Reference number
ISO 22442-2:2020
© ISO 2024
International Standard
ISO 22442-2:2020
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
Edition 3
2020-09
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Published (Edition 3, 2020)

ISO 22442-2:2020

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Format
CHF 96
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2020-09
    Stage
    : International Standard published [60.60]
  • Edition
     : 3
    Number of pages
     : 15
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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