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ISO FDIS 22442-2

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

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Organization: ISO
Publication Date: 11 May 2020
Status: active
Page Count: 26
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1.

NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.

This document does not cover the utilization of human tissues in medical devices.

This document does not specify a quality management system for the control of all stages of production of medical devices.

Document History

ISO FDIS 22442-2
May 11, 2020
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices...
November 1, 2015
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
This part of ISO 22442 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical...
December 15, 2007
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
A description is not available for this item.

References

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