SIST EN 61508-6:2011

Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (IEC 61508-6:2010)

IEC 61508-6:2010 contains information and guidelines on IEC 61508-2 and IEC 61508 3. Annex A gives a brief overview of the requirements of IEC 61508-2 and IEC 61508-3 and sets out the functional steps in their application. Annex B gives an example technique for calculating the probabilities of hardware failure and should be read in conjunction with 7.4.3 and Annex C of IEC 61508-2 and Annex D. Annex C gives a worked example of calculating diagnostic coverage and should be read in conjunction with Annex C of IEC 61508-2. Annex D gives a methodology for quantifying the effect of hardware-related common cause failures on the probability of failure. Annex E gives worked examples of the application of the software safety integrity tables specified in Annex A of IEC 61508-3 for safety integrity levels 2 and 3. 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.  NEW! Also available: IEC Standards+ 61508:2010, containing all parts, together with a commented Redline version. Changes made in this 2nd edition are highlighted and commented by a leading world expert.

Funktionale Sicherheit sicherheitsbezogener elektrischer/elektronischer/programmierbarer elektronischer Systeme - Teil 6: Anwendungsrichtlinie für IEC 61508-2 und IEC 61508-3 (IEC 61508-6:2010)

Sécurité fonctionnelle des systèmes électriques/électroniques/électroniques programmables relatifs à la sécurité - Partie 6: Lignes directrices pour l'application de la CEI 61508-2 et de la CEI 61508-3 (CEI 61508-6:2010)

La CEI 61508-6:2010 contient des informations et lignes directrices sur la CEI 61508-2 et la CEI 61508-3. L'Annexe A présente un bref aperçu des exigences de la CEI 61508-2 et de la CEI 61508-3 et établit les étapes fonctionnelles de leur application. L'Annexe B donne une technique servant d'exemple pour le calcul des probabilités de défaillance du matériel; il convient de la lire conjointement au 7.4.3 et à l'Annexe C de la CEI 61508-2, et à l'Annexe D. L'Annexe C donne un exemple élaboré de calcul de la couverture de diagnostic; il convient de la lire conjointement avec l'Annexe C de la CEI 61508-2. L'Annexe D donne une méthodologie de quantification de l'effet des défaillances de cause commune relatives au matériel sur la probabilité de défaillance. L'Annexe E donne des exemples d'application des tableaux d'intégrité de sécurité du logiciel spécifiés dans l'Annexe A de la CEI 61508-3 pour les niveaux 2 et 3 d'intégrité de sécurité. Cette deuxième édition annule et remplace la première édition publiée en 1998 dont elle constitue une révision technique. Elle a fait l'objet d'une révision approfondie et intègre de nombreux commentaires reçus lors des différentes phases de révision.

Funkcijska varnost električnih/elektronskih/elektronsko programirljivih varnostnih sistemov - 6. del: Smernice za uporabo IEC 61508-2 in IEC 61508-3 (IEC 61508-6:2010)

1.1 Ta del IEC 61508 vsebuje informacije in smernice o IEC 61508-2 in IEC 61508-3.
– dodatek A podaja kratek pregled zahtev IEC 61508-2 in IEC 61508-3 ter določa funkcijske stopnje pri njihovi uporabi;
– dodatek B podaja vzorčno tehniko za izračun verjetnosti okvare strojne opreme in se mora brati v povezavi s 7.4.3 in dodatkom C IEC 61508-2 in dodatkom D;
– dodatek C podaja zgled za izračun diagnostične pokritosti in se mora brati v povezavi z dodatkom C IEC 61508-2;
– dodatek D podaja metodologijo za kvantifikacijo učinka pogostih vzrokov okvar, povezanih s strojno opremo, na verjetnost okvare;
– dodatek E podaja zgled za uporabo preglednic celovite varnosti programske opreme, ki jih določa dodatek A IEC 61508-3, za raven celovite varnosti 2 in 3.
1.2 IEC 61508-1, IEC 61508-2, IEC 61508-3 in IEC 61508-4 so osnovne varnostne objave, čeprav ta status ne velja v okviru nezapletenih varnostnih sistemov E/E/PE (glej točko 3.4.3 IEC 61508-4). Kot osnovne varnostne objave so namenjeni temu, da jih uporabljajo tehnični odbori pri pripravi standardov v skladu z načeli, opredeljenimi v Vodilu IEC 104 in Vodilu ISO/IEC 51. IEC 61508-1, IEC 61508-2, IEC 61508-3 in IEC 61508-4 se lahko tudi uporabijo kot samostojne objave. Horizontalno varnostno delovanje tega mednarodnega standarda ne velja za medicinsko opremo v skladu s serijo IEC 60601.
1.3 Ena od odgovornosti tehničnega odbora je, če je primerno, da uporabi temeljne varnostne objave pri pripravi svojih objav. V tem okviru zahteve, preskusne metode ali preskusni pogoji te temeljne varnostne objave ne veljajo, razen če se objave, ki so jih pripravili tehnični odbori, nanje izrecno sklicujejo ali jih vključujejo.
1.4 Slika 1 prikazuje celoten okvir serije IEC 61508 in nakazuje vlogo IEC 61508-6 pri doseganju funkcijske varnosti E/E/PE-varnostnih sistemov.

