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ISO 22442-3:2007 (R2022)

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

Summary

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.

Notes

90.93 : Norme internationale confirmée

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 11/27/2007
Confirmation Date 09/14/2022
Edition 1
Page Count 22
EAN ---
ISBN ---
Weight (in grams) ---
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