ISO - TS 11796
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
| Organization: | ISO |
| Publication Date: | 1 July 2023 |
| Status: | active |
| Page Count: | 42 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
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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