DIN EN ISO 10993-15/A1:2009-03

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); English version FprEN ISO 10993-15:2009, Amendment 1 / Note: Date of issue 2009-03-23

Évaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages (ISO 10993-15:2000); Version anglaise FprEN ISO 10993-15:2009, Amendement 1 / Attention: Date de parution 2009-03-23

Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2000); Englische Fassung FprEN ISO 10993-15:2009, Änderung 1 / Achtung: Erscheinungsdatum 2009-03-23

Información:

Fecha Anulación:

2019-10 /Withdrawn

ICS:

11.100.20 - Biological evaluation of medical devices

Equivalencias internacionales:

FprEN ISO 10993-15 (2009-01)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-15:2009-10

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 tests, Decomposition, Decomposition products, Degradation, Determination, English language, Evaluations, Identification, Medical devices, Medical products, Metals, Quantification, Toxicological testing

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