufacturing process, equipment and procedures, new approval testing will usually not be required for renewal of the AoM certificate. However , significant changes to the approved conditions may render new approval testing necessary, although a reduced scope of testing would typically be accepted, depending on the significance of the change.4 Extension or change of approved range 4.1 Request for extensionAn existing AoM certificate may be extended or changed with respect to the “range of approval”. Extension of the range of approval may be applied for at any time.4.2 Documentation requirements for extensionFor extensions of, or for significant changes to the approved products or process, the approval documentation specified in Sec.3 shall be re-submitted highlighting the changes to the already approved manufacturing process.A new manufacturing summary and a new testing and inspection plan shall be submitted, includinginformation about new equipment, extended capacity of the existing equipment or change of the product scope.4.3 Test plan and test productsFor test plan proposal, see Sec.4 [2].S e c t i o n 24.4 Survey for extension of the approvalA works survey for extension of the approval may be deemed necessary, e.g. if range of products forextension are produced using a manufacturing process, equipment or procedures that were not part of initial approval. Manufacturer shall invite the Society's surveyor for extension survey.4.5 Approval testing for extensionFor extensions of an existing approval to include new products, material or application areas, full approval testing (same as for initial approval) according to Sec.4 will normally be required unless otherwise agreed with the Society.5 Survey reportFor initial, renewal or extension of the approval, the surveyor will prepare a survey report including applicable checklists. The manufacturer shall give the surveyor the necessary access and information in order to complete the report and checklists.6 Final approval report by manufacturerOn completion of the approval testing, the manufacturer shall prepare and submit a detailed approval report.The approval report shall preferably be organized with the same indexing as given in this program as well as in the relevant individual approval programme. The report shall contain all the information requested in [2.2], [2.3] and [2.4], as well as Sec.3 and Sec.4. The report shall include the request for approval,information on manufacturing route and equipment, documentation of all relevant tests and test results, and include original test records endorsed by the surveyor .The language of the submitted documentation shall be English.The approval report shall be signed and dated by the manufacturer’s representative, and submitted to the local DNV GL office.Incomplete report, or test results not complying with the given requirements may be returned to the manufacturer for correction.7 Evaluation by DNV GLThe evaluation of compliance with the approval requirements is based on the final approval report, the surveys, and the survey report with applicable checklists.In case of insufficient documentation or test results the manufacturer will be informed for further actions.8 Issuance of certificateProvided the manufacturer is found to have adequate qualifications, the approval report is in compliance with the applicable requirements, all tests are completed and the test results comply with the applicable requirements, an approval of manufacturer certificate will be issued. The certificate will include a list ofproducts covered by the approval. The certificate will be forwarded to the manufacturer , and an entry