SIST EN ISO 13849-2:2013
(Main)Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
This Standard specifies the procedures and conditions to be followed for the validation by analysis and testing of the safety functions provided, the category achieved and the performance level achieved of the safety-related parts of the control system (SRP/CS) in compliance with ISO 13849-1, using the design rationale provided by the designer.
Sicherheit von Maschinen und Geräten - Sicherheitsbezogene Teile von Steuerungen - Teil 2: Validierung (ISO 13849-2:2012)
Diese Internationale Norm legt die Vorgehensweisen und Bedingungen in Übereinstimmung mit ISO 13849-1 fest, die bei der Validierung durch Analyse und Prüfung zu befolgen sind, für
- die vorgesehenen Sicherheitsfunktionen, und
- die ausgeführten Kategorien, und
- den erreichten Performance Level
der sicherheitsbezogenen Teile der Steuerung (SRP/CS), bei Anwendung der durch den Konstrukteur vorgesehenen sinnvollen Gestaltung.
ANMERKUNG Anforderungen für programmierbare elektronische Systeme einschließlich der damit verbundenen Software sind in ISO 13849 1:2006, 4.6 und in den Normen der Reihe der IEC 61508-Reihe enthalten.
Sécurité des machines - Parties des systèmes de commande relatifs à la sécurité - Partie 2: Validation (ISO 13849-2:2012)
L'ISO 13849-2:2012 spécifie les modes opératoires et conditions à suivre pour la validation par analyse et par essais des fonctions de sécurité spécifiées, de la catégorie atteinte et du niveau de performance atteint par les parties d'un système de commande relatives à la sécurité (SRP/CS) conçu conformément à l'ISO 13849-1.
Varnost strojev - Z varnostjo povezani deli krmilnih sistemov - 2. del: Potrjevanje (ISO 13849-2:2012)
Ta standard določa postopke in pogoje, ki jih je treba upoštevati pri potrjevanju z analizo in preskušanju podanih varnostnih funkcij, dosežene kategorije in dosežene ravni zmogljivosti z varnostjo povezanih delov krmilnih sistemov (SRP/CS) v skladu s standardom ISO 13849-1, in sicer na podlagi utemeljitve načrta, ki jo posreduje načrtovalec.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13849-2:2013
01-april-2013
1DGRPHãþD
SIST EN ISO 13849-2:2008
Varnost strojev - Z varnostjo povezani deli krmilnih sistemov - 2. del: Potrjevanje
(ISO 13849-2:2012)
Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO
13849-2:2012)
Sicherheit von Maschinen und Geräten - Sicherheitsbezogene Teile von Steuerungen -
Teil 2: Validierung (ISO 13849-2:2012)
Sécurité des machines - Parties des systèmes de commande relatifs à la sécurité -
Partie 2: Validation (ISO 13849-2:2012)
Ta slovenski standard je istoveten z: EN ISO 13849-2:2012
ICS:
13.110 Varnost strojev Safety of machinery
25.040.40 Merjenje in krmiljenje Industrial process
industrijskih postopkov measurement and control
SIST EN ISO 13849-2:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13849-2:2013
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SIST EN ISO 13849-2:2013
EUROPEAN STANDARD
EN ISO 13849-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 13.110 Supersedes EN ISO 13849-2:2008
English Version
Safety of machinery - Safety-related parts of control systems -
Part 2: Validation (ISO 13849-2:2012)
Sécurité des machines - Parties des systèmes de Sicherheit von Maschinen - Sicherheitsbezogene Teile von
commande relatives à la sécurité - Partie 2: Validation (ISO Steuerungen - Teil 2: Validierung (ISO 13849-2:2012)
13849-2:2012)
This European Standard was approved by CEN on 14 October 2012.
CEN 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 CEN-CENELEC Management Centre or to any CEN 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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13849-2:2012: E
worldwide for CEN national Members.
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SIST EN ISO 13849-2:2013
EN ISO 13849-2:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC .4
2
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SIST EN ISO 13849-2:2013
EN ISO 13849-2:2012 (E)
Foreword
This document (EN ISO 13849-2:2012) has been prepared by Technical Committee ISO/TC 199 “Safety of
machinery” in collaboration with Technical Committee CEN/TC 114 “Safety of machinery” the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13849-2:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13849-2:2012 has been approved by CEN as a EN ISO 13849-2:2012 without any
modification.
