TUST_Guidelines for tunnelling risk management-隧道风险管理指南-2004

合集下载

Guidelinesforcor...

Guidelinesforcor...

Guidelines for correct electrical supply & testing for lifts in service - including builders lifts.PurposeTo provide practical guidance on Prescribed Inspection and Testing requirements for passenger lifts.To ensure passenger lifts installed in commercial building structures, which are available for passenger use, are provided with electrical supply and protective devices designed for safe operation.ApplicationThese guidelines apply to a lift Installer, electricians, builders and building owners in control of installations where lifts are used to convey passengersBackgroundPassenger lifts used in all Victorian commercial installations are considered to be a safety service as defined in Australian/New Zealand Wiring Rules. As such they are to be installed to conform to requirements of AS/NZS 3000:2007 & AS1735.2 prior to use for conveying passengers. Often in early stages of construction passenger lifts are commissioned to be used as a lift to convey persons and materials during the remainder of the construction stage. This type of passenger lift is commonly termed as a ‘builders lift’.Where a passenger lift is to be used as a ‘builders lift’ it must meet all requirements for the testing and commissioning to ensure performance and safety mechanisms are verified. Passenger lifts, being a safety service, are required to have prescribed electrical installation work inspected by a licensed electrical inspector prior to the lift being placed in service. This is a requirement of Electricity Safety (Installation) Regulations 2009.Inspection of electrical installation workAn electrician who is responsible for the carrying out of prescribed electrical installation work must ensure that the work is inspected by a licensed electrical inspector in accordance with the regulations before the electrical installation is connected to the electricity supply, or if the electrical circuits or electrical equipment handled in the course of the work were not disconnected from the electricity supply, before the work is first used after it is completed. An electrician must ensure that the licensed electrical inspector inspecting any prescribed electrical installation work is not a person who is employed by the electrician; or a related body corporate of the electrician.Energy Safe Victoria requirementsThe passenger lift shall pass all requirements of the Prescribed Inspection before handover for use.Recommended items to be inspected for verification∙All mains and sub mains cables from the point of supply through to the lift switchboard associated with the lift installation to ensure appropriate WS rating is provided∙Basic protection (protection against direct contact with live parts), e.g. insulation and enclosure∙Fault protection (protection against indirect contact with exposed conductive parts)∙Protection against hazardous parts, e.g. enclosure, guarding or screening of flammable materials, hot surfaces and parts that may cause physical injury∙Protection against spread of fire, e.g. penetration of fire barriers∙Motor room door installation and labelling∙General condition of the electrical equipment, e.g. signs of damage that could impair safe operation, disconnection of unused electrical equipmentMains∙Identification of cable cores∙Current carrying capacity of mains∙Voltage drop, e.g. size and length of conductors and load∙Underground installation conditions, e.g. enclosure, depth of burial, mechanical protection∙Connection of wiring∙Protection against external influencesSwitchboards∙Location, e.g. access and egress, not in restricted location∙Protective devices, e.g. selection and setting of adjustable protective devices for compliance with over current protection, arc fault protection and discrimination∙Isolating devices, e.g. main switches∙Connecting devices, e.g. neutral bars, earth bars and active links∙Connection and fixing of wiring and switchgear∙Identification and labelling of electrical equipment, and∙Protection against external influences, e.g. mechanical damageDefinitionsLicensed Electrical Inspector means a person holding an inspector's licence underthe Electricity Safety (Installations) Regulations 2009Passenger lift in this document means an electrically controlled lift that is capable of conveying passengers, but does not include a lift installed in a single private residence in accordance with AS1735.18Safety service has the same meaning as it has in the Australian/New Zealand Wiring Rules AS/NZS 3000:2007Prescribed electrical installation work. For the purposes of Electricity Safety Act 1998 section 45, prescribed electrical installation work means work on all or part of any of the following electrical installations if they are ordinarily operated at low voltage or a voltage exceeding low voltage— circuit protective devices, switchgear, control gear, wiring systems and accessories (other than fire detection and alarm systems) installed to provide control and protection of passenger liftsVerification— All measures by means of which compliance of the electrical installation with the relevant requirements of AS/NZS 3000 and AS/NZS3017:2000 is checked. Further informationElectricity Safety Act 1998Electricity Safety (Installation) Regulations 1999Acts & Regulations are available from Information Victoria on 1 300 366 366 or order on line at .au. They can be viewed by visiting the ESV web site at .auAustralian/New Zealand Wiring Rules means AS/NZS 3000, Australian/New Zealand Standard, "Electrical installations", as published or amended from time to timeAS/NZS 3017:2000 means AS/NZS 3017:2000, Australian/New Zealand Standard, Electrical installations – Verification guidelinesAS1735.2 means AS1735.2, Australian/New Zealand Standard, "Lifts, escalators and moving walks – General requirements", as published or amendedfrom time to timeStandards Australia publications can be obtained by contacting Standards Australia on 1 300 654 646 or by visiting the web site at .auThis guidance material has been prepared using current and best information available to Energy Safe Victoria. You should check the legislation referred to in this document and make your own judgement about what action you need to undertake to ensure compliance with the law.。

特殊性质药品的污染控制丁之章1赵汝萍2

特殊性质药品的污染控制丁之章1赵汝萍2

特殊性质药品的污染控制丁之章1 赵汝萍2发布时间:2023-07-05T05:45:47.389Z 来源:《健康世界》2023年7期作者:丁之章1 赵汝萍2 [导读] 在生产过程中,特殊性质药品的污染控制是药品生产企业极为重视的环节,因为特殊性质药品的特点,如,高活性、精神类、麻醉类等,将直接或间接影响普通药品的用药安全,因此,药品生产企业对于特殊性质药品的生产管理,都会采取极为严格的污染控制措施。

常见的污染控制措施有单独生产厂房、专线、专用设备等。

本文分析了国内外各官方针对特殊药品的污染控制措施,可作为药品生产企业的参考。

江苏海岸药业有限公司江苏省苏州市吴江区 215211摘要:在生产过程中,特殊性质药品的污染控制是药品生产企业极为重视的环节,因为特殊性质药品的特点,如,高活性、精神类、麻醉类等,将直接或间接影响普通药品的用药安全,因此,药品生产企业对于特殊性质药品的生产管理,都会采取极为严格的污染控制措施。

常见的污染控制措施有单独生产厂房、专线、专用设备等。

本文分析了国内外各官方针对特殊药品的污染控制措施,可作为药品生产企业的参考。

关键词:特殊性质、污染、专线生产、高活性特殊性质药品是指低剂量即可能导致不良反应,需要进行全面毒性评估,制定基于健康的暴露限度(HBEL)[1],根据其内在毒性和药品特性进行识别,主要包括基因毒性化合物、低剂量可产生生殖反应和/或发育反应的化合物,低剂量可引起目标器官严重毒性的化合物,高药效的化合物,具有高致敏性的化合物,以及麻醉类和精神类药品;各国法规,包括FDA、NMPA、EMA和WHO等以及一些行业组织[2-3],对于特殊药品的污染控制均提出了明确的要求,主要包括如下:特殊性质药品产尘量大的操作区域应当保持相对负压,对于有细胞毒性的品种,应使用隔离装置。

洁净室空调系统排风前要安装中效以上的过滤器,并按照排风系统相关管理定期更换过滤器,排至室外的废气应当经过净化处理并符合要求,排风口应远离其他空气净化系统的进风口。

Guideline_Normothermia

Guideline_Normothermia

AST Guideline Statement for the Maintenance of Normothermiain the Perioperative PatientIntroductionThe maintenance of normothermia in the perioperative patient is essential during all phases of the surgical procedure. Measures to monitor and maintain body temperature should begin in the preoperative phase and continue into the postoperative phase of the surgical procedure. The monitoring of patient temperature is the responsibility of all surgical team members and not just the anesthesia provider.AST Guideline StatementMaintaining normothermia in the perioperative patient is a collaborative effort between the anesthesia provider, the surgeon, perioperative personnel, and perianesthesia personnel. Maintaining Perioperative NormothermiaPerioperative temperature management is imperative to positive surgical outcomes. The body maintains its temperature between 36°C and 38°C by balancing heat production and heat loss. The thermoregulatory mechanisms in the central nervous system (CNS) control this function. The body loses heat through radiation (from tissues), conduction (contact with cool surfaces), evaporation (respiration), and convection (exposure to the environment). Intraoperative hypothermia is one complication for patients receiving general anesthesia, especially in geriatric and pediatric populations. Under anesthesia, the average adult loses 0.5° to 1.5°C (0.9° to 2.7°F), and the greatest heat loss occurs during the first hour of anesthesia. The maintenance of normothermia during the intraoperative period prevents complications associated with hypothermia.Hyperthermia during the surgical procedure can be caused by dehydration, fever, pre-medication, excessive drapes, and a closed anesthesia breathing circuit. In some instances, the surgical procedure may be delayed to permit fluid administration and a reduction in patient temperature, including discontinuing the use of any warming devices. The patient’s body temperature should be continuously monitored throughout the surgical procedure in order to assess metabolic changes.Risk Factors for Hypothermia∙Large volume of irrigation∙Major blood or fluid loss∙Exposure of a large body cavity∙Patient’s age∙Patient’s physical status and preexisting conditions∙Cold surgical environment∙Length and type of surgical procedure∙Type of anesthesiaComplications Associated with Hypothermia∙Coagulopathy∙Altered metabolism, ie metabolic acidosis∙Wound infections∙Shivering∙Cardiovascular effects∙Surgical bleedingExample Protocol for Preventing Hypothermia in the Surgical Patient1.Limit the amount of skin exposed during all phases of the surgical procedure.Suggestions: Surgical team members coordinate efforts to keep patient covered andwarm during the preoperative and postoperative phases with the use of warm blankets or warming devices.2.Monitor patient’s temperature during all phases of the surgical procedure.Suggestions: This is primarily a role of the anesthesia provider, but the circulating CSTor surgical assistant can provide assistance in monitoring the patient’s temperature bychecking the temperature surface monitor that is placed on the patient’s forehead.e warmed irrigation and infusion fluids/solutions.Suggestions: The CST and surgical assistant should use irrigation fluids obtained fromthe blanket and solution warmer located in the substerile room.e of warmed anesthetic gasesSuggestions: The anesthesia provider is responsible for this function.5.Monitor operating room temperature and humidity closely.Suggestions: The CST and surgical assistant should follow established recommendations for temperature and humidity levels in the operating room, and periodically check andrecord these levels for each operating room.6.Utilize heat-maintenance devices (head coverings, leggings, forced-air warming systems,hypothermia/hyperthermia mattress, reflective blankets/head coverings, radiant heatsources).Suggestions: The CST and surgical assistant should know the proper procedures foroperating warming devices and the safety protocol associated with the use of any type of warming device as established by hospital policy and manufacturer’s recommendations.Competency StatementsCompetency Statement Measurable Criteria1. Surgical technologists and surgical assistants are qualified to identify potential complications, associated with hypothermia and hyperthermia in the perioperative environment, and appropriate interventions for treatment. 1. Educational standards as established by the Core Curriculum for Surgical Technology.12. The subject areas of normothermia, hyperthermia and hypothermia are included in the didactic studies as a student.3. The proper use of thermoregulatory methods and devices is included in the didactic studies as a student.4. Students demonstrate the proper application of thermoregulatory methods during clinical rotation, including the proper use and operation of thermoregulatory devices, and are evaluated by preceptors and instructors.5. CSTs and surgical assistants perform patient care duties by applying thermoregulatory methods and devices in the perioperative setting as practitioners.6. CSTs and surgical assistants identify potential patient complications associated with the use of thermoregulatory methods and devices in the perioperative setting as practitioners, including contributing to the decision-making process of proper interventions to treat hyperthermia and hypothermia.7. CSTs and surgical assistants complete continuing education to remain current in their knowledge of hyperthermia, hypothermia, and maintenance of normothermia for the surgical patient.DefinitionsCore Temperature: A temperature of the interior of the body, ranging from 36.8° to 37.7°C (98° to 100°F)Normothermia: A core temperature range of 36°C to 38°C (96.8°F to 100.4°F) Hypothermia: A core temperature less than 36°C (96.8°F)Hyperthermia: A core temperature greater than 38°C (100.4°F)Unplanned perioperative hypothermia: An unexpected core temperature decrease to less than 36°C (96.8° F) as a result of surgeryReferences1.Core Curriculum for Surgical Technology. 5th ed. Littleton, CO: Association ofSurgical Technologists; 2002.2.DeFazio-Quinn DM, Schick L, eds. PeriAnesthesia Nursing Core Curriculum:Preoperative, Phase I and Phase II PACU Nursing. St Louis, MO: WB Saunders;2004.3.Drain CB. Perianesthesia Nursing: A Critical Care Approach. 4th ed.St Loui,MO: WB Saunders; 2003.4.Meeker M, Rothrock J, eds. Alexander’s Care of the Patient in Surgery. 12th ed.5.St. Louis, MO: CV Mosby; 2003.6.Phillips N. Berry & Kohn’s Operating Room Technique. 10th ed. St Louis, MO:7.2004.8.Price P, Frey K, Junge TL, eds. Surgical Technology for the SurgicalTechnologist: A Positive Care Approach. 2nd ed. Clifton Park, NY: DelmarThomson Learning; 2004.9.Wagner VD. Impact of perioperative temperature management on patient safety.Surgical Services Management, 2003; 9 (4): 38-43.。

2011胃癌临床实践指南(英文)

2011胃癌临床实践指南(英文)

* Hans Gerdes, MD ¤ Þ
Memorial Sloan-Kettering Cancer Center Robert E. Glasgow, MD ¶ Huntsman Cancer Institute at the University of Utah James A. Hayman, MD, MBA § University of Michigan Comprehensive Cancer Center
Printed by jin qingyun on 7/28/2011 9:45:32 PM. For personal use only. Not approved for distribution. Copyright © 2011 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines™ Version 2.2011 Panel Members Gastric Cancer
Principles of Systemic Therapy Mary F. Mulcahy, MD ‡/Lead Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Version 2.2011
IMPORTANT NOTE REGARDING LEUCOVORIN SHORTAGE, PLEASE SEE MS-20
Continue
Version 2.2011, 05/13/11 © National Comprehensive Cancer Network, Inc. 2011, All rights reserved. The NCCN Guidelines™ and this illustration may not be reproduced in any form without the express written permission of NCCN®.

