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SLOVENSKI STANDARD
01-december-2018
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SIST EN 60812:2007
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Failure modes and effects analysis (FMEA and FMECA) (IEC 60812:2018)
Ta slovenski standard je istoveten z: EN IEC 60812:2018
ICS:
03.120.01 Kakovost na splošno Quality in general
21.020 =QDþLOQRVWLLQQDþUWRYDQMH Characteristics and design of
VWURMHYDSDUDWRYRSUHPH machines, apparatus,
equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60812
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2018
ICS 03.120.01; 03.120.30; 21.020 Supersedes EN 60812:2006
English Version
Failure modes and effects analysis (FMEA and FMECA)
(IEC 60812:2018)
Analyse des modes de défaillance et de leurs effets (AMDE Ausfalleffektanalyse (FMEA und FMECA)
et AMDEC) (IEC 60812:2018)
(IEC 60812:2018)
This European Standard was approved by CENELEC on 2018-09-14. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60812:2018 E
European foreword
The text of document 56/1775/FDIS, future edition 3 of IEC 60812, prepared by IEC/TC 56
"Dependability" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-06-14
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2021-09-14
document have to be withdrawn
This document supersedes EN 60812:2006.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60812:2018 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:
IEC 60300-1 NOTE Harmonized as EN 60300-1
IEC 60300-3-1 NOTE Harmonized as EN 60300-3-1
IEC 60300-3-12 NOTE Harmonized as EN 60300-3-12
IEC 60300-3-11 NOTE Harmonized as EN 60300-3-11
IEC 61025 NOTE Harmonized as EN 61025
IEC 61078 NOTE Harmonized as EN 61078
IEC 61165 NOTE Harmonized as EN 61165
IEC 61508 series NOTE Harmonized as EN 61508 series
IEC 61709 NOTE Harmonized as EN 61709
IEC 62061 NOTE Harmonized as EN 62061
IEC 62308 NOTE Harmonized as EN 62308
IEC 62502 NOTE Harmonized as EN 62502
IEC 62508 NOTE Harmonized as EN 62508
IEC 62551 NOTE Harmonized as EN 62551
IEC 62740 NOTE Harmonized as EN 62740
IEC 62741 NOTE Harmonized as EN 62741
ISO 9000 NOTE Harmonized as EN ISO 9000
ISO 13849-1 NOTE Harmonized as EN ISO 13849-1
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60050-192 - International electrotechnical vocabulary - - -
Part 192: Dependability
IEC 60812
Edition 3.0 2018-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Failure modes and effects analysis (FMEA and FMECA)
Analyse des modes de défaillance et de leurs effets (AMDE et AMDEC)
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 03.120.01 03.120.30 21.020 ISBN 978-2-8322-5915-3
– 2 – IEC 60812:2018 © IEC 2018
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms, definitions and abbreviated terms . 9
3.1 Terms and definitions . 9
3.2 Abbreviated terms . 13
4 Overview . 14
4.1 Purpose and objectives . 14
4.2 Roles, responsibilities and competences . 14
4.3 Terminology . 15
5 Methodology for FMEA . 15
5.1 General . 15
5.2 Plan the FMEA . 17
5.2.1 General . 17
5.2.2 Define the objectives and scope of analysis . 17
5.2.3 Identify boundaries and scenarios . 17
5.2.4 Define decision criteria for treatment of failure modes . 19
5.2.5 Determine documentation and reporting requirements . 20
5.2.6 Define resources for analysis . 21
5.3 Perform the FMEA . 22
5.3.1 General . 22
5.3.2 Sub-divide item or process into elements . 22
5.3.3 Identify functions and performance standards for each element . 23
5.3.4 Identify failure modes . 23
5.3.5 Identify detection methods and existing controls . 23
5.3.6 Identify local and final effects of failure modes . 24
5.3.7 Identify failure causes . 25
5.3.8 Evaluate relative importance of failure modes . 26
5.3.9 Identify actions . 28
5.4 Document the FMEA . 29
Annex A (informative) General considerations for tailoring an FMEA . 30
A.1 General . 30
A.1.1 Overview . 30
A.1.2 Start point for FMEA in the hierarchy . 30
A.1.3 Degree of detail in analysis . 31
A.1.4 Prioritization of failure modes . 32
A.2 Factors influencing FMEA tailoring . 33
A.2.1 Reuse of data/information from analysis of similar item . 33
A.2.2 Maturity of item design and project progress . 34
A.2.3 Degree of innovation . 34
A.3 Examples of FMEA tailoring for items and processes . 34
A.3.1 General . 34
A.3.2 Example of tailoring an FMEA for an office equipment product . 35
A.3.3 Example of tailoring an FMEA for a distributed power system . 35
A.3.4 Example of tailoring an FMEA for medical processes . 36
IEC 60812:2018 © IEC 2018 – 3 –
A.3.5 Example of tailoring an FMEA for electronic control systems . 36
A.3.6 Example of tailoring an FMEA for a pump hydro block . 37
A.3.7 Example of tailoring an FMEA for a wind turbine for power generation . 37
Annex B (informative) Criticality analysis methods . 38
B.1 General . 38
B.2 Measurement scales for criticality parameters . 38
B.2.1 General . 38
B.2.2 Scale definition . 38
B.2.3 Assessing likelihood . 39
B.3 Assigning criticality using a matrix or plot . 40
B.3.1 General . 40
B.3.2 Criticality matrix . 40
B.3.3 Criticality plots . 41
B.4 Assigning criticality using a risk priority number . 42
B.4.1 General . 42
B.4.2 Risk priority number . 42
B.4.3 Alternative risk priority number method . 44
Annex C (informative) Example of FMEA report content . 46
C.1 General . 46
C.2 Example of generation of reports from a database information system for an
FMEA of a power supply unit . 46
Annex D (informative) Relationship between FMEA and other dependability analysis
techniques . 52
Annex E (informative) Application considerations for FMEA . 53
E.1 General .
...