IEC 61508是一項用於工業領域的國際標準，其名稱是《電氣/電子/可程式電子安全相關系統的功能安全》（Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems (E/E/PE, or E/E/PES）。 IEC 61508是由國際電工委員會發布，其目的要建立一個可應用於各種工業領域的基本功能安全標準。它將功能安全定義為：「是受控設備（EUC）或受控設備系統總體安全中的一部分；其安全性是依賴於電氣/電子/可程式電子（E/E/PE）安全相關系統、其他技術的安全相關系統或外部風險降低措施的正確機能。」（摘自维基百科）
EC Ec61508-1 Edition 2.0 2010-04 INTERNATIONAL STANDARD NORME INTERNATIONALE BASIC SAFETY PUBLICATION PUBLICATION FONDAMENTALE DE SECURITE Functional safety of electrical/electronic/programmable electronic safety-related systems Part 1: General requirements Securite fonctionnelle des systemes electriques/electroniques/electroniques programmables relatifs a la securite Partie 1: Exigences generales INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE NTERNAT○NALE PRICE CODE CODE PRIX XB cs13.110;25.040;29.020 SBN9782-88910-524-3 R Registered trademark of the International Electrotechnical Commission Marque depose de la Commission Electrotechnique Internationale 2 61508-1|EC:2010 CONTENTS FOREWORD INTRODUCTION 1 Scope 579 2 Normative references .12 3 Definitions and abbreviations 4 Conformance to this standard 22 5 Documentation 13 5.1 Objectives 13 5.2 Requirements 13 6 Management of functional safety 14 6.1 Objectives 14 6.2 Requirements 14 7 Overall safety lifecycle requirements .17 7.1 General 17 71.1 Introduction 17 7.1.2 Objectives and requirements-general 20 7.1.3 Objectives 25 7.1.4 Requirements 25 7.2 Concept......., 25 7.2. 1 Objective 25 7.2.2 Requirements.. 国画 .26 7. 3 Overall scope definition 26 7.3.1 Objectives 26 7.3.2 Requirements ................ ...“. .26 7.4 Hazard and risk analysis 27 7.4.1 Objectives…… :.::.. .27 7.4.2 Requirements… 27 7.5 Overall safety requirements 7.5.1 Objective 29 7.5.2 Requirements 7.6 Overall safety requirements allocation .30 7.6.1 Objectives 30 7.6.2 Requirements 7.7 Overall operation and maintenance planning 35 7.7.1 Objective 35 7.7.2 Requirements 35 7.8 Overall safety validation planning 37 7.8.1 Objective 37 7.8.2 Requirements 37 7.9 Overall installation and commissioning planning .38 7.9. 1 Objectives ..38 7.9.2 Requirements 38 7. 10 E/E/PE system safety requirements specification 38 7.10. 1 Objective 39 7.10.2 Requirements 39 7.11 E/E/PE safety-related systems- realisation 61508-1@|EC:2010 7.11.1 Objective 7.11.2 Requirements… 41 7. 12 other risk reduction measures- specification and realisation 41 7.12.1 Objective 41 7.12.2 Requirements 41 7.13 Overall installation and commissioning 7.13.1 Objectives 41 7.13.2 Requirements 42 7.14 Overall safety validation 42 7.14.1 Objective 42 7.14.2 Requirements 42 7.15 Overall operation, maintenance and repair 43 7.15. 1 Objective 43 7.15.2 Requirements 43 7.16 Overall modification and retrofit 46 7.16.1 Objective .46 7.16.2 Requirements 47 7.17 Decommissioning or disposal 48 7.17.1 Objective .48 7.17.2 Requirements 48 7.18 Verification 49 7.18.1 Objective… 49 7.18.2 Requirements 49 8 Functional safety assessment 50 8.1 Objective 50 8.2 Requirements 50 Annex a(informative)Example of a documentation structure 54 Bibliography .60 Figure 1-Overall framework of the lEc 61508 series Figure 2-Overall safety lifecycle 18 Figure 3-E/E/PE system safety lifecycle (in realisation phase) 19 Figure4- Software safety lifecycle( in realisation phase)……… 19 Figure 5- Relationship of overall safety lifecycle to the E/E/PE system and software safety lifecycles.……… Figure 6 -Allocation of overall safety requirements to E/E/PE safety-related systems and other risk reduction measures 32 Figure 7-Example of operations and maintenance activities model.......s.......45 Figure 8-Example of operation and maintenance management model 46 Figure 9-Example of modification procedure model 48 Figure A 1- Structuring information into document sets for user groups ..59 Table 1 -overall safety lifecycle- overview 21 Table 2- Safety integrity levels -target failure measures for a safety function operating in low demand mode of operation 33 Table 3- safety integrity levels target failure measures for a safety function operating in high demand mode of operation or continuous mode of operation 34 4 61508-1@|Ec:2010 Table 4-Minimum levels of independence of those carrying out functional safety assessment (overall safety lifecycle phases 1 to 8 and 12 to 16 inclusive (see Figure 2)).......53 Table 5-Minimum levels of independence of those carrying out functional safety assessment (overall safety lifecycle phases 9 and 10, including all phases of E/E/PE system and software safety lifecycles(see Figures 2,3 and 4)) 53 Table A. 1-Example of a documentation structure for information related to the overall safety lifecycle… .56 Table A.2-Example of a documentation structure for information related to the E/E/PE system safety lifecycle .57 Table A3- Example of a documentation structure for information related to the software safety lifecycle 58 61508-1@|EC:2010 5 NTERNATIONAL ELECTROTECHNICAL COMMISSION FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/ PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS Part 1: General requirements FOREWORD 1)The International Electrotechnical Commission(IEC) is a worldwide organization for standardization comprising all national electrote chnical committees (IEC National Committees). The abject of iEc is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications Technical Reports, Publicly Available Specifications (PAs) and Guides (hereafter referred to as"lEC Publication(s). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (Iso)in accordance with conditions determined by agreement between the two organizations 2)The formal decisions or agreements of IEc on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested ec national committees BEC Publications have the form of recommendations for international use and are accepted by lEc National Committees in that sense. while all reasonable efforts are made to ensure that the technical content of iec Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4In order to promote international uniformity, IEC National Committees undertake to apply lEc Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corres ponding national or regional publication shall be clearly indicated in 5)EC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to lEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies 6)All users should ensure that they have the latest edition of this publication 7)No liability shall attach to lEC or its directors, employees, servants or agents including individual experts and nembers of its technical committees and lEc National Committees for any personal injury property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees )and expenses arising out of the publication, use of, or reliance upon, this IEc Publication or any other IEC Publications 8)Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is ble for the s pu 9)Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held res ponsible for identifying any or all such patent rights International Standard iEc 61508-1 has been prepared by subcommittee 65A: System aspect of IEc technical committee 65: Industrial-process measurement, control and automation This second edition cancels and replaces the first edition published in 1998. This edition constitutes a technical revision This edition has been subject to a thorough review and incorporates many comments received at the various revision stages It has the status of a basic safety publication according to lEC Guide 104 6 61508-1|EC:2010 The text of this standard is based on the following documents FDIS Report on voting 65A/548/FD|S 65A/572/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table This publication has been drafted in accordance with the iso/EC Directives, Part 2 A list of all parts of the IEC 61508 series, published under the general title Functional safety of electrical/electronic programmable electronic safety-related systems, can be found on the IEC Website The committee has decided that the contents of this publication will remain unchanged until the maintenanceresultdateindicatedontheiecwebsiteunderhttp://webstore.iecchinthedata related to the specific publication At this date, the publication will be reconfirmed · withdrawn replaced by a revised edition, or · amended. 61508-1@|EC:2010 7 NTROdUCTION Systems comprised of electrical and/or electronic elements have been used for many years to perform safety functions in most application sectors. Computer-based systems (generically referred to as programmable electronic systems)are being used in all application sectors to perform non-safety functions and, increasingly, to perform safety functions. If computer system technology is to be effectively and safely exploited, it is essential that those responsible for making decisions have sufficient guidance on the safety aspects on which to make these decisions This International Standard sets out a generic approach for all safety lifecycle activities for systems comprised of electrical and/or electronic and/or programmable electronic (E/E/PE) elements that are used to perform safety functions. This unified approach has been adopted in order that a rational=d consistent technical policy be developed for all electrically-based safety-related systems. A major objective is to facilitate the development of product and application sector international standards based on the iec 61508 series NOTE 1 Examples of product and application sector international standards based on the IEc 61508 series are given in the bibliography (see references , and [3D In most situations, safety is achieved by