ISO/TS 11796:2023

International Standard   Current Edition
· Approved on 27 July 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

ISO/TS 11796:2023 Files

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Current Edition

ISO/TS 11796:2023 Scope

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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