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BSI PD ISO/TS 10993-19:2020

Biological evaluation of medical devices -- Physico-chemical, morphological and topographical characterization of materials
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BSI PD ISO/TS 10993-19:2020

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

PUBLISH DATE 2020
PAGES 24
BSI PD ISO/TS 10993-19:2020

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 ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.

Chemical characterization of materials is covered by ISO 10993-18.

The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.

SDO BSI: British Standards Institution
Document Number ISO/TS 10993-19
Publication Date March 16, 2020
Language en - English
Page Count 24
Revision Level
Supercedes
Committee CH/194
Publish Date Document Id Type View
March 16, 2020 PD ISO/TS 10993-19:2020 Revision