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About This Item
Full Description
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.
Document History
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AAMI/ISO TIR10993-19:2020
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Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials- Most Recent
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AAMI/ISO TIR10993-19:2006
Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials [Historical]- Historical Version