This standard was last reviewed and confirmed in 2015. Therefore this version remains current.
Abstract Preview
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.
General information
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Status : PublishedPublication date : 2007-12
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Edition : 1Number of pages : 22
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- ICS :
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Biological evaluation of medical devices
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Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Now confirmed
ISO 22442-3:2007
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