ISO/TS 11796:2023

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.