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Normas DIN – AENOR
DIN EN ISO 10993-13/A1:2009-02

DIN EN ISO 10993-13/A1:2009-02

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998); English version prEN ISO 10993-13:2008, Amendment 1 / Note: Date of issue 2009-02-16

Evaluation biologique des dispositifs médicaux - Partie 13: Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères (ISO 10993-13:1998); Version anglaise prEN ISO 10993-13:2008, Amendement 1 / Attention: Date de parution 2009-02-16

Biologische Beurteilung von Medizinprodukten - Teil 13: Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren (ISO 10993-13:1998); Englische Fassung prEN ISO 10993-13:2008, Änderung 1 / Achtung: Erscheinungsdatum 2009-02-16

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

prEN ISO 10993-13 (2008-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-13:2009-08

Resumen:
The document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished medical devices ready for clinical use. It describes two test methods to generate degradtion products, an accelerated degradataion test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. It considers only those degradation products generated by a chemical alteration of the finished polymeric device.
Keywords:
Accelerated, Bioassay, Biological tests, Decomposition, Decomposition products, Degradability, Degradation, Deterioration, English language, Evaluations, Identification, Medical devices, Medical equipment, Medical products, Methods, Polymers, Quantification, Real-time, Screening-method, Specification (approval), Testing, Verification
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