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Norm
ÖNORM EN ISO 22442-3
Issue date: 2008 04 01
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical device...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 30 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered
non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents
ÖNORM EN ISO 22442-3
2008 04 01
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the eliminati...
Norm
↖
ÖNORM EN 12442-3
2000 12 01
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Valida...
Norm
Norm
Issue date :
2007 11 27
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
Norm
Issue date :
2007 11 27
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
Norm
Issue date :
2007 11 27
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
