DIN EN ISO 10993-15:2018 Edition

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Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (Draft)

Published By	Publication Date	Number of Pages
DIN	2018-05	52

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Categories: 11.100.20 - Biological evaluation of medical devices, DIN

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Description

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behaviour in the body. The described chemical methodologies are a means to generate degradation products for further assessments.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2018-05
Pages Count	52
Language	Germany
Descriptors	Alloys, Bioassay, Biological analysis and testing, Biological tests, CE marking, Decomposition, Decomposition products, Definitions, Degradation, Determination, Electrochemical methods, Evaluations, Guide books, Identification, Implants (surgical), Medical devices, Medical products, Metals, Quantification, Reagents, Specimen preparation, Testing, Toxicological testing, Verification, Sample preparation, Deterioration
File Size	1.3 MB
ICS Codes	11.100.20 - Biological evaluation of medical devices

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DIN EN ISO 10993-15:2018 Edition

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