IEC 61508-1:2010

Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)

Looking for deeper insights? Check out IEC 61508:2010 CMV, which includes commented versions of Parts 1 to 7 of IEC 61508. These commented versions highlight the changes made from previous editions and provide explanations from a world-leading expert on the reasons behind the most significant changes.
IEC 61508-1:2010 covers those aspects to be considered when electrical/electronic/programmable electronic (E/E/PE) systems are used to carry out safety functions. A major objective of this standard is to facilitate the development of product and application sector international standards by the technical committees responsible for the product or application sector. This will allow all the relevant factors, associated with the product or application, to be fully taken into account and thereby meet the specific needs of users of the product and the application sector. A second objective of this standard is to enable the development of E/E/PE safety-related systems where product or application sector international standards do not exist. This second edition cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. It has been subject to a thorough review and incorporates many comments received at the various revision stages. It has the status of a basic safety publication according to IEC Guide 104.
This publication is of high relevance for Smart Grid.

Sécurité fonctionnelle des systèmes électriques/électroniques/électroniques programmables relatifs à la sécurité - Partie 1: Exigences générales

IEC 61508-1:2010 covers those aspects to be considered when electrical/electronic/programmable electronic (E/E/PE) systems are used to carry out safety functions. A major objective of this standard is to facilitate the development of product and application sector international standards by the technical committees responsible for the product or application sector. This will allow all the relevant factors, associated with the product or application, to be fully taken into account and thereby meet the specific needs of users of the product and the application sector. A second objective of this standard is to enable the development of E/E/PE safety-related systems where product or application sector international standards do not exist. This second edition cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. It has been subject to a thorough review and incorporates many comments received at the various revision stages. It has the status of a basic safety publication according to IEC Guide 104.
This publication is of high relevance for Smart Grid.

General Information

• Status: Published
• Publication Date: 29-Apr-2010
• ICS: 13.110 - Safety of machinery
• ICS: 25.040.40 - Industrial process measurement and control
• ICS: 29.020 - Electrical engineering in general
• Technical Committee: SC 65A - System aspects
• Current Stage: PPUB - Publication issued
• Start Date: 30-Apr-2010
• Completion Date: 15-Apr-2010

Relations

• Revises: IEC 61508-1:1998/COR1:1999 - Corrigendum 1 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements
• Effective Date: 05-Sep-2023
• Revises: IEC 61508-1:1998 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see <a href="http://www.iec.ch/61508">www.iec.ch/61508</a>)
• Effective Date: 05-Sep-2023

Overview

IEC 61508-1:2010 is a key international standard focusing on the functional safety of electrical, electronic, and programmable electronic (E/E/PE) safety-related systems. This standard, published by the International Electrotechnical Commission (IEC), establishes the general requirements for the design, implementation, and maintenance of safety functions carried out by E/E/PE systems to ensure reliable and safe operation.

A major goal of IEC 61508-1:2010 is to support technical committees responsible for product and application sectors by providing a foundational framework. This enables the development of tailored international standards that meet specific user needs across various industries. Moreover, it facilitates the creation of E/E/PE safety-related systems in areas lacking specific sector standards.

As the second edition, this updated standard incorporates extensive technical revisions and expert commentary, reflecting the evolution of safety practices since the original 1998 release. Furthermore, it holds the status of a basic safety publication per IEC Guide 104, underscoring its foundational role in functional safety.

Key Topics

IEC 61508-1:2010 covers a comprehensive set of critical safety aspects including:

• Functional Safety Lifecycle: Defines stages from concept, hazard and risk analysis, overall safety requirements, system realization, to installation, commissioning, operation, maintenance, modification, and decommissioning.
• Safety Integrity Levels (SILs): Specifications for quantifying and achieving the required reliability and safety performance of safety functions.
• Management of Functional Safety: Organizational measures and procedural controls essential for sustaining functional safety throughout the lifecycle.
• Documentation and Verification: Requirements for proper record-keeping and evidence to demonstrate conformance, including functional safety assessments.
• Risk Reduction Measures: Identification and implementation of safety-related systems alongside other risk mitigation strategies.
• E/E/PE System Realization and Validation: Guidelines for the design, development, and validation of electrical and electronic safety-related systems aligned with functional safety objectives.

