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Normas DIN – AENOR
DIN EN 1641:2004-09

DIN EN 1641:2004-09

Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2004

Art dentaire - Dispositifs pour l'art dentaire - Produits; Version allemande EN 1641:2004

Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Werkstoffe; Deutsche Fassung EN 1641:2004

Fecha Anulación:
2010-02 /Withdrawn
Equivalencias internacionales:

EN 1641 (2004-06)

Relación con otras normas DIN:

Reemplazada por: DIN EN 1641:2010-02

Reemplaza a: DIN EN 1641:1996-10

Reemplaza a: DIN EN 1641:2002-10

Resumen:
The standard specifies general requiremnts for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
Keywords:
Biocompatibility, Biological hazards, Chemical hazards, Chemical properties, Clinical, Compatibility, Composition, Data of the manufacturer, Definitions, Dental equipment, Dental materials, Dentistry, Information, Instructions for use, Labelling, Marking, Material properties, Materials, Medical devices, Medical equipment, Medical products, Medical sciences, Packages, Physical properties, Production, Properties, Protection, Specification (approval), Sterilization (hygiene), Symbols, Technical documents, Testing
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