IEC GUIDE 104:2010

The preparation of safety publications and the use of basic safety publications and group safety publications

IEC Guide 104:2010(E) is mandatory and defines procedures for the preparation of safety publications in addition to ISO/IEC Guide 51, including the preparation and use of basic safety publications and group safety publications. Also describes the relationship between TCs with horizontal safety functions or group safety functions and product TCs. In the context of this guide, "safety" relates to the safety of persons, domestic animals, livestock and property. The main changes with respect to the previous edition are as follows:
- updates the third edition, in the light of experience, to align it with IEC Guide 108;
- includes a better description of the group safety function and group safety publications in subclause 5.1.3;
- includes a clarification in Annex A of measures in case of a single fault condition.

General Information

• Status: Published
• Publication Date: 29-Aug-2010
• ICS: 29.020 - Electrical engineering in general
• ICS: 47.020.70 - Navigation and control equipment
• Technical Committee: ACOS - ACOS
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 24-Jul-2019

Relations

• Revised: IEC GUIDE 104:2019 - The preparation of safety publications and the use of basic safety publications and group safety publications
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC GUIDE 104


®

Edition 4.0 2010-08







GUIDE




colour
inside

The preparation of safety publications and the use of basic safety publications
and group safety publications




IEC GUIDE 104:2010(E)

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Copyright © 2010 IEC, Geneva, Switzerland



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IEC GUIDE 104


®

Edition 4.0 2010-08







GUIDE




colour
inside

The preparation of safety publications and the use of basic safety publications
and group safety publications



INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
R
ICS 29.020 ISBN 978-2-88912-140-3
® Registered trademark of the International Electrotechnical Commission

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– 2 – Guide 104 © IEC:2010(E)


CONTENTS


FOREWORD.3

INTRODUCTION.5


1 Scope.6

2 Normative references.6

3 Terms and definitions .6

4 Assignment of horizontal safety functions and of group safety functions .7

5 Safety publications.8

5.1 Basic safety publications and group safety publications.8
5.1.1 General .8
5.1.2 Basic safety publications.8
5.1.3 Group safety publications.8
5.2 Product safety publications .9
5.3 References to other publications.10
5.4 Safety during the life of equipment .10
6 Responsibilities of TCs with horizontal safety functions or group safety functions.10
6.1 Liaison with other TCs .10
6.2 Requests from product TCs for new work.11
7 Responsibilities of product TCs.11
7.1 General .11
7.2 Application of basic safety publications .11
7.3 Application of group safety publications.11
7.4 New work requests to TCs with safety functions .12
Annex A (normative) Safety aspects relating to electrical equipment .13
Annex B (informative) Relationship between different levels within the IEC .18
Bibliography .19

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Guide 104 © IEC:2010(E) – 3 –


INTERNATIONAL ELECTROTECHNICAL COMMISSION

______________



THE PREPARATION OF SAFETY PUBLICATIONS AND

THE USE OF BASIC SAFETY PUBLICATIONS AND

GROUP SAFETY PUBLICATIONS





FOREWORD


1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object 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 “IEC
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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC 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.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC 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 IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC 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
indispensable for the correct application of this publication.
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 responsible for identifying any or all such patent rights.
This fourth edition of IEC Guide 104 has been prepared, in accordance with ISO/IEC

Directives, Part 1, Annex A, by the IEC Advisory Committee on Safety (ACOS). This guide is a
mandatory guide in accordance with SMB Decision 136/8.
This fourth edition cancels and replaces the third edition published in 1997.
The main changes with respect to the previous edition are as follows:
1) updates the third edition, in the light of experience, to align it with IEC Guide 108,
Guidelines for ensuring the coherency of IEC publications – Application of horizontal
standards;
2) includes a better description of the group safety function and group safety publications in
subclause 5.1.3;
3) includes a clarification in Annex A of measures in case of a single fault condition;
4) deletes Annexes B and C of the third edition;

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5) stipulates that the reference to technical committees with a basic and/or group safety

function is to be given in the IEC Catalogue or on the IEC Website;

6) replaces the word “should” by “shall” in several places, due to the fact that this Guide 104 is

mandatory.


