Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials

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Hardcopy , PDF

Language(s)

English

Published date

16-03-2020

Publisher

British Standards Institution

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.

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.This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO10993-9, ISO10993-13, ISO10993-14 and ISO10993-15.Chemical characterization of materials is covered by ISO10993-18.The ISO10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.

Committee	CH/194
DocumentType	Standard
ISBN	9780580997556
Pages	24
PublisherName	British Standards Institution
Status	Current
Supersedes	DD ISO/TS 10993-19:2006

Standards	Relationship
ISO/TS 10993-19:2020	Identical

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PD ISO/TS 10993-19:2020

Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials

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