ISO/TS 11796:2023

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.

General information

Status
: Published

Publication date
: 2023-07
Edition
: 1

Number of pages
: 34
Technical Committee
: ISO/TC 194 Biological and clinical evaluation of medical devices
ICS
:
11.100.20 Biological evaluation of medical devices