The standard also provides detailed requirements regarding software safety lifecycle management, emphasizing the integration of software within safety-critical E/E/PE systems.

Applications

IEC 61508-1:2010 is highly relevant across a broad spectrum of industries where E/E/PE systems execute safety functions, notably including:

• Smart Grid Technologies: Enabling safe and reliable electrical grid automation and control systems.
• Industrial Automation: Designing safety instrumentation and control systems protecting machinery and personnel.
• Process Industries: Ensuring safety in chemical, oil, gas, and manufacturing sectors with programmable logic controllers and safety instrumented systems.
• Transportation Systems: Providing requirements for embedded safety systems within vehicles, aerospace, and rail applications.
• Medical Devices: Assisting in the development of programmable electronic systems that must meet stringent safety criteria.

The standard's lifecycle approach supports organizations in realizing, maintaining, and enhancing safety-related systems, reducing risk exposure, and complying with legal and regulatory frameworks.

Related Standards

For deeper integration and sector-specific guidance, IEC 61508-1:2010 aligns with and supports:

• IEC 61508 Parts 2-7: Cover specific aspects such as hardware requirements, software requirements, and additional guidance for safety-related systems.
• Sector-Specific Standards Derived from IEC 61508: Including IEC 61511 (process industries), ISO 13849 (machine safety), and ISO 26262 (automotive functional safety).
• IEC Guide 104: Framework for basic safety publications, clarifying IEC 61508's role as a foundational document.
• Commented Versions IEC 61508:2010 CMV: Providing annotated insights and explanations by experts to facilitate understanding of changes and rationale behind requirements.

By following IEC 61508-1:2010 alongside related standards, organizations can ensure cohesive and comprehensive safety strategies that address both general and specific application needs.

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Keywords: IEC 61508-1:2010, functional safety, electrical/electronic/programmable electronic safety-related systems, safety integrity levels, safety lifecycle, risk reduction, safety assessment, Smart Grid safety, safety standards, IEC functional safety

Standards Content (Sample)

IEC 61508-1 ®
Edition 2.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
BASIC SAFETY PUBLICATION
PUBLICATION FONDAMENTALE DE SÉCURITÉ
Functional safety of electrical/electronic/programmable electronic safety-related
systems –
Part 1: General requirements
Sécurité fonctionnelle des systèmes électriques/électroniques/électroniques
programmables relatifs à la sécurité –
Partie 1: Exigences générales
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IEC 61508-1 ®
Edition 2.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
BASIC SAFETY PUBLICATION
PUBLICATION FONDAMENTALE DE SÉCURITÉ
Functional safety of electrical/electronic/programmable electronic safety-related
systems –
Part 1: General requirements
Sécurité fonctionnelle des systèmes électriques/électroniques/électroniques
programmables relatifs à la sécurité –
Partie 1: Exigences générales
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 13.110; 25.040; 29.020 ISBN 978-2-88910-524-3
– 2 – 61508-1 © IEC:2010
CONTENTS
FOREWORD.5
INTRODUCTION.7
1 Scope.9
2 Normative references.12
3 Definitions and abbreviations .12
4 Conformance to this standard .12
5 Documentation .13
5.1 Objectives .13
5.2 Requirements .13
6 Management of functional safety.14
6.1 Objectives .14
6.2 Requirements .14
7 Overall safety lifecycle requirements .17
7.1 General .17
7.1.1 Introduction .17
7.1.2 Objectives and requirements – general .20
7.1.3 Objectives .25
7.1.4 Requirements .25
7.2 Concept.25
7.2.1 Objective .25
7.2.2 Requirements .26
7.3 Overall scope definition .26
7.3.1 Objectives .26
7.3.2 Requirements .26
7.4 Hazard and risk analysis .27
7.4.1 Objectives .27
7.4.2 Requirements .27
7.5 Overall safety requirements .28
7.5.1 Objective .29
7.5.2 Requirements .29
7.6 Overall safety requirements allocation.30
7.6.1 Objectives .30
7.6.2 Requirements .31
7.7 Overall operation and maintenance planning .35
7.7.1 Objective .35
7.7.2 Requirements .35
7.8 Overall safety validation planning.37
7.8.1 Objective .37
7.8.2 Requirements .37
7.9 Overall installation and commissioning planning.38
7.9.1 Objectives .38
7.9.2 Requirements .38
7.10 E/E/PE system safety requirements specification .38
7.10.1 Objective .39
7.10.2 Requirements .39
7.11 E/E/PE safety-related systems – realisation .41

