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EVS-EN 62304:2006/A1:2015

Medical device software - Software life-cycle processes

General information

Valid from 04.11.2015
Base Documents
IEC 62304:2006/A1:2015; EN 62304:2006/A1:2015
ICS Groups
11.040 Medical equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN IEC 62304:2021
15.11.2019
Main + amendment
EVS-EN 62304:2006+A1:2015
04.11.2015
Amendment
EVS-EN 62304:2006/A1:2015
06.10.2006
Main
EVS-EN 62304:2006

IEC 62304 defines the life cycle requirements for medical device software as it is often an integral part of the device’s technology. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

IEC 62304 is intended to add requirements to deal with legacy software, where the software design is before the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives.

EN 62304:2006/A1:2015 modifies the European standard EN 62304:2006.

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English