General Information

• Status: Published
• Publication Date: 11-Apr-2011
• ICS: 25.040.40 - Industrial process measurement and control
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Apr-2011
• Due Date: 11-Jun-2011
• Completion Date: 12-Apr-2011
• Ref Project: EN 61508-6:2010 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3

Relations

• Replaces: SIST EN 61508-6:2007 - Functional safety of electrical/electronic/programmable electronic safety-related systems -- Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3
• Effective Date: 01-May-2011
• Revised: oSIST prEN IEC 61508-6:2025 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508)
• Effective Date: 23-Jan-2023
• Revises: oSIST prEN IEC 61508-6:2025 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508)
• Effective Date: 11-Oct-2022
• Revised: SIST EN 61508-6:2007 - Functional safety of electrical/electronic/programmable electronic safety-related systems -- Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3
• Effective Date: 07-May-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2011
1DGRPHãþD
SIST EN 61508-6:2007
)XQNFLMVNDYDUQRVWHOHNWULþQLKHOHNWURQVNLKHOHNWURQVNRSURJUDPLUOMLYLKYDUQRVWQLK
VLVWHPRYGHO6PHUQLFH]DXSRUDER,(&LQ,(&,(&

Functional safety of electrical/electronic/programmable electronic safety-related systems
- Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (IEC 61508-
6:2010)
Funktionale Sicherheit sicherheitsbezogener
elektrischer/elektronischer/programmierbarer elektronischer Systeme - Teil 6:
Anwendungsrichtlinie für IEC 61508-2 und IEC 61508-3 (IEC 61508-6:2010)
Sécurité fonctionnelle des systèmes électriques/électroniques/électroniques
programmables relatifs à la sécurité - Partie 6: Lignes directrices pour l'application de la
CEI 61508-2 et de la CEI 61508-3 (CEI 61508-6:2010)
Ta slovenski standard je istoveten z: EN 61508-6:2010
ICS:
25.040.40 Merjenje in krmiljenje Industrial process
industrijskih postopkov measurement and control
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 61508-6
NORME EUROPÉENNE
May 2010
EUROPÄISCHE NORM
ICS 25.040.40 Supersedes EN 61508-6:2001

English version
Functional safety of electrical/electronic/programmable electronic safety-
related systems -
Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3
(IEC 61508-6:2010)
Sécurité fonctionnelle des systèmes Funktionale Sicherheit sicherheitsbezogener
électriques/électroniques/électroniques elektrischer/elektronischer/programmierbarer
programmables relatifs à la sécurité - elektronischer Systeme -
Partie 6: Lignes directrices Teil 6: Anwendungsrichtlinie für IEC 61508-2
pour l'application de la CEI 61508-2 und IEC 61508-3
et de la CEI 61508-3 (IEC 61508-6:2010)
(CEI 61508-6:2010)
This European Standard was approved by CENELEC on 2010-05-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61508-6:2010 E
Foreword
The text of document 65A/553/FDIS, future edition 2 of IEC 61508-6, prepared by SC 65A, System
aspects, of IEC TC 65, Industrial-process measurement, control and automation, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 61508-6 on 2010-05-01.
This European Standard supersedes EN 61508-6:2001.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-02-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-05-01
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61508-6:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
[1] IEC 61511 series NOTE  Harmonized in EN 61511 series (not modified).
[2] IEC 62061 NOTE  Harmonized as EN 62061.
[3] IEC 61800-5-2 NOTE  Harmonized as EN 61800-5-2.
[4] IEC 61078:2006 NOTE  Harmonized as EN 61078:2006 (not modified).
[5] IEC 61165:2006 NOTE  Harmonized as EN 61165:2006 (not modified).
[16] IEC 61131-3:2003 NOTE  Harmonized as EN 61131-3:2003 (not modified).
[18] IEC 61025:2006 NOTE  Harmonized as EN 61025:2007 (not modified).
[26] IEC 60601 series NOTE  Harmonized in EN 60601 series (partially modified).
[27] IEC 61508-1:2010 NOTE  Harmonized as EN 61508-1:2010 (not modified).
[28] IEC 61508-5:2010 NOTE  Harmonized as EN 61508-5:2010 (not modified).
[29] IEC 61508-7:2010 NOTE  Harmonized as EN 61508-7:2010 (not modified).
__________
- 3 - EN 61508-6:2010
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 61508-2 2010 Functional safety of EN 61508-2 2010
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 EN 61508-3 2010
electrical/electronic/programmable electronic
safety-related systems -
Part 3: Software requirements
IEC 61508-4 2010 Functional safety of EN 61508-4 2010
electrical/electronic/programmable electronic
safety-related systems -
Part 4: Definitions and abbreviations

IEC 61508-6 ®
Edition 2.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Functional safety of electrical/electronic/programmable electronic safety-related
systems –
Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3

Sécurité fonctionnelle des systèmes électriques/électroniques/électroniques
programmables relatifs à la sécurité –
Partie 6: Lignes directrices pour l'application de la CEI 61508-2 et de la
CEI 61508-3
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XE
CODE PRIX
ICS 25.040.40 ISBN 978-2-88910-529-8
– 2 – 61508-6 © IEC:2010
CONTENTS
FOREWORD.6
INTRODUCTION.8
1 Scope.10
2 Normative references .12
3 Definitions and abbreviations.12
Annex A (informative) Application of IEC 61508-2 and of IEC 61508-3.13
Annex B (informative) Example of technique for evaluating probabilities of hardware
failure .21
Annex C (informative) Calculation of diagnostic coverage and safe failure fraction –
worked example.76
Annex D (informative) A methodology for quantifying the effect of hardware-related
common cause failures in E/E/PE systems.80
Annex E (informative) Example applications of software safety integrity tables of
IEC 61508-3 .95
Bibliography.110

Figure 1 – Overall framework of the IEC 61508 series .11
Figure A.1 – Application of IEC 61508-2 .17
Figure A.2 – Application of IEC 61508-2 (Figure A.1 continued).18
Figure A.3 – Application of IEC 61508-3 .20
Figure B.1 – Reliability Block Diagram of a whole safety loop .22
Figure B.2 – Example configuration for two sensor channels.26
Figure B.3 – Subsystem structure .29
Figure B.4 – 1oo1 physical block diagram .30
Figure B.5 – 1oo1 reliability block diagram.31
Figure B.6 – 1oo2 physical block diagram .32
Figure B.7 – 1oo2 reliability block diagram.32
Figure B.8 – 2oo2 physical block diagram .33
Figure B.9 – 2oo2 reliability block diagram.33
Figure B.10 – 1oo2D physical block diagram.33
Figure B.11 – 1oo2D reliability block diagram .34
Figure B.12 – 2oo3 physical block diagram .34
Figure B.13 – 2oo3 reliability block diagram.35
Figure B.14 – Architecture of an example for low demand mode of operation.40
Figure B.15 – Architecture of an example for high demand or continuous mode of
operation .49
Figure B.16 – Reliability block diagram of a simple whole loop with sensors organised
into 2oo3 logic .51
Figure B.17 – Simple fault tree equivalent to the reliability block diagram presented on
Figure B.1.52
Figure B.18 – Equivalence fault tree / reliability block diagram.52
Figure B.19 – Instantaneous unavailability U(t) of single periodically tested
components .54
Figure B.20 – Principle of PFD calculations when using fault trees.55
avg
61508-6 © IEC:2010 – 3 –
Figure B.21 – Effect of staggering the tests .56
Figure B.22 – Example of complex testing pattern .56
Figure B.23 – Markov graph modelling the behaviour of a two component system .58
Figure B.24 – Principle of the multiphase Markovian modelling .59
Figure B.25 – Saw-tooth curve obtained by multiphase Markovian approach.60
Figure B.26 – Approximated Markovian model .60
Figure B.27 – Impact of failures due to the demand itself.61
Figure B.28 – Modelling of the impact of test duration.61
Figure B.29 – Multiphase Markovian model with both DD and DU failures.62
Figure B.30 – Changing logic (2oo3 to 1oo2) instead of repairing first failure.63
Figure B.31 – "Reliability" Markov graphs with an absorbing state .63
Figure B.32 – "Availability" Markov graphs without absorbing states .65
Figure B.33 – Petri net for modelling a single periodically tested component.66
Figure B.34 – Petri net to model common cause failure and repair resources.69
Figure B.35 – Using reliability block diagrams to build Petri net and auxiliary Petri net
for PFD and PFH calculations .70
Figure B.36 – Simple Petri net for a single component with revealed failures and
repairs .71
Figure B.37 – Example of functional and dysfunctional modelling with a formal
language.72
Figure B.38 – Uncertainty propagation principle.73
Figure D.1 – Relationship of common cause failures to the failures of individual
channels .82
Figure D.2 – Implementing shock model with fault trees.93

