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Normas DIN – AENOR
DIN EN ISO 10993-9:2018-05

DIN EN ISO 10993-9:2018-05

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018 / Note: Date of issue 2018-04-20*Intended as replacement for DIN EN ISO 10993-9 (2010-04).

Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation (ISO/DIS 10993-9:2018); Version allemande et anglaise prEN ISO 10993-9:2018 / Attention: Date de parution 2018-04-20*Prévu pour remplacer DIN EN ISO 10993-9 (2010-04).

Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und Quantifizierung von möglichen Abbauprodukten (ISO/DIS 10993-9:2018); Deutsche und Englische Fassung prEN ISO 10993-9:2018 / Achtung: Erscheinungsdatum 2018-04-20*Vorgesehen als Ersatz für DIN EN ISO 10993-9 (2010-04).

Fecha:
2018-05 /Active
Equivalencias internacionales:

ISO/DIS 10993-9 (2018-04)

prEN ISO 10993-9 (2018-04)

Resumen:
This part of 10993 is intended to present the general principles on which the specific material investigations to identify and quantify degradation products described in ISO 10993-13 (polymers), ISO 10993-14 (ceramics) and ISO 10993-15 (metals and alloys) are based. Information obtained from these studies is intended to be used in the biological evaluations described in the remaining parts of ISO 10993.
Keywords:
Bioassay, Biochemicals, Biodegradability, Biology, CE marking, Decomposition products, Definitions, Degradation, Deterioration, Determination, Evaluations, Identification, Medical devices, Medical products, Medical technology, Quantification
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