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EN 12442-2:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Dec 15, 2007

CEN

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

European Norm

11.120.01   Pharmaceutics in general

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Scope

This Part of prEN 12442 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. Note 1: Requirements for the riks analysis of the use of materials of animal origin in medical devices are described in prEN 12442-1.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN 12442-2:2000
99.60 Withdrawal effective
Dec 15, 2007

REVISED BY

WITHDRAWN
EN ISO 22442-2:2007