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EN ISO 22442-2:2007

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) EN ISO 22442-2:2007

Publication date:   Apr 30, 2008

General information

99.60 Withdrawal effective   Nov 25, 2015

CEN

CEN/TC 316 Medical products utilizing cells, tissues and/or their derivatives

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

ISO 22442-2:2007 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 12442-2:2000

NOW

WITHDRAWN
EN ISO 22442-2:2007
99.60 Withdrawal effective
Nov 25, 2015

REVISED BY

WITHDRAWN
EN ISO 22442-2:2015