Guidelines for Tunnelling Risk Management

Guidelines for Tunnelling Risk Management

International Tunnel Association Working Group No. 2 Guidelines for Tunnelling Risk Management2002-10-21International Tunnelling Association,Working Group No. 2Guidelines for Tunnelling RiskManagement2002-10-21Revision 0Issue 2002-10-21Author Søren Degn Eskesen, Per Tengborg, Jørgen Kampmann, Trine Holst VeichertsContents0Abstract 51Introduction and scope 62Use of risk management 73Objectives of risk management 10 3.1Scope 10 3.2Risk objectives 10 3.3Risk management strategy 114Risk management in early design stages 13 4.1Establish risk policy 13 4.2Risk acceptance criteria 13 4.3Qualitative risk assessment 14 4.4Specific risk assessment 165Risk management during tendering and contractnegotiation 17 5.1Risk management during preparation of tenderdocuments 17 5.2Risk management during selection of contractor 19 5.3Risk clauses in contract 20 6Risk management during construction 22 6.1Contractor's risk management 22 6.2Owner's risk management 23 7Typical components of risk management 24 7.1Introduction 24 7.2Hazard identification 24 7.3Classification 257.4Quantitative risk assessment 328Risk management tools 34 8.1Fault tree analysis 34 8.2Event tree analysis 35 8.3Decision tree analysis 35 8.4Multirisk 36 8.5Monte Carlo simulation 379Glossary 3810References 390AbstractThe paper gives guidance to all those who have the job of preparing the overall scheme for the identification and management of risks in tunnelling and underground projects. The text provides owners and consultants with what is modern-day industry practice for risk assessment, and describes the stages of risk management throughout the entire project from concept to start of operation.1Introduction and scopeTunnelling and underground construction works impose risks on all parties involved as well as on those not directly involved in the project. The very nature of tunnel projects implies that any potential tunnel owner will be fac-ing considerable risks when developing such a project. Due to the inherent uncertainties, including ground and groundwater conditions, there might be significant cost overrun and delay risks as well as environmental risks. Also, as demonstrated by spectacular tunnel collapses and other disasters in the recent past, there is a potential for large scale accidents during tunnelling work. Furthermore, for tunnels in urban areas there is a risk of damage to a range of third party persons and property, which will be of particular con-cern where heritage designated buildings are involved. Finally there is a risk that the problems which the tunnelling project cause to the public will give rise to public protests affecting the course of the project.Traditionally, risks have been managed indirectly through the engineering deci-sions taken during the project development. These guidelines consider that pre-sent risk management processes can be significantly improved by using sys-tematic risk management techniques throughout the tunnel project develop-ment. By the use of these techniques potential problems can be clearly iden-tified such that appropriate risk mitigation measures can be implemented in a timely manner.The use of risk management from the early stages of a project, where major decisions such as choice of alignment and selection of construction methods can be influenced, is essential.The purpose of this document is to1.indicate to owners what is recommended industry best-practice forrisk management; and2.present guidelines to designers as to the preparation and implementa-tion of a comprehensive tunnel risk management system.For the purposes of this document "risk management" is the overall term which includes risk identification, risk assessment, risk analysis, risk elimi-nation and risk mitigation and control. See glossary in section 9.2Use of risk managementIn order to fulfil the scope these guidelines provide a description of risk management activities that may be used for tunnels and underground works. Below is shown how risk management may be used throughout the project from the early planning stage through to start of operation:•Phase 1: Early Design Stage (Feasibility and Conceptual Design) -Establish risk policy (section 4.1)-Risk acceptance criteria (section 4.2)-Qualitative risk assessment of the project (section 4.3)-Detailed analysis of areas of special interest or concern (section4.4)•Phase 2: Tendering & Contract Negotiation-Requirements in tender documents (section 5.1)-Risk assessment in tender evaluation (section 5.2)-Risk clauses in contract (section 5.3)•Phase 3: Construction Phase-Contractor's risk management (section 6.1)-Owner's risk management (section 6.2)-Joint risk management team between the owner and the contractor In phase 1 the responsibility of establishing a risk policy and carrying out risk assessment is the owner's alone. In phase 2 the potential contractor has certain input to the tender regarding risk management, but the owner is still the primary responsible party. In phase 3 however, the primary responsibil-ity moves on to the contractor to establish a risk management system and to carry out effective risk management. The owner should supervise, inspect and participate in this work. The owner should further continue to assess and mitigate risks not covered by the contractor.It is important that the risk management is performed in an environment of good cooperation between the parties. To achieve this, partnering may be a valuable tool. The process of partnering may be formulated as an exercise in encouraging good communications between the parties. It may be a formula for minimising cost to the owner while maximising profit for the contractor and encompasses joint planning and problem solving, scheduling, mitigationof delays and value engineering. The process of "partnering" may therefore be seen as a risk mitigation measure for the owner and the contractor.An overview of the risk management activities as seen from the owner's point of view is presented in figure 1. Risk assessments made by the contractor solely for his own purposes, such as the assessment of the risks he is involved in by submitting the tender, are not included.Owner Contractor Supervision and support ofcontractor's risk managementAssessment and mitigation of owner's riskEstablish risk management system Figure 1 - Risk management activity flow for owner and contractor Joint work in riskmanagement team3Objectives of risk managementThe identification of risks resulting from design and construction is an es-sential task early in a project. In order to form a common reference for all parties involved (e.g. the owner, designers, insurers and contractors) a con-struction risk policy should be established by the owner.A construction risk policy for the project may indicate:•scope,•risk objectives, and•risk management strategy.3.1ScopeAs an example, the scope may include the following risks or consequences: 1.Risk to the health and safety of workers, including personal injury and, inthe extreme, loss of life,2.Risk to the health and safety of third parties,3.Risk to third party property, specifically existing buildings and structures,cultural heritage buildings and above and below ground infrastructure, 4.Risks to the environment including possible land, water or air pollutionand damage to flora and fauna,5.Risk to the owner in delay to the completion,6.Risk to the owner in terms of financial losses and additional unplannedcosts.3.2Risk objectivesThe risk objectives may be given as general objectives supplemented by specific objectives for each type of risk. The general objectives of the con-struction risk policy could be that proper risk management throughout the project will be ensured at all stages of the project by the:•Identification of hazards•Identification of measures to eliminate or mitigate risks•Implementation of measures to eliminate or mitigate risks where economically feasible or required according to the specific risk ob-jectives or health and safety legislation.Economically feasible may be defined using the ALARP principle i.e. to reduce all risks covered to a level as low as reasonably practicable.The construction risk policy may indicate that emphasis should be placed on minimising overall risk by reducing the likelihood of occurrence of events with large consequences, e.g. with several fatalities or of significant political concern. This should be done if the owner considers low probability events with high consequences to be of more concern than high probability events with low consequences; even if the risk, expressed as probability times con-sequence, is the same.The construction risk policy may also include some general statements on allocation of risks between parties, e.g. a risk should be allocated to the party who has the best means for controlling the risk.For each type of risk, specific minimum risk objectives may be defined in addition to the general risk objectives. For example, the general public should be exposed only to a small additional risk from construction of the tunnel or underground works; compared to the risk they are exposed to as users of buildings, cars, bicycles, public transport and when walking in the adjacent streets.3.3Risk management strategyAs part of the construction risk policy a risk management strategy should be adopted. A recommended strategy is to carry out construction risk assess-ments at each stage of design and construction in accordance with the in-formation available and the decisions to be taken or revised at each stage. Any risk management strategy should include:• a definition of the risk management responsibilities of the various par-ties involved (different departments within the owner's organisation,consultants, contractors)• a short description of the activities to be carried out at different stages of the project in order to achieve the objectives• a scheme to be used for follow-up on results obtained through the risk management activities by which information about identified hazards (nature and significance) is freely available and in a format that can be communicated to all parties, which may best be accomplished by some form of comprehensive risk register•follow-up on initial assumptions regarding the operational phase •monitoring, audit and review procedures4Risk management in early design stages For effective risk management of a tunnelling project (or any other type of construction work) it is vital that risk management is begun as early as pos-sible, preferably during the project feasibility and early planning stages. The owner's risk policy sets the objectives of the exercise and existing members of the project team (and new members when they join the project team) should have the whole risk management process in their minds when carry-ing out their work.It is important to note that the success and benefits of implementing effec-tive risk management depends on the quality of the identified risk mitigating actions and on the active involvement, experience and general opinion of the participants (owner, designers and contractors).Risk management is not achieved by the enforcement of systems and proce-dures alone, but can be enhanced through seminars and meetings where an understanding and appreciation of the risk management objectives are dis-seminated throughout the organisations.4.1Establish risk policyThe primary step in establishing a risk management system is for the owner to formulate a risk policy as described in section 3.4.2 Risk acceptance criteriaThe risk objectives expressed in general terms in the owners risk policy should be "translated" into risk acceptance criteria suitable for use in the risk assessment activities planned to be carried out. This may include:•Risk acceptance criteria to be used in qualitative risk assessment. The risk classification shown in section 7.3.3 is an example of such criteria. •Risk acceptance criteria to be used in quantitative risk assessments. For each type of risk to be covered by a quantitative risk assessment theywould usually be expressed as:- A limit above which the risk is considered unacceptable and thus must be reduced regardless of the costs.- A limit below which it is not required to consider further risk re-duction.-An area between the two limits where risk mitigation shall be con-sidered and mitigation measures implemented according to the cir-cumstances, e.g. using the ALARP principle mentioned in section3.A document should be provided that explains how the risk acceptance crite-ria were established in relation to the statements on risk objectives in the owner's risk policy.4.3Qualitative risk assessmentDuring the early design stage, a qualitative risk assessment should be car-ried out focussed on the identification of potential hazards to the construc-tion activities expected to be included in the project, and covering all types of risk noted in the construction risk policy.The main purposes of this work is to raise the awareness of all concerned to the major risks involved in the construction and to provide a structured basis for the design decisions to be taken in the early design stage. The results can also be used for selection of specific topics for more detailed analyses as described in section 4.4. Finally the work can be used as starting point for the risk management during tendering.The timing of the qualitative risk assessment should be such that major de-sign changes are still possible. Depending on the time schedule of the early design it may be feasible to update the first qualitative risk assessment later in this design phase.The qualitative risk assessment should include:•Hazard identification. See section 7.2.•Classification of the identified hazards. See section 7.3. •Identification of risk mitigation measures.•Details of the risks in the project risk register indicating risk class and risk mitigation measures for each hazard.The identification and classification is best carried out through brainstorm-ing sessions with risk screening teams consisting of multi-disciplinary, technically and practically experienced experts guided by experienced risk analysts. The aim should be to identify all conceivable hazardous eventsthreatening the project including those risks of low frequency but high pos-sible consequence.In the identification and classification process due regard should be taken of common causes for hazardous events such as:•Complexity and maturity of the applied technology•Adverse unexpected ground and groundwater conditions •Technical and/or managerial incompetence•Human factors and/or human errors.•Lack of sufficient communication and co-ordination between internal and external interfaces•Combinations of several unwanted events that individually are not necessarily criticalThe identified hazards are classified according to the magnitude of the risk they represent. The purpose of this classification is to provide a framework for the decisions to be made on implementation of risk mitigation measures. Classification systems should be established covering frequencies and con-sequences as well as classification of risks on the basis of the frequency and consequence classes. The classification system may be included in the risk acceptance criteria, see section 4.2.The identification of risk mitigation measures may be carried out by the same or a different team and this team should preferably have a representa-tive of all the major parties to the project.Where risk levels conflict with the project's risk acceptance criteria, it is mandatory to identify risk-reducing actions and provide documentation for the management decision on which actions are to be implemented. The re-sults should be registered in the project risk register.Risk mitigation in this phase of the project will primarily result in changes in technical solutions and possibly in alternative working procedures. Fur-ther, many risk-reducing actions can be decisions or statements to be written into the tender documents.At this point it should be possible to establish whether implementation of a set of risk-mitigating actions will in fact reduce the risk to an acceptable level. If this does not appear to be the case, other approaches must be ex-plored.4.4Specific risk assessmentFor hazards of specific interest, e.g. due to the severity of the risk involved or the significance of the design decision to be taken, a more detailed risk analysis than the general qualitative analysis described in section 4.3 may be carried out. The outcome of this analysis should also be documented in the project risk register.The work may comprise one or more of the following:• A fault tree analysis of the causes of the hazards, see section 8•An event tree analysis of the consequences, see section 8• A full quantification of the risk, see section 7.4, e.g. with the purpose of evaluating the cost-benefit ratio of implementation of mitigating meas-ures or providing a quantitative basis for a decision between alternative courses of action.5Risk management during tendering and contract negotiation5.1Risk management during preparation of tenderdocuments5.1.1Main risk management activitiesThe following risk management activities should be carried out during preparation of the tender documents:•Specification of technical and other requirements in the tender docu-ments such that the risks are managed in accordance with the risk pol-icy. The results of the qualitative risk assessment carried out during the early design stage should be used as part of the basis.The specification of technical and other requirements should detail re-sponsibilities for risks in accordance with any general principlesadopted for the project covering allocation of risks. E.g. risks should be allocated to the party who has the best means for controlling them, as mentioned in section 3.2.•The qualitative risk assessment carried out in the early design stages should be repeated when the tender documents are near completion as the basis for final modifications of the tender documents and to docu-ment that risk has been managed in accordance with the risk policy.•Definition of the information requested from the tenderers in order to allow an evaluation of the tenderers' ability to manage risk and of the differences in risk between the proposals made by the different tender-ers. See section 5.1.2.•Specification of requirements in the tender document concerning the contractor's risk management activities during execution of the contract, see section 5.1.3.5.1.2Information to be provided with the tenderIn order to ensure a basis for comparing and evaluating the tenderers, the tender documents should state the information that each tenderer must pre-sent in this respect. This information should include:•Information on structured risk management in similar projects and their outcomes•CV for persons to be responsible for the risk management and details of any specialist organisation that has been involved•General description of the tenderer's intentions regarding his project-specific organisation and his risk management objectives•Overview and description of the major risks perceived by the tenderer in the project•The tenderer’s proposed strategy for the management of major risks to the project and how success will be defined and measured.It should be stated that some or all of the above information provided by the tenderers will be used as a basis for the owner's tender evaluation. The in-formation will help to illustrate whether the contractor is capable of carrying out the necessary systematic risk analysis, and the expected risk manage-ment performance.5.1.3Requirements to be specified in the tender documentsThe tender documents should specify that the contractor must perform risk management in accordance with the owner's risk policy. The contractor's risk management system and approaches must be compatible with the owner's, thereby reducing and controlling risks both to himself, to the owner and the public.Requirements concerning the contractor's risk management system should be described. This could include such matters as:•Organisation and qualifications of risk management staff•Types of risks to be considered and evaluated. These will be concerned with construction issues and any related design activities under the con-tractor's control.•Activities, i.e. description of a minimum requirement of activities to be included in the contractor's risk management, including systematic risk identification, classification of risks by frequency and consequence, and identification of risk elimination and risk mitigating measures•Time schedule for risk management activities (including requirements to carry out risk assessment in time to allow implementation of identi-fied risk mitigating measures)•Co-ordination with the owner's risk management and risk management team•Co-ordination with the other contractors' risk management•Co-ordination between risk management and the contractor's other sys-tems, such as quality management and environmental management.•Control of risks from sub-contractors’ activities•Specific requirements concerning risk management in explicit fields should be stated (examples could be modification to the construction methods for areas identified as of particular concern, i.e. construction methods related to risk to third party buildings or requirements concern-ing securing against unintentional ground water lowering)The owner's risk policy, risk acceptance criteria and risk classification sys-tem should be stated in the tender documents. The owner's risk management activities should be briefly mentioned. It should be carefully considered and pointed out to what extent the contractor will have insight into the owner's risk analysis results. Further, it should be stated in the tender documents that the contractor is responsible for effective risk management regardless of the extent and detail of the risk information deriving from the owner.It is recommended that the tender documents require that the owner be in-volved in the risk management during construction and that a risk manage-ment team is established with participants from the contractor and from the owner (see figure 1).5.2Risk management during selection of contractor Providing tenderers are clearly informed in tender documents, the applica-tion of risk management techniques by the owner can be valuable in the se-lection of the successful tenderer. Identifying risk issues in the tenders can be used as a basis for tender negotiations. The evaluation of tenders in re-spect of risk may be qualitative (based on a points system) or on a quantita-tive basis to the extent that the tender price might be adjusted accordingly.The evaluation of the risk issues in the tenders should include:•An evaluation of the contractor's ability to identify and control risks by the choice and implementation of technical solutions. An evaluation is also needed of his ability to apply systematic risk management in the work that he will undertake;•Systematic assessment of the differences in risk between the project proposals by different tenderers;•Evaluation of the risk management expertise at the contractor's disposalWhere a qualitative risk assessment is envisaged, the means of achieving this need to be considered during the preparation of the tender documenta-tion. For each identified risk, the tenders need to be compared and areas where there are differences should be highlighted.Where a quantitative risk assessment is envisaged, the recommended ap-proach is first to carry out a quantitative risk assessment on the owner's pro-ject as described in Section 7.4. This could be carried out in the time period between the issue and the receipt of tenders. The risk in each tender is quantified by taking the owner's quantitative risk assessment and for each risk considering the differences in frequency and consequence. The input to the quantification could be obtained from reliable information obtained from external sources and/or through brainstorming sessions. The experience and competence of those on the brainstorming team is vital. The final outcome will be the quantification of the risks involved in each tender. This has the benefit of a level comparison even if the absolute value of the risk is uncer-tain.This quantification is particularly useful for the risk of economic loss to the owner, and the risk of delay to the completion of the project. These evalua-tions could be directly compared with the contract price in the tenders and the assignment of a certain monetary value might be made per month's esti-mated or potential delay of project completion.For other risks it may be more difficult to obtain reliable results from a full quantification analysis, and a qualitative comparison may be all that is practi-cable.5.3Risk clauses in contractWhen a contractor has been chosen, negotiations between the owner and the contractor may lead to a detailed contractual description of the risk man-agement system to be implemented on the project. This may be based on a combination of the intentions of the owner and the suggested procedures of the contractor with the purpose of improving the co-operation between the parties.Alternative technical solutions will also be negotiated on the basis of risk assessments carried out and stated in the contract.The risk assessment of the successful tender may have identified some pre-viously undetected areas of risk or special concern. In order to reduce these risks to an acceptable level, additional risk mitigation clauses may be intro-duced in the contract. An example could be that the contractor has proposed a modification to the construction methods envisaged by the owner, which is advantageous except for a secondary risk of impact to the environment. This risk to the environment is then mitigated by additional requirements.6Risk management during constructionIn the early design and tender and contract negotiation phases certain risks may be transferred, either contractually or through insurance, others may be retained and some risks can be eliminated and/or mitigated. In the construc-tion phase, possibilities of risk transfer are minimal and the most advanta-geous strategy for both owner and contractor is to reduce the severity of as many risks as possible through the planning and implementation of risk eliminating and/or risk mitigating initiatives.6.1Contractor's risk managementBased on what has been agreed in the contract, the contractor's responsibil-ity could be as proposed in figure 1. The contractor is responsible for the fulfilment of the owner's risk policy and should start by establishing a care-fully planned, well-structured and easy-to-use risk management system. The structure of the risk management system is of great importance for the straightforwardness of the further work with detailed identification of haz-ards and assessment of risks. See section 7.The contractor must identify hazards and classify risks using systems which are compatible with the systems used by the owner (see section 7.2 and 7.3) and should propose mitigation measures to reduce the identified risks. In cases where the implementation of the mitigation measures could lead to major delay or could in any other way cause a loss to the owner, the owner should approve the intended mitigation prior to its implementation.The contractor's risk management strategy should be implemented by all members of his staff whatever their job functions. The identification of haz-ards and control of risk, and the techniques involved, should be seen as an essential part of all the design and construction activities of the project. In-formation and training should be given, as necessary, to all personnel throughout the project. The owner should be invited to be present and to participate in the contractor's risk management meetings, presentations and training sessions.Timely consideration and actions are of the essence in risk mitigation meas-ures. The aim is to anticipate, and put in place effective proactive preventa-。

