ISO International Standard

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.