61508-1 © IEC:2010 – 3 –
7.11.1 Objective .41
7.11.2 Requirements .41
7.12 Other risk reduction measures – specification and realisation.41
7.12.1 Objective .41
7.12.2 Requirements .41
7.13 Overall installation and commissioning.41
7.13.1 Objectives .41
7.13.2 Requirements .42
7.14 Overall safety validation.42
7.14.1 Objective .42
7.14.2 Requirements .42
7.15 Overall operation, maintenance and repair .43
7.15.1 Objective .43
7.15.2 Requirements .43
7.16 Overall modification and retrofit .46
7.16.1 Objective .46
7.16.2 Requirements .47
7.17 Decommissioning or disposal.48
7.17.1 Objective .48
7.17.2 Requirements .48
7.18 Verification .49
7.18.1 Objective .49
7.18.2 Requirements .49
8 Functional safety assessment .50
8.1 Objective .50
8.2 Requirements .50
Annex A (informative) Example of a documentation structure.54
Bibliography .60

Figure 1 – Overall framework of the IEC 61508 series .11
Figure 2 – Overall safety lifecycle .18
Figure 3 – E/E/PE system safety lifecycle (in realisation phase) .19
Figure 4 – Software safety lifecycle (in realisation phase) .19
Figure 5 – Relationship of overall safety lifecycle to the E/E/PE system and software
safety lifecycles.20
Figure 6 – Allocation of overall safety requirements to E/E/PE safety-related systems
and other risk reduction measures.32
Figure 7 – Example of operations and maintenance activities model .45
Figure 8 – Example of operation and maintenance management model .46
Figure 9 – Example of modification procedure model.48
Figure A.1 – Structuring information into document sets for user groups .59

Table 1 – Overall safety lifecycle – overview.21
Table 2 – Safety integrity levels – target failure measures for a safety function operating
in low demand mode of operation .33
Table 3 – Safety integrity levels – target failure measures for a safety function operating
in high demand mode of operation or continuous mode of operation .34

– 4 – 61508-1 © IEC:2010
Table 4 – Minimum levels of independence of those carrying out functional safety
assessment (overall safety lifecycle phases 1 to 8 and 12 to 16 inclusive (see Figure 2)) .53
Table 5 – Minimum levels of independence of those carrying out functional safety
assessment (overall safety lifecycle phases 9 and 10, including all phases of E/E/PE
system and software safety lifecycles (see Figures 2, 3 and 4)) .53
Table A.1 – Example of a documentation structure for information related to the overall
safety lifecycle .56
Table A.2 – Example of a documentation structure for information related to the E/E/PE
system safety lifecycle.57
Table A.3 – Example of a documentation structure for information related to the
software safety lifecycle .58

61508-1 © IEC:2010 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/
PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS –

Part 1: General requirements
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
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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.
International Standard IEC 61508-1 has been prepared by subcommittee 65A: System aspects,
of IEC technical committee 65: Industrial-process measurement, control and automation.
This second edition cancels and replaces the first edition published in 1998. This edition
constitutes a technical revision.
This edition has been subject to a thorough review and incorporates many comments received
at the various revision stages.
It has the status of a basic safety publication according to IEC Guide 104.

– 6 – 61508-1 © IEC:2010
The text of this standard is based on the following documents:
FDIS Report on voting
65A/548/FDIS 65A/572/RVD
Full information on the voting for the approval of this standard 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 list of all parts of the IEC 61508 series, published under the general title Functional safety of
electrical / electronic / programmable electronic safety-related systems, can be found on the
IEC website.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
61508-1 © IEC:2010 – 7 –
INTRODUCTION
Systems comprised of electrical and/or electronic elements have been used for many years to
perform safety functions in most application sectors. Computer-based systems (generically
referred to as programmable electronic systems) are being used in all application sectors to
perform non-safety functions and, increasingly, to perform safety functions. If computer system
technology is to be effectively and safely exploited, it is essential that those responsible for
making decisions have sufficient guidance on the safety aspects on which to make these
decisions.
This International Standard sets out a generic approach for all safety lifecycle activities for
systems comprised of electrical and/or electronic and/or programmable electronic (E/E/PE)
elements that are used to perform safety functions. This unified approach has been adopted in
order that a rational and consistent technical policy be developed for all electrically-based
safety-related systems. A major objective is to facilitate the development of product and
application sector international standards based on the IEC 61508 series.
NOTE 1 Examples of product and application sector international standards based on the IEC 61508 series are
given in the Bibliography (see references [1], [2] and [3]).
In most situations, safety is achieved by a number of systems which rely on many technologies
(for example mechanical, hydraulic, pneumatic, electrical, electronic, programmable electronic).
Any safety strategy must therefore consider not only all the elements within an individual
system (for example sensors, controlling devices and actuators) but also all the safety-related
systems making up the total combination of safety-related systems. Therefore, while this
International Standard is concerned with E/E/PE safety-related systems, it may also provide a
framework within which safety-related systems based on other technologies may be
considered.
It is recognized that there is a great variety of applications using E/E/PE safety-related systems
in a variety of application sectors and covering a wide range of complexity, hazard and risk
potentials. In any particular application, the required safety measures will be dependent on
many factors specific to the application. This International Standard, by being generic, will
enable such measures to be formulated in future product and application sector international
standards and in revisions of those that already exist.
This International Standard
– considers all relevant overall, E/E/PE system and software safety lifecycle phases (for
example, from initial concept, through design, implementation, operation and maintenance
to decommissioning) when E/E/PE systems are used to perform safety functions;
– has been conceived with a rapidly developing technology in mind; the framework is
sufficiently robust and comprehensive to cater for future developments;
– enables product and application sector international standards, dealing with E/E/PE safety-
related systems, to be developed; the development of product and application sector
international standards, within the framework of this standard, should lead to a high level of
consistency (for example, of underlying principles, terminology etc.) both within application
sectors and across application sectors; this will have both safety and economic benefits;
– provides a method for the development of the safety requirements specification necessary
to achieve the required functional safety for E/E/PE safety-related systems;
– adopts a risk-based approach by which the safety integrity requirements can be
determined;
– introduces safety integrity levels for specifying the target level of safety integrity for the
safety functions to be implemented by the E/E/PE safety-related systems;
NOTE 2 The standard does not specify the safety integrity level requirements for any safety function, nor does it
mandate how the safety integrity level is determined. Instead it provides a risk-based conceptual framework and
example techniques.
– 8 – 61508-1 © IEC:2010
– sets target failure measures for safety functions carried out by E/E/PE safety-related
systems, which are linked to the safety integrity levels;
– sets a lower limit on the target failure measures for a safety function carried out by a single
E/E/PE safety-related system. For E/E/PE safety-related systems operating in
– a low demand mode of operation, the lower limit is set at an average probability of a
–5
dangerous failure on demand of 10 ;
– a high demand or a continuous mode of operation, the lower limit is set at an average
–9 -1
frequency of a dangerous failure of 10 [h ];
NOTE 3 A single E/E/PE safety-related system does not necessarily mean a single-channel architecture.
NOTE 4 It may be possible to achieve designs of safety-related systems with lower values for the target safety
integrity for non-complex systems, but these limits are considered to represent what can be achieved for relatively
complex systems (for example programmable electronic safety-related systems) at the present time.
– sets requirements for the avoidance and control of systematic faults, which are based on
experience and judgement from practical experience gained in industry. Even though the
probability of occurrence of systematic failures cannot in general be quantified the standard
does, however, allow a claim to be made, for a specified safety function, that the target
failure measure associated with the safety function can be considered to be achieved if all
the requirements in the standard have been met;
– introduces systematic capability which applies to an element with respect to its confidence
that the systematic safety integrity meets the requirements of the specified safety integrity
level;
– adopts a broad range of principles, techniques and measures to achieve functional safety
for E/E/PE safety-related systems, but does not explicitly use the concept of fail safe.
However, the concepts of “fail safe” and “inherently safe” principles may be applicable and
adoption of such concepts is acceptable providing the requirements of the relevant clauses
in the standard are met.
61508-1 © IEC:2010 – 9 –
FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/
PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS –

Part 1: General requirements
1 Scope
1.1 This International Standard covers those aspects to be considered when
electrical/electronic/programmable electronic (E/E/PE) systems are used to carry out safety
functions. A major objective of this standard is to facilitate the development of product and
application sector international standards by the technical committees responsible for the
product or application sector. This will allow all the relevant factors, associated with the product
or application, to be fully taken into account and thereby meet the specific needs of users of
the product and the application sector. A second objective of this standard is to enable the
development of E/E/PE safety-related systems where product or application sector international
standards do not exist.
1.2 In particular, this standard
a) applies to safety-related systems when one or more of such systems incorporates
electrical/electronic/programmable electronic elements;
NOTE 1 In the context of low complexity E/E/PE safety-related systems, certain requirements specified in this
standard may be unnecessary, and exemption from compliance with such requirements is possible (see 4.2, and
the definition of a low complexity E/E/PE safety-related system in 3.4.3 of IEC 61508-4).
NOTE 2 Although a person can form part of a safety-related system (see 3.4.1 of IEC 61508-4), human factor
requirements related to the design of E/E/PE safety-related systems are not considered in detail in this standard.
b) is generically-based and applicable to all E/E/PE safety-related systems irrespective of the
application;
c) covers the achievement of a tolerable risk through the application of E/E/PE safety-related
systems, but does not cover hazards arising from the E/E/PE equipment itself (for example
electric shock);
d) applies to all types of E/E/PE safety-related systems, including protection systems and
control systems;
e) does not cover E/E/PE systems where
– a single E/E/PE system is capable on its own of meeting the tolerable risk, and
– the required safety integrity of the safety functions of the single E/E/PE system is less
than that specified for safety integrity level 1 (the lowest safety integrity level in this
standard).
f) is mainly concerned with the E/E/PE safety-related systems whose failure could have an
impact on the safety of persons and/or the environment; however, it is recognized that the
consequences of failure could also have serious economic implications and in such cases
this standard could be used to specify any E/E/PE system used for the protection of
equipment or product;
NOTE 3 See 3.1.1 of IEC 61508-4.
g) considers E/E/PE safety-related systems and other risk reduction measures, in order that
the safety requirements specification for the E/E/PE safety-related systems can be
determined in a systematic, risk-based manner;
h) uses an overall safety lifecycle model as the technical framework for dealing systematically
with the activities necessary for ensuring the functional safety of the E/E/PE safety-related
systems;
– 10 – 61508-1 © IEC:2010
NOTE 4 Although the overall safety lifecycle is primarily concerned with E/E/PE safety-related systems, it could
also provide a technical framework for considering any safety-related system irrespective of the technology of that
system (for example mechanical, hydraulic or pneumatic).
i) does not specify the safety integrity levels required for sector applications (which must be
based on detailed information and knowledge of the sector application). The technical
committees responsible for the specific application sectors shall specify, where appropriate,
the safety integrity levels in the application sector standards;
j) provides general requirements for E/E/PE safety-related systems where no product or
application sector international standards exist;
k) requires malevolent and unauthorised actions to be considered during hazard and risk
analysis. The scope of the analysis includes all relevant safety lifecycle phases;
NOTE 5 Other IEC/ISO standards address this subject in depth; see ISO/IEC/TR 19791 and IEC 62443 series.
l) does not cover the precautions that may be necessary to prevent unauthorized persons
damaging, and/or otherwise adversely affecting, the functional safety of E/E/PE safety-
related systems (see k) above);
m) does not specify the requirements for the development, implementation, maintenance
and/or operation of security policies or security services needed to meet a security policy
that may be required by the E/E/PE safety-related system;
n) does not apply for medical equipment in compliance with the IEC 60601 series.
1.3 This part of the IEC 61508 series of standards includes general requirements that are
applicable to all parts. Other parts of the IEC 61508 series concentrate on more specific topics:
– parts 2 and 3 provide additional and specific requirements for E/E/PE safety-related
systems (for hardware and software);
– part 4 gives definitions and abbreviations that are used throughout this standard;
– part 5 provides guidelines on the application of part 1 in determining safety integrity levels,
by showing example methods;
– part 6 provides guidelines on the application of parts 2 and 3;
– part 7 contains an overview of techniques and measures.
1.4 IEC 61508-1, IEC 61508-2, IEC 61508-3 and IEC 61508-4 are basic safety publications,
although this status does not apply in the context of low complexity E/E/PE safety-related
systems (see 3.4.3 of IEC 61508-4). As basic safety publications, they are intended for use
by technical committees in the preparation of standards in accordance with the principles
contained in IEC Guide 104 and ISO/IEC Guide 51. IEC 61508-1, IEC 61508-2, IEC 61508-3
and IEC 61508-4 are also intended for use as stand-alone publications. The horizontal safety
function of this international standard does not apply to medical equipment in compliance with
the IEC 60601 series.
NOTE One of the responsibilities of a technical committee is, wherever applicable, to make use of basic safety
publications in the preparation of its publications. In this context, the requirements, test methods or test conditions
of this basic safety publication will not apply unless specifically referred to or included in the publications prepared
by those technical committees.
1.5 Figure 1 shows the overall framework of the IEC 61508 series and indicates the role that
IEC 61508-1 plays in the achievement of functional safety for E/E/PE safety-related systems.

