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EN 12442-3:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents EN 12442-3:2000

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 the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN 12442-3:2000
99.60 Withdrawal effective
Dec 15, 2007

REVISED BY

PUBLISHED
EN ISO 22442-3:2007