最新欧洲急性肺栓塞指南,看这5张图就够了!GW-ICC2019

最新欧洲急性肺栓塞指南,看这5张图就够了!GW-ICC2019

最新欧洲急性肺栓塞指南,看这5张图就够了!GW-ICC2019 控制血糖果然重要,但降低CVD风险才是首要目标。

静脉血栓栓塞(VTE)包括深静脉血栓(DVT)或肺栓塞(PE),是仅次于心肌梗死和卒中的全球第三常见的急性心血管综合征。

PE的年发病率为39-115/100000,纵向研究表明,每年PE发病率呈上升趋势。

在美国,PE每年可能导致<30万人死亡,是心血管疾病的一个重要死因。

而在中国,PE的30天全因死亡率约为4.9%-6.6%。

2019年8月31日在巴黎举行的ESC大会上发布了第4版急性肺栓塞诊断和管理指南,相比于2014年版指南,新指南在诊断、风险评估、急性期治疗、慢性期治疗、特殊人群管理和随访等方面进行了更新。

在2019年第三十届长城心脏病学会议(GW-ICC)上,来自首都医科大学附属北京安贞医院的刘巍教授对2019年ESC/ERS急性肺栓塞诊断和管理指南进行了解读,获得了与会人员的广泛关注。

精彩抢先看,相较于2014版肺栓塞指南,今年的指南更新了以下内容:•血流动力学不稳定和高危肺栓塞•适应风险的诊断方法•新的诊断建议•对右心室功能障碍的风险评估及其预后重要性的新建议•综合管理办法•急性肺栓塞后延长治疗的适应症•肿瘤相关的肺栓塞•长期随访与晚期后遗症01PE危险因素02血流动力学不稳定和高危PE的定义03高危PE的诊断流程无血流动力学障碍PE的诊断流程05修订的日内瓦肺栓塞临床预测规则诊断方法推荐07肺栓塞严重指数(PESI)及其简化版本sPESI08风险评估新增推荐09基于早期死亡风险的PE分层10急性肺栓塞经风险调整治疗策略11急性期治疗新增推荐12高危PE急性期治疗新增推荐13急性期治疗▎血流动力学和呼吸支持•氧气和通气•急性右室衰竭药物治疗•机械循环支持和氧合:ECMO的使用与较高的并发症发生率相关,即使使用时间很短。

目前,单独使用ECMOO联合抗凝仍存在争议。

•心脏骤停的高级生命支持:如果心脏骤停可能是急性肺栓塞引起的,应遵循指南进行生命支持。

妇科手术感染预防指南PPT课件

妇科手术感染预防指南PPT课件
6
干预措施
术前
➢控制感染:远离手术部位的感染,在择期手术前都认真甄别并予以合理治疗。 ➢积极控制血糖:围术期积极控制血糖,争取血糖控制在200mg/dl(11.1mmol/L)以内*。 ➢清洁皮肤:2018年ACOG 指南建议,腹部手术患者术前夜间行(全身)淋浴或沐浴, 但指南未明确指出最佳洗涤剂及洗涤时间。 ➢细菌阴道病筛查问题:细菌性阴道病为术后感染的重要因素。该指南建议子宫切除 术前筛查细菌性阴道病,对合并细菌性阴道病患者,术前及术后需应用甲硝唑治疗至 少4d,以降低阴道残端感染的发生率。
13
结语
20世纪80年代初,预防性抗生素的应用使许多术后感染得以避免,但也 因药物的滥用导致了许多耐药的发生。.
随着医疗技术的发展及临床实践不断总结,抗生素的使用逐渐规范。
减少术后切口感染作为一项长期而艰巨的工作,医务人员应严格执 行《消毒隔离管理总则》,术前加强患者无菌宣传教育,术中严格 遵循无菌原则,规范操作,术后加强护理,注意心理干预,严密把 控治疗的各环节,以期降低切口感染的发生率,提高医疗质量。
14
THANK YOU
感谢聆听,批评指导
15
10
抗生素应用原则:适应症
阴式
经腹
腹腔镜
机器人
子宫切除术的患者应接受单剂量的 抗菌药物,目前推荐的单剂量的药物为 头孢唑林,指南不建议诊断性腹腔镜及 开腹探查的患者预防性应用抗生素。
11
抗生素应用原则:适应症
对于行子宫输卵管造影/输卵管通液的患者,若术前有盆腔炎性疾病病史或手术 时发现输卵管异常,建议预防性使用抗生素,常用多西环素。 行超声宫腔造影术、子宫内膜活检或消融、宫内节育器置入、宫颈组织活检的 患者因感染率微乎其微,均不推荐预防性应用抗生素。 人工流产的女性应预防性使用抗生素,研究发现,该举措可降低术后41%的感 染率。 阴道前后壁修补或阴道网片植入术者的患者可预防性应用抗生素。 目前尚不清楚预防性抗生素在外阴切除术中的作用,鉴于外阴皮肤上的细菌菌 群较多,此类手术切口类似清洁-污染手术,故给予单剂抗生素预防。

残留溶剂的指导原则英文

残留溶剂的指导原则英文
However, the content of solvents in such products should be evaluated and justified.
All residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements.
Drug products should contain no higher levels of residual solvents than can be supported by safety data.
Some solvents that are known to cause unacceptable toxicities (Class 1, Table 1) should be avoided in the production of drug substances, excipients, or drug products unless their use can be strongly justified in a risk-benefit assessment.
PART I:
Impurities:guidline for residual solvents
Introduction
The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of low toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

ins指南对静脉治疗的目标要求

ins指南对静脉治疗的目标要求

ins指南对静脉治疗的目标要求英文回答:The goal of intravenous therapy, as outlined in the INS guidelines, is to provide safe and effective administration of medications and fluids directly into the veins. This method of treatment allows for rapid absorption and immediate therapeutic effect. The following objectives are set forth in the guidelines to ensure the achievement of this goal:1. Patient Safety: The primary objective of intravenous therapy is to ensure patient safety throughout the entire process. This includes proper patient identification, verification of the correct medication and dosage, and adherence to aseptic technique during insertion and maintenance of the intravenous line. Regular assessment and monitoring of the patient's condition are also essential to identify any potential complications or adverse reactions.2. Optimal Medication Administration: Intravenous therapy aims to provide the most effective and efficient delivery of medications. This involves selecting the appropriate route of administration, such as a peripheral vein or a central venous access device, based on the medication's characteristics and the patient's condition. The guidelines emphasize the importance of proper medication preparation, dilution, and compatibility to ensure accurate dosing and minimize the risk of medication errors.3. Fluid and Electrolyte Balance: Intravenous therapy is commonly used to restore and maintain fluid and electrolyte balance in patients with dehydration, electrolyte imbalances, or other fluid-related disorders. The guidelines provide recommendations for the selection and administration of appropriate fluids, taking into consideration the patient's age, underlying condition, and specific fluid needs. Close monitoring of fluid intake, output, and electrolyte levels is necessary to prevent complications such as fluid overload or electrolyte disturbances.4. Infection Prevention: Invasive procedures associated with intravenous therapy pose a risk of infection. The guidelines emphasize the importance of strict adherence to infection prevention practices, including hand hygiene, proper disinfection of the insertion site, and the use of sterile techniques during line insertion and maintenance. Regular assessment and monitoring for signs of infection, such as redness, swelling, or discharge at the insertion site, are essential to detect and treat infections promptly.5. Patient Education and Collaboration: The successful implementation of intravenous therapy requires active involvement and collaboration between healthcare providers and patients. The guidelines highlight the importance of patient education regarding the purpose, benefits, and potential risks of intravenous therapy. Patients should be informed about the signs and symptoms of complications and instructed on how to care for the intravenous line at home, if applicable.中文回答:根据INS指南,静脉治疗的目标是为了提供安全有效的药物和液体直接注入静脉的治疗方法。

ISTAGuidelines包装运输&跌落测试标准

ISTAGuidelines包装运输&跌落测试标准

OUR VISION is "Just Right Transport Packaging" packaging which meets the protective needs of the product, as well as meeting the economical and environmental needs of the product's shipper and user. This Just Right Packaging is designed and certified against Just Right preshipment testing which adequately simulates the hazards of actual transportation/distribution.
These Guidelines are intended to provide the user of ISTA® Test Procedures and Projects and other ISTA documents with insight and information on the protocols, and what factors to consider in selection, use, and results interpretation.
6
Face, Edge and Corner
Identification
6
Samples
6-7
Retesting
7-8
Repeated Testing
8
Line Extension Policy
8
Identification of Product and

Guideline for Design of_Tunnel-翻译版

Guideline for Design of_Tunnel-翻译版

隧道设计准则Guidelines for the Design of TunnelsThis report is edited by Heinz Duddeck,Animateur o[the ITA Working Group on General Approaches in the Design of Tunnels.Present address:Pro[.Heinz Duddeck,Technical University of Braunschweig,Beethovenstrasse 51,3300Braunschweig,Federal Republic of Germany.翻译翻译日期:日期:2011–03–01隧道设计准则国际隧道协会一般设计方法工作组摘要:这份国际隧道协会工作组的第二份报告是关于隧道一般设计方法,其概括了国际上隧道设计一般程序。

绝大部分的隧道工程,土地都主动提供隧道开挖的稳定性。

因此,隧道设计一般方法包括了实地勘测、地面探查、原位监测以及应力和变形分析。

对于后者,本文介绍了目前应用的各种结构设计模型(包括观察法)。

同时给出了隧道衬砌的详细结构设计准则的和隧道设计的国家推荐准则。

本文基于广泛的隧道工程实践经验,希望能给世界各地的隧道设计者提供参考。

Guidelines for the Design of TunnelsITA Working Group on General Approaches to the Design of TunnelsAbstract :This second report by the ITA Working Group on General Approaches to the Design of Tunnels presents international design procedures for tunnels.In most tunnelling projects,the ground actively participates in providing stability to the opening.Therefore,the general approach to the design of tunnels includes site investigations,ground probings and in-situ monitoring,as well as the analysis of stresses and deformations.For the latter,the different structural design models applied at present--including the observational method--are presented.Guidelines for the structural detailing of the tunnel lining and national recommendations on tunnel design are also given.It is hoped that the information herein,based on experiences from a wide range of tunnelling projects,will be disseminated to tunnel designers throughout the world.1准则的范围国际隧道协会(ITA )隧道一般设计方法研究组成立于1978年。

