Standard [WITHDRAWN]
DIN EN ISO 22442-2:2016-05
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015); German version EN ISO 22442-2:2015
- German title
- Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 2: Kontrollen der Beschaffung, Materialgewinnung und Handhabung (ISO 22442-2:2015); Deutsche Fassung EN ISO 22442-2:2015
- Publication date
- 2016-05
- Original language
- German
- Pages
- 27
- Publication date
- 2016-05
- Original language
- German
- Pages
- 27
- DOI
- https://dx.doi.org/10.31030/2401771
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Overview
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 devices utilizing materials of animal origin. It applies where required by the risk management process as described in ISO 22442-1. This part of ISO 22442 does not apply to in vitro diagnostic medical devices. The committee responsible for this standard is NA 027-02-21 AA "Medizinische Produkte auf Basis des Tissue Engineering" ("Medical devices utilizing tissues") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).
Content
ICS
DOI
This document replaces DIN EN ISO 22442-2:2008-03 .
This document has been replaced by: DIN EN ISO 22442-2:2021-04 .