3
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SIST EN ISO 13849-2:2013
EN ISO 13849-2:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive Machinery, 2006/42/EC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard confers, within the limits of the scope of this standard, a presumption of conformity with the
relevant Essential Requirements 1.2.1 of that Directive and associated EFTA regulations.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
4
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SIST EN ISO 13849-2:2013
INTERNATIONAL ISO
STANDARD 13849-2
Second edition
2012-10-15
Safety of machinery — Safety-related
parts of control systems —
Part 2:
Validation
Sécurité des machines — Parties des systèmes de commande relatives
à la sécurité —
Partie 2: Validation
Reference number
ISO 13849-2:2012(E)
©
ISO 2012
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the
address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Validation process . 1
4.1 Validation principles . 1
4.2 Validation plan . 3
4.3 Generic fault lists . . 4
4.4 Specific fault lists. 4
4.5 Information for validation . 4
4.6 Validation record . 6
5 Validation by analysis . 6
5.1 General . 6
5.2 Analysis techniques . 7
6 Validation by testing . 7
6.1 General . 7
6.2 Measurement accuracy . 8
6.3 More stringent requirements . 8
6.4 Number of test samples . 8
7 Validation of safety requirements specification for safety functions .9
8 Validation of safety functions . 9
9 Validation of performance levels and categories .10
9.1 Analysis and testing .10
9.2 Validation of category specifications .10
9.3 Validation of MTTF , DC and CCF .12
d avg
9.4 Validation of measures against systematic failures related to performance level and
category of SRP/CS .13
9.5 Validation of safety-related software .13
9.6 Validation and verification of performance level .14
9.7 Validation of combination of safety-related parts .14
10 Validation of environmental requirements .15
11 Validation of maintenance requirements .15
12 Validation of technical documentation and information for use .16
Annex A (informative) Validation tools for mechanical systems .17
Annex B (informative) Validation tools for pneumatic systems .21
Annex C (informative) Validation tools for hydraulic systems .31
Annex D (informative) Validation tools for electrical systems .40
Annex E (informative) Example of validation of fault behaviour and diagnostic means .53
Bibliography .78
© ISO 2012 – All rights reserved iii
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13849-2 was prepared by Technical Committee ISO/TC 199, Safety of machinery.
This second edition cancels and replaces the first edition (ISO 13849-2:2003), which has been technically
revised in order to adapt to ISO 13849-1:2006. In addition, the new Annex E provides an example for the
validation of fault behaviour and diagnostic means.
ISO 13849 consists of the following parts, under the general title Safety of machinery — Safety-related
parts of control systems:
— Part 1: General principles for design
— Part 2: Validation
Annexes A to D, which are informative, are structured according to Table 1.
Table 1 — Structure of Annexes A to D of this part of ISO 13849
List of basic safety List of well-tried List of well-tried Fault lists and
principles safety principles components fault exclusions
Annex Technology
Table(s)
A Mechanical A.1 A.2 A.3 A.4, A.5
B Pneumatic B.1 B.2 — B.3 to B.18
C Hydraulic C.1 C.2 — C.3 to C.12
Electrical (includes
D D.1 D.2 D.3 D.4 to D.21
electronics)
iv © ISO 2012 – All rights reserved
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
Introduction
The structure of safety standards in the field of machinery is as follows:
a) type-A standards (basic safety standards) giving basic concepts, principles for design and general
aspects that can be applied to machinery;
b) type-B standards (generic safety standards) dealing with one safety aspect or one type of safeguard
that can be used across a wide range of machinery:
— type-B1 standards on particular safety aspects (for example safety distances, surface
temperature, noise);
— type-B2 standards on safeguards (for example two-hand controls, interlocking devices,
pressure-sensitive devices, guards);
c) type-C standards (machine safety standards) dealing with detailed safety requirements for a
particular machine or group of machines.
This document is a type-B standard as stated in ISO 12100.
The requirements of this document can be supplemented or modified by a type-C standard.
For machines which are covered by the scope of a type-C standard and which have been designed and built
according to the requirements of that standard, the requirements of that type-C standard take precedence.
This part of ISO 13849 specifies the validation process for the safety functions, categories and performance
levels for the safety-related parts of control systems. It recognizes that the validation of safety-related
parts of control systems can be achieved by a combination of analysis (see Clause 5) and testing (see
Clause 6), and specifies the particular circumstances in which testing ought to be carried out.
