EN 1640:2009

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
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55/WG 7 - Steering Committee
• Current Stage: 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
• Start Date: 04-Jun-2025
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 1640:2010 - Dentistry - Medical devices for dentistry - Equipment

Relations

• Replaces: EN 1640:2004 - Dentistry - Medical devices for dentistry - Equipment
• Effective Date: 31-Oct-2009

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

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

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 11Bibliography . 12
(ISO 10650-1:2004) SIST EN 1640:2010

(ISO 10650-2:2007) EN ISO 11143, Dentistry — Amalgam separators (ISO 11143:2008) EN ISO 11498, Dental handpieces — Dental low-voltage electrical motors (ISO 11498:1997) EN ISO 13294, Dental handpieces — Dental air-motors (ISO 13294:1997) EN ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
(ISO 14155-1:2003) EN ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) EN ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) EN ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical disinfectants (ISO 21530:2004) 3 Terms and definitions For the purposes of this European Standard, the terms and definitions given in EN 21942-1:1991,
EN 21942-4:1993 and the following apply. 3.1
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