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DIN EN ISO 22442-1:2018-09
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018More info
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.
| Author | DIN |
|---|---|
| Editor | DIN |
| Document type | Draft |
| Format | File |
| expiration_de_validite | 2018-09-27 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Number of pages | 73 |
| Cross references | prEN ISO 22442-1 (2018-08), IDT |
| Set | MYSTD-20STD |
| Year | 2018 |
| Document history | |
| Country | Germany |
| Keyword | DIN EN ISO 22442;EN ISO 22442;EN ISO 22442-1;22442 |