IEC 62304:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical device software - Software life cycle processes
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
27-06-2019
09-05-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.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Superseded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 |
| NS-ISO/IEC 42001:2023 | Information technology - Artificial intelligence - Management system |
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