Back

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
Directives or regulations
None

Standard history

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

EVS-EN 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 main text and the amendment can be found from the standard’s history.

EVS-EN 62304:2006/A1:2015 is intended to add requirements to deal with legacy software, where the software design is prior to the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives.
*
*
*
PDF
22.80 € incl tax
Paper
22.80 € incl tax
Browse a standard: 2.40 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 07.05.2015
Main

EVS-EN 62304:2006

Medical device software - Software life-cycle processes
Valid from 06.10.2006
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Withdrawn from 02.01.2020