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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 ISO 22442-3:2007

Publication date:   Nov 27, 2007

General information

90.92 Standard to be revised   Oct 29, 2024

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Published

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 22442-3:2007
90.92 Standard to be revised
Oct 29, 2024

REVISED BY

IN_DEVELOPMENT
ISO/AWI 22442-3