This document specifies the framework and the methodology to evaluate and demonstrate the applicability of a validated non-animal method from an OECD test guideline to assess the skin sensitizing potential of a medical device or a medical device material. This document addresses:
— the database of reference chemical skin sensitizers and non-skin sensitizers;
— reference materials;
— feasibility testing of candidate test methods, including any method optimization for use with extracts of medical devices;
— prevalidation of candidate test methods;
— the interlaboratory study:
— sample preparation and coding;
— spiking of the extracts from the negative control medical device material;
— data collection;
— statistical analysis to assess reliability and reproducibility.
The use of the approaches described in this document to assess the applicability of a candidate test method does not imply that the candidate test method can be used as a stand-alone test for evaluating the skin sensitization potential of medical devices. For certain candidate test methods, integrated approaches and/or defined approaches are needed. The evaluation of skin sensitization potential of a medical device is described in ISO 10993-10.