RO
SR EN ISO 22442-3:2008
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)
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.
Status :
Valid
Approval date : 5/27/2008
Publish date : 5/29/2008
Number of pages : 33
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices
- Replaces SR EN 12442-3:2002