DIN EN ISO 10993-15:2018-05

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018 / Note: Date of issue 2018-04-20*Intended as replacement for DIN EN ISO 10993-15 (2009-10).

Évaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages (ISO/DIS 10993-15:2018); Version allemande et anglaise prEN ISO 10993-15:2018 / Attention: Date de parution 2018-04-20*Prévu pour remplacer DIN EN ISO 10993-15 (2009-10).

Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO/DIS 10993-15:2018); Deutsche und Englische Fassung prEN ISO 10993-15:2018 / Achtung: Erscheinungsdatum 2018-04-20*Vorgesehen als Ersatz für DIN EN ISO 10993-15 (2009-10).

Información:

Fecha:

2018-05 /Active

ICS:

11.100.20 - Biological evaluation of medical devices

Equivalencias internacionales:

ISO/DIS 10993-15 (2018-04)

prEN ISO 10993-15 (2018-04)

Resumen:

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.

Keywords:

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

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