The text of this IEC Guide is based on the following documents:


Four month’s vote Report on voting

C/1601/DV C/1622/RV



Full information on the voting for the approval of this Guide can be found in the report on voting

indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
A bilingual version of this publication may be issued at a later date.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

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Guide 104 © IEC:2010(E) – 5 –


INTRODUCTION


Technical Committees dealing with subjects relating to safety for the whole, or for a specific

part, of their activities, are required by SMB Decision 136/8 to follow the provisions of this

Guide, which is to be used in conjunction with the ISO/IEC Directives and with the Guide listed

under Clause 2.


In this Guide, the term “technical committees”, hereinafter referred to as TCs, also includes

subcommittees. The term “publication” includes “standard”, “technical report”, “technical

specification” and “guide”. In addition, the term “product” includes “process”, “service” and

combinations thereof, commonly known as “systems”.

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THE PREPARATION OF SAFETY PUBLICATIONS AND

THE USE OF BASIC SAFETY PUBLICATIONS AND

GROUP SAFETY PUBLICATIONS








1 Scope


This mandatory Guide defines procedures for the preparation of safety publications in addition

to ISO/IEC Guide 51, including the preparation and use of basic safety publications and group
safety publications. It also describes the relationship between TCs with horizontal safety
functions or group safety functions and product TCs.
In the context of this guide, "safety” relates to the safety of persons, domestic animals,
livestock and property.
2 Normative references
The following referenced documents are indispensable for the application of this document. For
dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments) applies.
ISO/IEC Directives, Part 1, Procedures for the technical work
ISO/IEC Directives, Part 2, Rules for the structure and drafting of International Standards
ISO/lEC Guide 51, Safety aspects – Guidelines for their inclusion in standards
3 Terms and definitions
For the purposes of this document, the terms and definitions of ISO/IEC Guide 51 as well as
the following terms and definitions apply.
3.1
basic safety publication
publication on a specific safety-related matter, applicable to many electrotechnical products

3.2
group safety publication
publication covering all safety aspects of a specific group of products within the scope of two or
more product TCs
NOTE Group safety publications are primarily intended to be stand-alone product safety publications, but may also
be used by TCs as source material in the preparation of their publications, as detailed in 7.3.
3.3
product safety publication
publication covering all safety aspects of one or more products within the scope of a single
product TC
3.4
product TC
TC with a scope which covers a specific product or group of products

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Guide 104 © IEC:2010(E) – 7 –


3.5

horizontal safety function

task assigned to a TC to prepare one or more basic safety publications


3.6

group safety function

task assigned to a product TC to prepare one or more group safety publications


3.7

normal condition

condition in which all means of protection are intact

3.8
single fault condition
condition in which there is a fault of a single protection (but not a reinforced protection) or of a
single component or a device
NOTE If a single fault condition results in one or more other fault conditions, all are considered as one single fault
condition.
3.9
reinforced protection
single protection system, which provides a degree of protection against hazards equivalent to
two levels of protection
4 Assignment of horizontal safety functions and of group safety functions
The assignment of horizontal safety functions and of group safety functions is the responsibility
of the Advisory Committee on Safety (ACOS), subject to confirmation by the SMB
(Standardization Management Board). For the structure of IEC safety standards see Annex B.
Assignments are periodically reviewed by ACOS.
The assignment of a horizontal safety function or a group safety function to a technical
committee is made with the purpose of:
– ensuring the consistency of IEC publications relating to safety aspects common to a
number of technical committees by avoiding duplication of work and contradictory
requirements;
– reducing the size and cost of lEC publications by avoiding duplication of texts;
– improving mutual understanding among engineers of different technical disciplines.

A horizontal safety function or a group safety function may be assigned to a TC for the whole or
for a specific part of its activities.
The IEC Catalogue and website (see also http://www.iec.ch/dyn/www/f?p=103:
44:0::::FSP_ORG_ID,FSP_LANG_ID:3235,25) shall provide a method for identifying basic
safety publications and horizontal safety publications.

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5 Safety publications


5.1 Basic safety publications and group safety publications


5.1.1 General


Basic safety publications and group safety publications shall contain only matters relevant to

the horizontal safety function or group safety function, and should be written in a manner

clearly understandable by product TCs.


