Superseded
Standard
Historical
DIN EN ISO 22442-1:2008-03
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007
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Summary
This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control.
Notes
À remplacer par DIN EN ISO 22442-1 (2015-08).
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 03/01/2008 |
| Cancellation Date | 05/01/2016 |
| Page Count | 36 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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