ISO/IEC Guide 51:1990
(Main)Guidelines for the inclusion of safety aspects in standards
Guidelines for the inclusion of safety aspects in standards
Principes directeurs pour inclure dans les normes les aspects liés à la sécurité
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Standards Content (Sample)
GUIDE 51
Guidelines for the inclusion of
safety aspects in standards
First edition 1990
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Page
Contents Foreword
............................ ii IS0 (the International Organization for Standardization) and
Foreword.~
IEC (the International Electrotechnical Commission) together
iii
Introduction . form a system for worldwide standardization as a whole.
National bodies that are members of IS0 or IEC participate in
1
1 Scope . the development of International Standards through technical
committees established by the respective organization to deal
............................. 1 with particular fields of technical activity. IS0 and IEC technical
2 Normative references.
committees collaborate in fields of mutual interest. Other inter-
3 Definitions . 1 national organizations, governmental and non-governmental,
in liaison with IS0 and IEC, also take part in the work.
2
4 Regulatory implications in relation to safety . . . . . . . . . . .
This Guide was developed jointly by the Technical Advisory
2 Group ISO/TAG 11, Safety, and the IEC Advisory Committee
5 General principles for developing standards . . . . . . . . . . .
on Safety, IEUACOS. It is the first of a series intended to pro-
.............. 2 vide a harmonized approach to the concept of safety when
6 Principles of preparing safety standards
preparing International Standards.
2
6.1 Planning of work .
In view of the diversity of safety aspects in standardization, this
2
6.2 Analysis .
Guide may need to be supplemented by sectoral guides, for
example, as regards
3
6.3 Structure .
- personal protection ;
3
6.4 Drafting .
- fire prevention;
3
6.4.1 Title .
- health care and medicine;
4
6.4.2 Requirements for safety. .
-
consumer products;
..... 4
6.4.3 Testing and compliance (verification)
- packaging and transport of goods;
.................. 5
6.4.4 Information for safety
-
machinery and equipment;
..................... 5
6.4.5 Minimum marking -
chemicals;
6.4.6 Instructions for use, including installation - building and civil engineering;
5
and maintenance. .
- transport.
6
6.4.7 Packaging .
This Guide may be revised in due course on the basis of prac-
Warning statements in standards. . 6 tical experience. Committees writing standards are invited to
6.4.8
inform ISO/TAG 11, or IEC/ACOS respectively, of any dif-
........................................ 7 ficulties encountered with the implementation of its provisions.
Bibliography
0 IS0 1990
All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including
photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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decision-making is based on two interrelated considerations :
Introduction
evaluating the risk and judging the safety.
The concept of safety is closely related to safeguarding the in-
tegrity of people and property. With the increasing complexity
Evaluating risk - assessing the probability of harm, the
of products, processes or services entering the market, it is ob-
magnitude of the consequent injury by identifying the
vious that safety has gained considerable importance in our
characteristics and the likely conditions of use relevant to
contemporary world.
safety and means of quantifying them - is an empirical
scientific activity.
Safety is dealt with in standards work in many different forms,
at different levels, in all areas of technology and for most prod-
Judging safety - assessing the acceptability of risks - is
ucts, processes or services.
an activity associated with such factors as the socio-
economic and educational background of the society con-
Safety is a balance between freedom from risks of harm and
cerned, and whether design, or manufacturing processes,
other demands to be met by a product, process or service
could play a role in increasing safety.
among which such items as utility, suitability for purpose, and
the like are included.
As safety will pose different problems it is impossible to provide
There can be no absolute safety. Even at the highest level of a set of precise provisions and recommendations that will apply
in every case. However, these guidelines, when followed on a
safety, a product, process or service can only be relatively safe.
judicious “use when applicable” basis, will help in developing
The conventions of society, including levels of safety or
degrees of risk, are subject to changes. In this respect, reasonably consistent standards.
. . .
III
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lSO/IEC GUIDE 51 : 1990 (El
Guidelines for the inclusion of safety aspects in standards
1 Scope NOTES
1 In standardization, the safety of products is generally considered
This Guide provides standards-writers with a concept of safety
with a view to achieving the most favourable balance between a
with the purpose of promoting safety through standards. It
number of factors, including non-technical factors such as human
outlines procedures for identifying those characteristics of
behaviour, that will reduce risks to persons and property to an accept-
products that are relevant to safety and for making appropriate
able level (level of safety).
provisions for them.
2 Sometimes, the word safety is also used instead of, or together
with, a word describing the function - usually protection or warning/
The result may be a standard dealing exclusively with safety
alarm. Although not incorrect, the word safety as a descriptive adjec-
aspects or the inclusion of clauses specific to safety in a general
tive need not be used in this case since it conveys no useful extra infor-
standard.
mation but is likely to be interpreted as an assurance of guaranteed
freedom from risks of harm. A recommended approach therefore is to
NOTES
replace, wherever possible, the word safety by an indication of the
objective.
used throughout this Guide - includes
1 The term “standard” -
Technical Report and Guide.
Examples are :
2 Similarly, the term “product” - used throughout this Guide -
-
and combinations thereof commonly “protective helmet” (instead of “safety helmet”);
includes “process”, “service”,
known as “systems”.
-
“protective impedance device” (instead of “safety
impedance”).
2 Normative references
3.2 risk: The probable rate of occurrence of a hazard caus-
IS0 3864 : 1984, Safety colours and safety signs.
ing harm and the degree of severity of the harm.
IEWSO Directives, Part 2: Methodology for the development
of In terna tional Standards, 1989.
3.3 hazard: A potential source of harm.
