This standard has been revised by ISO 10993-10:2021
Abstract
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.
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Status: WithdrawnPublication date: 2010-08
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Edition: 3Number of pages: 67
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- ICS :
- 11.100.20 Biological evaluation of medical devices
Life cycle
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Previously
WithdrawnISO 10993-10:2002
WithdrawnISO 10993-10:2002/Amd 1:2006
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Now
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Revised by
PublishedISO 10993-10:2021
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