PD ISO/TS 11796:2023 - Page 2

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. | Status: Current

1 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.