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EVS-EN 62304:2006+A1:2015

Medical device software - Software life-cycle processes

General information

Valid from 15.11.2019
Base Documents
IEC 62304:2006; EN 62304:2006; EN 62304:2006/AC:2008; 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
03.04.2009
Corrigendum
06.10.2006
Main

IEC 62304 defines the life cycle requirements for medical device software as it is often an integral part of the device’s technology.  Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfils those intentions without causing any unacceptable risks.

IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. It provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities further divided into a set of tasks.

As a foundation, it is assumed that medical device software is developed and maintained within a quality management system and a risk management system. EN 62304:2006/A1:2015 is intended to add requirements to deal with legacy software.

The text of IEC 62304:2006 has been approved in Europe as EN 62304:2006 without any modification.

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