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

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

Status : Current   Published : March 2020

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PDF

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HARDCOPY



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.




Standard NumberPD ISO/TS 10993-19:2020
TitleBiological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
StatusCurrent
Publication Date16 March 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-1, ISO 10993-18
Informative References(Provided for Information)ASTM F 665, ISO 17853, ISO 13565-2, ASTM F 2081, ISO 13565-1, ISO 14971, ISO 4287, ASTM D 968, ISO 5436-2, ISO 22442-1, ISO 17190-5, ASTM G 174, ISO 18757, ISO 18754, ASTM F 754, EN 623-4, ASTM F 732, ASTM F 1854, EN 828, ISO 3274, ASTM D 1894, ISO 22442-3, ISO 13320, ASTM F 735, ISO 16610-21, ISO/TR 10993-22, ISO 22442-2, ISO 13565-3, ISO 4288, EN 725-5, ISO 13319, ASTM F 1877, ASTM D 4060, ISO 10993-9, ISO 12179, ASTM D 1044, EN 455-3, ISO 10993-14, ISO 10993-13, ISO 5832-1, ASTM F 1978, ISO 10993-15, ISO 5436-1
ReplacesDD ISO/TS 10993-19:2006
International RelationshipsISO/TS 10993-19:2020
DescriptorsMedical equipment, Chemical properties, Shape, Identification methods, Medical instruments, Health and safety requirements, Contour, Physical chemistry, Safety measures, Biological analysis and testing, Surfaces
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux Partie 19: Caractérisations physicochimique, morphologique et topographique des matériaux
CommitteeCH/194
ISBN978 0 580 99755 6
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size2.103 MB
Price£186.00


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