1529914

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

standard by International Organization for Standardization , 12/15/2007

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Full Description

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.

 

Product Details

Published:
12/15/2007
File Size:
1 file , 230 KB
Same As:
BS EN ISO 22442-3:2007, BS EN ISO 22442-3:2007
Note:
This product is unavailable in Ukraine, Russia, Belarus