ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
OVERVIEW
ISO 22442-3:2007 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. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2007 |
| No. of Pages | 22 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | ISO/TC 194 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |