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AAMI/IEC 62304 AMD 1:2016
Medical device software - Software life cycle processes, Amendment 1More info
Amendment 1 updates the standard to add requirements to deal with LEGACY SOFTWARE, where the software design is prior to the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives. Software safety classification changes include clarification of requirements and updating of the software safety classification to include a risk-based approach
| Author | ANSI/AAMI/IEC |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-04-07 |
| ICS | 11.040.01 : Medical equipment in general 35.240.80 : IT applications in health care technology |
| Cross references | IEC 62304 AMD 1 (2015-06), IDT |
| Modify | ANSI/AAMI/IEC 62304 (2006) |
| Year | 2016 |
| Document history | |
| Country | USA |
| Keyword | ANSI 62304;ANSI/AAMI/IEC 62304;62304;ANSI/AAMI/IEC 62304-2006/Amd 1-2016 |