Abstract
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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General information
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Status: PublishedPublication date: 2023-07Stage: International Standard published [60.60]
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Edition: 1Number of pages: 34
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Technical Committee :ISO/TC 194ICS :11.100.20
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