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  • BS EN ISO 22442-2:2020

    Current The latest, up-to-date edition.
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    Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  14-12-2020

    Publisher:  British Standards Institution

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    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 ISO22442-1. 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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    Committee CH/194
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes
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