ISO 22442-2:2020
Current
The latest, up-to-date edition.
Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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French, English
15-09-2020
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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 ISO 224421.
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.
| DocumentType |
Standard
|
| Pages |
17
|
| ProductNote |
THIS STANDARD ALSO REFERS TO 2003/32/CE, (UE) n° 722/2012
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PN-EN ISO 22442-2:2021-04 | Identical |
| SN EN ISO 22442-2:2021 | Identical |
| EN ISO 22442-2:2020 | Identical |
| UNI EN ISO 22442-2:2021 | Identical |
| NF EN ISO 22442-2:2020 | Identical |
| I.S. EN ISO 22442-2:2020 | Identical |
| ÖNORM EN ISO 22442-2:2021 05 15 | Identical |
| UNE-EN ISO 22442-2:2022 | Identical |
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