Jetzt auswählen und bestellen
85,85 €
exkl. USt.
In den Warenkorb
Icon ISO
Icon ISO
Norm

ISO 22442-2:2020

Ausgabedatum: 2020 09 15

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufact...
Gültig
Herausgeber:
International Organization for Standardization
Format:
Digital | 15 Seiten
Sprache:
Englisch

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.

ISO 22442-2:2020
2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, colle...
Norm
ISO 22442-2:2015
2015 11 02
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, colle...
Norm
ISO 22442-2:2007
2007 11 27
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, colle...
Norm