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Status : Active
Standard Type : Main
Document No : ISO 22442-3:2007
Document Year : 2007
Pages : 22
Edition : 1
Section Volume : Biological evaluation of medical devices (ISO/TC 194.)
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.