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.
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO/TS 11796 |
| Publication Date | Not Available |
| Language | en - English |
| Page Count | |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 194 |