IEC/ISO Directives, Part 3: Drafting and presentation of lnter-
national Standards, 1989.
3.4 harm: Physical injury and/or damage to health or prop-
erty.
: 1986, General terms and their definitions
ISO/IEC Guide 2
concerning standardization and related activities.
3.5 level of safety: A level of how far safety is to be pursued
ISOIIEC Guide 7 : 1982, Requirements for standards suitable
in a given context, assessed by reference to an acceptable risk,
for product certification.
based on the current values of society.
ISO/IEC Guide 37 : 1983, Instructions for use of products of
consumer interest.
3.6 safety standard: A document that deals exclusively
with the safety aspects of a product, process or service.
ISO/IEC Guide50 : 1987, Childsafetyandstandards - General
guidelines.
NOTE - In some cases, standards covering more than safety aspects
are also called “safety standards”.
Then, separate treatment of the
safety aspects - as distinct from other aspects not related to safety -
is essential.
3 Definitions
For the purposes of this Guide, the following definitions apply.
37 intended use: The use of a product, process or service
under conditions or for purposes in accordance with specifi-
3.1 safety: Freedom from unacceptable risk of harm.
cations and instructions provided by the supplier - including
[ISO/IEC Guide 2:1986, definition 2.5.1 information for publicity purposes.
1
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ISOAEC GUIDE 51 : 1990 (E)
-
3.8 reasonably foreseeable misuse: The use of a product, of risks still remaining;
process or service under conditions or for purposes not in-
-
tended by the supplier, but which may happen, induced by the of risks incurred when making protective means inef-
design of the product in combination with, or as a result of, fective, or if protective equipment is not worn.
common human behaviour.
Independently of the character and extent of the measures
specified, consideration should be given, as appropriate, to the
4 Regulatory implications in relation to safety inclusion in the standard of a statement on the need for training
as regards safe use of the product.
Safety is of special concern to regulatory authorities. In many
It should be indicated in the standard which of the measures
fields, regulations concerned with safety refer to standards,
either making them mandatory or recognizing them as “ap- contained in the last three actions mentioned above should be
proved” to provide means of compliance with statutory re- detailed in the operating manual, and/or shown on the prod-
uct.
quirements : the “deemed to satisfy” approach.
Consequently, requirements dealing with safety aspects which
could form part of governmental, or intergovernmental, regu- 6 Principles of preparing safety standards
lations should receive priority when preparing standards.
6.1 Planning of work
5 General principles for developing standards
Close coordination with,in and among committees responsible
for different products is necessary in order to create a coherent
When preparing a standard, it is the task of a committeel),
approach to the treatment of safety in the preparation of stan-
bearing in mind both the intended use and reasonably
dards. The use of a hierarchy of standards will ensure that each
foreseeable misuse of a product,
specialized standard is restricted to specific aspects and makes
reference to standards of wider application for all other relevant
-
to direct its attention to the aspects relevant to safety in
aspects. Such hierarchy is built on
identifying the hazards present, and
- basic safety standard, comprising basic concepts,
-
to include. requirements with a view to avoiding or
principles and requirements with regard to general safety
reducing risks emanating from such hazards.
aspects, applicable to all kinds or a wide range of products,
in the same, or similar, manner;
The following strategy should be used to prepare the standard :
- group safety standard, comprising requirements with
a) identify the hazards arising from all stages and con-
regard to safety aspects, applicable to several, or to a group
ditions for the use of the product, including installation,
of similar, products - in the same, or similar, manner -
maintenance and eventual destruction/disposal;
making reference, as far as possible, to relevant re-
quirements (based on the appropriate level of safety),
b) evaluate the risks arising from the hazards identified;
specified in “basic safety standards”;
c) judge the level of safety required;
- product safety standard, comprising safety re-
quirements for a specific product, or a group of products,
d) eliminate hazards or minimize them by specifying
which are necessary for, and applicable to, the specific
design criteria (“built-in” safety).
product with a view to its intended use - making reference,
as far as possible, to relevant requirements (based on the
Insofar as it is not reasonably practicable to eliminate or
appropriate level of safety) specified in “basic safety stan-
minimize hazards, it should be specified in the standard that
dards” and “group safety standards”.
appropriate protective means be recommended, or provided
with the product in order to protect those at risk.
6.2 Analysis
Insofar as these protective means are considered insufficient,
Every proposal for preparing or revising a safety standard -
or if their application would make the product unsuitable for
as for any standard - should identify what is to be included
use, it is necessary in the standard to specify the use of protec-
in the standard and for whom it is intended. This is usually
tive means independent of the product, such as protective
achieved by answering the following questions :
means at the place where the product is used, or personal pro-
tective equipment for the user.
A. What is the purpose of the standard?
Where none of these measures can reasonably be specified -
Is it to become
or else, in addition to them - suitable methods should be
-
specified in the standard to warn those at risk a basic safety standard?
1) Unless otherwise stated, the term “committee(s)“, when used in this Guide, is meant to cover both IS0 and IEC technical committees, subcom-
mittees or working groups.
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ISO/IEC GUIDE 51 : 1990 (E)
-
-
radiation hazards (radio-frequency, infra-red, ultra-
a group safety standard?
violet, high-intensity visible light; coherent light; ionizing
-
radiation; etc. 1.
a product safety standard?
Once the content of the future standard has been delineated,
Considering its purpose :
the following points may be used as help to indicate items
which should be considered when dealing with aspects relating
-
Which aspects relating to safety arise?
to safety.
-
Will the standard be used for type testing?
Items pertaining to users’ needs
a)
-
Will the standard
...
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