Table B.1 – Terms and their ranges used in this annex (applies to 1oo1, 1oo2, 2oo2,
1oo2D, 1oo3 and 2oo3) .27
Table B.2 – Average probability of failure on demand for a proof test interval of six
months and a mean time to restoration of 8 h .36
Table B.3 – Average probability of failure on demand for a proof test interval of one
year and mean time to restoration of 8 h.37
Table B.4 – Average probability of failure on demand for a proof test interval of two
years and a mean time to restoration of 8 h .38
Table B.5 – Average probability of failure on demand for a proof test interval of
ten years and a mean time to restoration of 8 h .39
Table B.6 – Average probability of failure on demand for the sensor subsystem in the
example for low demand mode of operation (one year proof test interval and
8 h MTTR) .40
Table B.7 – Average probability of failure on demand for the logic subsystem in the
example for low demand mode of operation (one year proof test interval and
8 h MTTR) .41
Table B.8 – Average probability of failure on demand for the final element subsystem
in the example for low demand mode of operation (one year proof test interval and
8 h MTTR) .41
Table B.9 – Example for a non-perfect proof test .42
Table B.10 – Average frequency of a dangerous failure (in high demand or continuous
mode of operation) for a proof test interval of one month and a mean time to
restoration of 8 h .45

– 4 – 61508-6 © IEC:2010
Table B.11 – Average frequency of a dangerous failure (in high demand or continuous
mode of operation) for a proof test interval of three month and a mean time to
restoration of 8 h .46
Table B.12 – Average frequency of a dangerous failure (in high demand or continuous
mode of operation) for a proof test interval of six month and a mean time to restoration
of 8 h .Error! Bookmark not defined.
Table B.13 – Average frequency of a dangerous failure (in high demand or continuous
mode of operation) for a proof test interval of one year and a mean time to restoration
of 8 h .Error! Bookmark not defined.
Table B.14 – Average frequency of a dangerous failure for the sensor subsystem in the
example for high demand or continuous mode of operation (six month proof test
interval and 8 h MTTR) .49
Table B.15 – Average frequency of a dangerous failure for the logic subsystem in the
example for high demand or continuous mode of operation (six month proof test
interval and 8 h MTTR) .50
Table B.16 – Average frequency of a dangerous failure for the final element subsystem
in the example for high demand or continuous mode of operation (six month proof test
interval and 8 h MTTR) .50
Table C.1 – Example calculations for diagnostic coverage and safe failure fraction .78
Table C.2 – Diagnostic coverage and effectiveness for different elements .79
Table D.1 – Scoring programmable electronics or sensors/final elements .88
Table D.2 – Value of Z – programmable electronics .89
Table D.3 – Value of Z – sensors or final elements .89
Table D.4 – Calculation of β or β .90
int D int
Table D.5 – Calculation of β for systems with levels of redundancy greater than 1oo2 .91
Table D.6 – Example values for programmable electronics .92
Table E.1 – Software safety requirements specification .96
Table E.2 – Software design and development – software architecture design .97
Table E.3 – Software design and development – support tools and programming
language.98
Table E.4 – Software design and development – detailed design .99
Table E.5 – Software design and development – software module testing and
integration .100
Table E.6 – Programmable electronics integration (hardware and software). 100
Table E.7 – Software aspects of system safety validation .101
Table E.8 – Modification .101
Table E.9 – Software verification .102
Table E.10 – Functional safety assessment .102
Table E.11 – Software safety requirements specification . 104
Table E.12 – Software design and development – software architecture design .104
Table E.13 – Software design and development – support tools and programming
language.105
Table E.14 – Software design and development – detailed design .106
Table E.15 – Software design and development – software module testing and
integration .106
Table E.16 – Programmable electronics integration (hardware and software). 107
Table E.17 – Software aspects of system safety validation . 108
Table E.18 – Modification .108

