Approved Work Item
ISO/AWI TS 11967
Biological evaluation of medical devices — Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18
Reference number
ISO/AWI TS 11967
Edition 1
© ISO 2026
Approved Work Item
Under development
A working group has prepared a draft.

Abstract

This document provides guidance on: • the purpose of chemical characterization testing and possible uses of the data generated; • selecting a laboratory and establishing its competence for the testing required; • what information a should be provided to a testing laboratory. This document is intended to support the commissioning of chemical characterization testing in accordance with ISO 10993-18.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 194
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
8
Decent Work and Economic Growth
12
Responsible Consumption and Production

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