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Norm

ISO 22442-3:2007

Ausgabedatum: 2007 11 27

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 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (exc...
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Herausgeber:
International Organization for Standardization
Format:
Digital | 22 Seiten
Sprache:
Englisch

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.

ISO 22442-3:2007
2007 11 27
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the eliminat...
Norm