a number of systems which rely on many technologies for example mechanical, hydraulic, pneumatic, electrical, electronic, programmable electronic Any safety strategy must therefore consider not only all the elements within an individua system(for example sensors, controlling devices and actuators but also all the safety-related systems making up the total com bination of safety-related systems. Therefore, while this International Standard is concerned with E/E/PE safety-related systems, it may also provide a framework within which safety-related systems based on other technologies may be considered It is recognized that there is a great variety of applications using E/E/PE safety-related systems in a variety of application sectors and covering a wide range of complexity, hazard and risk potentials. In any particular application, the required safety measures will be dependent on many factors specific to the application. This International Standard, by being generic, wil standards and in revisions of those that already ex/s oduct and application sector international enable such measures to be formulated in future pre This International standard considers all relevant overall, E/E/PE system and software safety lifecycle phases(for example, from initial concept, through design, implementation, operation and maintenance to decommissioning) when E/E/PE systems are used to perform safety functions has been conceived with a rapidly developing technology in mind the framework is sufficiently robust and comprehensive to cater for future developments enables product and application sector internaional standards, dealing with E/E/PE safety related systems, to be developed; the development of product and application sector international standards, within the frames of this standard, should lead to a high level of insistency (for example, of underlying principles, terminology etc. )both within application sectors and across application sectors; this will have both safety and economic benefits provides a method for the development of the safety requirements specification necessary to achieve the required functional safety for e/E/PE safety-related systems adopts a risk-based approach by which the safety integrity requirements can be determined introduces safety integrity levels for specifying the target level of safety integrity for the safety functions to be implemented by the e/E/PE safety-related systems; NoTE 2 The standard does not specif safety integrity level requirements for any safety function, nor does it mandate how the safety integrity level is determined. Instead it provides a risk-based conceptual framework and example techniques 8 61508-1|EC:2010 sets target failure measures for safety functions carried out by E/E/PE safety-related systems, which are linked to the safety integrity levels sets a lower limit on the target failure measures for a safety function carried out by a single E/E/PE safety-related system For E/E/PE safety-related systems operating in a low demand mode of operation, the lower limit is set at an average probability of a dangerous failure on demand of 10-5 a high demand or a continuous mode of operation, the lower limit is set at an average frequency of a dangerous failure of 10-9[h-1 NOTE 3 A single E/E/PE safety-related system does not necessarily mean a single-channel architecture NOTE 4 It may be possible to achieve designs of safety-related systems with lower values for the target safety ntegrity for non-complex systems, but these limits are considered to represent what can be achieved for relatively complex systems(for example programmable electronic safety-related systems)at the present time sets requirements for the avoidance and control of systematic faults, which are based or experience and judgement from practical experience gained in industry. Even though the probability of occurrence of systematic failures cannot in general be quantified the standard does, however, allow a claim to be made, for a specified safety function that the target failure measure associated with the safety function can be considered to be achieved if all the requirements in the standard have been met introduces systematic capability which applies to an element with respect to its confidence that the systematic safety integrity meets the requirements of the specified safety integrity level adopts a broad range of principles, techniques and measures to achieve functional safety for E/E/PE safety-related systems, but does not explicitly=e the concept of fail safe However, the concepts of "fail safe"and"inherentl-afe"principles may be applicable and adoption of such concepts is acceptable providing the requirements of the relevant clauses in the standard are met
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