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SSH EN 62304:2006/AC:2008

Medical device software - Software life-cycle processes

Dec 9, 2014

General information

60.60     Jan 1, 2009

DPS

DPS/KT 6

Pure national standard

11.040  

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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

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PUBLISHED
SSH EN 62304:2006/AC:2008
60.60 Standard published
Jan 1, 2009