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IEC 62304:2006 ED1

Medical device software - Software life cycle processes

Jun 26, 2015

General information

60.60     May 9, 2006

IEC

TC 62/SC 62A

International Standard

11.040.01  

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Scope

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

Life cycle

NOW

PUBLISHED
IEC 62304:2006 ED1
60.60 Standard published
May 9, 2006

CORRIGENDA / AMENDMENTS

PUBLISHED
IEC 62304:2006/AMD1:2015 ED1

REVISED BY

ABANDON
IEC 62304 ED2

PROJECT
IEC 62304 ED2