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. It includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.
SANS 10993-10:2004 history
2004SANS 10993-10:2004 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity