DANSK DS/ISO/TS 11796 PDF

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.[1] The evaluation of skin sensitization potential of a medical device is described in ISO 10993-10.