DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 22442-2
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
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
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).
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 027-05-10 AA - Medical devices utilizing tissues
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
Responsible international committee
ISO/TC 194 - Biological and clinical evaluation of medical devices
