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AAMI/ISO TIR10993-19:2020
Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.
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Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]