This standard was last reviewed and confirmed in 2022.
Therefore this version remains current.
Abstract
PreviewISO 22442-3:2007 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.
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Status: PublishedPublication date: 2007-12
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Edition: 1Number of pages: 22
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- ICS :
- 11.100.20 Biological evaluation of medical devices
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| Format | Language | |
|---|---|---|
| std 1 118 | ||
| std 2 118 | Paper |
- CHF118
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