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This part of ISO 22442 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin. It applies where required by the risk management process as described in ISO 22442-1. This part of ISO 22442 does not apply to in vitro diagnostic medical devices. The committee responsible for this standard is NA 027-02-21 AA "Medizinische Produkte auf Basis des Tissue Engineering" ("Medical devices utilizing tissues") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).
This document replaces DIN EN ISO 22442-2:2008-03 .
This document has been replaced by: DIN EN ISO 22442-2:2021-04 .