DS/EN ISO 22442-1:2015 (Valid to: 30-06-2021)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

Valid to: 30-06-2021
Replaced by:
Price from:
€ 86.06


This part of ISO 22442 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 nonviable.
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. This part of ISO 22442 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
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.

Number of pages: 42

Published: 2016-02-04

Date of approval: 2015-12-15

International relationships : EN ISO 22442-1:2015 IDT ISO 22442-1:2015 IDT

ICS: 11.100.99 - Other standards related to laboratory medicine

Item number: M299768

*Expected revoked date: 30-06-2021



  • CEN/TC 316
  • ISO/TC 194/SC 1

Danish committee