ISO 22442-2:2015

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling ISO 22442-2:2015

Publication date:   Nov 2, 2015

95.99 Withdrawal of Standard   Sep 15, 2020

General information

95.99 Withdrawal of Standard   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

ISO 22442-2:2015 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 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management.
The manufacturers should refer to ISO 22442‑3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents.
ISO 22442-2:2015 does not cover the utilization of human tissues in medical devices.
ISO 22442-2:2015 does not specify a quality management system for the control of all stages of production of medical devices.
It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485.
NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 22442-2:2007

NOW

WITHDRAWN
ISO 22442-2:2015
95.99 Withdrawal of Standard
Sep 15, 2020

REVISED BY

PUBLISHED
ISO 22442-2:2020