IEC GUIDE 116:2010
(Main)Guidelines for safety related risk assessment and risk reduction for low voltage equipment
Guidelines for safety related risk assessment and risk reduction for low voltage equipment
IEC Guide 116:2010(E) is non-mandatory and complements ISO/IEC Guide 51 and establishes guidelines useful for achieving safety in low voltage equipment. These guidelines include risk assessment, in which the knowledge and experience of the design, use, incidents, accidents and harm related to low voltage equipment are brought together in order to assess the risks during the relevant phases of the life of the equipment and to implement the basics for risk reduction measures. This IEC guide should be used by technical committees as far as appropriate and to the extent they decide to apply it. It gives additional guidance to ISO/IEC Guides 50, 51 and 71 on the information required to allow risk assessment to be carried out performed.
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IEC GUIDE 116 ®
Edition 1.0 2010-08
GUIDE
colour
inside
Guidelines for safety related risk assessment and risk reduction
for low voltage equipment
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IEC GUIDE 116 ®
Edition 1.0 2010-08
GUIDE
colour
inside
Guidelines for safety related risk assessment and risk reduction
for low voltage equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
W
ICS 29.020 ISBN 978-2-88912-150-2
– 2 – Guide 116 © IEC:2010(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .8
4 Basic principles .10
4.1 Principle of safety integration .10
4.2 Basic concepts .11
4.3 Information for risk assessment.14
4.3.1 General .14
4.3.2 Information related to LV equipment description .14
4.3.3 Related standards and other applicable documents .14
4.3.4 Information related to experience on the use .14
4.3.5 Relevant ergonomic principles.15
5 Determination of the limits of the LV equipment.15
6 Hazard identification.15
7 Risk estimation.17
7.1 General .17
7.2 Elements of risk .17
7.2.1 Combination of elements of risk.17
7.2.2 Severity of harm .18
7.2.3 Probability of occurrence of harm .19
7.2.4 Risk index .20
7.3 Aspects to be considered during risk estimation .20
7.3.1 Exposure of persons and livestock .20
7.3.2 Type, frequency and duration of exposure .20
7.3.3 Accumulation and synergy of effects.21
8 Risk evaluation.21
8.1 General .21
8.2 Aspects to be considered during risk evaluation .21
8.2.1 Human factors .21
8.2.2 Reliability of protective measures .22
8.2.3 Possibility to defeat or circumvent protective measures .22
8.2.4 Ability to maintain protective measures.23
8.2.5 Information for use .23
8.2.6 Current values of society .23
8.3 Elimination of hazards or reduction of risk by protective measures .23
8.4 Comparison of risks.24
9 Risk reduction .24
10 Documentation .27
Annex A (normative) Safety aspects relating to low voltage equipment .28
Annex B (informative) Supporting standards .33
Annex C (informative) Examples of hazards, hazardous situations and hazardous
events .34
Annex D (informative) Tool for the application of this IEC Guide .35
Guide 116 © IEC:2010(E) – 3 –
Bibliography.38
Figure 1 – Principle of safety integration .11
Figure 2 – Iterative process of risk assessment and risk reduction .13
Figure 3 – Elements of risk for risk estimation.17
Figure 4 – Graph for risk estimation .18
Figure 5 – Risk reduction process.26
– 4 – Guide 116 © IEC:2010(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GUIDELINES FOR SAFETY RELATED RISK ASSESSMENT
AND RISK REDUCTION FOR LOW VOLTAGE EQUIPMENT
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,
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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
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interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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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 first edition of IEC Guide 116 has been prepared, in accordance with ISO/IEC Directives,
Part 1, Annex A, by the IEC Advisory Committee on Safety (ACOS). This is a non-mandatory
guide in accordance with SMB Decision 136/8.
The text of this IEC Guide is based on the following documents:
Four months’ vote Report on voting
C/1614/DV C/1634/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.
Guide 116 © IEC:2010(E) – 5 –
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.
– 6 – Guide 116 © IEC:2010(E)
INTRODUCTION
This non-mandatory IEC Guide is intended to be applied to risk assessment and risk reduction
for safety of low voltage equipment.
This IEC Guide reflects ISO/IEC Guide 51 and gives additional guidance to ISO/IEC Guides
50, 51, and 71 on more detailed practical information for carrying out risk assessment and on
basics to implement risk reduction, in order to assess risks commonly considered during all
relevant phases of the life of low voltage equipment.
This IEC Guide is intended to be applicable for TCs and SCs when they elaborate their own
safety standards for the related products, if they have decided to carry out a structured risk
assessment. This Guide can also be used when new features of a product are not covered by
existing standards.
The use of this Guide implies that safety-related standards are also taken into account when
available (see also Annex B) and using them automatically reflects the state of the art as
defined in ISO/IEC Guide 2.
Guide 116 © IEC:2010(E) – 7 –
GUIDELINES FOR SAFETY RELATED RISK ASSESSMENT
AND RISK REDUCTION FOR LOW VOLTAGE EQUIPMENT
1 Scope
This non-mandatory IEC Guide complements ISO/IEC Guide 51
...
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