ISO 11796:2023

Description

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.