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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.020 Medical sciences and health care facilities in general>11.020.20 Medical science>BS EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
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immediate downloadReleased: 2020-12-14
BS EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling

BS EN ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling

CURRENCY
LANGUAGE
English
Standard number:BS EN ISO 22442-2:2020
Pages:28
Released:2020-12-14
ISBN:978 0 539 01670 3
Status:Standard
DESCRIPTION
This standard BS EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives is classified in these ICS categories:
  • 11.100.99 Other standards related to laboratory medicine
  • 11.100.20 Biological evaluation of medical devices
  • 11.020.20 Medical science

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.


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