Animal tissues and their derivatives for use in medical devices Part 2: Source, collection and processing controls (draft)

FprEN ISO 22442-2:2015

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

Scope: This document specifies requirements for controls on the sourcing, collection, and handling of animals and animal tissues used as starting materials for the manufacture of medical devices. It applies to medical devices, including in vitro diagnostic medical devices, that utilize animal tissues or their derivatives. The purpose is to establish processes minimizing the risk of transmitting infectious agents to patients.