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Normas DIN – AENOR
DIN EN ISO 10993-18:2018-09

DIN EN ISO 10993-18:2018-09

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018 / Note: Date of issue 2018-08-03

Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque (ISO/DIS 10993-18:2018); Version allemande et anglaise prEN ISO 10993-18:2018 / Attention: Date de parution 2018-08-03

Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems (ISO/DIS 10993-18:2018); Deutsche und Englische Fassung prEN ISO 10993-18:2018 / Achtung: Erscheinungsdatum 2018-08-03

Fecha Anulación:
2021-03 /Withdrawn
Equivalencias internacionales:

ISO/DIS 10993-18 (2018-08)

prEN ISO 10993-18 (2018-08)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-18:2021-03

Resumen:
This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: - the identification of its materials of construction (medical device configuration); - the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); - the characterization of the medical device for chemical substances that were introduced during manufacturing (e. g., mould release agents, process contaminants); - the estimation of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); - the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document may also be used for chemical characterization (e. g., the identification and/or quantification) of degradation products.
Keywords:
Alloys, Applications, Bioassay, Biological tests, CE marking, Ceramics, Characteristics, Chemical, Chemical analysis and testing, Chemical properties, Definitions, Determination, Evaluations, Health hazards, Identification, Medical devices, Medical equipment, Medical products, Metals, Methods, Specification (approval), Testing
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