1、BSI Standards Publication Safety aspects Guidelines for their inclusion in standards PD ISO/IEC Guide 51:2014National foreword This Published Document is the UK implementation of ISO/IEC Guide 51:2014. The UK participation in its preparation was entrusted to Technical Committee S/-, Management Syste
2、ms Sector Policy and Strategy Committee. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standard
3、s Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 86240 3 ICS 01.120 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 April 2014. A
4、mendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/IEC Guide 51:2014Safety aspects Guidelines for their inclusion in standards Aspects lis la scurit Principes directeurs pour les inclure dans les normes ISO/IEC 2014 Reference number ISO/IEC GUIDE 51:2014(E) GU
5、IDE 51 Third edition 2014-04-01 PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E)ii ISO/IEC 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO/IEC 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any me
6、ans, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Genev
7、a 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) ISO/IEC 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definit
8、ions . 1 4 Use of the terms “safety” and “safe” 3 5 Elements of risk . 3 6 Achieving tolerable risk 4 6.1 Iterative process of risk assessment and risk reduction. 4 6.2 Tolerable risk 5 6.3 Risk reduction 6 6.4 Validation . 8 7 Safety aspects in standards . 8 7.1 Types of safety standard . 8 7.2 Ana
9、lysis of proposed new standards . 9 7.3 Preparatory work . 9 7.4 Drafting .10 Bibliography .14 PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) are worldwide federations of nati
10、onal standards bodies (ISO member bodies and IEC national committees). The work of preparing International Standards is normally carried out through ISO and IEC technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be rep
11、resented on that committee. International organizations, governmental and non-governmental, in liaison with ISO or IEC, also take part in the work. ISO collaborates closely with IEC on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules g
12、iven in the ISO/IEC Directives, Part 2. Draft Guides adopted by the responsible Committee or Group are circulated to the member bodies for voting. Publication as a Guide requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the ele
13、ments of this document may be the subject of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. ISO/IEC Guide 51 was prepared by a Joint Working Group of the ISO Committee on Consumer Policy (COPOLCO) and the IEC Advisory Committee on Safety (ACOS
14、). This third edition cancels and replaces the second edition (ISO/IEC Guide 51:1999) which has been technically revised. The main changes compared with the second edition are as follows: strengthened focus on risk reduction in the overall risk assessment process, including revised Figure 2; replace
15、ment of the term “harmful event” with the term “hazardous event”; updating of terms used in the context of consumer safety; revision of Figure 3 to specify the risk reduction steps in greater detail; addition of a new Introduction providing more background information; addition of specific provision
16、s and references relative to vulnerable consumers; revision of Clause 2 (Normative references) and the Bibliography; reorganization and consolidation of the content in Clauses 6 and 7.iv ISO/IEC 2014 All rights reserved PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) Introduction Work on standards
17、 deals with safety aspects in many different forms across a wide range of technologies and for most products, processes, services and systems (referred to as “products and systems” in this Guide). The increasing complexity of products and systems entering the market makes it necessary to place a hig
18、h priority on consideration of safety aspects. This Guide provides practical guidance to drafters of standards to assist them in including safety aspects in standards. The underlying principles of this Guide can also be used wherever safety aspects require consideration, and as a useful reference fo
19、r other stakeholders such as designers, manufacturers, service providers, policy makers and regulators. The approach described in this Guide aims at reducing risk that can arise in the use of products or systems, including use by vulnerable consumers. This Guide aims to reduce the risk arising from
20、the design, production, distribution, use (including maintenance) and destruction or disposal of products or systems. The complete life cycle of a product or system (including both the intended use and the reasonably foreseeable misuse) is considered, whether the product or system is intended to be
21、used in the workplace, in the household environment, or for recreational activities. The goal is to achieve tolerable risk for people, property and the environment, and to minimize adverse effects on the environment. Hazards can pose different safety problems and can vary significantly depending on
22、the end user of a product or system, including the integrity of control mechanisms, and the environment in which a product or system is used. Whereas it is possible to control risks to a greater extent in the workplace, this might not be the situation in the home environment or when vulnerable consu
23、mers use the product or system. Consequently, this Guide might need to be supplemented by other publications for particular fields of interest or users. An indicative list of such publications appears in the Bibliography. This Guide is intended to be applicable to the drafting of all new standards a
24、nd to existing standards at their next revision. It is important to distinguish the respective roles of quality and of safety. However, it might be necessary to consider quality requirements in standards to ensure that the safety requirements are consistently met. NOTE 1 The term “standard” used thr
25、oughout this Guide includes international standards, technical specifications, publicly available specifications, technical reports and guides. NOTE 2 Standards can deal exclusively with safety aspects or can include clauses specific to safety. NOTE 3 Unless otherwise stated, when the term “committe
26、e” is used in this Guide, it refers to technical committees, subcommittees or working groups of both ISO and IEC. ISO/IEC 2014 All rights reserved v PD ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards 1 Scope This Guide provides requirements and recommendations for th
27、e drafters of standards for the inclusion of safety aspects in standards. It is applicable to any safety aspect related to people, property or the environment, or to a combination of these. NOTE 1 For example, it can be applicable to people only, or to people and property, or to people, property and
