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About This Item
Full Description
- 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.
This part of ISO 22442 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.
This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.
This part of ISO 22442 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.
Cross References:
ISO 10993-1
ISO 14971
ISO 22442-2
ISO 22442-3
93/42/EEC
ISO 10993-2
ISO 10993-3
ISO 10993-4
ISO 10993-5
ISO 10993-6
ISO 10993-7
ISO 10993-9
ISO 10993-10
ISO 10993-11
ISO 10993-12
ISO 10993-13
ISO 10993-14
ISO 10993-15
ISO 10993-16
ISO 10993-17
ISO 10993-18
ISO 10993-19
ISO 10993-20
ISO 11135
ISO 11137
ISO 11737
ISO 13408-1
ISO 13408-2
ISO 13408-3
ISO 13408-4
ISO 13408-5
ISO 13408-6
ISO 13408-7
ISO 13485
ISO 14160
ISO 14937
ISO 17664
ISO 17665-1
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN ISO 22442-1:2020
Medical devices utilizing animal tissues and their derivatives-Application of risk management- Most Recent
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BS EN ISO 22442-1:2015
viewing
Medical devices utilizing animal tissues and their derivatives-Application of risk management- Historical Version
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BS EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives-Application of risk management- Historical Version
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BS 05/30106190 DC
EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management- Historical Version
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BS EN 12442-1:2000
Animal tissues and their derivatives utilized in the manufacture of medical devices-Analysis and management of risk- Historical Version