made in the Society's list of approved manufacturers on the internet (the Approval Finder ).S e c t i o n 29 ValidityThe AoM certificate is valid for three (3) years with no intermediate assessment unless otherwise requested by the Society.Guidance note:The surveyor shall be given the opportunity to survey and check at any time all plants and equipment used in the manufacture and testing. The manufacturer shall assist the surveyor to enable him to verify that approved processes are adhered to and to witness the selection and testing as required by the rules.---e-n-d---o-f---g-u-i-d-a-n-c-e---n-o-t-e---Renewal of the certificate must be done before the expiry date. For renewal the validity time is extended with three years. Certificates which have expired at the time of renewal will be adjusted according to previous validity date.For extension of a certificate the validity period will not be changed unless the extension is combined with a renewal, i.e. that all corresponding requirements for renewal are fulfilled.Any significant alteration to the approved condition during the period of validity, e.g. as described in the approval documentation (Sec.3 of this programme and relevant individual approval programme) shall be reported to the Society. The Society will decide if a new survey/re-testing shall be performed.Any changes to the name of the manufacturer shall be brought to the attention of the Society. In order to change the name on a certificate the manufacturer shall present formal evidence of the new name, and send an application to the Society accordingly.New requirements introduced in the Society's rules or class programs during the period of validity mayrequire updating of the approval documentation or additional approval testing. Unless otherwise required by the Society, the new requirements shall take effect at the next extension or renewal of the AoM certificate.10 Suspension or withdrawal of certificatesAn approval of manufacturer certificate may be suspended or withdrawn at any time if the Society finds it justified.Provisions for suspension and withdrawal of a certificate are given by DNV GL rules RU SHIP Pt.1 Ch.1.S e c t i o n 3SECTION 3 DOCUMENTATION REQUIREMENTS1 IntroductionThis section is specifying the general documentation required for initial approval. For alterations to theequipment, processes, procedures etc. covered by an existing certificate, the corresponding documentation shall be updated and submitted to the Society for evaluation (surveys, renewal and/or extension of the approval may be required). Further documentation requirements are given in the individual approval of manufacturer programs.2 Approval reportThis section includes the general documentation to be provided in the approval report applicable for all relevant AoM's. Only information relevant for the manufacturing of the products covered by the AoM certificate shall be submitted. See also Sec.2 [1.3] and Sec.2 [6].3 Statistics of previous productionA report giving statistical information about recent production, e.g. with respect to chemical composition and mechanical properties of similar grades and products shall be submitted. The report shall preferably be based on products subject to third party verified certification.4 General documentation of manufacturing route and equipmentAll procedures and documentation to be submitted as required by this programme and by each of the individual programs shall be traceable and dated documents with track of revisions etc., and should in general be part of the manufacturer’s QA manual.The following shall be submitted:—organisation structure and quality assurance