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
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.
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 22442 |
| Publication Date | Not Available |
| Language | en - English |
| Page Count | |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 194/SC 1 |