E9 Statistical Principles for Clinical Trials

E9 Statistical Principles for Clinical Trials

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH H ARMONISED T RIPARTITE G UIDELINES TATISTICAL P RINCIPLES FOR C LINICAL T RIALSE9Current Step 4 versiondated 5 February 1998This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.E9Document HistoryFirst CodificationHistory Date New Codification November 2005 E9 Approval by the Steering Committee under Step 2 and release for public consultation. 16 January 1997 E9Current Step 4 versionE9 Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 5 February 1998 E9S TATISTICAL P RINCIPLES FOR C LINICAL T RIALSICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 5 February 1998, this guideline is recommended foradoption to the three regulatory parties to ICHTABLE OF CONTENTSI.INTRODUCTION (1)1.1Background and Purpose (1)1.2Scope and Direction (2)II.CONSIDERATIONS FOR OVERALL CLINICAL DEVELOPMENT (3)2.1Trial Context (3)2.1.1Development Plan (3)2.1.2Confirmatory Trial (4)2.1.3Exploratory Trial (4)2.2Scope of Trials (4)2.2.1Population (4)2.2.2Primary and Secondary Variables (5)2.2.3Composite Variables (6)2.2.4Global Assessment Variables (6)2.2.5Multiple Primary Variables (7)2.2.6Surrogate Variables (7)2.2.7 Categorised Variables (7)2.3Design Techniques to Avoid Bias (8)2.3.1Blinding (8)2.3.2Randomisation (9)III.TRIAL DESIGN CONSIDERATIONS (11)3.1Design Configuration (11)3.1.1Parallel Group Design (11)3.1.2Crossover Design (11)3.1.3Factorial Designs (12)3.2Multicentre Trials (12)3.3Type of Comparison (14)3.3.1Trials to Show Superiority (14)3.3.2Trials to Show Equivalence or Non-inferiority (14)3.3.3Trials to Show Dose-response Relationship (16)Statistical Principles for Clinical Trials3.4Group Sequential Designs (16)3.5Sample Size (16)3.6Data Capture and Processing (18)IV.TRIAL CONDUCT CONSIDERATIONS (18)4.1Trial Monitoring and Interim Analysis (18)4.2Changes in Inclusion and Exclusion Criteria (19)4.3Accrual Rates (19)4.4Sample Size Adjustment (19)4.5Interim Analysis and Early Stopping (19)4.6Role of Independent Data Monitoring Committee (IDMC) (21)V.DATA ANALYSIS CONSIDERATIONS (21)5.1Prespecification of the Analysis (21)5.2Analysis Sets (22)5.2.1Full Analysis Set (22)5.2.2Per Protocol Set (23)5.2.3Roles of the Different Analysis Sets (24)5.3Missing Values and Outliers (24)5.4Data Transformation (25)5.5Estimation, Confidence Intervals and Hypothesis Testing (25)5.6Adjustment of Significance and Confidence Levels (26)5.7Subgroups, Interactions and Covariates (26)5.8Integrity of Data and Computer Software Validity (27)VI.EVALUATION OF SAFETY AND TOLERABILITY (27)6.1Scope of Evaluation (27)6.2Choice of Variables and Data Collection (27)6.3Set of Subjects to be Evaluated and Presentation of Data (28)6.4Statistical Evaluation (29)6.5Integrated Summary (29)VII.REPORTING (29)7.1Evaluation and Reporting (29)7.2Summarising the Clinical Database (31)7.2.1Efficacy Data (31)7.2.2 Safety Data (32)GLOSSARY (32)S TATISTICAL P RINCIPLES FOR C LINICAL T RIALSI. INTRODUCTION1.1 Background and PurposeThe efficacy and safety of medicinal products should be demonstrated by clinical trials which follow the guidance in 'Good Clinical Practice: Consolidated Guideline' (ICH E6) adopted by the ICH, 1 May 1996. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline. The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate a succinct document on statistical issues related to clinical trials. This guidance is written primarily to attempt to harmonise the principles of statistical methodology applied to clinical trials for marketing applications submitted in Europe, Japan and the United States.As a starting point, this guideline utilised the CPMP (Committee for Proprietary Medicinal Products) Note for Guidance entitled 'Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorisations for Medicinal Products' (December, 1994). It was also influenced by 'Guidelines on the Statistical Analysis of Clinical Studies' (March, 1992) from the Japanese Ministry of Health and Welfare and the U.S. Food and Drug Administration document entitled 'Guideline for the Format and Content of the Clinical and Statistical Sections of a New Drug Application' (July, 1988). Some topics related to statistical principles and methodology are also embedded within other ICH guidelines, particularly those listed below. The specific guidance that contains related text will be identified in various sections of this document.E1A: The Extent of Population Exposure to Assess Clinical SafetyE2A: Clinical Safety Data Management: Definitions and Standards for Expedited ReportingE2B: Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsE2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsE3: Structure and Content of Clinical Study ReportsE4: Dose-Response Information to Support Drug RegistrationE5: Ethnic Factors in the Acceptability of Foreign Clinical DataE6: Good Clinical Practice: Consolidated GuidelineE7: Studies in Support of Special Populations: GeriatricsE8: General Considerations for Clinical TrialsE10: Choice of Control Group in Clinical TrialsM1: Standardisation of Medical Terminology for Regulatory PurposesM3: Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.Statistical Principles for Clinical TrialsThis guidance is intended to give direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development. The document will also assist scientific experts charged with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.1.2 Scope and DirectionThe focus of this guidance is on statistical principles. It does not address the use of specific statistical procedures or methods. Specific procedural steps to ensure that principles are implemented properly are the responsibility of the sponsor. Integration of data across clinical trials is discussed, but is not a primary focus of this guidance. Selected principles and procedures related to data management or clinical trial monitoring activities are covered in other ICH guidelines and are not addressed here. This guidance should be of interest to individuals from a broad range of scientific disciplines. However, it is assumed that the actual responsibility for all statistical work associated with clinical trials will lie with an appropriately qualified and experienced statistician, as indicated in ICH E6. The role and responsibility of the trial statistician (see Glossary), in collaboration with other clinical trial professionals, is to ensure that statistical principles are applied appropriately in clinical trials supporting drug development. Thus, the trial statistician should have a combination of education/training and experience sufficient to implement the principles articulated in this guidance.For each clinical trial contributing to a marketing application, all important details of its design and conduct and the principal features of its proposed statistical analysis should be clearly specified in a protocol written before the trial begins. The extent to which the procedures in the protocol are followed and the primary analysis is planned a priori will contribute to the degree of confidence in the final results and conclusions of the trial. The protocol and subsequent amendments should be approved by the responsible personnel, including the trial statistician. The trial statistician should ensure that the protocol and any amendments cover all relevant statistical issues clearly and accurately, using technical terminology as appropriate.The principles outlined in this guidance are primarily relevant to clinical trials conducted in the later phases of development, many of which are confirmatory trials of efficacy. In addition to efficacy, confirmatory trials may have as their primary variable a safety variable (e.g. an adverse event, a clinical laboratory variable or an electrocardiographic measure), a pharmacodynamic or a pharmacokinetic variable (as in a confirmatory bioequivalence trial). Furthermore, some confirmatory findings may be derived from data integrated across trials, and selected principles in this guidance are applicable in this situation. Finally, although the early phases of drug development consist mainly of clinical trials that are exploratory in nature, statistical principles are also relevant to these clinical trials. Hence, the substance of this document should be applied as far as possible to all phases of clinical development. Many of the principles delineated in this guidance deal with minimising bias (see Glossary) and maximising precision. As used in this guidance, the term 'bias' describes the systematic tendency of any factors associated with the design, conduct, analysis and interpretation of the results of clinical trials to make the estimate of a treatment effect (see Glossary) deviate from its true value. It is important to identify potential sources of bias as completely as possible so that attempts to limit such bias may be made. The presence of bias may seriously compromise the ability to draw valid conclusions from clinical trials.Statistical Principles for Clinical Trials Some sources of bias arise from the design of the trial, for example an assignment of treatments such that subjects at lower risk are systematically assigned to one treatment. Other sources of bias arise during the conduct and analysis of a clinical trial. For example, protocol violations and exclusion of subjects from analysis based upon knowledge of subject outcomes are possible sources of bias that may affect the accurate assessment of the treatment effect. Because bias can occur in subtle or unknown ways and its effect is not measurable directly, it is important to evaluate the robustness of the results and primary conclusions of the trial. Robustness is a concept that refers to the sensitivity of the overall conclusions to various limitations of the data, assumptions, and analytic approaches to data analysis. Robustness implies that the treatment effect and primary conclusions of the trial are not substantially affected when analyses are carried out based on alternative assumptions or analytic approaches. The interpretation of statistical measures of uncertainty of the treatment effect and treatment comparisons should involve consideration of the potential contribution of bias to the p-value, confidence interval, or inference.Because the predominant approaches to the design and analysis of clinical trials have been based on frequentist statistical methods, the guidance largely refers to the use of frequentist methods (see Glossary) when discussing hypothesis testing and/or confidence intervals. This should not be taken to imply that other approaches are not appropriate: the use of Bayesian (see Glossary) and other approaches may be considered when the reasons for their use are clear and when the resulting conclusions are sufficiently robust.II. CONSIDERATIONS FOR OVERALL CLINICAL DEVELOPMENT2.1 Trial Context2.1.1 Development PlanThe broad aim of the process of clinical development of a new drug is to find out whether there is a dose range and schedule at which the drug can be shown to be simultaneously safe and effective, to the extent that the risk-benefit relationship is acceptable. The particular subjects who may benefit from the drug, and the specific indications for its use, also need to be defined.Satisfying these broad aims usually requires an ordered programme of clinical trials, each with its own specific objectives (see ICH E8). This should be specified in a clinical plan, or a series of plans, with appropriate decision points and flexibility to allow modification as knowledge accumulates. A marketing application should clearly describe the main content of such plans, and the contribution made by each trial. Interpretation and assessment of the evidence from the total programme of trials involves synthesis of the evidence from the individual trials (see Section 7.2). This is facilitated by ensuring that common standards are adopted for a number of features of the trials such as dictionaries of medical terms, definition and timing of the main measurements, handling of protocol deviations and so on. A statistical summary, overview or meta-analysis (see Glossary) may be informative when medical questions are addressed in more than one trial. Where possible this should be envisaged in the plan so that the relevant trials are clearly identified and any necessary common features of their designs are specified in advance. Other major statistical issues (if any) that are expected to affect a number of trials in a common plan should be addressed in that plan.Statistical Principles for Clinical Trials2.1.2 Confirmatory TrialA confirmatory trial is an adequately controlled trial in which the hypotheses are stated in advance and evaluated. As a rule, confirmatory trials are necessary to provide firm evidence of efficacy or safety. In such trials the key hypothesis of interest follows directly from the trial’s primary objective, is always pre-defined, and is the hypothesis that is subsequently tested when the trial is complete. In a confirmatory trial it is equally important to estimate with due precision the size of the effects attributable to the treatment of interest and to relate these effects to their clinical significance.Confirmatory trials are intended to provide firm evidence in support of claims and hence adherence to protocols and standard operating procedures is particularly important; unavoidable changes should be explained and documented, and their effect examined. A justification of the design of each such trial, and of other important statistical aspects such as the principal features of the planned analysis, should be set out in the protocol. Each trial should address only a limited number of questions.Firm evidence in support of claims requires that the results of the confirmatory trials demonstrate that the investigational product under test has clinical benefits. The confirmatory trials should therefore be sufficient to answer each key clinical question relevant to the efficacy or safety claim clearly and definitively. In addition, it is important that the basis for generalisation (see Glossary) to the intended patient population is understood and explained; this may also influence the number and type (e.g. specialist or general practitioner) of centres and/or trials needed. The results of the confirmatory trial(s) should be robust. In some circumstances the weight of evidence from a single confirmatory trial may be sufficient.2.1.3 Exploratory TrialThe rationale and design of confirmatory trials nearly always rests on earlier clinical work carried out in a series of exploratory studies. Like all clinical trials, these exploratory studies should have clear and precise objectives. However, in contrast to confirmatory trials, their objectives may not always lead to simple tests of pre-defined hypotheses. In addition, exploratory trials may sometimes require a more flexible approach to design so that changes can be made in response to accumulating results. Their analysis may entail data exploration; tests of hypothesis may be carried out, but the choice of hypothesis may be data dependent. Such trials cannot be the basis of the formal proof of efficacy, although they may contribute to the total body of relevant evidence.Any individual trial may have both confirmatory and exploratory aspects. For example, in most confirmatory trials the data are also subjected to exploratory analyses which serve as a basis for explaining or supporting their findings and for suggesting further hypotheses for later research. The protocol should make a clear distinction between the aspects of a trial which will be used for confirmatory proof and the aspects which will provide data for exploratory analysis.2.2 Scope of Trials2.2.1 PopulationIn the earlier phases of drug development the choice of subjects for a clinical trial may be heavily influenced by the wish to maximise the chance of observing specific clinical effects of interest, and hence they may come from a very narrow subgroup of the total patient population for which the drug may eventually be indicated. However by the time the confirmatory trials are undertaken, the subjects in the trials should more closely mirror the target population. Hence, in these trials it is generally helpful toStatistical Principles for Clinical Trials relax the inclusion and exclusion criteria as much as possible within the target population, while maintaining sufficient homogeneity to permit precise estimation of treatment effects. No individual clinical trial can be expected to be totally representative of future users, because of the possible influences of geographical location, the time when it is conducted, the medical practices of the particular investigator(s) and clinics, and so on. However the influence of such factors should be reduced wherever possible, and subsequently discussed during the interpretation of the trial results.2.2.2 Primary and Secondary VariablesThe primary variable (‘target’ variable, primary endpoint) should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial. There should generally be only one primary variable. This will usually be an efficacy variable, because the primary objective of most confirmatory trials is to provide strong scientific evidence regarding efficacy. Safety/tolerability may sometimes be the primary variable, and will always be an important consideration. Measurements relating to quality of life and health economics are further potential primary variables. The selection of the primary variable should reflect the accepted norms and standards in the relevant field of research. The use of a reliable and validated variable with which experience has been gained either in earlier studies or in published literature is recommended. There should be sufficient evidence that the primary variable can provide a valid and reliable measure of some clinically relevant and important treatment benefit in the patient population described by the inclusion and exclusion criteria. The primary variable should generally be the one used when estimating the sample size (see section 3.5).In many cases, the approach to assessing subject outcome may not be straightforward and should be carefully defined. For example, it is inadequate to specify mortality as a primary variable without further clarification; mortality may be assessed by comparing proportions alive at fixed points in time, or by comparing overall distributions of survival times over a specified interval. Another common example is a recurring event; the measure of treatment effect may again be a simple dichotomous variable (any occurrence during a specified interval), time to first occurrence, rate of occurrence (events per time units of observation), etc. The assessment of functional status over time in studying treatment for chronic disease presents other challenges in selection of the primary variable. There are many possible approaches, such as comparisons of the assessments done at the beginning and end of the interval of observation, comparisons of slopes calculated from all assessments throughout the interval, comparisons of the proportions of subjects exceeding or declining beyond a specified threshold, or comparisons based on methods for repeated measures data. To avoid multiplicity concerns arising from post hoc definitions, it is critical to specify in the protocol the precise definition of the primary variable as it will be used in the statistical analysis. In addition, the clinical relevance of the specific primary variable selected and the validity of the associated measurement procedures will generally need to be addressed and justified in the protocol.The primary variable should be specified in the protocol, along with the rationale for its selection. Redefinition of the primary variable after unblinding will almost always be unacceptable, since the biases this introduces are difficult to assess. When the clinical effect defined by the primary objective is to be measured in more than one way, the protocol should identify one of the measurements as the primary variable on the basis of clinical relevance, importance, objectivity, and/or other relevant characteristics, whenever such selection is feasible.Statistical Principles for Clinical TrialsSecondary variables are either supportive measurements related to the primary objective or measurements of effects related to the secondary objectives. Their pre-definition in the protocol is also important, as well as an explanation of their relative importance and roles in interpretation of trial results. The number of secondary variables should be limited and should be related to the limited number of questions to be answered in the trial.2.2.3 Composite VariablesIf a single primary variable cannot be selected from multiple measurements associated with the primary objective, another useful strategy is to integrate or combine the multiple measurements into a single or 'composite' variable, using a pre-defined algorithm. Indeed, the primary variable sometimes arises as a combination of multiple clinical measurements (e.g. the rating scales used in arthritis, psychiatric disorders and elsewhere). This approach addresses the multiplicity problem without requiring adjustment to the type I error. The method of combining the multiple measurements should be specified in the protocol, and an interpretation of the resulting scale should be provided in terms of the size of a clinically relevant benefit. When a composite variable is used as a primary variable, the components of this variable may sometimes be analysed separately, where clinically meaningful and validated. When a rating scale is used as a primary variable, it is especially important to address such factors as content validity (see Glossary), inter- and intra-rater reliability (see Glossary) and responsiveness for detecting changes in the severity of disease.2.2.4 Global Assessment VariablesIn some cases, 'global assessment' variables (see Glossary) are developed to measure the overall safety, overall efficacy, and/or overall usefulness of a treatment. This type of variable integrates objective variables and the investigator’s overall impression about the state or change in the state of the subject, and is usually a scale of ordered categorical ratings. Global assessments of overall efficacy are well established in some therapeutic areas, such as neurology and psychiatry.Global assessment variables generally have a subjective component. When a global assessment variable is used as a primary or secondary variable, fuller details of the scale should be included in the protocol with respect to:1) the relevance of the scale to the primary objective of the trial;2) the basis for the validity and reliability of the scale;3) how to utilise the data collected on an individual subject to assign him/her to aunique category of the scale;4) how to assign subjects with missing data to a unique category of the scale, orotherwise evaluate them.If objective variables are considered by the investigator when making a global assessment, then those objective variables should be considered as additional primary, or at least important secondary, variables.Global assessment of usefulness integrates components of both benefit and risk and reflects the decision making process of the treating physician, who must weigh benefit and risk in making product use decisions. A problem with global usefulness variables is that their use could in some cases lead to the result of two products being declared equivalent despite having very different profiles of beneficial and adverse effects. For example, judging the global usefulness of a treatment as equivalent or superior to analternative may mask the fact that it has little or no efficacy but fewer adverse effects. Therefore it is not advisable to use a global usefulness variable as a primary variable. If global usefulness is specified as primary, it is important to consider specific efficacy and safety outcomes separately as additional primary variables.2.2.5 Multiple Primary VariablesIt may sometimes be desirable to use more than one primary variable, each of which (or a subset of which) could be sufficient to cover the range of effects of the therapies. The planned manner of interpretation of this type of evidence should be carefully spelled out. It should be clear whether an impact on any of the variables, some minimum number of them, or all of them, would be considered necessary to achieve the trial objectives. The primary hypothesis or hypotheses and parameters of interest (e.g. mean, percentage, distribution) should be clearly stated with respect to the primary variables identified, and the approach to statistical inference described. The effect on the type I error should be explained because of the potential for multiplicity problems (see Section 5.6); the method of controlling type I error should be given in the protocol. The extent of intercorrelation among the proposed primary variables may be considered in evaluating the impact on type I error. If the purpose of the trial is to demonstrate effects on all of the designated primary variables, then there is no need for adjustment of the type I error, but the impact on type II error and sample size should be carefully considered.2.2.6 Surrogate VariablesWhen direct assessment of the clinical benefit to the subject through observing actual clinical efficacy is not practical, indirect criteria (surrogate variables - see Glossary) may be considered. Commonly accepted surrogate variables are used in a number of indications where they are believed to be reliable predictors of clinical benefit. There are two principal concerns with the introduction of any proposed surrogate variable. First, it may not be a true predictor of the clinical outcome of interest. For example it may measure treatment activity associated with one specific pharmacological mechanism, but may not provide full information on the range of actions and ultimate effects of the treatment, whether positive or negative. There have been many instances where treatments showing a highly positive effect on a proposed surrogate have ultimately been shown to be detrimental to the subjects' clinical outcome; conversely, there are cases of treatments conferring clinical benefit without measurable impact on proposed surrogates. Secondly, proposed surrogate variables may not yield a quantitative measure of clinical benefit that can be weighed directly against adverse effects. Statistical criteria for validating surrogate variables have been proposed but the experience with their use is relatively limited. In practice, the strength of the evidence for surrogacy depends upon (i) the biological plausibility of the relationship, (ii) the demonstration in epidemiological studies of the prognostic value of the surrogate for the clinical outcome and (iii) evidence from clinical trials that treatment effects on the surrogate correspond to effects on the clinical outcome. Relationships between clinical and surrogate variables for one product do not necessarily apply to a product with a different mode of action for treating the same disease.2.2.7 Categorised VariablesDichotomisation or other categorisation of continuous or ordinal variables may sometimes be desirable. Criteria of 'success' and 'response' are common examples of dichotomies which require precise specification in terms of, for example, a minimum percentage improvement (relative to baseline) in a continuous variable, or a ranking categorised as at or above some threshold level (e.g., 'good') on an ordinal rating scale.。

耐药结核新规定

耐药结核新规定

相关链接:
1. WHO Guidelines for Drug-Resistant Tuberculosis Updated(指南报道)
2. Guidelines for the programmatic management of drug-resistant tuberculosis:2011 update (指南全文)
- 患者一旦诊断为结核病或在初始治疗前,快速药敏试验应较常规试验更广泛地用于异烟肼和利福平或利福平单药药敏试验中,以便更早识别耐药结核病患者。此方法被认为是最经济有效的,并推荐尽早使用适当的治疗方案,以避免不必要的死亡。
- 通过痰涂片镜检和培养(而不仅仅是痰涂片镜检)监测患者,对于多药耐药(MDR)TB可尽早检出其治疗失败。建议用户注意培养性状所呈现的质量差异,因为假阳性结果将导致不必要的持续治疗或更改治疗方案,从而增加毒性风险。
--------------------------------------------------------------------------------
近日,《欧洲呼吸杂志》(European Respiratory Journal)在线发布了世界卫生组织(WHO)的《耐药结核病(TB)规划管理指南(2011版)》。该指南的发布为更好地控制耐药TB提供了新方法。
耐药结核新规定.txt小时候觉得父亲不简单,后来觉得自己不简单,再后来觉得自己孩子不简单。越是想知道自己是不是忘记的时候,反而记得越清楚。WHO更新耐药结核病规划管理指南 打印文件阅读人数:48 添加时间:2011-9-6 【已有0条评论】我要评论分享到: Tags: 结核病
- 对于MDR-TB患者,推荐使用新生代氟喹诺酮类和乙硫异烟胺。

隧道风险管理(中英对照)

隧道风险管理(中英对照)

RISK MANAGEMENT FOR TUNNELS隧道风险管理1.INTRODUCTIONThe main risks during operation are inflow of water, earthquakes, collapse and above all fire.The most probable loss scenario for underground traffic facilities (tunnels, railway stations) is an uncontrollable fire.There are two main causes for tunnels fire: either they are caused by technical defects or they are the result of a traffic accident.When a fire burnt out of control, people are in acute danger on account of the toxic fumes, immense heat, severely restricted visibility, and inadequate possibilities for escape and evacuation and as a result of panic on part of those affects.Fire is 20 times more likely to break out in a road tunnel than in a railway tunnel.1.简介运营中主要风险是进水、地震、倒塌,当然最重要的是火灾。

对于地下交通设施(隧道、地铁站),最有可能的损失情况是失去控制的火灾。

隧道火灾有两个主要原因,技术缺陷和交通事故。

当火灾发生并失去控制时,人们会面临极大的危险,由于:有毒气体、强烈的热度、严重的视觉限制,微小的逃生和撤退的可能和由于上面原因引起的恐慌后果。

AS 1443-2004

AS 1443-2004

AS 1443—2004Australian Standard™Carbon and carbon-manganese steel—Cold finished barsAS 1443This Australian Standard was prepared by Committee MT-001, Iron and Steel. It was approved on behalf of the Council of Standards Australia on 28 November 2003 and published on 18 February 2004.The following are represented on Committee MT-001:Australasian Railway AssociationAustralian Building Codes BoardAustralian Foundry InstituteAustralian Steel InstituteBureau of Steel Manufacturers of AustraliaInstitute of Materials Engineering AustraliaKeeping Standards up-to-dateStandards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased.Detailed information about Standards can be found by visiting the Standards Web Shop at .au and looking up the relevant Standard in the on-line catalogue.Alternatively, the printed Catalogue provides information current at 1 January each year, and the monthly magazine, The Global Standard, has a full listing of revisions and amendments published each month.Australian Standards TM and other products and services developed by Standards Australia are published and distributed under contract by SAI Global, which operates the Standards Web Shop.We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at mail@.au, or write to the Chief Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001.This Standard was issued in draft form for comment as DR 03311.AS 1443—2004Australian Standard™Carbon and carbon-manganese steel—Cold finished barsOriginated as AS G17—1966.Previous edition AS 1443—1994.Fifth edition 2004.COPYRIGHT© Standards Australia InternationalAll rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher.Published by Standards Australia International LtdGPO Box 5420, Sydney, NSW 2001, AustraliaISBN 0 7337 5729 4AS 1443—2004 2PREFACEThis Standard was prepared by the Australian members of the Joint Standards Australia/Standards New Zealand Committee MT-001, Iron and Steel, to supersede AS 1443―1994, Carbon steels and carbon-manganese steels―Cold-finished bars. After consultation with stakeholders in both countries, Standards Australia and Standards New Zealand decided to develop this Standard as an Australian rather than an Australian/New Zealand Standard.The objective of this Standard is to specify requirements for cold-finished carbon steel and carbon-manganese steel bars, manufactured from hot-rolled bars and semifinished products, for general engineering purposes.The objective of this revision is to revise the specifications and quality requirements for suppliers and purchasers of carbon and carbon manganese steels that are manufactured as cold finished bars.To reflect changes in steel-making technology and to meet industry requirements, the steel grades have been revised and grade prefix letters ‘M’ and ‘U’ introduced to indicate steel quality.Steel grades with specified mechanical properties have been revised so that they align with other grades in this Standard. A table of mechanical properties of steels in the machined condition has been added.Dimensional tolerances have been completely revised so that they align more closely with overseas Standards and industry practice.The terms ‘normative’ and ‘informative’ have been used in this Standard to define the application of the appendix to which they apply. A ‘normative’ appendix is an integral part of a Standard, whereas an ‘informative’ appendix is only for information and guidance.AS 1443—20043CONTENTSPage1 SCOPE (4)DOCUMENTS (4)2 REFERENCED3 DEFINITIONS (5)4 DESIGNATION (6)5 CONDITION OF STEEL ON DELIVERY (7)6 MATERIALS (8)DEFECTS (8)FROM7 FREEDOMTOLERANCES (9)8 DIMENSIONAL (9)9 TENSILETEST10 ROUNDING OF TEST RESULT VALUES (10)11 MARKING (11)APPENDICESA PURCHASING GUIDELINES (19)B MEANS FOR DEMONSTRATING COMPLIANCE WITH THIS STANDARD (21)C REQUIREMENTS FOR MAXIMUM SURFACE IMPERFECTION DEPTHAND RECOMMENDED MACHINING ALLOWANCES (23)AS 1443—2004 4STANDARDS AUSTRALIAAustralian StandardCarbon and carbon-manganese steel—Cold finished bars1 SCOPEThis Standard specifies requirements for cold-finished carbon steel and carbon-manganesesteel bars manufactured from hot-rolled bars and semifinished products (see AS 1442), forgeneral engineering purposes. The Standard applies to steel supplied to specified chemicalcomposition only or to specified chemical composition and mechanical properties. Itpermits the addition of elements, such as boron, and micro-alloying elements for theachievement of special properties.NOTES:1 Advice and recommendations on information that should be supplied by the purchaser at thetime of enquiry and order are given in Appendix A.2 Alternative means for determining compliance with this Standard are given in Appendix B.2 REFERENCED DOCUMENTSThe following documents are referred to in this Standard.AS1171 Non-destructive testing—Magnetic particle testing of ferromagnetic products, components and structures1199 Sampling procedures and tables for inspection by attributes1199.0 Part 0: Introduction to the ISO 2859 attributes sampling system1199.1 Part 1: Sampling schemes indexed by acceptance quality limit (AQL) forlot-by-lot inspection.1391 Method for tensile testing of metals1442 Carbon steels and carbon-manganese steels―Hot-rolled and semifinished products1654 ISO system of limits and fits1654.1 Part 1: Bases of tolerances, deviations and fits1654.2 Part 2: Tables of standard tolerances grades and limit deviations for holesand shafts1733 Methods for the determination of grain size in metals2062 Non-destructive testing—Penetrant testing of products and components2338 Preferred dimensions of wrought metal products2706 Numerical values—Rounding and interpretation of limiting values4177 Caravan and light trailer towing components4177.2 Part 2: 50 mm towballsAS/NZS1050 Methods for analysis of iron and steel1050.1 Part 1: Sampling of iron and steel for chemical analysisStandards Australia .au5 AS 1443—2004.au Standards Australia AS/NZS ISO9001 Quality management systems—Requirements9004Quality management systems—Guidelines for performance improvements HB 18Guidelines for third-party certification and accreditation HB 18.28 Guide 28: General rules for a model third-party certification scheme forproductsISO2566 Steel ―Conversion of elongation values2566-1 Part 1: Carbon and low alloy steels3 DEFINITIONSFor the purpose of this Standard, the definitions below apply.3.1 BarFinished product of solid section which may be rectangular, square, round or hexagonal incross-section.3.2 Bar conditions3.2.1 Bright barsBars produced by cold drawing, cold rolling, turning and polishing or precision grinding,and which have a smooth surface free from scale and harmful imperfections.3.2.2 Cold-sized barsBars which are sized by cold drawing or cold rolling to provide closer dimensionaltolerances than occur for hot-rolled bars, but which may contain some surfaceimperfections.3.2.3 Peeled barsBars which are finished by rough machining.3.3 Bar shapes3.3.1 Flat bars (flats)Bars of rectangular cross-section, 1.5 mm or greater in thickness and less than 600 mm inwidth, supplied in straight lengths or coils and having edges of controlled contour.3.3.2 Hexagonal bars (hexagons)Bars of regular hexagonal cross-section supplied in straight lengths or coils.3.3.3 Round bars (rounds)Bars of circular cross-section supplied in straight lengths or coils.3.3.4 Square bars (squares)Bars of square cross-section supplied in straight lengths or coils.3.4 Fully killed steelSteel deoxidized with a strong deoxidizing agent such as silicon or aluminium in order toreduce the oxygen content to prevent a reaction between carbon and oxygen duringsolidification.AS 1443—2004 63.5 Merchant quality steelProduct having wider carbon and manganese ranges than those of specified carbon steels(see Table 2). It is not subject to product analysis tolerances, grain size requirements ormodification with special additions.3.6 Test batchFinished steel of the same size, produced from the same cast and from the same heat-treatment batch.3.7 Test pieceA prepared piece for testing, made from a test specimen.3.8 Test sampleA portion of material or product, or a group of items selected from a test batch by asampling procedure.3.9 Test specimenA portion or a single item taken from the test sample for the purpose of applying aparticular test.4 DESIGNATION4.1 GeneralThe steel designation shall comprise the number of this Australian Standard, i.e. AS 1443,followed by a diagonal slash and additional characters in accordance with Clauses 4.2 and4.3. Additional designations for austenitic grain size are given in Clause 4.4.4.2 Steels supplied to chemical composition onlyThe designation of steel supplied to a specified chemical composition shall be in accordance with the following designations:(a) A prefix letter, if applicable, as follows:(i) M: Merchant quality steel.(ii) U: Unspecified deoxidation.(iii) X: Major deviation in chemical composition of any grade from the corresponding AISI-SAE grade.NOTE: Information on AISI-SAE grades is given in the relevant steel products manual of theIron and Steel Society of AIME which is located at 410 Commonwealth Drive, Warrendale,PA 15086-7512, USA.(b) A four-digit series designation, as follows, wherein the first two digits of the numberindicate the type of steel and the last two digits indicate the approximate mean of thespecified carbon range:(i) 10XX: Plain carbon steels.(ii) 11XX: Sulfurized free-cutting carbon steels.(iii) 12XX: Phosphorized and sulfurized free-cutting carbon steels.(iv) 13XX: Carbon-manganese steels.NOTE: The double ‘X’ has no significance other than to indicate the position for digits to beadded.Standards Australia .au7 AS 1443—2004.au Standards Australia Modification symbols should be added to the series designation as follows:(i) For lead-bearing steels, the letter ‘L’ is used to indicate that the steel contains lead,and is placed between the second and third characters of the four-digit seriesdesignation.(ii) For aluminium-killed steels, the letter ‘A’ is placed between the second and thirdcharacters of the four-digit series designation.(iii) For boron-treated steels, the letter ‘B’ is placed between the second and thirdcharacters of the four-digit series designation.(iv) For micro-alloyed steels, the letter ‘M’ is placed between the second and thirdcharacters of the four-digit series designation.Examples of designation: AS 1443/12L14, AS 1443/10A10, AS 1443/10B22, AS 1443/10M40, AS 1443/X1038.4.3 Steels supplied to chemical composition and mechanical propertiesThe designation of steels supplied to chemical composition and mechanical properties shallconsist of the following:(a)The prefix letters ‘D’ or ‘T’, if applicable. NOTE: These designations normally apply to drawn or turned products, respectively. (b) The number 3, 4, 5, 6, 11, 12, 13 or 14, to indicate the steel grade.Examples of designation: AS 1443/D3, AS 1443/T5.4.4 Austenitic grain sizeThe following designations consisting of suffix letters ‘CG’ or ‘FG’ indicate the austeniticgrain size of the steel as defined in AS 1733:(a) CG: Coarse.(b) FG: Fine.Example of designation: AS 1443/1030FG.NOTE: The absence of these suffix letters indicates that the steel may be coarse-grained or fine-grained at the supplier’s option.5 CONDITION OF STEEL ON DELIVERY5.1 GeneralSteel shall be supplied in one of the following conditions:(a) Bright barsCold-drawn, cold-rolled, turned and polished, cold-drawn and precision ground orturned and precision ground.(b) Cold-sized barsCold-drawn or cold-rolled.(c) Peeled barsRough machined.In addition, stress relieving or normalizing heat treatments may be specified.5.2 Steel supplied to chemical compositionSteel supplied to chemical composition shall comply with the requirements of Tables 1, 2, 3or 4.AS 1443—2004 85.3 Steels supplied to chemical composition and mechanical propertiesSteels supplied in either the cold-drawn or cold-rolled condition and which have notreceived a subsequent heat treatment shall comply with the chemical composition andmechanical properties specified in Table 5 and Table 6. Steels in all other conditions shallcomply with the chemical composition and mechanical properties specified in Table 7.6 MATERIALS6.1 Chemical composition6.1.1 GeneralThe method of sampling for chemical analysis shall be in accordance with AS/NZS 1050.1.Chemical composition shall be determined by any procedures which are not less accuratethan those given in AS/NZS 1050.1.6.1.2 Cast analysisWherever possible a chemical analysis of the steel from each cast shall be made todetermine the proportions of the specified elements. In cases where it is impracticable toobtain samples from liquid steel, analysis of test samples taken in accordance with therequirements of AS/NZS 1050.1 may be reported as cast analysis.The reported cast analysis of the steel shall conform to the requirements of Tables 1, 2, 3and 4 for the appropriate grade.6.1.3 Residual elementsFor steels complying with this Standard, residual elements are acceptable to the followinglimits:(a) Chromium: 0.30% max.(b) Copper: 0.35% max.(c) Molybdenum: 0.10% max.(d) Nickel: 0.35% max.NOTE: The amount of residual elements may affect subsequent processes, especially thoseinvolving cold working, welding and heat treatment.6.1.4 Product analysisFor grades of steel excluding those designated ‘U’ or ‘M’, with prior hot-rolled cross-sectional areas up to and including 0.06 m2, the results of individual determinations carriedout on the product shall be within the product analysis tolerance limits specified in Table 5.Where several determinations of a single element, excluding lead, are carried out onproducts from any one cast, the spread of individual results shall not extend both above andbelow the range specified in Tables 1, 3 and 4.6.2 Tensile test requirementsWhen tested in accordance with Clause 9, steels requiring tensile testing shall meet therelevant requirements of Tables 6 and 7.7 FREEDOM FROM DEFECTS7.1 GeneralThe steel shall be free from internal and surface defects that would render it unsuitable forits particular application.Standards Australia .auIf, after acceptance of the steel and provided it has been properly treated after delivery, subsequent processing reveals that it contains defects found to be detrimental, the steel shall be deemed not to comply with this Standard.7.2 Bright bars7.2.1 Cold-drawn and cold-rolled barsThe maximum permissible depth of surface imperfections shall be in accordance with the requirements for surface condition designation B (see Appendix C).7.2.2 Turned and polished or precision ground barsThe surface shall be free from imperfections of hot-rolled origin.7.3 Cold-sized or peeled barsThe maximum permissible depth of surface imperfections shall be in accordance with the requirements for surface conditions designated ‘commercial’ for cold-sized bars, or those designated F for peeled bars (see Appendix C).8 DIMENSIONAL TOLERANCESSteel bars shall meet the following dimensional tolerance requirements:(a) Tolerances for cross-sectional dimensionsThe tolerances for cross-sectional dimensions of round, square, hexagonal and flat bars shall be graded in accordance with Table 8 and shall conform to the limits given in Table 9.(b) Tolerances for lengthWith the exception of coils, the length of all bars shall be between 3 m and 7 m. They shall conform to the requirements of the mill length or the set length categories of Table 10.NOTE: Bars may be in the cropped, saw-cut or chamfered form.(c) Tolerances for straightnessWith the exception of coils, the maximum allowable deviation from straightness shall be as follows:(i) ForapplicationscommercialThe straightness requirements for commercial applications shall be inaccordance with Table 11.(ii) For critical applicationsThe straightness requirements for critical applications applies to round bars lessthan 25 mm diameter and shall be less than 0.1 mm deviation from a straightline in 300 mm (1:3000).NOTES:1 All straightness measurements are taken at least 50 mm from the end of theproduct.2 Examples of critical applications are spindles for small electric motors.9 TENSILE TEST9.1 Condition of test samplesTest samples shall be tested in the as-supplied condition.9.2 SamplingWhen mechanical test certificates are required, test sampling shall be taken from each batch at a frequency to be agreed between purchaser and the supplier.NOTE: As a guideline, sampling frequencies of one sample for a batch of steel up to 25 t and two samples for a batch of steel exceeding 25 t are recommended.9.3 Location and preparation of test piecesTest pieces shall be located and prepared as follows (see also AS 1391):(a) Bars up to 40 mm diameter or major cross-sectional dimension shall be tested axially,either in full section or by using a proportional test piece.(b) Bars with nominal cross-sectional dimensions greater than 40 mm shall have the axisof the test specimen parallel to the axis of the bar and as near as practicable to a point one-sixth of the distance between diagonally (or diametrically) opposite surfaces. A proportional test piece shall be used.(c) Rectangular bars of width greater than 40 mm and thickness not greater than 40 mmshall be tested either in full thickness or by using a proportional test piece with its axis parallel to the axis of the product, and as near as practicable to a position one quarter of the width and one half of the thickness from adjacent surfaces of the bar. (d) Rectangular products of thickness greater than 40 mm shall be tested using aproportional test piece with its axis parallel to the axis of the product, and as near as practicable to a point one-sixth of the distance from a surface of the bar between opposite surfaces.9.4 Method of testThe yield strength (0.2% proof stress), tensile strength and percentage elongation shall be determined in accordance with AS 1391.The rate of straining when approaching the yield point shall conform to the limits of the standard strain rate given in AS 1391.The elongation results shall be reported on a gauge length of Lo = 5.65√So, where So is the cross-sectional area of the test piece before testing. If necessary, conversion of results froma non-proportional gauge length shall be in accordance with ISO 2566-1.9.5 RetestingShould any tensile test piece first selected fail to comply with the requirements of Clause6.2, one or more of the following procedures shall be adopted:(a) For each failed test select two further test samples and test them in accordance withClause 9. Should the test results from these samples comply with the requirements of Clause 6.2, the steel is deemed to comply with this Standard.(b) Select test samples from each bar or coil and test in accordance with Clause 9. Thesteel is deemed to comply with this Standard if all test results comply with the requirements of Clause 6.2.(c) Reprocess the unit, which failed, and repeat the tests in accordance with Clause 9.The unit is deemed to comply with Clause 6.2.10 ROUNDING OF TEST RESULT VALUES10.1 GeneralWith the exception of tensile test results, the observed or calculated values shall be rounded to the same number of figures as in the specified values and then compared with the specified values. For example, for specified maximum or minimum values of 2.5, 2.50 and2.500, the observed or calculated value would be rounded respectively to the nearest 0.1, 0.01 and 0.001 (see also AS 2706).10.2 Tensile test resultsThe determined value of tensile strength shall be rounded to the nearest 10 MPa and the determined value of yield strength shall be rounded to the nearest 5 MPa.11 MARKINGSteel as supplied by the manufacturer shall be legibly and durably marked or tagged (for bundles) as follows:(a) To identify the manufacturer.(b) To enable it to be traced to the ladle of steel from which it was made.(c) To indicate the grade of steel.(d) To enable it to be identified with this Standard.(e) To indicate nominal size and shape, length and condition, e.g. ‘25 mm RND 3.0 mBRIGHT BAR COLD-DRAWN’.(f) To identify the quality plan, if applicable.(g) To indicate the number of pieces or total mass.NOTE: Manufacturers making a statement of compliance with this Australian Standard on a product, or on packaging or promotional material related to that product, are advised to ensure that such compliance is capable of being verified.TABLE 1CHEMICAL COMPOSITION REQUIREMENTS FOR CARBON STEELSChemical composition (cast analysis), percentCarbon Silicon (see Notes 2 and 3) Manganese Phosphorus SulfurGradedesignation AS 1443/ (see Note 1) Min. Max. Min. Max. Min. Max. Max. Max. 1004 (Note 4) 1010 1016 1020 1022 1030 1035 X1038 1040 1045 1050 1055 1058 — 0.08 0.13 0.18 0.18 0.28 0.32 0.35 0.37 0.43 0.48 0.50 0.560.06 0.13 0.18 0.23 0.23 0.34 0.38 0.42 0.44 0.50 0.55 0.60 0.630.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.100.35 0.35 0.35 0.35 0.35 0.35 0.35 0.35 0.35 0.35 0.35 0.35 0.350.25 0.30 0.60 0.30 0.70 0.60 0.60 0.70 0.60 0.60 0.60 0.60 0.300.50 0.60 0.90 0.60 1.00 0.90 0.90 1.00 0.90 0.90 0.90 0.90 0.550.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.0400.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040 0.040NOTES: 1 Steel grades may be treated with micro-alloying elements such as niobium, vanadium and titanium (for the designation requirements see Clause 4.2).2 For aluminium-killed steels, the maximum silicon content is 0.10%.3 For steel grades with a ‘U’ prefix, e.g. U1040 (see Clause 4.2(a)), the minimum silicon content does not apply and the material is not subject to product analysis or grain size requirements. 4This grade is not included in AS 1442.TABLE 2CHEMICAL COMPOSITION REQUIREMENTS FORMERCHANT QUALITY STEELSChemical composition (cast analysis), percentCarbon Silicon Manganese Phosphorus Sulfur Gradedesignation AS 1443/Min. Max. Max. Min. Max. Max. Max. M1020 M1030 M10400.15 0.25 0.350.25 0.35 0.450.35 0.35 0.350.30 0.30 0.400.90 0.90 0.900.050 0.050 0.0500.050 0.050 0.050NOTE: These grades are not subject to product analysis or grain size requirements.TABLE 3CHEMICAL COMPOSITION REQUIREMENTS FORFREE-CUTTING STEELSChemical composition (cast analysis), percentCarbon Silicon Manganese Phosphorus Sulfur Gradedesignation AS 1443/ Min. Max. Min. Max. Min. Max. Min. Max. Min. Max. X1112 1137 1144 1146 X1147 1214 12L14*0.08 0.32 0.40 0.42 0.40 — —0.15 0.39 0.48 0.49 0.47 0.15 0.15— 0.10 — 0.10 0.10 — —0.10 0.35 0.35 0.35 0.35 0.10 0.101.10 1.35 1.35 0.70 1.60 0.80 0.801.40 1.65 1.65 1.00 1.90 1.20 1.20— — — — — 0.04 0.040.040 0.040 0.040 0.040 0.040 0.09 0.090.20 0.08 0.24 0.08 0.07 0.25 0.250.30 0.13 0.33 0.13 0.12 0.35 0.35* For lead-bearing steels, the lead content is 0.15% to 0.35%.TABLE 4CHEMICAL COMPOSITION REQUIREMENTS FORCARBON-MANGANESE STEELSChemical composition (cast analysis), percent (see Note 1)Carbon Silicon (See Note 2)Manganese Phosphorus SulfurGradedesignation AS 1443/Min. Max. Min. Max. Min. Max. Max. Max. X1320 X1340 0.18 0.380.23 0.430.10 0.100.35 0.351.40 1.401.70 1.700.040 0.0400.040 0.040NOTES: 1 The steels may be treated with micro-alloying elements such as niobium, vanadium and titanium (see Clause 4.2).2For aluminium-killed steels, the maximum silicon content is 0.10%.TABLE 5PRODUCT ANALYSIS TOLERANCES FOR STEELS OF CROSS-SECTIONAL AREA UP TO AND INCLUDING 0.06 m2 EXCEPT FOR SULFUR IN SULFURIZED GRADES (applicable to steels supplied to chemical composition only)Element Limit or maximum ofspecified rangepercent Tolerances over maximum limit or under minimum limitpercentCarbon ≤0.25>0.25 ≤0.55>0.55 0.02 0.03 0.04Manganese ≤0.90>0.90 ≤1.90 0.03 0.06Phosphorus ≤0.040 0.008* Sulfur ≤0.040 0.008* Silicon ≤0.35 0.02 Lead ≥0.15 ≤0.35 0.03*Over maximum only.TABLE 6REQUIREMENTS FOR STEELS WITH SPECIFIED MECHANICALPROPERTIES DEVELOPED BY COLD DRAWING OR COLD ROLLINGMechanical propertiesSpecified size*(dia. orminor sectional dimension)mmGrade designation AS 1443/Chemical composition designations (see Tables 2 and 3) Greater than Less than or equal toYield strength†MPaMin.Tensile strength MPa Min. Elongation on 5.65√So percent Min. D3 D4 D5 D6 D11 D12 D13 D14‡M1020M1030M10401045 X1112 1214 12L14 1137— 16 38 — 16 38 — 16 38 — 16 38 — 16 38 — 16 38 — 16 38 — 16 3816 38 63 16 38 63 16 38 63 16 38 63 16 38 63 16 38 63 16 38 63 16 38 63380 370 340 440 430 410 510 480 460 540 510 500 350 330 290 350 330 290 350 330 290 510 480 460480 460 430 560 540 520 650 610 600 690 650 640 480 430 400 480 430 400 480 430 400 660 640 62012 12 13 10 11 12 8 9 10 8 8 9 8 12 12 7 8 9 7 8 9 7 7 8* Applicable for rounds up to 61 mm diameter, hexagons up to 63 mm across flats and squares up to 51 mm across flats.† When yielding does not occur, calculate 0.2% proof stress.‡ This steel is used for ball couplings for automotive purposes (see AS 4177.2).TABLE 7REQUIREMENTS FOR STEELS WITH SPECIFIED MECHANICALPROPERTIES DEVELOPED BY PROCESSES* OTHERTHAN COLD DRAWING OR COLD ROLLINGMechanical propertiesSpecified diametermmGrade designation AS 1443/Chemical compositiondesignations (see Tables 2 and 3)Greater than Less than orequal toYield strength†MPa Min. Tensile strength MPa Min. Elongation on 5.65√So percent Min. T3 T4 T5 T6 T11 T12 T13 T14M1020M1030 M1040 1045 X1112 1214 12L14 1137— 50 — — — — — — —50 250 260 260 260 260 260 260 260250 230 250 270 300 230 230 230 300410 410 500 540 600 370 370 370 60022 22 20 16 14 17 17 17 14* The mechanical property requirements in the Table are similar to those for hot-rolled products in the machined, turned or ground condition.† When yielding does not occur, calculate 0.2% proof stressTABLE 8TOLERANCE GRADES FOR COLD-FINISHED BARSForm and conditionBright barsRoundsPrecision groundCold drawnTurned and polishedSquare HexagonalFlat(see Note 4)Cold-sized Peeledh8 h10 h11 h11 h11 h11 h11 k12NOTES:1 Out-of-round, out-of-hexagon and out-of-square in bars have tolerances equal to one-half of thetolerance band. 2 The cross-sectional dimensions are measured at a distance of at least 150 mm from the end of theproduct. 3 Cross-sectional dimensions may be checked using instruments such as limit gap gauges, micrometer callipers and three-point measuring devices. Measurement is carried out at room temperature. 4Width tolerances are generally not applied to flats up to 7 mm thick.5 Tolerance grade h7 may be specified for precision ground bars for applications requiring greaterprecision. 6 Tolerance grade h9 may be specified for cold-drawn bright bars for applications requiring greaterprecision. 7 Tolerance grade h10 may be specified for turned and polished bars for applications requiring greater precision.8The tolerance grades have been derived from AS 1654.。

