EN 1640:2004
(Main)Dentistry - Medical devices for dentistry - Equipment
Dentistry - Medical devices for dentistry - Equipment
This European Standard specifies general requirements for items of 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 include requirements for 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 the level 2 and level 3 standards for dental instruments.
Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Ausrüstung
Diese Europäische Norm legt allgemeine Anforderungen an Ausrüstungsgegenstände fest, die in der Zahn-, Mund- und Kieferheilkunde verwendet werden und die Medizinprodukte sind. Sie enthält Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bauteile, die Verpackung, die Kennzeichnung, die Etikettierung und die Informationen durch den Hersteller.
Diese Norm enthält keine Anforderungen an dentale Röntgengeräte.
Diese Norm gilt nicht für zahnärztliche Instrumente, die mit einem zahnärztlichen Ausrüstungsgegenstand verbunden sind. Für diese Instrumente gelten die Normen der Ebenen 2 und 3 für zahnärztliche Instrumente.
Für Prüfungen, die die Konformität mit dieser Norm nachweisen, gelten die entsprechenden Normen der Ebene 3, falls anwendbar.
Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
La présente Norme européenne établit les exigences générales relatives aux pièces de matériel dentaire utilisées dans la pratique de l'art dentaire et constituant des dispositifs médicaux. Elle comporte également les exigences relatives aux performances prévues, aux caractéristiques de conception, aux composants, à l'emballage, au marquage, à l'étiquetage, ainsi qu'aux informations fournies par le fabricant.
La présente Norme européenne ne comporte pas d'exigences relatives au matériel à rayons X utilisé dans la pratique de l'art dentaire.
La présente Norme européenne ne s'applique pas aux instruments dentaires connectés à une pièce de matériel dentaire. Ceux-ci sont traités dans les normes de niveaux 2 et 3 sur les instruments dentaires.
Les essais destinés à établir la conformité à la présente norme sont décrits, le cas échéant, dans les normes de niveau 3.
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Oprema
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 1640:2005
01-januar-2005
1DGRPHãþD
SIST EN 1640:2000
=RER]GUDYVWYR0HGLFLQVNLSULSRPRþNL]D]RER]GUDYVWYR2SUHPD
Dentistry - Medical devices for dentistry - Equipment
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Ausrüstung
Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
Ta slovenski standard je istoveten z: EN 1640:2004
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN 1640:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 1640:2005
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SIST EN 1640:2005
EUROPEAN STANDARD
EN 1640
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2004
ICS 11.060.20 Supersedes EN 1640:1996
English version
Dentistry - Medical devices for dentistry - Equipment
Art dentaire - Dispositifs médicaux pour l'art dentaire - Zahnheilkunde - Medizinprodukte für die Zahnheilkunde -
Matériel Ausrüstung
This European Standard was approved by CEN on 17 March 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1640:2004: E
worldwide for CEN national Members.
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SIST EN 1640:2005
EN 1640:2004 (E)
Contents
page
Foreword.3
1 Scope.5
2 Normative references.5
3 Terms and definitions .6
4 Requirements.6
4.1 General.6
4.2 Chemical and physical properties .6
4.2.1 Materials.6
4.2.2 Contaminants and residues.6
4.2.3 Contact with substances .6
4.2.4 Ingress and leaking of substances.7
4.3 Control of contamination .7
4.4 Construction and environmental properties.7
4.5 Protection against radiation .7
4.6 Equipment connected to or equipped with an energy source.7
4.7 Protection against electrical risks .7
...
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