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SNV - SN EN ISO 22442-2

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

active, Most Current
Organization: SNV
Publication Date: 1 April 2021
Status: active
Page Count: 28
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

SN EN ISO 22442-2
April 1, 2021
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...
March 1, 2016
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
A description is not available for this item.
March 1, 2008
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...

References

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