2016 静脉血栓栓塞指南

2016 静脉血栓栓塞指南

2016 静脉血栓栓塞指南英文回答:The 2016 guidelines for the management of venous thromboembolism (VTE) were published by the AmericanCollege of Chest Physicians (ACCP) and provide comprehensive recommendations for the prevention, diagnosis, and treatment of VTE. These guidelines are based on the latest scientific evidence and expert consensus and represent the current best practices for the management of VTE.Key recommendations from the 2016 guidelines include:The use of risk assessment tools to identify patientsat risk for VTE.The use of thromboprophylaxis measures to prevent VTEin high-risk patients.The use of anticoagulant therapy to treat VTE.The use of mechanical measures to prevent pulmonary embolism (PE) in patients with VTE.The 2016 guidelines also provide specific recommendations for the management of specific types of VTE, such as deep vein thrombosis (DVT) and PE. These recommendations are based on the latest evidence and expert consensus and provide guidance for the optimal managementof these conditions.中文回答:2016静脉血栓栓塞指南由美国胸科学院(ACCP)发布,为预防、诊断和治疗静脉血栓栓塞(VTE)提供了全面建议。

NCCN临床实践指南:小细胞肺癌(2015.V2)

NCCN临床实践指南:小细胞肺癌(2015.V2)

NCCN Guidelines Index SCLC Table of Contents Discussion
Clinical Trials: NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. To find clinical trials online at NCCN Member Institutions, click here: /clinical_trials/physician.html. NCCN Categories of Evidence and Consensus: All recommendations are category 2A unless otherwise specified. See NCCN Categories of Evidence and Consensus.
Printed by su xiangjiang on 4/19/2015 6:22:57 AM. For personal use only. Not approved for distribution. Copyright © 2015 National Comprehensive Cancer Network, Inc., All Rights Reserved.
NCCN Guidelines Discussion
Ranee Mehra, MD † Fox Chase Cancer Center Robert E. Merritt, MD ¶ The Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute Cesar A. Moran, MD ≠ The University of Texas MD Anderson Cancer Center Jyoti D. Patel, MD † Robert H. Lurie Comprehensive Cancer Center of Northwestern University David C. Portnoy, MD † The University of Tennessee Health Science Center Neal Ready, MD, PhD † Duke Cancer Institute Charles C. Williams, Jr., MD † Moffitt Cancer Center NCCN Kristina Gregory, RN, MSN, OCN Miranda Hughes, PhD

