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IEC 62304:2006+AMD1:2015 CSV
IEC 62304
IEC 62304:2006
Medical device software - Software life cycle processes
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.
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Consolidated version
The content of amendment(s) is incorporated into the publication. The track changes mode shows where the publication has been modified by the amendment.
DiscoverTechnical committee
TC 62/SC 62A Common aspects of medical equipment, software, and systemsKeywords
Cyber security - Smart city| Publication type | International Standard |
| Publication date | 2006-05-09 |
| Edition | 1.0 |
| ICS | 11.040.01 |
| Stability date | 2026 |
| ISBN number | 2831886376 |
| Pages | 155 |
| File size | 2.22 MB |
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