Dentistry - Medical devices for dentistry - Equipment

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.

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. Diese Instrumente werden in EN 1639 beschrieben.
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 Nome européenne ne s’applique pas aux matériels à rayons X.
La présente Norme européenne ne s’applique pas aux instruments dentaires connectés à une pièce de matériel dentaire. Ceux-ci sont traités dans l’EN 1639.
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

Ta evropski standard določa splošne zahteve za zobozdravstveno opremo, ki se uporablja v zobozdravstveni praksi in je medicinski pripomoček. Vključuje zahteve za predvideno delovanje, lastnosti modela, sestavne dele, pakiranje, označevanje, uporabo nalepk in informacije, ki jih priskrbi proizvajalec. Ta evropski standard ne velja za zobozdravstveno rentgensko opremo. Ta evropski standard ne velja za noben zobozdravstveni instrument, povezan s predmetom zobozdravstvene opreme. Te instrumente vključuje standard EN 1639. Preskusi za dokazovanje skladnosti s tem standardom so navedeni v standardih 3. ravni, če je to primerno.

General Information

Status
Published
Publication Date
27-Oct-2009
Withdrawal Date
29-Apr-2010
Technical Committee
Current Stage
9060 - Closure of 2 Year Review Enquiry - Review Enquiry
Start Date
02-Dec-2019
Completion Date
02-Dec-2019

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - AusrüstungArt dentaire - Dispositifs médicaux pour l'art dentaire - MatérielDentistry - Medical devices for dentistry - Equipment11.060.20Dental equipmentICS:Ta slovenski standard je istoveten z:EN 1640:2009SIST EN 1640:2010en,fr,de01-januar-2010SIST EN 1640:2010SLOVENSKI
STANDARDSIST EN 1640:20051DGRPHãþD



SIST EN 1640:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1640
October 2009 ICS 11.060.20 Supersedes EN 1640:2004English Version
Dentistry - Medical devices for dentistry - Equipment
Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Ausrüstung This European Standard was approved by CEN on 19 September 2009.
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 CEN Management Centre 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 CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1640:2009: ESIST EN 1640:2010



EN 1640:2009 (E) 2 Contents page Foreword . 3Introduction . 41Scope . 52Normative references . 53Terms and definitions . 64Requirements . 64.1General . 64.2Chemical and physical properties . 64.2.1Materials . 64.2.2Contaminants and residues . 74.2.3Contact with substances . 74.2.4Ingress and leaking of substances . 74.3Control of contamination . 74.4Construction and environmental properties . 74.5Protection against radiation . 74.6Equipment connected to or equipped with an energy source . 84.7Programmable electronic subsystems (software programmes) . 84.8Protection against electrical risks .
...

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