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Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
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 StandardDetails 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.
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