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EVS-EN 1640:2009

Dentistry - Medical devices for dentistry - Equipment

General information

Valid from 06.01.2010
Base Documents
EN 1640:2009
ICS Groups
11.060.20 Dental equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
06.01.2010
Main
EVS-EN 1640:2009
Main
EVS-EN 1640:2004
This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to dental X-ray equipment. This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by EN 1639. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English