IEC 60812:2018

IEC 60812:2018 is an International Standard describing how failure modes and effects analysis (FMEA), including the FMECA variant, is planned, performed, documented and maintained. FMEA systematically identifies how items or processes might fail to perform their function and the local and global effects of those failures. Failure modes can be prioritised to support treatment decisions; when ranking involves at least severity of consequences, the analysis is called FMECA.

Source checked2/2 values · 2026-10-25Methodology

Specification

1 source

Kind	methodology
Origin	IEC TC 56 Dependability

Study notes

Published 2018-08-10 as edition 3.0 by IEC technical committee TC 56 (Dependability); it cancels and replaces the second edition, IEC 60812:2006.
Applies to hardware, software, processes including human action, and their interfaces, in any combination.
The normative text is generic and covers all applications; tailoring of the FMEA for different applications is described.
Informative annexes give examples of applications for safety, automotive, software and (service) processes.
Different reporting formats are described, including a database information system.
Alternative means of calculating risk priority numbers (RPN) and a criticality matrix based method are included.
The document describes the relationship of FMEA to other dependability analysis methods.
Document details: 165 pages, ISBN 9782832259153, ICS 03.120.01, 03.120.30 and 21.020, stability date 2029.
The purpose of FMEA is to establish how items or processes might fail to perform their function so that required treatments can be identified; causes of failure modes may also be identified.

Safety

An FMEA can be used in a safety analysis, for regulatory and other purposes, but as a generic standard it does not give specific guidance for safety applications.