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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

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Kehtiv alates 27.11.2007
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27.11.2007
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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.
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ISO 22442-1:2020

Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
Uusim versioon Kehtiv alates 15.09.2020
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ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
Uusim versioon Kehtiv alates 15.09.2020