Logo
Login Sign Up
Current Revision

ISO/TS 11796:2023

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
Best Price Guarantee

$200.97

2-5 Days

$200.97

SAVE 15%

$341.65


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


View in Library
or
International Organization for Standardization Logo

ISO/TS 11796:2023

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

PUBLISH DATE 2023
ISO/TS 11796:2023

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 July 1, 2023
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 194
Loading...

Failed to load document history.

Publish Date Document Id Type View