system including quality control responsibilities—manufacturing process description, visualized in flow charts indicating all process steps, and in particularthe associated testing and inspection points—list of the manufacturers written procedures for testing and inspection. The procedures need not to besubmitted (except as given below), but shall be available for review at the manufacturer’s works upon request—list of equipment used for chemical analysis, mechanical testing, metallographic examination, non-destructive testing, dimensional and thickness measurements, pressure testing, etc.—evidence of calibration for all relevant manufacturing and testing devices—documentation of the qualifications of personnel engaged in testing and inspection, including level ofcertification of non-destructive testing personnel. Where the number of relevant personnel exceeds 10, a list of personnel and their qualifications will suffice—manufacturers formal procedures (e.g. from quality manual) for product and test samples identificationand traceability.5 Manufacturing summaryThe manufacturer shall establish and submit a manufacturing summary for all products, material grades and dimensional ranges which shall be covered by the certificate. Several grades and/or size ranges may be combined into one manufacturing summary where this is convenient.The manufacturing summary shall specify the sequence of all important manufacturing and sampling/testing steps, and the conditions for control, e.g. by reference to instructions or procedures.S e c t i o n 3Supply of materials and subcontracted activities relevant for the approval shall be indicated, and the names of suppliers/subcontractors and their approval details shall be provided as appropriate. Production steps performed by subcontractors are subject to documentation and testing requirements as given by the approval programs.Where a manufacturer applies for extension of an existing approval to cover e.g. larger diameters, new supplier of starting material, etc., the manufacturing summary shall be updated accordingly.6 Manufacturer products specificationWhere required by the Society's rules, standards, approval programs or by the Society's representative,the manufacturer shall prepare a separate product specification document. The product specification shall specify all relevant limitations to the approved product and manufacturing process, i.e. where these are supplementary to the basic requirements of the rules, e.g.:—chemical composition with narrower range limitations —rolling parameters for NR, TM, BCA, COD steels—testing requirements and acceptance criteria for special steels, e.g. small scale test for BCA steels.The specification shall be a traceable document, numbered, dated, with revision numbering and signed by the manufacturer . It will be referred on the AoM certificate, and shall be made available to the surveyor on request.7 Manufacturers’ own certificate formWhere DNV GL certification of products using the manufacturer’s own certificate form is intended (e.g. in the format of EN 10204 type 3.1 or ISO 10474 type 3.1 etc.) a blank copy of the certificate form and a filled in certificate for a representative product/material shall be submitted. Legends and entries may be in national language, but all information which is required in order to enable assessment as per the DNV GL rules shall be in English language (e.g. in addition to the local language where relevant).S e c t i o n 4SECTION 4 APPROVAL TESTING1 General requirementsUnless otherwise specified, the testing and the test results shall comply with the appropriate requirements of the rules, e.g. RU