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AAMI/ISO 22442-3:2007 (R2016)
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agentsMore info
Specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. Does not cover other transmissible and non-transmissible agents.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-11-22 |
| ICS | 11.100.99 : Other standards related to laboratory medicine |
| Cross references | ISO 22442-3 (2007-12), IDT |
| Year | 2007 |
| Document history | |
| Country | USA |
| Keyword | ANSI 22442;ANSI/AAMI/ISO 22442;22442;ANSI/AAMI/ISO 22442-3-2007 (R2016) |