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ONORM EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
This document sets out the requirements for the control of the procurement, obtaining and handling (including storage and transport) of animals and tissues used in the manufacture of medical devices, with the exception of in vitro diagnostic medical devices, using materials of animal origin. It is used where the risk management process according to ISO 22442-1 prescribes it. This document does not cover the use of human tissue in medical devices. This document does not specify a quality management system to control all production steps of a medical device.
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Austrian Standards Institute [on]