61508-1 © IEC:2010 – 11 –
Figure 1 – Overall framework of the IEC 61508 series

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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.
IEC 61508-2:2010, Functional safety of electrical/electronic/programmable electronic safety-
related systems – Part 2: Requirements for electrical/electronic/programmable electronic
safety-related systems
IEC 61508-3:2010, Functional safety of electrical/electronic/programmable electronic safety-
related systems – Part 3: Software requirements
IEC 61508-4:2010 Functional safety of electrical/electronic/programmable electronic safety-
related systems – Part 4: Definitions and abbreviations
IEC Guide 104:1997, The preparation of safety publications and the use of basic safety
publications and group safety publications
ISO/IEC Guide 51:1999, Safety aspects – Guidelines for their inclusion in standards
3 Definitions and abbreviations
For the purposes of this document, the definitions and abbreviations given in IEC 61508-4
apply.
4 Conformance to this standard
4.1 To conform to this standard it shall be demonstrated that all the relevant requirements
have been satisfied to the required criteria specified (for example safety integrity level) and
therefore, for each clause or subclause, all the objectives have been met.
4.2 This standard specifies the requirements for E/E/PE safety-related systems and has been
developed to meet the full range of complexity associated with such systems. However, for low
complexity E/E/PE safety-related systems (see 3.4.3 of IEC 61508-4), where dependable field
experience exists which provides the necessary confidence that the required safety integrity
can be achieved, the following options are available:
– in product and application sector international standards implementing the requirements of
IEC 61508-1 to IEC 61508-7, certain requirements may be unnecessary and exemption
from compliance with such requirements is acceptable;
– if this standard is used directly for those situations where no product or application sector
international standard exists, certain of the requirements specified in this standard may be
unnecessary and exemption from compliance with such requirements is acceptable
providing this is justified.
4.3 Product or application sector international standards for E/E/PE safety-related systems
developed within the framework of this standard shall take into account the requirements of
ISO/IEC Guide 51 and IEC Guide 104.

