This standard was last reviewed and confirmed in 2016. Therefore this version remains current.
Abstract Preview
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
- pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
- details of in vivo (irritation and sensitization) test procedures;
- key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
General information
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Status : PublishedPublication date : 2010-08
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Edition : 3Number of pages : 67
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- ICS :
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Biological evaluation of medical devices
Buy this standard
| Format | Language | |
|---|---|---|
| Paper |
- CHF178
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 10993-10:2002
ISO 10993-10:2002/Amd 1:2006
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Now under review
ISO 10993-10:2010 -
Will be replaced by
ISO/DIS 10993-10
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