61508-6 © IEC:2010 – 5 –
Table E.19 – Software verification .109
Table E.20 – Functional safety assessment .109

– 6 – 61508-6 © IEC:2010
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/
PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS –

Part 6: Guidelines on the application
of IEC 61508-2 and IEC 61508-3

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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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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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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.
International Standard IEC 61508-6 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 2000. 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.

61508-6 © IEC:2010 – 7 –
The text of this standard is based on the following documents:
FDIS Report on voting
65A/553/FDIS 65A/577/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 stability 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.
– 8 – 61508-6 © IEC:2010
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.
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, though 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.
– sets target failure measures for safety functions carried out by E/E/PE safety-related
systems, which are linked to the safety integrity levels;

61508-6 © IEC:2010 – 9 –
– 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.

– 10 – 61508-6 © IEC:2010
FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/
PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS –

Part 6: Guidelines on the application
of IEC 61508-2 and IEC 61508-3

1 Scope
1.1 This part of IEC 61508 contains information and guidelines on IEC 61508-2 and
IEC 61508-3.
– Annex A gives a brief overview of the requirements of IEC 61508-2 and IEC 61508-3 and
sets out the functional steps in their application.
– Annex B gives an example technique for calculating the probabilities of hardware failure
and should be read in conjunction with 7.4.3 and Annex C of IEC 61508-2 and Annex D.
– Annex C gives a worked example of calculating diagnostic coverage and should be read in
conjunction with Annex C of IEC 61508-2.
– Annex D gives a methodology for quantifying the effect of hardware-related common
cause failures on the probability of failure.
– Annex E gives worked examples of the application of the software safety integrity tables
specified in Annex A of IEC 61508-3 for safety integrity levels 2 and 3.
1.2 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.
1.3 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.
1.4 Figure 1 shows the overall framework of the IEC 61508 series and indicates the role that
IEC 61508-6 plays in the achievement of functional safety for E/E/PE safety-related systems.

61508-6 © IEC:2010 – 11 –
Technical Requirements Other Requirements
Part 4
Part 1
Definitions &
Development of the overall
abbreviations
safety requirements
(concept, scope, definition,
hazard and risk analysis)
7.1 to 7.5
Part 5
Example of methods
for the determination Part 1
of safety integrity Documentation
levels Clause 5 &
Part 1
Annex A
Allocation of the safety requirements
to the E/E/PE safety-related systems
7.6
Part 1
Management of
functional safety
Clause 6
Part 1
Specification of the system safety
requirements for the E/E/PE
safety-related systems
Part 1
Functional safety
7.10 assessm ent
Clause 8
Part 6
Guidelines for the
application of
Parts 2 & 3
Part 2 Part 3
Realisation phase Realisation phase
for E/E/PE for safety-related
safety-related software
systems
Part 7
Overview of
techniques and
measures
Part 1
Installation, commissioning
& safety validation of E/E/PE
safety-related systems
7.13 - 7.14
Part 1
Operation, maintenance,repair,
modification and retrofit,
decommissioning or disposal of
E/E/PE safety-related systems
7.15 - 7.17
Figure 1 – Overall framework of the IEC 61508 series

– 12 – 61508-6 © IEC:2010
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
3 Definitions and abbreviations
For the purposes of this document, the definitions and abbreviations given in IEC 61508-4
apply.
61508-6 © IEC:2010 – 13 –
Annex A
(informative)
Application of IEC 61508-2 and of IEC 61508-3