Most of the procedures and conditions in this part of ISO 13849 are based on the assumption that the
simplified procedure for estimating the performance level (PL) described in ISO 13849-1:2006, 4.5.4, is
used. This part of ISO 13849 does not provide guidance for situations when other procedures are used
to estimate PL (e.g. Markov modelling), in which case some of its provisions will not apply and additional
requirements can be necessary.
Guidance on the general principles for the design (see ISO 12100) of safety-related parts of control
systems, regardless of the type of technology used (electrical, hydraulic, pneumatic, mechanical, etc.),
is provided in ISO 13849-1. This includes descriptions of some typical safety functions, determination
of their required performance levels, and general requirements of categories and performance levels.
Within this part of ISO 13849, some of the validation requirements are general, whereas others are
specific to the type of technology used.
© ISO 2012 – All rights reserved v
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SIST EN ISO 13849-2:2013
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SIST EN ISO 13849-2:2013
INTERNATIONAL STANDARD ISO 13849-2:2012(E)
Safety of machinery — Safety-related parts of control
systems —
Part 2:
Validation
1 Scope
This part of ISO 13849 specifies the procedures and conditions to be followed for the validation by
analysis and testing of
— the specified safety functions,
— the category achieved, and
— the performance level achieved
by the safety-related parts of a control system (SRP/CS) designed in accordance with ISO 13849-1.
NOTE Additional requirements for programmable electronic systems, including embedded software, are
given in ISO 13849-1:2006, 4.6, and IEC 61508 .
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 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
ISO 13849-1:2006, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 12100 and ISO 13849-1 apply.
4 Validation process
4.1 Validation principles
The purpose of the validation process is to confirm that the design of the SRP/CS supports the overall
safety requirements specification for the machinery.
The validation shall demonstrate that each SRP/CS meets the requirements of ISO 13849-1 and, in
particular, the following:
a) the specified safety characteristics of the safety functions provided by that part, as set out in the
design rationale;
b) the requirements of the specified performance level (see ISO 13849-1:2006, 4.5):
1) the requirements of the specified category (see ISO 13849-1:2006, 6.2),
© ISO 2012 – All rights reserved 1
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
2) the measures for control and avoidance of systematic failures (see ISO 13849-1:2006, Annex G),
3) if applicable, the requirements of the software (see ISO 13849-1:2006, 4.6), and
4) the ability to perform a safety function under expected environmental conditions;
c) the ergonomic design of the operator interface, e.g. so that the operator is not tempted to act in a
hazardous manner, such as defeating the SRP/CS (see ISO 13849-1:2006, 4.8).
Validation should be carried out by persons who are independent of the design of the SRP/CS.
NOTE “Independent person” does not necessarily mean that a third-party test is required.
Validation consists of applying analysis (see Clause 5) and executing functional tests (see Clause 6)
under foreseeable conditions in accordance with the validation plan. Figure 1 gives an overview of the
validation process. The balance between the analysis and testing depends on the technology used for
the safety-related parts and the required performance level. For Categories 2, 3 and 4 the validation of
the safety function shall also include testing under fault conditions.
The analysis should be started as early as possible in, and in parallel with, the design process. Problems
can then be corrected early while they are still relatively easy to correct, i.e. during steps “design and
technical realization of the safety function” and “evaluate the performance level PL” [the fourth and fifth
boxes down in in ISO 13849-1:2006, Figure 3]. It can be necessary for some parts of the analysis to be
delayed until the design is well developed.
Where necessary due to the system’s size, complexity or the effects of integrating it with the control
system (of the machinery), special arrangements should be made for
— validation of the SRP/CS separately before integration, including simulation of the appropriate input
and output signals, and
— validation of the effects of integrating safety-related parts into the remainder of the control system
within the context of its use in the machine.
2 © ISO 2012 – All rights reserved
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
Figure 1 — Overview of the validation process
“Modification of the design” in Figure 1 refers to the design process. If the validation cannot be
successfully completed, changes in the design are necessary. The validation of the modified safety-
related parts should then be repeated. This process should be iterated until all safety-related parts of
the safety functions are successfully validated.
4.2 Validation plan
The validation plan shall identify and describe the requirements for carrying out the validation process
for the specified safety functions, their categories and performance levels.
The validation plan shall also identify the means to be employed to validate the specified safety functions,
categories and performance levels. It shall set out, where appropriate
a) the identity of the specification documents,
b) the operational and environmental conditions during testing,
© ISO 2012 – All rights reserved 3
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
c) the analyses and tests to be applied,
d) the reference to test standards to be applied, and
e) the persons or parties responsible for each step in the validation process.
