Professional Documents
Culture Documents
National foreword
This British Standard is the UK implementation of EN IEC 60812:2018. It
is identical to IEC 60812:2018. It supersedes BS EN 60812:2006, which
is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee DS/1, Dependability.
A list of organizations represented on this committee can be obtained on
request to its secretary.
This publication does not purport to include all the necessary provisions
of a contract. Users are responsible for its correct application.
© The British Standards Institution 2018
Published by BSI Standards Limited 2018
ISBN 978 0 580 87537 3
ICS 03.120.30; 21.020; 03.120.01
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 31 October 2018.
English Version
This European Standard was approved by CENELEC on 201 8-09-1 4. 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.
© 201 8 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
European foreword
The text of document 56/1 775/FDIS, future edition 3 of IEC 6081 2, prepared by IEC/TC 56
"Dependability" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 6081 2:201 8.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 201 9-06-1 4
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2021 -09-1 4
document have to be withdrawn
Endorsement notice
The text of the International Standard IEC 6081 2:201 8 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:
2
BS EN IEC 60812:2018
EN IEC 6081 2:201 8 (E)
Annex ZA
(normative)
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.
3
BS EN IEC 60812:2018
CONTENTS
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
I N TRODU CTI ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2 N orm ati ve references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3 Term s, defin iti ons and abbrevi ated term s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3. 1 Term s and d efin itions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3. 2 Abbrevi ated term s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3
4 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4
4. 1 Purpose and obj ecti ves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4
4. 2 Rol es, responsi bi l iti es an d com petences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4
4. 3 Term inol og y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5
5 Method olog y for FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5
5. 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5
5. 2 Plan the FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7
5. 2. 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7
5. 2. 2 Defin e the obj ecti ves and scope of an al ysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7
5. 2. 3 I d entify bou nd ari es an d scen ari os . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7
5. 2. 4 Defin e d ecisi on cri teri a for treatm ent of fail ure m odes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9
5. 2. 5 Determ i ne docum en tation and reporti n g requ irem en ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5. 2. 6 Defin e resources for an al ysi s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5. 3 Perform th e FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5. 3. 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5. 3. 2 Sub-d i vid e i tem or process in to el em en ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5. 3. 3 I d entify fu ncti ons an d perform ance stan d ards for each el em en t . . . . . . . . . . . . . . . . . . . . . 23
5. 3. 4 I d entify failure m odes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5. 3. 5 I d entify d etection m eth od s an d existi ng con trols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5. 3. 6 I d entify local and fi n al effects of fai l ure m od es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5. 3. 7 I d entify failure causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5. 3. 8 Eval u ate relati ve im portance of failure m od es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5. 3. 9 I d entify acti ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5. 4 Docum ent th e FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Ann ex A (inform ati ve) G en eral consi d erati ons for tai lori n g an FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A. 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A. 1 . 1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A. 1 . 2 Start poi n t for FM EA in th e h ierarch y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A. 1 . 3 Degree of d etai l i n anal ysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
A. 1 . 4 Pri ori ti zati on of fai l ure m od es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
A. 2 Factors influ enci n g FM EA tai l ori ng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
A. 2. 1 Reuse of d ata/inform ati on from an al ysis of sim i lar i tem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
A. 2. 2 Maturity of item d esign and proj ect progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
