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Norm
ÖNORM EN ISO 10993-10
Issue date: 2010 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation ...
Withdrawn: 2014 10 15
Publisher:
Austrian Standards International
Format:
Digital | 80 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
This part of ISO 10993 includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
ÖNORM EN ISO 10993-10
2023 07 15
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)...
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ÖNORM EN ISO 10993-10
2014 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO...
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ÖNORM EN ISO 10993-10
2010 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO...
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ÖNORM EN ISO 10993-10
2010 01 01
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ÖNORM EN ISO 10993-10
2006 12 01
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ÖNORM EN ISO 10993-10
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