5.1.2 Basic safety publications

5.1.2.1 Basic safety publications should explain the principles on which they are founded, in
order to assist product TCs in applying their provisions. In addition, guidance should be given
to product TCs on how to apply information from a basic safety publication, for example, how to
choose the appropriate level of severity for a particular test.
5.1.2.2 A basic safety publication shall include in its scope the essence of the text given
below:
"This basic safety publication is primarily intended for use by technical Committees in the
preparation of standards in accordance with the principles laid down in IEC Guide 104 and
lSO/lEC Guide 51. It is not intended for use by manufacturers or certification bodies.
One of the responsibilities of a technical committee is, wherever applicable, to make use of
basic safety publications in the preparation of its publications. The requirements, test
methods or test conditions of this basic safety publication will not apply unless specifically
referred to or included in the relevant publications."
In a few cases, a basic safety publication may, in addition, be intended for use as a stand-
alone publication. In such cases, the first paragraph of the above statement should be modified
accordingly.
A basic safety publication shall include IEC Guide 104 and ISO/IEC Guide 51 in its list of
normative references.
5.1.2.3 It is essential that basic safety publications not be frequently amended or frequently
revised, because product TCs must be given time to align their publications with the current
edition.
5.1.3 Group safety publications

5.1.3.1 Group safety publications are primarily intended as product safety publications, but
shall also be used by other product TCs in applying their provisions. In addition, guidance
should be given to product TCs on how to apply information from a group safety publication, for
example, how to choose the appropriate level of severity for a particular test described in a
basic safety publication.
5.1.3.2 A group safety publication shall include in its scope the essence of the text given
below:
"This group safety publication is primarily intended to be used as a product safety standard
for the products mentioned in the scope, but shall also be used by technical committees in
the preparation of standards for products similar to those mentioned in the scope of this
standard, in accordance with the principles laid down in IEC Guide 104 and lSO/lEC Guide
51.

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Guide 104 © IEC:2010(E) – 9 –


One of the responsibilities of a technical committee is, wherever applicable, to make use of

basic safety publications and/or group safety publications in the preparation of its

publications."


A group safety publication shall include IEC Guide 104 and ISO/IEC Guide 51 in its list of

normative references.


5.1.3.3 It is essential that group safety publications not be frequently amended or frequently

revised, because product TCs must be given time to align their publications with the current

edition.


5.2 Product safety publications
5.2.1 In specifying requirements intended to eliminate hazards and reduce risks, the following
principles shall be applied:
– equipment shall be inherently safe by design and construction;
– where the above cannot be achieved, additional protective measures in relation to hazards
shall be specified;
– if there are any risks not reduced to a tolerable level by the above means, it shall be
specified that users need to be informed of such risks. If there is need for any training or for
the use of any personal protective equipment to reduce risks to a tolerable level, it shall be
specified that users need to be informed of this.
5.2.2 A product safety publication shall not be confined to electrical safety but shall cover all
safety aspects of the products within its scope. It shall also take account of the environmental
conditions in which the product is intended to be used and of the level of knowledge of
expected users.
NOTE Annex A of this Guide contains a list of safety aspects relating to electrical equipment.
5.2.3 Safety aspects and performance aspects should not be covered in the same publication,
as this makes it difficult to assess conformity with safety requirements alone. If, exceptionally,
there are reasons to cover them in the same publication, safety aspects and performance
aspects shall be clearly distinguished from each other. If there are performance criteria which
have safety implications, these are considered to be safety aspects and this shall be made
clear in the publication.
5.2.4 A product safety publication shall not include requirements which unnecessarily restrict
design or construction, or impede technical progress and development.
5.2.5 A product safety publication shall include all requirements necessary to reduce risks,

both in normal condition and in single fault condition, together with methods for checking
conformity.
The simultaneous occurrence of two independent and unrelated faults need not normally be
taken into account, because the likelihood of such an event is so low that the risk is generally
at a tolerable level. If a single fault condition results unavoidably in one or more other fault
conditions, all are considered as one single fault condition.
Some means of protection may be enhanced (e.g. reinforced) such that the technical
committees developing standards may consider a single fault condition of su
...