EN IEC 60812:2018
(Main)Failure modes and effects analysis (FMEA and FMECA)
Failure modes and effects analysis (FMEA and FMECA)
IEC 60812:2018 explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained. The purpose of failure modes and effects analysis (FMEA) is to establish how items or processes might fail to perform their function so that any required treatments could be identified. An FMEA provides a systematic method for identifying modes of failure together with their effects on the item or process, both locally and globally. It may also include identifying the causes of failure modes. Failure modes can be prioritized to support decisions about treatment. Where the ranking of criticality involves at least the severity of consequences, and often other measures of importance, the analysis is known as failure modes, effects and criticality analysis (FMECA). This document is applicable to hardware, software, processes including human action, and their interfaces, in any combination. An FMEA can be used in a safety analysis, for regulatory and other purposes, but this being a generic standard, does not give specific guidance for safety applications. This third edition cancels and replaces the second edition published in 2006. This edition constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: a) the normative text is generic and covers all applications; b) examples of applications for safety, automotive, software and (service) processes have been added as informative annexes; c) tailoring the FMEA for different applications is described; d) different reporting formats are described, including a database information system; e) alternative means of calculating risk priority numbers (RPN) have been added; f) a criticality matrix based method has been added; g) the relationship to other dependability analysis methods have been described. Keywords: failure modes and effects analysis (FMEA), failure modes effects and criticality analysis (FMECA)
Ausfalleffektanalyse (FMEA und FMECA)
Analyse des modes de défaillance et de leurs effets (AMDE et AMDEC)
IEC 60812:2018 explique comment l’analyse des modes de défaillance et de leurs effets (AMDE), comprenant la variante d’analyse des modes de défaillance, de leurs effets et de leur criticité (AMDEC), est planifiée, réalisée, documentée et maintenue. L'analyse des modes de défaillance et de leurs effets (AMDE) vise à établir dans quelle mesure des entités ou des processus sont susceptibles de ne plus s’acquitter de leur fonction, de manière à pouvoir identifier tout traitement exigé. Une AMDE offre une méthode systématique d'identification des modes de défaillance et de leurs effets sur l'entité ou le processus, tant au niveau local que global. Elle peut également inclure l’identification des causes des modes de défaillance. Les modes de défaillance peuvent être hiérarchisés pour aider au choix du traitement à appliquer. Lorsque le classement de la criticité concerne au moins la sévérité des conséquences, et souvent d'autres mesures d'importance, l’analyse est appelée analyse des modes de défaillance, de leurs effets et de leur criticité (AMDEC). Le présent document s'applique aux matériels, aux logiciels, aux processus incluant les actions humaines et à leurs interfaces, ou à toute combinaison de ceux-ci. Une AMDE peut être utilisée dans le cadre d'une analyse de sécurité avec des objectifs réglementaires ou autres. Toutefois, la présente norme étant générique, elle ne donne pas de recommandations particulières relatives aux applications de sécurité. Cette troisième édition annule et remplace la deuxième édition parue en 2006. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) le texte normatif est générique et couvre toutes les applications; b) des exemples d'applications pour la sécurité, le secteur automobile, les logiciels et les processus (service) ont été ajoutés sous forme d'annexes informatives; c) l'adaptation de l'AMDE à différentes applications est décrite; d) différents formats de génération de rapport sont décrits, y compris un système d'informations de base de données; e) d'autres méthodes de calcul des nombres prioritaires de risque (NPR) ont été ajoutées; f) une méthode reposant sur la matrice de criticité a été ajoutée; g) les relations avec d'autres méthodes d'analyse de la sûreté de fonctionnement sont décrites. Mots clés: modes de défaillance et de leurs effets (AMDE), analyse des modes de défaillance de leurs effets et de leur criticité (AMDEC)
Analiza vrste okvar in njihovih učinkov (FMEA in FMECA) (IEC 60812:2018)
Ta dokument pojasnjuje, kako je treba načrtovati, izvajati, dokumentirati ter vzdrževati analizo vrste okvar in njihovih učinkov (FMEA), vključno z različico analize vrst okvar, njihovih učinkov in kritičnosti (FMECA).
Namen analize vrste okvar in njihovih učinkov je ugotoviti, v katerih primerih elementi ali procesi ne opravljajo svoje funkcije, da se lahko oblikujejo potrebni ukrepi. Analiza vrste okvar in njihovih učinkov podaja sistematično metodo za prepoznavanje vrst okvar skupaj z njihovimi učinki na element ali proces (lokalno in globalno). Vključuje lahko tudi prepoznavanje vzrokov za vrste okvar. Vrste okvar so lahko prednostno obravnavane za podporo pri sprejemanju odločitev o ukrepih. Kadar stopnja kritičnosti vključuje vsaj resnost posledic (in pogosto druge pomembne ukrepe), je analiza označena kot
analiza vrst okvar, njihovih učinkov in kritičnosti (FMECA).
Ta dokument se uporablja za strojno opremo, programsko opremo, procese, ki vključujejo dejanja oseb, in njihove vmesnike (ali poljubno kombinacijo teh elementov).
Analiza vrste okvar in njihovih učinkov se lahko uporablja v sklopu varnostne analize za regulativne ter druge namene, vendar ta splošni standard ne podaja posebnih smernic za varnostne načine uporabe.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60812:2018
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
SIST EN IEC 60812:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60812:2018
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SIST EN IEC 60812:2018
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
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SIST EN IEC 60812:2018
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
EN IEC 60812:2018.
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
2
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SIST EN IEC 60812:2018
EN IEC 60812:2018 (E)
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 docum
...
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