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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).

2018-05 /Active
Equivalencias internacionales:

ISO/DIS 10993-9 (2018-04)

prEN ISO 10993-9 (2018-04)

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.
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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