A.1 General
Machinery, process plant and other equipment may, in the case of malfunction (for example
by failures of electrical, electronic and/or programmable electronic devices), present risks to
people and the environment from hazardous events such as fires, explosions, radiation
overdoses, machinery traps, etc. Failures can arise from either physical faults in the device
(for example causing random hardware failures), or from systematic faults (for example
human errors made in the specification and design of a system cause systematic failure under
some particular combination of inputs), or from some environmental condition.
IEC 61508-1 provides an overall framework based on a risk approach for the prevention
and/or control of failures in electro-mechanical, electronic, or programmable electronic
devices.
The overall goal is to ensure that plant and equipment can be safely automated. A key
objective of this standard is to prevent:
– failures of control systems triggering other events, which in turn could lead to danger (for
example fire, release of toxic materials, repeat stroke of a machine, etc.); and
– undetected failures in protection systems (for example in an emergency shut-down
system), making the systems unavailable when needed for a safety action.
IEC 61508-1 requires that a hazard and risk analysis at the process/machine level is carried
out to determine the amount of risk reduction necessary to meet the risk criteria for the
application. Risk is based on the assessment of both the consequence (or severity) and the
frequency (or probability) of the hazardous event.
IEC 61508-1 further requires that the amount of risk reduction established by the risk analysis
is used to determine if one or more safety-related systems are required and what safety
functions (each with a specified safety integrity) they are needed for.
IEC 61508-2 and IEC 61508-3 take the safety functions and safety integrity requirements
allocated to any system, designated as a E/E/PE safety-related system, by the application of
IEC 61508-1 and establish requirements for safety lifecycle activities which:
– are to be applied during the specification, design and modification of the hardware and
software; and
– focus on means for preventing and/or controlling random hardware and systematic failures
(the E/E/PE system and software safety lifecycles) .
—————————
Systems necessary for functional safety and containing one or more electrical (electro-mechanical), electronic
or programmable electronic (E/E/PE) devices are designated as E/E/PE safety-related systems and include all
equipment necessary to carry out the required safety function (see 3.5.1 of IEC 61508-4).
Safety integrity is specified as one of four discrete levels. Safety integrity level 4 is the highest and safety
integrity level 1 the lowest (see 3.5.4 and 3.5.8 of IEC 61508-4).
To enable the requirements of this standard to be clearly structured, a decision was made to order the
requirements using a development process model in which each stage follows in a defined order with little
iteration (sometimes referred to as a waterfall model). However, it is stressed that any lifecycle approach can
be used provided a statement of equivalence is given in the safety plan for the project (see Clause 7 of
IEC 61508-1).
– 14 – 61508-6 © IEC:2010
IEC 61508-2 and IEC 61508-3 do not give guidance on which level of safety integrity is
appropriate for a given required tolerable risk. This decision depends upon many factors,
including the nature of the application, the extent to which other systems carry out safety
functions and social and economic factors (see IEC 61508-1 and IEC 61508-5).
The requirements of IEC 61508-2 and IEC 61508-3 include:
– the application of measures and techniques , which are graded against the safety integrity
level, for the avoidance of systematic failures by preventative methods; and
– the control of systematic failures (including software failures) and random hardware
failures by design features such as fault detection, redundancy and architectural features
(for example diversity).
In IEC 61508-2, assurance that the safety integrity target has been satisfied for dangerous
random hardware failures is based on:
– hardware fault tolerance requirements (see Tables 2 and 3 of IEC 61508-2); and
– the diagnostic coverage and frequency of proof tests of subsystems and components, by
carrying out a reliability analysis using appropriate data.
In both IEC 61508-2 and IEC 61508-3, assurance that the safety integrity target has been
satisfied for systematic failures is gained by:
– the correct application of safety management procedures;
– the use of competent staff;
– the application of the specified safety lifecycle activities, including the specified
techniques and measures ; and
– an independent functional safety assessment .
The overall goal is to ensure that remaining systematic faults, commensurate with the safety
integrity level, do not cause a failure of the E/E/PE safety-related system.
IEC 61508-2 has been developed to provide requirements for achieving safety integrity in the
hardware of the E/E
...