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.
Document identifier
ISO 22442-3:2007
Title
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 Category
TC 194/SC 1: Tissue product safety
Publication date
2007-12-15
International Relationship
BS EN ISO 22442-3:2007 * BS EN ISO 22442-3:2007
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138 vnd |
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