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About This Item
Full Description
BS EN ISO 10993-10:2010 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.
Cross References:
ISO 10993-1:2009
ISO 10993-2
ISO 10993-9
ISO 10993-12
ISO 10993-13
ISO 10993-14
ISO 10993-15
ISO 10993-18
ISO 14155-1
ISO 14155-2
88/379/EEC
ISO 9394
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN ISO 10993-10:2023
Biological evaluation of medical devices-Tests for skin sensitization- Most Recent
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BS EN ISO 10993-10:2013
Biological evaluation of medical devices-Tests for irritation and skin sensitization- Historical Version
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BS EN ISO 10993-10:2010
viewing
Biological evaluation of medical devices-Tests for irritation and skin sensitization- Historical Version
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BS EN ISO 10993-10:2009
Biological evaluation of medical devices-Tests for irritation and delayed-type hypersensitivity- Historical Version
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BS 08/30170164 DC
BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for irritation and skin sensitization- Historical Version
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BS EN ISO 10993-10:2002
Biological evaluation of medical devices-Tests for irritation and delayed-type hypersensitivity- Historical Version
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BS EN ISO 10993-10:1996
Biological evaluation of medical devices-Tests for irritation and sensitization- Historical Version
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BS 5736-9:1986
Evaluation of medical devices for biological hazards-Method of test for eye irritation- Historical Version
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BS 5736-8:1984
Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices- Historical Version
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BS 5736-6:1983
Evaluation of medical devices for biological hazards-Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis- Historical Version
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BS 5736-7:1983
Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices- Historical Version