DIN EN 1639:2010-02
Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
| Fecha edición: |
2010-02-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by the level 2 and level 3 standards, for dental equipment.Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate. |
| Keywords: | CE marking|Check indication|Chemical properties|Classification|Cloth|Components|Connections|Contact|Data of the manufacturer|Definitions|Delivery conditions|Dental equipment|Dental instruments|Dentistry|Design|Electric energy|Electric shock|Electrical hazards|Electrical safety|Electricity|Energy|Energy sources|Environmental condition|Hazards|Hydraulics|Impurities|Indications|Information|Instructions for use|Instruments|Labelling|Marking|Material properties|Mechanical hazards|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Microbiological analysis|Noise (environmental)|Performance requirements|Physical properties|Pneumatics|Properties|Protection|Residues|Safety requirements|Specification (approval)|Status|Sterile|Surfaces|Symbols|Telltales|Temperature|Testing|Vibration |
| ICS: | 11.060.25 - Instrumentos dentales |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 1639:2009 |
|
Reemplazo Normas |
Reemplaza a DIN EN 1639:2004-09 Reemplaza a DIN EN 1639:2008-09 |
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