ISO/TS 11796
ISO/TS 11796


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. The OECD methods can be evaluated as is or, if necessary, after being adapted to test medical devices. This document includes consideration on the: — Database of reference chemical sensitizers and non-sensitizers — reference materials — Prevalidation of candidate methods — Interlaboratory study o Samples preparation and coding o Spiking of the extracts of negative reference material o Collection of the data o Statistical analysis to assess the reliability and reproducibility

General information 

  •  :  Under development
  •  : 1
  •  : ISO/TC 194 Biological and clinical evaluation of medical devices
  •  :
    11.100.20 Biological evaluation of medical devices

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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