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DIN EN ISO 22442-3:2008-03

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); German version EN ISO 22442-3:2007

Summary

This Part of ISO 22442 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 does not cover other transmissible and non-transmissible agents.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 03/01/2008
Page Count 31
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