Summary

Specifies requirements for the validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents during the manufacture of medical devices utilizing animal tissues.

Standard Details

Standard Number: ISO 22442-3:2007
Type: ISO Standard
Published by: ISO
Official Link: https://www.iso.org/standard/39351.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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ISO 22442-3:2007 — Medical devices utilizing animal tissues — Part 3: Validation of the elimination and/or inactivation of viruses and TSE agents

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