SHIP Pt.2.In case of newly built manufacturing facilities or newly developed types of products, material grades or manufacturing processes, the Society may request additional tests, increased number of test products and other dimensions of the products for testing.Further requirements are given in the individual approval of manufacturer programs.2 Manufacture of test productsThe manufacturer shall propose a detailed inspection and test plan (a formal document, dated and withversion number), based on the relevant individual approval program. The test plan proposal shall be accepted by the Society before manufacturing of the products to be tested.Surveyor shall be invited to witness all critical manufacturing steps for the production of test material/products, and for marking of the samples from which test specimens will be prepared. He shall also be given access to carry out a visual examination of the products intended for approval purposes for his reporting, e.g.of the surface condition.Records and data for the manufacture of the test products shall included in of the approval report.3 Witnessing of approval testingThe surveyor shall be given necessary access for verification of the calibration status of all relevant testing equipment, that is, testing equipment that will be used for testing of products supplied to DNV GL class. This is also applicable for tests carried out at laboratories recognized and/or approved by the Society.The surveyor shall be invited to witness all approval testing. Chemical composition test and metallographic analysis is exempted from this requirement unless specifically requested by the Society. If the required testing facilities are not available at the manufacturer , the approval tests may be carried out at a testing laboratory recognized and/or approved by the Society. In such case the surveyor shall be invited for witnessing at the relevant laboratory.The test reports shall be made available to the surveyor for endorsing.4 Testing requirementsUnless otherwise specified, the testing procedures, test pieces shape, and test pieces location and orientation shall comply with the applicable requirements of the rules and/or the applicable standards. The test results shall fulfil the requirements of the rules, e.g. RU SHIP Pt.2 or the applicable standard/specification, whichever is stricter (unless otherwise agreed). The following general reporting requirements apply for approval of material manufacturers:—sketches, drawings and photos showing the position of test blocks shall be included in the test report.Type of test blocks and their dimensions shall be reported and wherever necessary supported with photographic evidence—photographs of the tested specimens shall be included in the report. The dimensions of the specimens andthe fracture surfaces must be recognizable. The plots of registered load-deformation (stress-strain) curves obtained for the tensile tests shall be included. The loading rates shall be reported.。
「FDA-cGMP问答」实验室控制【前篇】
「FDA-cGMP问答」实验室控制【前篇】文章来源FDA,由珐成制药系统工程(上海)有限公司范宇翻译原创文章,欢迎转帖;尊重原创,从注明出处开始转帖请注明:GMP验证及自动化“FDA-cGMP 问答系列”,该系列选取美国FDA对设备、设施、QC等方面的问题和解决方案,并按不同类型分篇章的翻译。
它山之石,可以攻玉,我们希望通过我们的翻译,让更多人了解国际通行的cGMP的问题和对策,从而学习、反思我们自己平时工作中的不足,提升质量管理意识。
不积跬步,无以至千里,我们一起努力,为制药行业而奋斗吧!中文翻译仅供参考,如有异议请以原文为准1、许多龙头生产商的分析天平都提供内置的“自动校准”功能。
这样的自动校准程序是否可以信赖,并取代外部的性能检查?如果不可以,那么校准应该如何安排?不能只依赖于分析天平内部的自动校正功能,而排除外部性能检查(211.68)。
对于有内置自动校准功能的分析天平,建议定期进行外部的性能检查,但次数少于没有此功能的分析天平。
性能检查的频率取决于天平使用的频率和工艺或分析步骤的临界点和忍受度。
要注意,如果自动校验仪有问题,那么会影响到前后两次验证之间所制造的所有批次的产品。
此外,自动校准器的校准功能应定期验证-一般情况是一年一次-使用美国国家标准与技术研究所(NIST)- 可追溯的标准或NIST认证标准-其他国家在使用的合格标准。