A. 2. 3 Degree of in novation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
A. 3 Exam pl es of FM EA tai l ori ng for item s an d processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
A. 3. 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
A. 3. 2 Exam pl e of tailorin g an FM EA for an office equ i pm en t prod uct . . . . . . . . . . . . . . . . . . . . . . 35
A. 3. 3 Exam pl e of tailorin g an FM EA for a d istri bu ted power system . . . . . . . . . . . . . . . . . . . . . . . . 35
A. 3. 4 Exam pl e of tai lori n g an FM EA for m ed ical processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
BS EN IEC 60812:2018
Tabl e 1 – Exam pl e of term s comm onl y associ ated with levels of h i erarch y. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5
Tabl e A. 1 – Characteristi cs of top-down and bottom -up approach es to FM EA . . . . . . . . . . . . . . . . . . . . . . . 31
Tabl e A. 2 – Gen eral appl icati on of com m on approach es to FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Tabl e C. 1 – Exam pl e of fi elds sel ected for FM EA report of power su ppl y based on
database i nform ation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Tabl e C. 2 – Exam pl e of report of com pon ent FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Tabl e C. 3 – Exam pl e of report of parts with possible comm on cause failures . . . . . . . . . . . . . . . . . . . . . . . . 50
Tabl e C. 4 – Exam pl e of report of FM ECA usi n g RPN critical ity an al ysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Tabl e C. 5 – Exam pl e of report of FM ECA usi n g critical ity m atrix for gl obal effect . . . . . . . . . . . . . . . . . . 51
Tabl e F. 1 – Extract from FM EA of th e process of orderin g a dru g from a ph arm acy . . . . . . . . . . . . . . 60
Tabl e F. 2 – Extract from FM EA of paint sprayi n g step of a m an ufacturi n g process . . . . . . . . . . . . . . . . 61
Tabl e F. 3 – Al locati on an d assessm ent of u nrel iabi lity val ues for d ifferen t critical ity
categori es of fai lure m od es for th e electron ic system represented in Fi gure F. 1 . . . . . . . . . . . . . . . . . . . . 63
Tabl e F. 4 – Al locati on an d assessm ent of u nreli abi lity val ues for d ifferen t critical ity
categori es of fai l ure m od es for subsystem 2 of the system represen ted in Fi gure F. 1 . . . . . . . . . . . 63
Tabl e F. 5 – H azards an d safe/d an g erous fai lures i n an au tom ated train con trol system . . . . . . . . 65
Tabl e F. 6 – Extract from FM EA of th e process of m onitori ng bl ood sug ar (1 of 2) . . . . . . . . . . . . . . . . . 67
Tabl e F. 7 – Extract of autom oti ve el ectron ic part FM EA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Tabl e F. 8 – Extract from system FM EA for a rem ote control for a h i-fi system . . . . . . . . . . . . . . . . . . . . . . . 70
Tabl e F. 9 – Extract from desi gn FM EA for a rem ote control for a h i-fi system . . . . . . . . . . . . . . . . . . . . . . . 70
Tabl e F. 1 0 – Extract from process FM EA for a rem ote con trol for a hi -fi system . . . . . . . . . . . . . . . . . . . . 71
Tabl e F. 1 1 – Extract from m ain ten ance service FM EA for a rem ote con trol for a h i-fi
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
BS EN IEC 60812:2018
Tabl e F. 1 2 – Extract from an FM EDA for an el ectron ic circu i t in a safety con trol system
(1 of 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Tabl e F. 1 3 – Extract from an FM EA for a coffee-m aker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Tabl e F. 1 4 – Extract from an FM EA for an electron ic com pon ent m arking an d
encapsu l ation process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
BS EN IEC 60812:2018
FOREWORD
1 ) Th e I n ternati on al El ectrotech ni cal Com m i ssi on (I EC) i s a worl d wi d e organi zati on for stan dard i zati on com pri si n g
al l n ati on al el ectrotech ni cal com m i ttees (I EC N ati on al Com m i ttees). Th e obj ect of I EC i s to prom ote
i n ternati on al co-operati on on al l q uesti on s concern i n g stand ardi zati on i n th e el ectri cal an d el ectron i c fi el d s. To
thi s end and i n add i ti on to oth er acti vi ti es, I EC publ i sh es I n ternati on al Stan d ards, Techn i cal Speci fi cati ons,
Tech ni cal Reports, Publ i cl y Avai l abl e Speci fi cati on s (PAS) an d Gu i des (h ereafter referred to as “I EC
Publ i cati on (s)”). Th ei r preparati on i s entrusted to tech ni cal com m i ttees; any I EC N ati on al Com m i ttee i n terested
i n th e su bj ect d eal t wi th m ay parti ci pate i n thi s preparatory work. I n tern ati onal , governm en tal an d n on -
govern m ental organ i zati ons l i ai si ng wi th th e I EC al so parti ci pate i n th i s preparati on. I E C col l aborates cl osel y
wi th th e I n tern ati onal Organ i zati on for Stan d ard i zati on (I S O) i n accord an ce wi th con di ti on s determ i n ed by
agreem en t between th e two organ i zati ons.