Safety-related parts which have previously been validated to the same specification need only a
reference to that previous validation.
4.3 Generic fault lists
The validation process involves consideration of the behaviour of the SRP/CS for all faults to be
considered. A basis for fault consideration is given in the tables of fault lists in Annexes A to D, which are
based on experience and which contain
— the components/elements to be included, e.g. conductors/cables (see Annex D),
— the faults to be taken into account, e.g. short circuits between conductors,
— the permitted fault exclusions, taking into account environmental, operating and application
aspects, and
— a remarks section giving the reasons for the fault exclusions.
Only permanent faults are taken into account in the fault lists.
4.4 Specific fault lists
If necessary, a specific product-related fault list shall be generated as a reference document for the
validation process of the safety-related part(s). The list can be based on the appropriate generic list(s)
found in the annexes.
Where the specific product-related fault list is based on the generic list(s) it shall state
a) the faults taken from the generic list(s) to be included,
b) any other relevant faults to be included but not given in the generic list (e.g. common-cause failures),
c) the faults taken from the generic list(s) which may be excluded on the basis that the criteria given in
the generic list(s) (see ISO 13849-1:2006, 7.3) are satisfied, and
exceptionally
d) any other faults for which the generic list(s) do not permit an exclusion, but for which justification
and rationale for an exclusion is presented (see ISO 13849-1:2006, 7.3).
Where this list is not based on the generic list(s), the designer shall give the rationale for fault exclusions.
4.5 Information for validation
The information required for validation will vary with the technology used, the category or categories
and performance level(s) to be demonstrated, the design rationale of the system, and the contribution of
the SRP/CS to the reduction of the risk. Documents containing sufficient information from the following
list shall be included in the validation process to demonstrate that the safety-related parts perform the
specified safety functions to the required performance level or levels and category or categories:
a) specification of the required characteristics of each safety function, and its required category and
performance level;
b) drawings and specifications, e.g. for mechanical, hydraulic and pneumatic parts, printed circuit
boards, assembled boards, internal wiring, enclosure, materials, mounting;
4 © ISO 2012 – All rights reserved
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SIST EN ISO 13849-2:2013
ISO 13849-2:2012(E)
c) block diagram(s) with a functional description of the blocks;
d) circuit diagram(s), including interfaces/connections;
e) functional description of the circuit diagram(s);
f) time sequence diagram(s) for switching components, signals relevant for safety;
g) description of the relevant characteristics of components previously validated;
h) for safety-related parts other than those listed in g), component lists with item designations, rated
values, tolerances, relevant operating stresses, type designation, failure-rate data and component
manufacturer, and any other data relevant to safety;
i) analysis of all relevant faults (see also 4.3 and 4.4), such as those listed in the tables of Annexes A to
D, including the justification of any excluded faults;
j) an analysis of the influence of processed materials;
k) information for use, e.g. installation and operation manual/instruction handbook.
Where software is relevant to the safety function(s), the software documentation shall include
— a specification which is clear and unambiguous and which states the safety performance the
software is required to achieve,
— evidence that the software is designed to achieve the required performance level (see 9.5), and
— details of tests (in particular test reports) carried out to prove that the required safety
performance is achieved.
NOTE See ISO 13849-1:2006, 4.6.2 and 4.6.3, for requirements.
Information is required on how the performance level and average probability of a da
...
SLOVENSKI STANDARD
oSIST prEN ISO 13849-2:2010
01-september-2010
Varnost strojev - Z varnostjo povezani deli krmilnih sistemov - 2. del: Potrjevanje
(ISO/DIS 13849-2:2010)
Safety of machinery - Safety-related parts of control systems - Part 2: Validation
(ISO/DIS 13849-2:2010)
Sicherheit von Maschinen und Geräten - Sicherheitsbezogene Teile von Steuerungen -
Teil 2: Validierung (ISO/DIS 13849-2:2010)
Sécurité des machines - Parties des systèmes de commande relatifs à la sécurité -
Partie 2: Validation (ISO/DIS 13849-2:2010)
Ta slovenski standard je istoveten z: prEN ISO 13849-2
ICS:
13.110 Varnost strojev Safety of machinery
oSIST prEN ISO 13849-2:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 13849-2:2010
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oSIST prEN ISO 13849-2:2010
EUROPEAN STANDARD
DRAFT
prEN ISO 13849-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2010
ICS 13.110 Will supersede EN ISO 13849-2:2008
English Version
Safety of machinery - Safety-related parts of control systems -
Part 2: Validation (ISO/DIS 13849-2:2010)
Sécurité des machines - Parties des systèmes de Sicherheit von Maschinen und Geräten -
commande relatifs à la sécurité - Partie 2: Validation Sicherheitsbezogene Teile von Steuerungen - Teil 2:
(ISO/DIS 13849-2:2010) Validierung (ISO/DIS 13849-2:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 114.
