ISO/AWI TS 11967

Biological evaluation of medical devices — Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18 ISO/AWI TS 11967

Scope

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.