EN 12442-1:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk

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 EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 12442-1:2000
99.60 Withdrawal effective
Dec 15, 2007

REVISED BY

WITHDRAWN
EN ISO 22442-1:2007