This part of ISO 10993 describes test methods:
(a) to evaluate the potential of devices and their constituent materials to produce irritation; and
(b) to evaluate the potential of devices and their constituent materials to produce sensitization.
These test methods are recommended for most categories of device and mode of body contact given in ISO 10993-1. Of the tests listed, those appropriate to the end use of the device are to be selected. Guidance is also given for the preparation of materials specifically in relation to the above tests.
Guidance on the conduct of supplementary tests which may be required specifically for use in the oral, rectal, penile and vaginal areas is given in annex D.
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Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization (Adopted ISO 10993-10:1995)
Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de sensibilisation (norme ISO 10993- 10:1995 adoptée)