IEC GUIDE 116:2018

Guidelines for safety related risk assessment and risk reduction for low voltage equipment

IEC Guide 116:2018(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.
This second edition of IEC Guide 116 cancels and replaces its first edition published in 2010 and constitutes a technical revision; main changes with respect to the first edition are as follows:
- addition of a clause dealing with safety related security aspects, derived from the IEC 62443 series;
- reference to “domestic animals” rather than to “livestock”;
- alignment of definitions and Figure 2 with the latest edition of ISO/IEC Guide 51 (2014);

General Information

• Status: Published
• Publication Date: 06-Nov-2018
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 29.020 - Electrical engineering in general
• Technical Committee: ACOS - ACOS
• Current Stage: PPUB - Publication issued
• Start Date: 02-Oct-2018
• Completion Date: 07-Nov-2018

Relations

• Revises: IEC GUIDE 116:2010 - Guidelines for safety related risk assessment and risk reduction for low voltage equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC GUIDE 116 ®
Edition 2.0 2018-11
GUIDE
colour
inside
Guidelines for safety related risk assessment and risk reduction for low voltage
equipment
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IEC GUIDE 116 ®
Edition 2.0 2018-11
GUIDE
colour
inside
Guidelines for safety related risk assessment and risk reduction for low voltage

equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 29.020 ISBN 978-2-8322-6097-5

– 2 – IEC Guide 116:2018 © IEC:2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
1.3 Exclusion and limitation . 7
2 Normative references . 8
3 Terms definitions and abbreviations . 8
3.1 Terms and definitions. 8
3.2 Abbreviations . 12
4 Basic principles . 12
4.1 Principle of SAFETY INTEGRATION . 12
4.2 Basic concepts. 13
4.2.1 Information for RISK ASSESSMENT . 15
4.2.2 Information related to LV equipment description . 16
4.2.3 Related standards and other applicable documents . 16
4.2.4 Information related to application experience . 16
4.2.5 Relevant ergonomic principles . 16
5 Determination of the limits of the LV equipment . 16
6 HAZARD identification . 17
7 RISK estimation . 18
7.1 General . 18
7.2 Elements of RISK . 18
7.2.1 Combination of elements of RISK . 18
7.2.2 Severity of harm . 20
7.2.3 Probability of occurrence of harm . 21
7.2.4 RISK INDEX . 22
7.3 Aspects to be considered during RISK estimation . 22
7.3.1 Exposure of persons or domestic animals . 22
7.3.2 Type, frequency and duration of exposure . 22
7.3.3 Accumulation and synergy of effects . 23
8 RISK evaluation . 23
8.1 General . 23
8.2 Aspects to be considered during RISK evaluation . 23
8.2.1 Human factors . 23
8.2.2 Reliability of RISK REDUCTION MEASUREs . 24
8.2.3 Ability to defeat or circumvent PROTECTIVE MEASUREs . 24
8.2.4 Ability to maintain RISK REDUCTION MEASUREs . 25
8.2.5 Information for use . 25
8.2.6 Current values of society . 25
8.3 Elimination of hazards or reduction of RISK by RISK REDUCTION MEASUREs . 25
8.4 Comparison of RISKs . 26
9 RISK reduction . 26
10 Documentation . 29

Annex A (normative) SAFETY aspects relating to LOW VOLTAGE EQUIPMENT . 30
A.1 General . 30
A.2 Preliminary observations . 30
A.3 SAFETY INTEGRATION . 30
A.4 Protection against electrical hazards . 31
A.5 Protection against mechanical hazards . 31
A.6 Protection against other hazards . 31
A.6.1 General . 31
A.6.2 Explosion . 31
A.6.3 Hazards arising from electric, magnetic, and electromagnetic fields,
other ionising and non-ionising radiation . 32
A.6.4 Electric, magnetic or electromagnetic disturbances . 32
A.6.5 Optical radiation . 32
A.6.6 Fire . 32
A.6.7 Temperature . 32
A.6.8 Acoustic noise . 32
A.6.9 Biological and chemical effects . 32
A.6.10 Emissions, production and/or use of hazardous substances (e.g. gases,
liquids, dusts, mists, vapour) . 33
A.6.11 Unattended operation . 33
A.6.12 Connection to and interruption from power supply . 33
A.6.13 Combination of equipment . 33
A.6.14 Implosion . 33
A.6.15 Hygiene conditions . 33
A.6.16 Ergonomics . 33
A.7 FUNCTIONAL SAFETY and reliability . 33
A.7.1 General . 33
A.7.2 Equipment design . 34
A.7.3 Equipment type related hazards . 34
A.7.4 System faults . 34
A.8 SAFETY-RELATED SECURITY RISK . 34
A.9 Information requirements . 35
Annex B (informative) Supporting standards . 36
B.1 Basic SAFETY standards . 36
B.2 Group SAFETY standards . 36
Annex C (informative) Table C.1 – Examples of hazards, hazardous situations and
HAZARDOUS EVENTs . 37
Annex D (informative) Tool for the application of this IEC Guide . 39
Bibliography . 41

Figure 1 – Principle of safety integration . 13
Figure 2 – Iterative process of RISK ASSESSMENT and RISK reduction . 15
Figure 3 – Elements of RISK for RISK estimation . 19
Figure 4 – Graph for RISK estimation . 20
Figure 5 – RISK reduction process . 28

Table D.1 – RISK ASSESSMENT documentation . 39

– 4 – IEC Guide 116:2018 © IEC:2018
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,
Technical Reports, Publicly Available Specifications (PAS) and Gui
...