1 Scope
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 delayed-type hypersensitivity.
This part of ISO 10993 includes
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a) pretest considerations,
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b) details of the test procedures, and
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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.
Supplementary tests which are required specifically for devices used intradermally [A1_start]and[A1_end] in the ocular, oral, rectal, penile and vaginal areas are given in annex B.