If this draft becomes a European Standard, CEN 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.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 13849-2:2010: E
worldwide for CEN national Members.
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oSIST prEN ISO 13849-2:2010
prEN ISO 13849-2:2010 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 13849-2:2010
prEN ISO 13849-2:2010 (E)
Foreword
This document (prEN ISO 13849-2:2010) has been prepared by Technical Committee ISO/TC 199 “Safety of
machinery” in collaboration with Technical Committee CEN/TC 114 “Safety of machinery” the secretariat of
which is held by DIN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 13849-2:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
Endorsement notice
The text of ISO/DIS 13849-2:2010 has been approved by CEN as a prEN ISO 13849-2:2010 without any
modification.
3
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oSIST prEN ISO 13849-2:2010
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oSIST prEN ISO 13849-2:2010
DRAFT INTERNATIONAL STANDARD ISO/DIS 13849-2
ISO/TC 199 Secretariat: DIN
Voting begins on: Voting terminates on:
2010-05-27 2010-10-27
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Safety of machinery — Safety-related parts of control
systems —
Part 2:
Validation
Sécurité des machines — Parties des systèmes de commande relatifs à la sécurité —
Partie 2: Validation
[Revision of first edition (ISO 13849-2:2003)]
ICS 13.110
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Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Validation process.1
4.1 Validation principles.1
4.2 Validation plan.3
4.3 Generic fault lists .4
4.4 Specific fault lists.4
4.5 Information for validation .4
4.6 Validation record.6
5 Validation by analysis.7
5.1 General.7
5.2 Analysis techniques.7
6 Validation by testing .7
6.1 General.7
6.2 Measurement accuracy.8
6.3 Higher requirements.9
6.4 Number of test samples.9
7 Validation of safety requirements specification .9
8 Validation of safety functions .10
9 Validation of performance levels and categories .10
9.1 Analysis and testing of performance levels and categories.10
9.2 Validation of category specifications.11
9.3 Validation of MTTF , DC and CCF.13
d avg
9.4 Validation of measures against systematic failures related to performance level and
category of SRP/CS.13
9.5 Validation of safety-related software.14
9.6 Validation and verification of the performance level.14
9.7 Validation of combination of safety-related parts.15
10 Validation of environmental requirements .15
11 Validation of maintenance requirements.16
12 Validation of technical documentation and information for use.16
Annex A (informative) Validation tools for mechanical systems.17
Annex B (informative) Validation tools for pneumatic systems.22
Annex C (informative) Validation tools for hydraulic systems.34
Annex D (informative) Validation tools for electrical systems.44
Annex E (informative) Example of the validation of fault behaviour and diagnostic means .58
Bibliography.77
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13849-2 was prepared by Technical Committee ISO/TC 199, Safety of machinery.
This second edition cancels and replaces the first edition (ISO 13849-2:2003), which has been technically
revised in order to adapt to ISO 13849-1:2006. In addition the new Annex E provides an example for the
validation of fault behaviour and diagnostic means.
ISO 13849 consists of the following parts, under the general title Safety of machinery — Safety-related parts
of control systems:
⎯ Part 1: General principles for design
⎯ Part 2: Validation
Annexes A to D are informative and structured as given in Table 1.
Table 1 — Structure of the clauses of Annexes A to D
Annex Technology List of basic List of well-tried List of well-tried Fault lists and
safety principles safety principles components fault
exclusions
Clause
A Mechanical A.2 A.3 A.4 A.5
B Pneumatic B.2 B.3 B.4 B.5
C Hydraulic C.2 C.3 C.4 C.5
D Electrical (includes D.2 D.3 D.4 D.5
electronics)
This document includes a Bibliography.
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Introduction
This document is a type-B standard as stated in ISO 12100-1.
