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ISO 22442-2:2020

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

Publication date:   Sep 15, 2020

General information

60.60 Standard published   Sep 15, 2020

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

This document 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 other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 22442-2:2015

NOW

PUBLISHED
ISO 22442-2:2020
60.60 Standard published
Sep 15, 2020