61508-1 © IEC:2010 – 13 –
5 Documentation
5.1 Objectives
5.1.1 The first objective of the requirements of this clause is to specify the necessary
information to be documented in order that all phases of the overall, E/E/PE system and
software safety lifecycles can be effectively performed.
5.1.2 The second objective of the requirements of this clause is to specify the necessary
information to be documented in order that the management of functional safety (see Clause
6), verification (see 7.18) and the functional safety assessment (see Clause 8) activities can be
effectively performed.
NOTE 1 The documentation requirements in this standard are concerned, essentially, with information rather than
physical documents. The information need not be contained in physical documents unless this is explicitly declared
in the relevant subclause.
NOTE 2 Documentation may be available in different forms (for example on paper, film, or any data medium to be
presented on screens or displays).
NOTE 3 See Annex A concerning possible documentation structures.
NOTE 4 See reference [7] in the Bibliography.
5.2 Requirements
5.2.1 The documentation shall contain sufficient information, for each phase of the overall,
E/E/PE system and software safety lifecycles completed, necessary for effective performance
of subsequent phases and verification activities.
NOTE What constitutes sufficient information will be dependent upon a number of factors, including the complexity
and size of the E/E/PE safety-related systems and the requirements relating to the specific application.
5.2.2 The documentation shall contain sufficient information required for the management of
functional safety (Clause 6).
NOTE See notes to 5.1.2.
5.2.3 The documentation shall contain sufficient information required for the implementation
of a functional safety assessment, together with the information and results derived from any
functional safety assessment.
NOTE See notes to 5.1.2.
5.2.4 The information to be documented shall be as stated in the various clauses of this
standard unless justified or shall be as specified in the product or application sector
international standard relevant to the application
5.2.5 The availability of documentation shall be sufficient for the duties to be performed in
respect of the clauses of this standard.
NOTE Only the information necessary to undertake a particular activity, required by this standard, need be held by
each relevant party.
5.2.6 The documentation shall:
– be accurate and concise;
– be easy to understand by those persons having to make use of it;
– suit the purpose for which it is intended;
– be accessible and maintainable.

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5.2.7 The documentation or set of information shall have titles or names indicating the scope
of the contents, and some form of index arrangement so as to allow ready access to the
information required in this standard.
5.2.8 The documentation structure may take account of company procedures and the working
practices of specific product or application sectors.
5.2.9 The documents or set of information shall have a revision index (version numbers) to
make it possible to identify different versions of the document.
5.2.10 The documents or set of information shall be so structured as to make it possible to
search for relevant information. It shall be possible to identify the latest revision (version) of a
document or set of information.
NOTE The physical structure of the documentation will vary depending upon a number of factors such as the size
of the system, its complexity and organizational requirements.
5.2.11 All relevant documents shall be revised, amended, reviewed and approved under an
appropriate document control scheme.
NOTE Where automatic or semi-automatic tools are used for the production of documentation, specific procedures
may be necessary to ensure effective measures are in place for the management of versions or other control
aspects of the documents.
6 Management of functional safety
6.1 Objectives
6.1.1 The first objective of the requirements of this clause is to specify the responsibilities in
the management of functional safety of those who have responsibility for an E/E/PE safety-
related system, or for one or more phases of the overall E/E/PE system and software safety
lifecycles.
6.1.2 The second objective of the requirements of this clause is to specify the activities to be
carried out by those with responsibilities in the management of functional safety.
NOTE The organizational measures dealt with in this clause provide for the effective implementation of the
technical requirements and are solely aimed at the achievement and maintenance of functional safety of the E/E/PE
safety-related systems. The technical requirements necessary for maintaining functional safety will be specified as
part of the information provided by the supplier of the E/E/PE safety-related system and its elements and
components.
6.2 Requirements
6.2.1 An organisation with responsibility for an E/E/PE safety-related system, or for one or
more phases of the overall, E/E/PE system or software safety lifecycle, shall appoint one or
more persons to take overall responsibility for:
– the system and for its lifecycle phases;
– coordinating the safety-related activities carried out in those phases;
– the interfaces between those phases and other phases carried out by other organisations;
– carrying out the requirements of 6.2.2 to 6.2.11 and 6.2.13;
– coordinating functional safety assessments (see 6.2.12 b) and Clause 8) – particularly
where those carrying out the functional safety assessment differ between phases –
including communication, planning, and integrating the documentation, judgements and
recommendations;
– ensuring that functional safety is achieved and demonstrated in accordance with the
objectives and requirements of this s
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