The requirements of this document can be supplemented or modified by a type-C standard.
For machines which are covered by the scope of a type-C standard and which have been designed and built
according to the requirements of that standard, the requirements of that type-C standard take precedence.
This International Standard specifies the validation process, including both analysis and testing, for the safety
functions, categories and performance levels for the safety–related parts of control systems. Most of the
procedures and conditions in this International Standard are based on the assumption that the Simplified
Procedure described in ISO 13849-1:2006, 4.5.4 is used for the estimation of Performance Level (PL). When
a different procedure is used (e.g. Markov modelling), then some parts of this standard can not be applicable
and additional requirements can be necessary. This standard does not provide guidance specifically for the
case when other procedures are used to estimate PL.
Descriptions of the safety functions and the requirements for the categories and performance levels are given
in ISO 13849-1 which deals with the general principles for design. Some requirements for validation are
general and some are specific to the technology used. ISO 13849-2 also specifies the conditions under which
the validation by testing of the safety-related parts of control systems should be carried out.
ISO 13849-1 specifies the safety requirements and gives guidance on the principles for the design (see
ISO 12100-1) of the safety-related parts of control systems. For these parts it specifies categories and
performance levels and describes the characteristics of their safety functions, regardless of the type of energy
used.
The achievement of the requirements can be validated by any combination of analysis (see Clause 5) and
testing (see Clause 6). The analysis should be started as early as possible within the design process.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 13849-2
Safety of machinery — Safety-related parts of control
systems —
Part 2:
Validation
1 Scope
This International Standard specifies the procedures and conditions to be followed for the validation by
analysis and testing of:
⎯ the safety functions provided, and
⎯ the category achieved, and
⎯ the performance level achieved
of the safety-related parts of the control system (SRP/CS) in compliance with ISO 13849-1, using the design
rationale provided by the designer.
NOTE Requirements for programmable electronic systems, including embedded software, are given in
ISO 13849-1:2006, 4.6 and also IEC 61508-series.
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 12100-1, Safety of machinery — Basic concepts, general principles for design — Part 1: Basic
terminology, methodology
ISO 13849-1:2006, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13849-1 apply.
4 Validation process
4.1 Validation principles
The purpose of the validation process is to confirm the specification and the conformity of the design of the
SRP/CS within the overall safety requirements specification of the machinery.
The validation shall demonstrate that each SRP/CS meets the requirements of ISO 13849-1, in particular:
⎯ the specified safety characteristics of the safety functions provided by that part, as set out in the design
rationale;
⎯ the requirements of the specified performance level (see ISO 13849-1:2006, 4.5);
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⎯ the requirements of the specified category (see ISO 13849-1:2006, 6.2);
⎯ the measures for control and avoidance of systematic failures (see ISO 13849-1:2006, Annex G);
and
⎯ if applicable, the requirements of the software (see ISO 13849-1:2006, 4.6);
⎯ the ability to perform a safety function under expected environmental conditions.
NOTE Validation of the design of SRP/CS includes review activities. Validation and review should be made by
person(s) other than designer(s) of the relevant item. Review should be based on the safety requirements specification
and design documentation.
Validation consists of applying analysis and executing functional tests under normal conditions in accordance
with the validation plan. Figure 1 gives an overview of the validation process. The balance between the
analysis and testing depends on the technology and performance level. Where necessary for Category 2, 3
and 4 the safety function shall be validated by testing also under fault conditions.
The analysis should be started as early as possible and in parallel with the design process, so that problems
can be corrected early whilst they are still relatively easy to correct, i. e. during steps “design and technical
realisation of the safety function” and “evaluate the performance level PL” [box 4 and 5 of Figure 3 in
ISO 13849-1:2006]. It can be necessary for some parts of the analysis to be delayed until the design is well
developed.
For large systems, due to the size, complexity or integrated form (with the machinery) of the control system,
special arrangements may be made for:
⎯ validation of the SRP/CS separately before integration including simulation of the appropriate input and
output signals;
⎯ validation of the effects of integrating safety-related parts into the remainder of the control system within
the context of its use in the machine.
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NOTE The block "modification of the design" refers to the design process. If the validation cannot be successfully
completed, changes in the design are necessary. Afterwards the validation concerning the changed parts should be
repeated. This process should be iterated until all parts are successfully validated.
Figure 1 — Overview of the validation process
4.2 Validation plan
The validation plan shall identify and describe the requirements for carrying out the validation process of the
specified safety functions, their categories and performance levels.