最新WHO提出治疗TB17个标准

最新WHO提出治疗TB17个标准

【分享】WHO提出治疗TB17个标准-Standard 1.All persons with otherwise unexplained productive cough lasting two–three weeks or more should be evaluated for tuberculosis.任何人有无法解释的有痰咳嗽超过2到3星期必须要做结核检查Standard 2.All patients (adults, adolescents, and children who are capable of producing sputum) suspected of having pulmonary tuberculosis should have at least two, and preferably three, sputum specimens obtained for microscopic examination. When possible, at least one early morning specimen should be obtained.所以被怀疑有肺结核的人必须至少留两套,最好3套的痰液样本供显微镜检,如果可行的话至少有一套样本要在清晨留检Standard 3. For all patients (adults, adolescents, and children) suspected of having extrapulmonary tuberculosis, appropriate specimens from the suspected sites of involvement should be obtained for microscopy and, where facilities and resources are available, for culture and histopathological examination.所有被怀疑有肺外结核的人应取的所怀疑部位的组织样本供显微镜检,甚至是培养病菌及组织病理学检查Standard 4.All persons with chest radiographic findings suggestive of tuberculosis should have sputum specimens submitted for microbiological examination.所有胸部X光显示可能有肺结核的患者都应留痰液样本供微生物检查Standard 5.The diagnosis of sputum smear-negative pulmonary tuberculosis should be based on the following criteria: at least three negative sputum smears (including at least one early morning specimen); chest radiography findings consistent with tuberculosis; and lack of response to a trial of broad spectrum antimicrobial agents. (NOTE: Because the fluoroquinolones are active against M. tuberculosis complex and, thus, may cause transient improvement in persons with tuberculosis, they should be avoided.) For such patients, if facilities for culture are available, sputum cultures should be obtained. In persons with known or suspected HIV infection, the diagnostic evaluation should be expedited.痰液抹片阴性的肺结核诊断准则为:所有痰液抹片(包括至少一套清晨留检的痰液样本)为阴性,ˇ但胸部X光持续显示为肺结核.而且肺部病灶对广效性抗生素治疗没有疗效.对于这样的病患应该给予痰液培养检查.怀疑或是hiv带原病患这各诊断流程要快速一点.Standard 6.The diagnosis of intrathoracic (i.e., pulmonary, pleural, and mediastinal or hilar lymph node) tuberculosis in symptomatic children with negative sputum smears should be based on the finding of chest radiographic abnormalities consistent with tuberculosis and either a history of exposure to an infectious case or evidence of tuberculosis infection (positive tuberculin skin test or interferon gamma release assay). For such patients, if facilities for culture are available, sputum specimens should be obtained (by expectoration, gastric washings, or induced sputum) for culture.在痰液抹片检查为阴性但有症状的小孩若要诊断为胸内结核(也就是肺内,肋膜,中膈腔或气管的淋巴结)的准则为:胸部X光持续显示为结核且与确定结核病患有接触的病史或其它检查显示有结核感染(阳性的结核菌素皮肤测验或是阳性的干扰素gamma释放测验)对于酱子的病患如果可行的话应予以痰液样本的培养Standard 7.Any practitioner treating a patient for tuberculosis is assuming an important public health responsibility. To fulfill this responsibility the practitioner must not only prescribe an appropriate regimen but, also, be capable of assessing the adherence of the patient to the regimen and addressing poor adherence when it occurs. By so doing, the provider will be able to ensure adherence to the regimen until treatment is completed.所有治疗结核病患的医师应自觉担负着重要的公卫责任.为符合这项责任医师应给予正确配方之外也应完整评估治疗的持续性,特别注意病患有不遵医嘱的情形.所有医师都应该确保疗程的完整性.Standard 8.All patients (including those with HIV infection) who have not been treated previously should receive an internationally accepted first-line treatment regimen using drugs of known bioavailability. The initial phase should consist of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol.The preferred continuation phase consists of isoniazid and rifampicin given for four months. Isoniazid and ethambutol given for six months is an alternative continuation phase regimen that may be used when adherence cannot be assessed, but it is associated with a higher rate of failure and relapse, especially in patients with HIV infection. The doses of antituberculosis drugs used should conform to international recommendations. Fixed-dose combinations of two (isoniazid and rifampicin,three (isoniazid, rifampicin, and pyrazinamide), and four (isoniazid,rifampicin, pyrazinamide, and ethambutol) drugs are highly recommended,especially when medication ingestion is not observed.所有以前没有治疗过的结核病患(包括HIV感染者)应接受国际公认的第一线用药,开始的治疗必须包含两各月的isoniazid, rifampicin, pyrazinamide, and ethambutol药物治疗.接着是四各月的isoniazid and rifampicin 药物治疗(如果病患的用药顺从性无法评估也可以给予六各月Isoniazid and ethambutol 药物治疗,但是会有较高的治疗失败或复发的机率,尤其是HIV感染者更是如此).抗结核药物的剂量应符合国际标准,固定剂量的多重药物治疗(isoniazid and rifampicin两种合并,isoniazid, rifampicin, and pyrazinamide三种合并,以及isoniazid,rifampicin, pyrazinamide, and ethambutol四种合并)是被高度建议的,尤其是当病患用药无法监测时.第一个月~第二个月Isoniazid,rifampicin(initial phase)开始期pyrazinamide, ethambutol第三个月~第六个月Isoniazid , rifampicin(continuation phase)后续治疗期Standard 9.To foster and assess adherence, a patient-centered approach to administration of drug treatment, based on the patient’s needs and mutual respect bet ween the patient and the provider, should be developed for all patients. Supervision and support should be gender-sensitive and age-specific and should draw on the full range of recommended interventions and available support services, including patient counseling and education. A central element of the patient-centered strategy is the use of measures to assess and promote adherence to the treatment regimen and to address poor adherence when it occurs. These measures should be tailored to the individual patient’s circumstances and be mutually acceptable to the patient and the provider. Such measures may include direct observation of medication ingestion (directly observed therapy—DOT) by a treatment supporter who is acceptable and accountable to the patient and to the health system.为促进与评估用药顺虫性需建立以病患为中心,基于病患的需要以及医病间的相互尊重的治疗方式.对于病患的监督和支持应根据性别及年龄做调整,一定要给予病患完整的治疗以及充分的社会支持,包括病人的咨询与教育,以病患为中心的治疗策略最重要的部份是评估和促进用药的顺从性,并及时察觉不遵医嘱用药的情况. 而治疗的策略应该要根据个别病患的环境,和医师间的互动来做调整,这些策略可以包括由病人信得过的人直接看着病患服用药物(DOT).Standard 10.All patients should be monitored for response to therapy, best judged inpatients with pulmonary tuberculosis by follow-up sputum microscopy (two specimens) at least at the time of completion of the initial phase of treatment (two months), at five months, and at the end of treatment. Patients who have positive smears during the fifth month of treatment should be considered as treatment failures and have therapy modified appropriately. (See Standards 14 and 15.) In patients with extrapulmonary tuberculosis and in children, the response to treatment is best assessed clinically. Follow-up radiographic examinations are usually unnecessary and may be misleading.所有病患都应监测治疗反应,在最初治疗时,第二各月时,第五各月时,以及结束治疗时应该做两套痰液显微镜检追踪.第五各月时痰液抹片如仍为阳性应是为治疗失败,治疗配方应重新评估(键标准14.15).在肺外结核还有儿童治疗反应应根据临床评估,胸部x光追踪通常是不必要而且是可能会误导的.Standard 11.A written record of all medications given, bacteriologic response, and adverse reactions should be maintained for all patients.所有病患的用药纪录,细菌学上的反应以及副作用,都应详细'记载Standard 12.In areas with a high prevalence of HIV infection in the general population and where tuberculosis and HIV infection are likely to co-exist, HIV counseling and testing is indicated for all tuberculosis patients as part of their routine management. In areas with lower prevalence rates of HIV, HIV counseling and testing is indicated for tuberculosis patients with symptoms and/or signs of HIV-related conditions and in tuberculosis patients having a history suggestive of high risk of HIV exposure.在HIV感染盛行区域以及结核和HIV共同感染盛行区域的结核病患,常规的HIV检查是必须的.如果是HIV低感染盛行区域,HIV检查只施行在有HIV相关症状的结核病患以及暴露于HIV的高危险病患.Standard 13.All patients with tuberculosis and HIV infection should be evaluated to determine if antiretroviral therapy is indicated during the course of treatment for tuberculosis. Appropriate arrangements for access to antiretroviral drugs should be made for patients who meet indications for treatment. Gven the complexity of co-administration of antituberculosis treatment and antiretroviral therapy, consultation with a physician who is expert in this area is recommended before initiation of concurrent treatment for tuberculosis and HIV infection, regardless of which disease appeared first. However, initiation of treatment for tuberculosis should not be delayed. Patients with tuberculosis and HIV infection should also receive cotrimoxazole as prophylaxis for other infections.同时感染结合及HIV的病患,必须评估是否再治疗结合的疗程中加入抗HIV病毒的治疗,如果评估后应同时做抗病毒的治疗应给予适当的配方.由于抗结核合并抗病毒治疗的复杂性,在开始做治疗时应照会对此方面有经验的专家.无论如何抗结核治疗不可以拖延,同时感染结核与HIV的病患应该接受cotrimoxazole 药物治疗防制其它感染Standard 14.An assessment of the likelihood of drug resistance, based on history of prior treatment, exposure to a possible source case having drug-resistant organisms, and the community prevalence of drug resistance, should be obtained for all patients. Patients who fail treatment and chronic cases should always be assessed for possible drug resistance For patients in whom drug resistance is considered to be likely, culture and drug susceptibility testing for isoniazid, rifampicin, and ethambutol. should be performed promptly.所有结核病患必须从以前治疗的病史及接触有抗药菌株的结核病患的病史来评估是否有抗药性的可能性.所有治疗失败以及慢性结合的病患都应评估抗药性的可能性,如果病患可能有抗药性感染应该做菌株培养以及对isoniazid, rifampicin, and ethambutol 药物的感受性测验.Standard 15.Patients with tuberculosis caused by drug-resistant (especially multipledrug resistant [MDR]) organisms should be treated with specialized regimens containing second-line antituberculosis drugs. At least four drugs which the organisms are known or presumed to be susceptible should be used, and treatment should be given for at least 18 months. Patient centered measures are required to ensure adherence. Consultation with a provider experienced in treatment of patients with MDR tuberculosis should be obtained.被多重抗药菌株感染的结核病患必须以包含第二线抗结核药物的特殊配方来治疗.至少四种对菌株有疗效的药物应包含在配方内,而治疗时间至少要18各月.建立以病患为中心的治疗方式,确保病患服药的持续性.必须照会对治疗抗药菌株有经验的专家.Standard 16.All providers of care for patients with tuberculosis should ensure that persons (especially children under 5 years of age and persons with HIV infection)who are in close contact with patients who have infectious tuberculosis are evaluated and managed in line with international recommendations. Children under 5 years of age and persons with HIV infection who have been in contact with an infectious case should be evaluated for both latent infection with M. tuberculosis and for active tuberculosis.医疗提供者都应该确定所有和结核病患有密切接触的人必须接受符合国际标准的结核评估与处理,小于五岁的儿童和HIV带原者如有接触的病史应该接受潜伏性及活动性结核评估与处理Standard 17.All providers must report both new and retreatment tuberculosis cases and their treatment outcomes to local public health authorities, in conformance with applicable legal requirements and policies.所有医疗提供者必须报告新病患及重新治疗者名单以及她们的治疗结果给地方公卫机构,以符合当地法令要求.。

  1. 1、下载文档前请自行甄别文档内容的完整性,平台不提供额外的编辑、内容补充、找答案等附加服务。
  2. 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
  3. 3、如文档侵犯您的权益,请联系客服反馈,我们会尽快为您处理(人工客服工作时间:9:00-18:30)。