2) Th e form al d eci si on s or ag reem en ts of I EC on tech n i cal m atters express, as n earl y as possi bl e, an i n ternati on al
con sensu s of opi ni on on th e rel evan t subj ects si nce each techn i cal com m i ttee h as represen tati on from all
i n terested I EC N ati onal Com m ittees.
3) I EC Publ i cati ons h ave the form of recom m end ati on s for i ntern ati on al use an d are accepted by I EC N ati on al
Com m i ttees i n th at sen se. Whi l e al l reason abl e efforts are m ade to ensu re th at th e tech n i cal content of I EC
Publ i cati on s i s accu rate, I EC cann ot be h el d responsi bl e for th e way i n whi ch th ey are used or for an y
m i si nterpretati on by an y en d u ser.
4) I n ord er to prom ote i n tern ati onal u n i form i ty, I EC N ati onal Com m i ttees un d ertake to appl y I EC Pu bl i cati on s
tran sparentl y to th e m axi m u m exten t possi bl e i n thei r n ati onal an d regi on al pu bl i cati on s. Any d i vergen ce
between an y I EC Publ i cati on and th e correspon di ng n ati onal or regi on al pu bl i cati on sh al l be cl earl y i n di cated i n
the l atter.
5) I EC i tsel f d oes n ot provi d e an y attestati on of conform i ty. I n depen d en t certi fi cati on bod i es provi de conform i ty
assessm en t servi ces and , i n som e areas, access to I EC m arks of con form i ty. I EC i s n ot respon si bl e for an y
servi ces carri ed out by i nd epend ent certi fi cati on bodi es.
6) Al l u sers shou l d en su re that th ey h ave the l atest ed i ti on of thi s pu bl i cati on .
7) N o l i abi l i ty shal l attach to I EC or i ts d i rectors, em pl oyees, servants or ag en ts i ncl u d i n g i n d i vi du al experts an d
m em bers of its tech n i cal com m i ttees and I EC N ati on al Com m i ttees for an y person al i n j u ry, property d am age or
oth er dam age of an y n ature whatsoever, wheth er di rect or i n di rect, or for costs (in cl u d i n g l eg al fees) and
expen ses ari si n g out of the publ i cation , u se of, or rel i an ce u pon , thi s I EC Pu bl i cati on or an y other I EC
Publ i cati on s.
8) Atten ti on i s drawn to th e N orm ati ve references ci ted i n th i s publ i cati on . U se of the referen ced pu bl i cati ons i s
i n di spensabl e for the correct appl i cati on of th i s pu bl i cati on.
9) Atten ti on i s drawn to th e possi bi l i ty that som e of the el em ents of thi s I EC Publ i cati on m ay be the su bj ect of
patent ri g hts. I EC sh al l not be h el d responsi bl e for i d enti fyi n g any or al l such paten t ri ghts.
I n tern ati on al Stan dard I EC 6081 2 h as been prepared by I EC tech n ical com m ittee 56:
Depen d abi l ity.
This th ird ed ition cancel s an d repl aces the second ed iti on publ ished in 2006. Th is ed ition
constitutes a techn ical revision .
This ed i ti on incl u des the fol lowi ng si g n ifican t techn ical chan ges wi th respect to the previ ous
ed i tion:
a) th e n orm ati ve text is g en eric an d covers all applicati ons;
b) exam ples of applications for safety, autom oti ve, software an d (service) processes h ave
been add ed as i nform ati ve ann exes;
c) tai l ori n g the FM EA for d ifferent appl icati ons is d escri bed;
d) d ifferent reportin g form ats are d escribed, incl u din g a d atabase i nform ati on system ;
e) altern ative m eans of calcu latin g risk pri ori ty num bers (RPN ) have been ad d ed ;
f) a cri tical ity m atrix based m ethod h as been ad ded;
g) th e relati onsh i p to other depen d abi l ity an al ysis m eth ods h ave been d escri bed .