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Normas DIN – AENOR
DIN EN ISO 10993-1:2010-04

DIN EN ISO 10993-1:2010-04

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009 / Note: To be replaced by DIN EN ISO 10993-1 (2017-04).

Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un système de gestion du risque (ISO 10993-1:2009); Version allemande EN ISO 10993-1:2009 / Attention: À remplacer par DIN EN ISO 10993-1 (2017-04).

Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2009); Deutsche Fassung EN ISO 10993-1:2009 / Achtung: Vorgesehener Ersatz durch DIN EN ISO 10993-1 (2017-04).

Fecha:
2010-04 /Active
Equivalencias internacionales:

EN ISO 10993-1 (2009-10)

ISO 10993-1 (2009-10)

TS EN ISO 10993-1 (2014-04-16)

Relación con otras normas DIN:
Resumen:
The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the number and exposure of test animals by giving preference to chemical constituent testing and in vitro models, in situations where these methods yield equally relevant information to that obtained from in vivo models. It is not intended that this international standard will provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical devices. Where a particular application warrants it, experts in the product or in the area of application concerned can choose to establish specific tests and criteria, described in a product-specific vertical standard. This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device, taking into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.
Keywords:
Bioassay, Biocompatibility, Biological, Biological analysis and testing, Biological hazards, Biological tests, Categories, CE marking, Classification, Compatibility, Definitions, Evaluations, Fine mechanics, Fitness for purpose, Human body, Implants (surgical), Management systems, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Principles, Risk management, Selection, Surgical equipment, Testing, Use
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