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IEC 62304:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical device software - Software life cycle processes
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

06-27-2019

Published date

05-09-2006

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.

Committee
TC 62/SC 62A
DocumentType
Standard
Pages
279
ProductNote
NEW CHILD AMD 1 IS NOW ADDED.
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy

Standards Relationship
ANSI/AAMI IEC 62304:2006+AMD1:2016 Identical
UNE-EN 62304:2007 Identical

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US$400.00
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