1. Many leading analytical balance manufacturers provide built-in 'auto calibration' features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be?The auto-calibration feature of a balance may not be relied upon to the exclusion of an external performance check (211.68). For a scale with a built-in auto-calibrator, we recommend that external performance checks be performed on a periodic basis, but less frequently as compared to a scale without this feature. The frequency of performance checks depends on the frequency of use of the scale and the criticality and tolerance of the process or analytical step. Note that all batches of a product manufactured between two successive verifications would be affected should the check of the auto-calibrator reveal a problem. Additionally, the calibration of an auto-calibrator should be periodically verified--a common frequency is once a year--using National Institute of Standards and Technology (NIST)-traceable standards or NIST-accredited standards in use in other countries.2、当确认药物稳定性测试方法是否可以指示稳定性时,CGMPs 要求对药物进行强制分解研究吗?不要求。
BP1611-R-1204-01西罗莫司文献调研报告
BP1611-R-1204-01西罗莫司文献调研报告目录1.基本信息 (3)1.1药物名称 (3)1.1.1活性成分 (3)1.1.2原料药 (3)1.2适应症 (4)1.3剂型及规格 (4)1.4用法用量 (4)1.5物料来源...................................................................... 错误!未定义书签。
2.1原研上市批准情况 (4)2.1.1欧盟........................................................................ 错误!未定义书签。
2.1.2JP ............................................................................ 错误!未定义书签。
2.2国内上市及注册受理情况 (5)2.2.1上市批准情况 (5)2.2.2注册受理情况 (5)2.3注册分类 (6)3.工艺综述 (6)4.质量标准来源 (6)5.分析方法 (6)5.1有关物质 (6)5.2含量 (6)6.API 理化性质 (6)6.1性状 (6)6.2熔点 (6)6.3晶型 (7)6.4光学异构现象 (7)6.5干燥失重 (7)6.6引湿性 (7)6.7水溶性及pH依赖溶解度 (7)6.8水溶液及pH相关溶液稳定性 (7)6.9pKa (7)6.10性质资料 ................................................................... 错误!未定义书签。
6.11杂质谱分析 (7)6.11.1杂质谱系 (7)6.11.2残留溶剂 (8)6.12化学稳定性 (8)1.基本信息1.1药物名称1.1.1活性成分原料为西罗莫司,衍生物为替西罗莫司见下:1.2适应症CFDA 批准说明书1:适用于接受肾移植的患者,预防器官排斥。
第五届国际粉体工业/散装技术会议暨展览会在沪召开
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静态密封件的选用准则
表 I 静态密封件的选用准则
密封件
用途
形式
页码
O形圈
5
径向 轴向 静态 动态 内部 外部
标准
尺寸 范围
mm
工作温 度范围
oC
压力
MPa max.
材料
进一步资料见O形圈样本
挡圈, 无切口 BV/BU
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截面直径约0.35至40 mm和内径达5,000 mm的产 品都有货。
Ø d1
图1 O-形圈尺寸
Ø d2
优点
和其他的密封件相比,O-形圈有更多的优点: - 经济,提供低成本的解决方案 - 简单,一体的沟槽结构降低硬件和设计成本 - 结构紧凑,允许较小的硬件 - 方便,极简单的安装,降低风险 - 适用于范围很宽的密封问题: 静态,动态,单作 用或双作用 - 复合物选择的范围宽,与大多数流体相容 - 世界各地随时有货,维护和修理更方便
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发 气 力 输 送 设 备 ,为 实 现 原 料 管 塞 输 送 富林泰克 ( 北京 )电 子 技术 有 限 公 司 信 易 开 发 了 高压 密 封 旋 转 下 料 阀 ,其 特 本 公 司 是 世 界 上 最 大 的 力 和 称 重 传 点 : 密封 压 力 0. 4M Pa 约 4 ( kg/c m ) 为 感 器制 造 商之 一 。FLI NTEC 为 全不 锈钢 止 ;旋 转 体 侧 板 上 采 用 密 封 构 造 ,成 功 结 构 、高 阻抗 ( 1100欧姆 ) ,全金 属 焊接 的 减 少 漏 气 量 ;漏 气 直 接 从 本 体 排 出 的 密 封 产 品 。全 部 拥 有 0I L, NTE M P,P TB, 构 造 ,还 实 现 原 料 安 定 的 排 出 及 旋 转 体 料 、石 化 、 日化 、化 肥 、饲料 、食 品 、高 FM ,EX 认 证 。 适用 于各 种 恶劣 环境 , 高 容 积 效 率 的 提 高 ;本 体 防 咬料 的 构 造 , 精 度 ,高 可 靠 性 的 计 量 和 力 测 量 场 合 。 可 以把 原 料 破 碎 率 降 低 到 最 小 。 填充 色母 粒 、电力 电缆 料等 各行 业 。
国际粉体检测与控制联合会工作总结
国际粉体检测与控制联合会工作总结由于我联合会成立较晚,机构小、人员少、财力单薄,所以工作一直处于维持状态。
但是,近一年多的时间里在代理理事长谢植教授的认真领导下,联合会的工作力度得到了加强。
根据联合会社团法人登记证书上规定的业务范围(学术交流、理论研究、业务培训、国际合作和咨询服务)的要求,联合会积极开展了国际国内的学术交流和人员来往,促进了本领域的科学技术的发展。
为了实现2006年末提出的2007年的工作计划,落实"中国科协第七次全国代表大会"的会议精神,联合会的代理理事长谢植教授和秘书长李新光博士领导秘书处的同志们,积极开展与国际上本领域知名学者学术交往,保证了联合会的组织规模扩大和学术活动的进一步活跃,促进了我国在该领域的科学研究和技术发展。
在国际国内粉体检测与控制领域,联合会的学术影响和地位日益提高,在国际上已经成为一个重要的学术团体,中国学者已经在该领域成为重要的学术核心,并得到世界发达国家知名学者们的重视和认可,他们已经成为联合会的深入发展的主要学术力量。
为了不断发展和巩固联合会在国际学术组织中的地位和影响,我们作了以下几项工作。
一、认真学习《中国科协全国学会组织通则》,积极扩大本领域的国际会员队伍,搞好联合会的组织建设。
通过实践经验,我们深深感到:一个社会团体的组织建设是它能健康成长的基本保证。
由于我联合会是国际学术组织,所以在国内对于国际学术团体的组织建设和人员管理,没有成型和好经验可以借鉴。
根据这种情况,联合会认真学习《通则》精神,结合国际学术组织发展的需要,联合会秘书处曾与十几个国家的学者和专家对联合会这样的国际学术团体建设征求意见和建议。
