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ANSI/AAMI/ISO 22442-3:2007/(R)2016
Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents
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Summary
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. Annex 3
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2007 |
| Confirmation Date | 01/01/2016 |
| Page Count | 0 |
| Themes | Biological Evaluation |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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