BS PD ISO/TS 10993-19:2020

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

BSI Group , 03/16/2020

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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 thoseproperties that are relevant to biological evaluation and the medical device's intended use (clinicalapplication and duration of use) even if such properties overlap with clinical effectiveness.Cross References:ISO 10993-1ISO 10993-18ASTM F 665ISO 17853ISO 13565-2ASTM F 2081ISO 13565-1ISO 14971ISO 4287ASTM D 968ISO 5436-2ISO 22442-1ISO 17190-5ASTM G 174ISO 18757ISO 18754ASTM F 754EN 623-4ASTM F 732ASTM F 1854EN 828ISO 3274ASTM D 1894ISO 22442-3ISO 13320 ASTM F 735ISO 16610-21ISO/TR 10993-22ISO 22442-2ISO 13565-3ISO 4288EN 725-5ISO 13319ASTM F 1877ASTM D 4060ISO 10993-9ISO 12179ASTM D 1044EN 455-3ISO 10993-14ISO 10993-13ISO 5832-1ASTM F 1978ISO 10993-15 ISO 5436-1

Product Information

Published: 03/16/2020
Pages: 24
ISBN: 9780580997556
File Size: 1 file , 2.1 MB
Language: English
Note: This product is unavailable in Ukraine, Russia, Belarus
BS PD ISO/TS 10993-19:2020
BS DD ISO/TS 10993-19:2006

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