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Norm
ÖNORM EN ISO 22442-2
Issue date: 2021 05 15
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufact...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 27 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
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.
ÖNORM EN ISO 22442-2
2021 05 15
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, colle...
Norm
↖
ÖNORM EN ISO 22442-2
2016 03 15
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, colle...
Norm
ÖNORM EN ISO 22442-2
2008 04 01
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, colle...
Norm
ÖNORM EN 12442-2
2000 12 01
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Contro...
Norm
Norm
Issue date :
2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
Norm
Issue date :
2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
