ISO 22442-1:2015

ISO 22442-1:2015 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. 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.

ISO 22442-1:2015 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

ISO 22442-1:2015 does not specify a quality management system for the control of all stages of production of medical devices.

ISO 22442-1:2015 does not cover the utilization of human tissues in medical devices.

NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.

NOTE 2 For guidance on the application of this part of ISO 22442, see Annex A.