28、 the environment. NOTE 2 The term “products and systems” used throughout this Guide includes products, processes, services and systems. NOTE 3 Safety aspects can also be applicable to long-term health consequences. 2 Normative references There are no normative references. 3 T erms a nd definiti ons
29、For the purposes of this document, the following terms and definitions apply. 3.1 harm injury or damage to the health of people, or damage to property or the environment 3.2 hazard potential source of harm (3.1) 3.3 hazardous event event that can cause harm (3.1) 3.4 hazardous situation circumstance
30、 in which people, property or the environment is/are exposed to one or more hazards (3.2) 3.5 inherently safe design measures taken to eliminate hazards (3.2) and/or to reduce risks (3.9) by changing the design or operating characteristics of the product or system 3.6 intended use use in accordance
31、with information provided with a product or system, or, in the absence of such information, by generally understood patterns of usage GUIDE ISO/IEC GUIDE 51:2014(E) ISO/IEC 2014 All rights reserved 1 PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) 3.7 reasonably foreseeable misuse use of a product
32、 or system in a way not intended by the supplier, but which can result from readily predictable human behaviour Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. the elderly, children and persons with disabilities. For more information, see ISO 1
33、0377. Note 2 to entry: In the context of consumer safety, the term “reasonably foreseeable use” is increasingly used as a synonym for both “intended use (3.6)” and “reasonably foreseeable misuse.” 3.8 residual risk risk (3.9) remaining after risk reduction measures (3.13) have been implemented 3.9 r
34、isk combination of the probability of occurrence of harm (3.1) and the severity of that harm Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.4), the occurrence of a hazardous event (3.3) and the possibility to avoid or limit the harm. 3.10 risk analys
35、is systematic use of available information to identify hazards (3.2) and to estimate the risk (3.9) 3.11 risk assessment overall process comprising a risk analysis (3.10) and a risk evaluation (3.11) 3.12 risk evaluation procedure based on the risk analysis (3.10) to determine whether tolerable risk
36、 (3.15) has been exceeded 3.13 risk reduction measure protective measure action or means to eliminate hazards (3.2) or reduce risks (3.9) EXAMPLE Inherently safe design (3.5); protective devices; personal protective equipment; information for use and installation; organization of work; training; app
37、lication of equipment; supervision. 3.14 safety freedom from risk (3.9) which is not tolerable 3.15 tolerable risk level of risk (3.9) that is accepted in a given context based on the current values of society Note 1 to entry: For the purposes of this Guide, the terms “acceptable risk” and “tolerabl
38、e risk” are considered to be synonymous. 3.16 vulnerable consumer consumer at greater risk (3.9) of harm (3.1) from products or systems, due to age, level of literacy, physical or mental condition or limitations, or inability to access product safety (3.14) information2 ISO/IEC 2014 All rights reser
39、ved PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) 4 Use of the terms “safety” and “safe” 4.1 The term “safe” is often understood by the general public as the state of being protected from all hazards. However, this is a misunderstanding: “safe” is rather the state of being protected from recogni
40、zed hazards that are likely to cause harm. Some level of risk is inherent in products or systems (see 3.14). 4.2 The use of the terms “safety” and “safe” as descriptive adjectives should be avoided when they convey no useful extra information. In addition, they are likely to be misinterpreted as an
41、assurance of freedom from risk. The recommended approach is to replace, wherever possible, the terms “safety” and “safe” with an indication of the objective. EXAMPLES “Protective helmet” instead of “safety helmet”; “protective impedance device” instead of “safety impedance”; “slip resistant floor-co
42、vering” instead of “safe floor-covering”. 5 Elements of risk The risk associated with a particular hazardous situation depends on the following elements: a) the severity of harm that can result from the considered hazard; b) the probability of occurrence of that harm, which is a function of: the exp
43、osure to the hazard; the occurrence of a hazardous event; the possibilities of avoiding or limiting the harm. The elements of risk are shown in Figure 1. Figure 1 Elements of risk ISO/IEC 2014 All rights reserved 3 PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) 6 Achieving tolerable risk 6.1 Iter
44、ative process of risk assessment and risk reduction The iterative process of risk assessment and risk reduction for each hazard is essential in achieving tolerable risk. The critical issue for drafters of standards to address, as a product or system goes through the supply chain from development to
45、disposal, is to determine whether the iterative process of risk assessment is assumed by: the standards drafting committee, to perform the risk assessment for specific and known hazards (e.g. a product-specific standard that is used to demonstrate regulatory compliance); or the standard readers/user
46、s, to perform the risk assessment (e.g. manufacturer/supplier of the product or system) for hazards that they identify (e.g. based on ISO 12100 or ISO 14971). The following procedure should be used to reduce risks to a tolerable level (see Figure 2): a) identify the likely users for the product or s
47、ystem, including vulnerable consumers and others affected by the product; b) identify the intended use, and assess the reasonably foreseeable misuse, of the product or system; c) identify each hazard (including reasonably foreseeable hazardous situations and events) arising in the stages and conditi
48、ons for the use of the product or system, including installation, operation, maintenance, repair and destruction/disposal; d) estimate and evaluate the risk to the affected user group arising from the hazard(s) identified: consideration should be given to products or systems used by different user g
49、roups; evaluation can also be made by comparison with similar products or systems; e) if the risk is not tolerable, reduce the risk until it becomes tolerable. Figure 2 shows the iterative process of risk assessment and risk reduction.4 ISO/IEC 2014 All rights reserved PD ISO/IEC Guide 51:2014 ISO/IEC GUIDE 51:2014(E) Figure 2 Iterative process of risk assessment and risk reduction 6.2 Tolerable risk 6.2.1 All products and systems include hazards and, therefore, some level of residual risk. However, the risk
