EN ISO 22442-1:2007

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)

Publication date:   Dec 20, 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 22442-1:2007 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. ISO 22442-1:2007 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
contamination by bacteria, moulds or yeasts;
contamination by viruses;
contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
material responsible for undesired pyrogenic, immunological or toxicological reactions.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 12442-1:2000

NOW

WITHDRAWN
EN ISO 22442-1:2007
99.60 Withdrawal effective
Nov 25, 2015

REVISED BY

WITHDRAWN
EN ISO 22442-1:2015