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EVS-EN 1639:2009

Dentistry - Medical devices for dentistry - Instruments

General information
Valid from 06.01.2010
Base Documents
EN 1639:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
Status
Date
Type
Name
06.01.2010
Main
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, reprocessing, 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 EN 1640. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.
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