SIS-EN-ISO-10993-10 › Historical Revision Information
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
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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 a) pretest considerations, b) details of the test procedures, and 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 in the ocular, oral, rectal, penile and vaginal areas are given in annex B.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
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Designation Name
SS-EN ISO 10993-10
Revision Level
EDITION 2
Status
Superseded
Publication Date
March 14, 2003
Language(s)
English
Page Count
56
International Equivalent
ISO 10993-10:2002 IDT* EN ISO 10993-10:2002 IDT