ISO/TS 11796:2023

Biological evaluation of medical devices - Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

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.

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