TopicRESEARCHTitleGuidelines for tunnelling risk management: International Tunnelling Association, Working GroupNo. 2AuthorS. D. Eskesen, P. Tengborg, J. Kampmann, T. H. VeichertsOriginally publishedin the Journal "Tunnelling and Underground Space Technology",Vol. 19, Nr. 3, pp. 217 - 237, Year 2004.Copyright © 2004, Elsevier Science Limited, ; All Rights reserved. Working Group:WG 2 - "Research"Open Session, Seminar, Workshop:-Others:ReportAbstract:These guidelines, prepared by Working Group 2 (Research) of the International Tunnelling Association, are repared in order to give guidance to all those who have the job of preparing the overall scheme for theidentification and management of risks in tunnelling and underground projects. The guidelines provide ownersand consultants with what is modern-day industry practice for risk assessment, and describes the stages of riskmanagement throughout the entire project implementation from concept to start of operation.Résumé:-Remarks:-Secretariat : ITA-AITES c/o EPFL - Bât. GC – CH-1015 Lausanne - SwitzerlandFax : +41 21 693 41 53 - Tel. : +41 21 693 23 10 - e-mail : secretariat@ - ITA/AITES Accredited MaterialGuidelines for tunnelling risk management:InternationalTunnelling Association,Working Group No.2qSøren Degn Eskesen,Per Tengborg,Jørgen Kampmann,Trine Holst VeichertsITA Working Group 2,Research,ITA-AITES,c/o EPFL,Bat GC,CH 1015Lausanne,SwitzerlandAbstractThese guidelines,prepared by Working Group 2(Research)of the International Tunnelling Association,are prepared in order to give guidance to all those who have the job of preparing the overall scheme for the identification and management of risks in tunnelling and underground projects.The guidelines provide owners and consultants with what is modern-day industry practice for risk assessment,and describes the stages of risk management throughout the entire project implementation from concept to start of operation.Ó2004Elsevier Ltd.All rights reserved.PrefaceFront page articles in the news on spectacular tunnel collapses during the 1990s focused the public and in particular potential tunnel owners Õattention on the in-herent risk associated with underground construction works.As a result,risk management became an integral part of most underground construction projects during the late 1990s.However,from discussions in interna-tional forums,it became clear that handling and man-agement of risks were performed in many different ways,some more concise than others.Out of the discussions came the idea of establishing international guidelines on tunnelling risk management.Work on these guidelines began at the meeting of ITA Working group 2‘‘Research’’in Oslo in June 1999.After much study,discussions and investigations,the guidelines were completed in April 2003.These guidelines consider that present risk manage-ment processes can be significantly improved by using systematic risk management techniques throughout thetunnel project development.By the use of these tech-niques,potential problems can be clearly identified such that appropriate risk mitigation measures can be implemented in a timely manner.The guidelines show how risk management may be utilised throughout the phases of a project implemen-tation:1.Early Design Phase2.Tendering and Contract Negotiation Phase3.Construction PhaseThe guidelines also contain some typical components of risk management and a short introduction to general risk management tools as well as a glossary of risk terms.Finally,an example of how risk management was carried out for the Copenhagen Metro following prin-ciples similar to those presented in the guidelines is in-cluded as an appendix.The practice of performing risk management requires much experience,practical and theoretical knowledge.It is,therefore,not expected that these guidelines will cover every aspects of tunnelling risk management,but it isqDisclaimer:The International Tunnelling Association (ITA)publishes this report to,in accordance with its statutes,facilitate the exchange of information,in order:to encourage planning of the subsurface for the benefit of the public,environment and sustainable development to promote advances in planning,design,construction,maintenance and safety of tunnels and underground space,by bringing together information thereon and by studying questions related thereto.However,ITA accepts no responsibility or liability whatsoever with regard to the material published in this report.This material is:information of a general nature only which is not intended to address the specific circumstances of any particular individual or entity;not necessarily comprehensive,complete,accurate or up to date;sometimes collected from external sources over which ITA services have no control and for which ITA assumes no responsibility;may not be ITA position,not professional or legal advice (if you need specific advice,you should always consult a suitably qualified professional).0886-7798/$-see front matter Ó2004Elsevier Ltd.All rights reserved.doi:10.1016/j.tust.2004.01.001Space Technology 19(2004)217–237/locate/tustTunnelling andUnderground Space Technologyincorporating Trenchless Technology Researchintended to provide some basic knowledge and indicate what is recommended industry best practice for tunnel-ling risk management.It is hoped that this knowledge will be continuously improved by the use of these guidelines.As coordinator of preparing the guideline within the ITA Working Group No.2,I wish to acknowledge the important contributions of the following persons:Mr. Jørgen Kampmann and Mrs.Trine Hoist Veicherts, who have provided major contributions based on their valuable experience gained from working as risk man-ager and risk coordinator on major underground pro-jects,Dr.Birger Schmidt and Mr.Per Tengborg and all members of working group No.2,who contributed greatly to the study,Mr.John Summers,Dr.John An-derson,Dr.Robert Sturk,Prof.Fulvio Tonon,Mr. Peter Lundhus and Mr.Donald Lamont,who reviewed the guidelines and provided valuable comments and contributions,Prof.Andre Assis and Herr Dr.Harald Wagner,who guided our study as Tutors and Mssr. Yann Leblais,who led the study as Animateur assisted by Vice-Animateaur Mr.Yoshihiro Hiro Takano.Søren Degn EskesenCoordinator,ITA Working Group2Research 1.Introduction and scopeTunnelling and underground construction works impose risks on all parties involved as well as on those not directly involved in the project.The very nature of tunnel projects implies that any potential tunnel owner will be facing considerable risks when developing such a project.Due to the inherent uncertainties,including ground and groundwater conditions,there might be significant cost overrun and delay risks as well as envi-ronmental risks.Also,as demonstrated by spectacular tunnel collapses and other disasters in the recent past, there is a potential for large scale accidents during tunnelling work.Furthermore,for tunnels in urban ar-eas there is a risk of damage to a range of third party persons and property,which will be of particular con-cern where heritage designated buildings are involved. Finally,there is a risk that the problems which the tunnelling project cause to the public will give rise to public protests affecting the course of the project.Traditionally,risks have been managed indirectly through the engineering decisions taken during the project development.These guidelines consider that present risk management processes can be significantly improved by using systematic risk management tech-niques throughout the tunnel project development.By the use of these techniques potential problems can be clearly identified such that appropriate risk mitigation measures can be implemented in a timely manner.The use of risk management from the early stages of a project,where major decisions such as choice of align-ment and selection of construction methods can be in-fluenced,is essential.The purpose of this document is to1.indicate to owners what is recommended industrybest-practice for risk management and2.present guidelines to designers as to the preparationand implementation of a comprehensive tunnel risk management system.For the purposes of this document,‘‘risk manage-ment’’is the overall term which includes risk identifi-cation,risk assessment,risk analysis,risk elimination and risk mitigation and control,see Glossary.e of risk managementIn keeping with the task of the Working Group,these guidelines provide a description of risk management activities that may be used for tunnels and underground works.Below is shown how risk management may be used throughout the project from the early planning stage through to start of operation:•Phase1:Early Design Stage(Feasibility and Concep-tual Design)-Establish risk policy(Section4.1),-Risk acceptance criteria(Section4.2),-Qualitative risk assessment of the project(Section4.3),-Detailed analysis of areas of special interest or con-cern(Section4.4).•Phase2:Tendering and Contract Negotiation -Requirements in tender documents(Section5.1), -Risk assessment in tender evaluation(Section5.2), -Risk clauses in contract(Section5.3).•Phase3:Construction Phase-ContractorÕs risk management(Section6.1),-OwnerÕs risk management(Section6.2),-Joint risk management team between the owner and the contractor.In phase1,the responsibility of establishing a risk policy and carrying out risk assessment is the ownerÕs alone.In phase2,the potential contractor has certain input to the tender regarding risk management,but the owner is still the primary responsible party.In phase3, however,the primary responsibility moves on to the contractor to establish a risk management system and to carry out effective risk management.The owner should supervise,inspect and participate in this work.The owner should further continue to assess and mitigate risks not covered by the contractor.It is important that the risk management is performed in an environment of good cooperation between the parties.To achieve this,partnering may be a valuable tool.The process of partnering may be formulated as an218S.Degn Eskesen et al./Tunnelling and Underground Space Technology19(2004)217–237ITA/AITES Accredited Materialexercise in encouraging good communications between the parties.It may be a formula for minimising cost to the owner while maximising profit for the contractor and encompasses joint planning and problem solving, scheduling,mitigation of delays and value engineering. The process of‘‘partnering’’may therefore be seen as a risk mitigation measure for the owner and the contractor.An overview of the risk management activities as seen from the ownerÕs point of view is presented in Fig.1. Risk assessments made by the contractor solely for his own purposes,such as the assessment of the risks he is involved in by submitting the tender,are not included.3.Objectives of risk managementThe identification of risks resulting from design and construction is an essential task early in a project.In order to form a common reference for all parties involved (e.g.,the owner,designers,insurers and contractors),a construction risk policy should be established by the owner.A construction risk policy for the project may indicate:•scope,•risk objectives,and•risk managementstrategy.Fig.1.Risk management activityflow for owner and contractor.S.Degn Eskesen et al./Tunnelling and Underground Space Technology19(2004)217–237219ITA/AITES Accredited Material3.1.ScopeAs an example,the scope may include the following risks or consequences:1.Risk to the health and safety of workers,includingpersonal injury and,in the extreme,loss of life.2.Risk to the health and safety of third parties.3.Risk to third party property,specifically existingbuildings and structures,cultural heritage buildings and above and below ground infrastructure.4.Risks to the environment including possible land,water or air pollution and damage toflora and fauna.5.Risk to the owner in delay to the completion.6.Risk to the owner in terms offinancial losses and ad-ditional unplanned costs.3.2.Risk objectivesThe risk objectives may be given as general objectives supplemented by specific objectives for each type of risk. The general objectives of the construction risk policy could be that proper risk management throughout the project will be ensured at all stages of the project by the:•Identification of hazards.•Identification of measures to eliminate or mitigate risks.•Implementation of measures to eliminate or mitigate risks where economically feasible or required accord-ing to the specific risk objectives or health and safety legislation.Economically feasible may be defined using the ALARP principle,i.e.,to reduce all risks covered to a level a s l ow a s r easonably p racticable.The construction risk policy may indicate that em-phasis should be placed on minimising overall risk by reducing the likelihood of occurrence of events with large consequences, e.g.,with several fatalities or of significant political concern.This should be done if the owner considers low probability events with high consequences to be of more concern than high prob-ability events with low consequences;even if the risk, expressed as probability times consequence,is the same.The construction risk policy may also include some general statements on allocation of risks between par-ties,e.g.,a risk should be allocated to the party who has the best means for controlling the risk.For each type of risk,specific minimum risk objec-tives may be defined in addition to the general risk ob-jectives.For example,the general public should be exposed only to a small additional risk from construc-tion of the tunnel or underground works;compared to the risk they are exposed to as users of buildings,cars, bicycles,public transport and when walking in the ad-jacent streets.3.3.Risk management strategyAs part of the construction risk policy,a risk man-agement strategy should be adopted.A recommended strategy is to carry out construction risk assessments at each stage of design and construction in accordance with the information available and the decisions to be taken or revised at each stage.Any risk management strategy should include:•a definition of the risk management responsibilities of the various parties involved(different depart-ments within the ownerÕs organisation,consultants, contractors),•a short description of the activities to be carried out at different stages of the project in order to achieve the objectives,•a scheme to be used for follow-up on results obtained through the risk management activities by which in-formation about identified hazards(nature and sig-nificance)is freely available and in a format that can be communicated to all parties,which may best be accomplished by some form of comprehensive risk register,•follow-up on initial assumptions regarding the opera-tional phase,•monitoring,audit and review procedures.4.Risk management in early design stagesFor effective risk management of a tunnelling project (or any other type of construction work),it is vital that risk management is begun as early as possible,prefera-bly during the project feasibility and early planning stages.The ownerÕs risk policy sets the objectives of the exercise and existing members of the project team(and new members when they join the project team)should have the whole risk management process in their minds when carrying out their work.It is important to note that the success and benefits of implementing effective risk management depends on the quality of the identified risk mitigating actions and on the active involvement,experience and general opinion of the participants(owner,designers and contractors).Risk management is not achieved by the enforcement of systems and procedures alone,but can be enhanced through seminars and meetings where an understanding and appreciation of the risk management objectives are disseminated throughout the organisations.4.1.Establish risk policyThe primary step in establishing a risk management system is for the owner to formulate a risk policy as described in Section3.220S.Degn Eskesen et al./Tunnelling and Underground Space Technology19(2004)217–237ITA/AITES Accredited Material4.2.Risk acceptance criteriaThe risk objectives expressed in general terms in theownerÕs risk policy should be‘‘translated’’into risk ac-ceptance criteria suitable for use in the risk assessmentactivities planned to be carried out.This may include:•Risk acceptance criteria to be used in qualitative risk assessment.The risk classification shown in Section7.3.3is an example of such criteria.•Risk acceptance criteria to be used in quantitative risk assessments.For each type of risk to be covered by a quantitative risk assessment,they would usually be expressed as:-A limit above which the risk is considered unac-ceptable and thus must be reduced regardless ofthe costs.-A limit below which it is not required to considerfurther risk reduction.-An area between the two limits where risk mitiga-tion shall be considered and mitigation measuresimplemented according to the circumstances,e.g.,using the ALARP principle mentioned in Section3.A document should be provided that explains howthe risk acceptance criteria were established in relationto the statements on risk objectives in the ownerÕs riskpolicy.4.3.Qualitative risk assessmentDuring the early design stage,a qualitative risk as-sessment should be carried out focussed on the identi-fication of potential hazards to the constructionactivities expected to be included in the project,andcovering all types of risk noted in the construction riskpolicy.The main purposes of this work are to raise theawareness of all concerned to the major risks involved inthe construction and to provide a structured basis forthe design decisions to be taken in the early design stage.The results can also be used for selection of specifictopics for more detailed analyses as described in Section4.4.Finally the work can be used as a starting point forthe risk management during tendering.The timing of the qualitative risk assessment shouldbe such that major design changes are still possible.Depending on the time schedule of the early design itmay be feasible to update thefirst qualitative risk as-sessment later in this design phase.The qualitative risk assessment should include:•Hazard identification,see Section7.2.•Classification of the identified hazards,see Section7.3.•Identification of risk mitigation measures.•Details of the risks in the project risk register indicat-ing risk class and risk mitigation measures for each hazard.The identification and classification is best carried out through brainstorming sessions with risk screening teams consisting of multi-disciplinary,technically and practically experienced experts guided by experienced risk analysts.The aim should be to identify all con-ceivable hazardous events threatening the project in-cluding those risks of low frequency but high possible consequence.In the identification and classification process,due regard should be taken of common causes for hazardous events such as:•Complexity and maturity of the applied technology.•Adverse unexpected ground and groundwater conditions.•Technical and/or managerial incompetence.•Human factors and/or human errors.•Lack of sufficient communication and co-ordination between internal and external interfaces.•Combinations of several unwanted events that indi-vidually are not necessarily critical.The identified hazards are classified according to the magnitude of the risk they represent.The purpose of this classification is to provide a framework for the decisions to be made on implementation of risk mitiga-tion measures.Classification systems should be estab-lished covering frequencies and consequences as well as classification of risks on the basis of the frequency and consequence classes.The classification system may be included in the risk acceptance criteria,see Section4.2.The identification of risk mitigation measures may be carried out by the same or a different team and this team should preferably have a representative of all the major parties to the project.Where risk levels conflict with the projectÕs risk ac-ceptance criteria,it is mandatory to identify risk-re-ducing actions and provide documentation for the management decision on which actions are to be im-plemented.The results should be registered in the pro-ject risk register.Risk mitigation in this phase of the project will pri-marily result in changes in technical solutions and pos-sibly in alternative working procedures.Further,many risk-reducing actions can be decisions or statements to be written into the tender documents.At this point,it should be possible to establish whe-ther implementation of a set of risk-mitigating actions will in fact reduce the risk to an acceptable level.If this does not appear to be the case,other approaches must be explored.4.4.Specific risk assessmentFor hazards of specific interest,e.g.,due to the se-verity of the risk involved or the significance of the de-sign decision to be taken,a more detailed risk analysis than the general qualitative analysis described in SectionS.Degn Eskesen et al./Tunnelling and Underground Space Technology19(2004)217–237221ITA/AITES Accredited Material4.3may be carried out.The outcome of this analysis should also be documented in the project risk register.The work may comprise one or more of the following:•A fault tree analysis of the causes of the hazards,see Section8.•An event tree analysis of the consequences,see Section8.•A full quantification of the risk,see Section7.4,e.g., with the purpose of evaluating the cost-benefit ratio of implementation of mitigating measures or provid-ing a quantitative basis for a decision between alter-native courses of action.5.Risk management during tendering and contract negotiation5.1.Risk management during preparation of tender documents5.1.1.Main risk management activitiesThe following risk management activities should be carried out during preparation of the tender documents:•Specification of technical and other requirements in the tender documents such that the risks are managed in accordance with the risk policy.The results of the qualitative risk assessment carried out during the early design stage should be used as part of the basis.The specification of technical and other requirements should detail responsibilities for risks in accordance with any general principles adopted for the project covering allocation of risks,e.g.,risks should be allo-cated to the party who has the best means for control-ling them,as mentioned in Section3.2.•The qualitative risk assessment carried out in the early design stages should be repeated when the ten-der documents are near completion as the basis forfi-nal modifications of the tender documents and to document that risk has been managed in accordance with the risk policy.•Definition of the information requested from the ten-derers in order to allow an evaluation of the tender-ersÕability to manage risk and of the differences in risk between the proposals made by the different ten-derers,see Section5.1.2.•Specification of requirements in the tender document concerning the contractorÕs risk management activi-ties during execution of the contract,see Section5.1.3.rmation to be provided with the tenderIn order to ensure a basis for comparing and evalu-ating the tenderers,the tender documents should state the information that each tenderer must present in this respect.This information should include:•Information on structured risk management in simi-lar projects and their outcomes.•CV for persons to be responsible for the risk manage-ment and details of any specialist organisation that has been involved.•General description of the tendererÕs intentions re-garding his project-specific organisation and his risk management objectives.•Overview and description of the major risks perceived by the tenderer in the project.•The tendererÕs proposed strategy for the management of major risks to the project and how success will be defined and measured.It should be stated that some or all of the above in-formation provided by the tenderers will be used as a basis for the ownerÕs tender evaluation.The information will help to illustrate whether the contractor is capable of carrying out the necessary systematic risk analysis, and the expected risk management performance.5.1.3.Requirements to be specified in the tender docu-mentsThe tender documents should specify that the con-tractor must perform risk management in accordance with the ownerÕs risk policy.The contractorÕs risk management system and approaches must be compati-ble with the ownerÕs,thereby reducing and controlling risks both to himself,to the owner and the public.Requirements concerning the contractorÕs risk man-agement system should be described.This could include such matters as:•Organisation and qualifications of risk management staff.•Types of risks to be considered and evaluated.These will be concerned with construction issues and any re-lated design activities under the contractorÕs control.•Activities,i.e.,description of a minimum requirement of activities to be included in the contractorÕs risk management,including systematic risk identification, classification of risks by frequency and consequence, and identification of risk elimination and risk mitigat-ing measures.•Time schedule for risk management activities(includ-ing requirements to carry out risk assessment in time to allow implementation of identified risk mitigating measures).•Co-ordination with the ownerÕs risk management and risk management team.•Co-ordination with the other contractorsÕrisk management.•Co-ordination between risk management and the contractorÕs other systems,such as quality manage-ment and environmental management.•Control of risks from sub-contractorsÕactivities.•Specific requirements concerning risk management in explicitfields should be stated(examples could be222S.Degn Eskesen et al./Tunnelling and Underground Space Technology19(2004)217–237ITA/AITES Accredited Materialmodification to the construction methods for areas identified as of particular concern,i.e.,construction methods related to risk to third party buildings or re-quirements concerning securing against unintentional ground water lowering).The ownerÕs risk policy,risk acceptance criteria and risk classification system should be stated in the tender documents.The ownerÕs risk management activities should be briefly mentioned.It should be carefully considered and pointed out to what extent the contrac-tor will have insight into the ownerÕs risk analysis re-sults.Further,it should be stated in the tender documents that the contractor is responsible for effective risk management regardless of the extent and detail of the risk information deriving from the owner.It is recommended that the tender documents require that the owner be involved in the risk management during construction and that a risk management team is established with participants from the contractor and from the owner(see Fig.1).5.2.Risk management during selection of contractorProviding tenderers are clearly informed in tender documents,the application of risk management tech-niques by the owner can be valuable in the selection of the successful tenderer.Identifying risk issues in the tenders can be used as a basis for tender negotiations. The evaluation of tenders in respect of risk may be qualitative(based on a points system)or on a quanti-tative basis to the extent that the tender price might be adjusted accordingly.The evaluation of the risk issues in the tenders should include:•An evaluation of the contractorÕs ability to identify and control risks by the choice and implementation of technical solutions.An evaluation is also needed of his ability to apply systematic risk management in the work that he will undertake.•Systematic assessment of the differences in risk be-tween the project proposals by different tenderers.•Evaluation of the risk management expertise at the contractorÕs disposal.Where a qualitative risk assessment is envisaged,the means of achieving this need to be considered during the preparation of the tender documentation.For each identified risk,the tenders need to be compared and areas where there are differences should be highlighted.Where a quantitative risk assessment is envisaged,the recommended approach isfirst to carry out a quantita-tive risk assessment on the ownerÕs project as described in Section7.4.This could be carried out in the time period between the issue and the receipt of tenders.The risk in each tender is quantified by taking the ownerÕs quantitative risk assessment and for each risk consid-ering the differences in frequency and consequence.The input to the quantification could be obtained from re-liable information obtained from external sources and/ or through brainstorming sessions.The experience and competence of those on the brainstorming team is vital. Thefinal outcome will be the quantification of the risks involved in each tender.This has the benefit of a level comparison even if the absolute value of the risk is uncertain.This quantification is particularly useful for the risk of economic loss to the owner,and the risk of delay to the completion of the project.These evaluations could be directly compared with the contract price in the tenders and the assignment of a certain monetary value might be made per monthÕs estimated or potential delay of project completion.For other risks,it may be more difficult to obtain reliable results from a full quantification analysis,and a qualitative comparison may be all that is practicable.5.3.Risk clauses in contractWhen a contractor has been chosen,negotiations between the owner and the contractor may lead to a detailed contractual description of the risk management system to be implemented on the project.This may be based on a combination of the intentions of the owner and the suggested procedures of the contractor with the purpose of improving the co-operation between the parties.Alternative technical solutions will also be negotiated on the basis of risk assessments carried out and stated in the contract.The risk assessment of the successful tender may have identified some previously undetected areas of risk or special concern.In order to reduce these risks to an acceptable level,additional risk mitigation clauses may be introduced in the contract.An example could be that the contractor has proposed a modification to the con-struction methods envisaged by the owner,which is advantageous except for a secondary risk of impact to the environment.This risk to the environment is then mitigated by additional requirements.6.Risk management during constructionIn the early design and tender and contract negotia-tion phases,certain risks may be transferred,either contractually or through insurance,others may be re-tained and some risks can be eliminated and/or miti-gated.In the construction phase,possibilities of risk transfer are minimal and the most advantageous strat-egy for both owner and contractor is to reduce the se-verity of as many risks as possible through the planning and implementation of risk eliminating and/or risk mitigating initiatives.S.Degn Eskesen et al./Tunnelling and Underground Space Technology19(2004)217–237223ITA/AITES Accredited Material。

相关文档
最新文档