The validation plan shall also identify the means to be employed to validate the specified safety functions,
categories and performance levels. It shall set out, where appropriate:
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a) the identity of the specification documents;
b) the operational and environmental conditions during testing;
c) the analyses and tests to be applied;
d) the reference to test standards to be applied;
e) the persons or parties who are responsible for each validation part.
Safety-related parts which have previously been validated to the same specification need only a reference to
that previous validation.
4.3 Generic fault lists
The validation process involves consideration of behaviour of the SRP/CS for all faults to be considered. A
basis for fault consideration is given in the fault lists in the informative annexes (A.5, B.5, C.5 and D.5) which
are based on experience. The generic fault lists contain:
⎯ the components/elements to be included, e. g. conductors/cables (see D.5.2);
⎯ the faults to be taken into account, e. g. short circuits between conductors;
⎯ the permitted fault exclusions taking into account environmental, operating and application aspects;
⎯ a remarks section giving the reasons for the fault exclusions.
In the fault lists only permanent faults are taken into account.
4.4 Specific fault lists
A specific product-related fault list shall be generated as a reference document for the validation process of
the safety-related part(s). The list can be based on the appropriate generic list(s) found in the annex(es).
Where the specific product-related fault list is based on the generic list(s) it shall state:
⎯ the faults taken from the generic list(s) to be included;
⎯ any other relevant faults to be included but not given in the generic list (e. g. common cause failures);
⎯ the faults taken from the generic list(s) which may be excluded on the basis that the criteria given in the
generic list(s) (see ISO 13849-1:2006, 7.3) are satisfied;
and, exceptionally
⎯ any other faults for which the generic list(s) do not permit an exclusion, but for which justification and
rationale for an exclusion is presented (see ISO 13849-1:2006, 7.3).
Where this list is not based on the generic list(s) the designer shall give the rationale for fault exclusions.
4.5 Information for validation
The information required for validation will vary with the technology used, the category(ies) and performance
level(s) to be demonstrated, the design rationale of the system and the contribution of the SRP/CS to the
reduction of the risk. Documents containing sufficient information from the list below shall be included in the
validation process to demonstrate the performance level(s), the category(ies) and the safety function(s) of the
safety-related parts which have been achieved:
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a) specification of the required characteristics of each safety function, and its required category and
performance level;
b) drawings and specifications, e. g. for mechanical, hydraulic and pneumatic parts, printed circuit boards,
assembled boards, internal wiring, enclosure, materials, mounting;
c) block diagram(s) with functional description of the blocks;
d) circuit diagram(s) including interfaces/connections;
e) functional description of the circuit diagram(s);
f) time sequence diagram(s) for switching components, signals relevant for safety;
g) description of the relevant characteristics of components previously validated;
h) for other safety-related parts (excluding those listed in g)) component lists with item designations, rated
values, tolerances, relevant operating stresses, type designation, failure rate data and component
manufacturer and any other data relevant for safety;
i) analysis of all relevant faults (see also 4.2) listed e. g. in A.5, B.5, C.5 and D.5, including the justification
of any excluded faults;
j) an analysis of the influence of processed materials;
k) information for use, e.g. installation and operation manual.
Where software is relevant to the safety function(s), the software documentation shall include:
1) a specification which is clear and unambiguous and states the safety performance the software is
required to achieve, and
2) evidence that the software is designed to achieve the required performance level, and
3) details of tests (in particular test reports) carried out to prove that the required safety performance is
achieved.
Information is required on how the performance level and average probability of a dangerous failure per hour
is determined. The documentation of the quantifiable aspects shall include:
1) the safety-related block diagram (see ISO 13849-1:2006, Annex B) or designated architecture (see
ISO 13849-1:2006, 6.2);
2) the determination of MTTF , DC and CCF;
d (avg)
3) the determination of category (see Table 2).
Information is required for documentation on systematic aspects of the SRP/CS.
Information is required how the combination of several SRP/CS fulfils the performance level requirements.
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Table 2 — Documentation requirements for categories as part of the performance levels
Documentation requirement Category for which
documentation is required
B 1 2 3 4
Basic safety principles X X X X X
Expected operating stresses X X X X X
Influences of processed material X X X X X
Performance during other relevant external influences X X X X X
Well–tried components – X – – –
Well–tried safety principles – X X X X
Mean time to dangerous failure (MTTF) of
...
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