作了大量的组织建设工作。
(一)、认真选定新的理事和国际会员,加速扩大会员队伍,搞好联合会的组织建设。
各国理事普遍认为,学术团体必须以国际知名学者为骨干力量和核心,开展学术交流和人员交往,才能保证联合会的健康发展和队伍的迅速扩大。
科莱恩推出通过OK compost可堆肥生物降解认证的颜料,助力可持续发展
汪多仁·纳米稀土二氧化铈的开发与应用进展2021年 第47卷·35·材料与应用Development and application progress of nano rare earth cerium dioxideWang Duoren(Shijinggou United Chemical Plant of PetroChina Jilin Petrochemical Company, Jilin 132101, Jilin, China)Abstract: The properties, optimum operating conditions and related conditions of nano rare earth cerium dioxide are introduced in this paper. The advantages of new process development are analyzed and summarized, and the development trend of new product development is expounded. The prospect of expanding the scope of application and expanding the market demand are discussed.Key words: nano rare earth cerium dioxide; development; application (R-03)科莱恩推出通过OK compost 可堆肥生物降解认证的颜料,助力可持续发展Clariant launches OK compost compostable biodegradable certified pigments to help sustainable development为了实现可持续发展目标和履行塑料循环经济的承诺,塑料制品生产商越来越多地使用可降解聚合物。
企业常用术语
企业常用术语(中英文对照)添加剂(Additives or finish)消泡剂(Antifoaming agent)阻燃剂(Flame Retardants)阻燃性能(Flame retardency)_耐磨性(Abrasion resistance)_光化学降解(Actinic degradation)_日晒牢度紫外线稳定性(Ultraviolet stability)耐干性和水洗性质(Dry cleaning & laundering resistance)抗热性能(Heat resistance)耐热测试粘着力(Adhesion)_含固量(Solidity content)_丙烯酸酯共聚体(Acrylics Copolymers)卷曲(Crimp)-纤维的波状卷曲。
卷曲幅度(Crimp Amplitude),与无卷曲的直形纤维相比而量得的卷曲波峰的高度。
卷曲率(Crimp frequency)每1英寸的卷曲数。
卷曲百分比(Crimp percent)卷曲时的长度占拉下时的纤维长度的百分数.卷曲能量(Crimp energy),把纤维扩下需用的力。
特(Tex)计量纤维细度的公制单位,1特等于1000米长纤维的克数。
分特(Decitex,略作Dtex)计量纤维细度的公制单位,1分特等于100米长纤维的克数,1分特(Dtex)=1/10特(Tex) 旦尼尔(Denier)可略作旦或d,欧美国家彩的纤维细度单位,1旦等于9000料长纤维的克数,1d=9Tex=90Dtex。
密耳(Mil)1密耳等于千分之一英寸。
英美等国用于计量纤维直径和薄膜厚度的单位。
天然纤维(Natural fibers)—由植物中提取出的纤维素分子再聚合而成的纤维素纤维。
例如,蚕丝(silk)羊毛(Wool),棉花(Cotton) 亚麻(Flax),苎麻(Ramie)黄麻(Jute)和石棉(Asbestos)后整理(Afrertreatment or Finishing)在纤网成形加固后的进一步加工处理,例如热轧、浸渍、褶皱、柔顺化和印花等。
湖北省商务厅关于2019年美国费城生物技术大会暨展览会组展工作的通知
湖北省商务厅关于2019年美国费城生物技术大会暨展览会组展工作的通知文章属性•【制定机关】湖北省商务厅•【公布日期】2018.09.14•【字号】•【施行日期】2018.09.14•【效力等级】地方规范性文件•【时效性】现行有效•【主题分类】机关工作正文湖北省商务厅关于2019年美国费城生物技术大会暨展览会组展工作的通知各市、州、直管市、神农架林区商务局(委),各相关企业:为进一步加大我省生物技术、医药产业出口企业积极开拓美国及美洲市场的力度,推动我省生物技术、医药产业产品出口,我厅计划组织我省生物技术、医药产业企业参加2019年美国费城生物技术大会暨展览会。
现将有关组展工作通知如下:一、展览名称中文名称:2019年美国费城生物技术大会暨展览会英文名称:BIO INTERNATIONAL CONVENTION 2019二、展览时间、地点时间:2019年6月3日-6月6日地点:美国费城展览中心三、展会介绍美国生物技术大会暨展览会创办于1993年,是由美国生物技术创新组织/BIOTECHNOLOGY INNOVATION ORGANIZATION举办的生物技术业界重要盛会。
该组织原名:美国生物技术产业组织/BIOTECHNOLOGY INDUSTRY ORGANIZATION,于2016年1月4日更名,该机构是全球生物技术行业最大的贸易组织,致力于生物技术和医药产业的发展及国际间的交流合作,促进生物产业的全面进步。
大会(暨展览会)将专业性展览会与专题讲座相结合,业已发展成为全球规模最大、档次最高的生物技术盛会,在业界享有极高的声誉,是全球行业的引导者和信息技术交流中心。
对于生物技术尚处于初步发展阶段的中国而言,该大会(暨展览会)正是我国生物技术企业面向全球开拓产品和服务市场、寻求合作和建设渠道的重要平台。
该大会(暨展览会)以多地巡回展的方式举办,2017年举办于圣地亚哥,2018年举办于波士顿,2019年又迁到费城举办。
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2020年美国国际粉体工业展会IPBS
展会介绍
展会时间:2020年04月28日
举办周期:两年一届
主办单位:UBM
展会地址:美国-芝加哥-美国芝加哥Rosemont会展中心
展会详情
目前国外最大最著名的博览会,展会于1976年初次成功举行,至今已有39年的前史。
美国世界粉末与块状固体博览会致力于美国和世界加工工业,来自世界各地的加工、制造和出产的工程师、经理以及负责操作、设备、包装的管理人员和一般企业的经理将会集合于此。
芝加哥拥有超越7500家制造企业,其中4700家食物加工厂,2800家化工处理厂和100多家制药厂,这些工厂在去年创造了超越2030亿美元的收入。
功用齐全的美国世界粉体展提供了一个以市场为基础,对加工技术,产品和设备提供系统和全方位的服务,一起就专门活动和散装固体粉末加工,化学加工,制药加工为重点,为加工工业提供一条龙的解决计划。
展品范围
工业粉体原料:滑石、重钙、石英、硅灰石、高岭土、云母、石墨等各类非金属矿粉体;碳化硅、氮化硅、白碳黑、钛白粉、金刚石等工业合成粉体原料金属粉体材料:镍粉、锌粉、银粉、铜粉、铝粉、铁粉及氧化镍、氧化锌、氧化铝、氧化铁等微纳米粉体材料:微纳米镍粉、银粉、锌粉、铝粉、铁粉、锆粉、钛粉及氧化镍、氧化锌、氧化铝、氧化铁、氧化钛、碳酸钙、氧化硅、碳化硅、微纳米粉体衍生化合物等粉体制备技术及基本工艺:粉碎、研磨、混合、分离、筛分、过滤、烧结、制粒和压块、固体粉体干燥等工程设备及相关技术;计量投料、卸料、散料输送、仓储设备、真空装置、管道技术粉体检测及理化分析仪器:激光粒度分析仪、比表面积及孔径分析仪、白度仪、微纳米颗粒图象分析仪及实验室、化验室设备。
流量、料位、粉尘浓度、湿度等各种在线检测设备、二次仪表安全环保技术:工业火警防护、电气防爆、非电气防爆、过程安全、排放控制、工作域安全等辅助材料:过滤材料、筛网、研磨介质、密封件、粉体加工助剂等。