ISO 22442-3:2007

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ISO 22442-3:2007 is an international standard focused on the validation of the elimination and/or inactivation of viruses and TSE (Transmissible Spongiform Encephalopathy) agents during the manufacture of medical devices that utilize animal tissue or products derived from animal tissue. The standard applies to non-viable medical devices and those that have been rendered non-viable, excluding in vitro diagnostic devices.