EN 1639:2009

Dentistry - Medical devices for dentistry - Instruments

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.

Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Instrumente

Diese Europäische Norm legt allgemeine Anforderungen an Instrumente fest, die in der Zahn-, Mund- und Kieferheilkunde verwendet werden und die Medizinprodukte sind. Sie enthält Anforderungen an die vorge-sehene Leistung, die Konstruktionsmerkmale, die Bauteile, die Wiederaufbereitung, die Verpackung, die Kennzeichnung, die Etikettierung der Instrumente und die Informationen durch den Hersteller.
Diese Norm gilt nicht für eine notwendige Energiequelle, an die ein Instrument angeschlossen werden muss. Diese Energiequellen werden in EN 1640 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 - Instruments

La présente Norme européenne spécifie les exigences générales relatives aux instruments utilisés 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 la restérilisation pour les instruments réutilisables, à l’emballage, au marquage, à l’étiquetage ainsi qu’aux informations fournies par le fabricant.
La présente Norme européenne ne s’applique pas aux sources d’énergie nécessaires auxquelles les instruments doivent être raccordés. Ces sources d’énergie sont traitées dans l’EN 1640.
Les essais destinés à établir la conformité à la présente Norme européenne sont décrits, le cas échéant, dans les normes de niveau 3.

Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Instrumenti

Ta evropski standard določa splošne zahteve za instrumente, ki se uporabljajo v zobozdravstveni praksi in so medicinski pripomočki. Vključuje zahteve za predvideno delovanje, lastnosti modela, sestavne dele, predelavo za ponovno uporabo, pakiranje, označevanje, uporabo nalepk in informacije, ki jih priskrbi proizvajalec. Ta evropski standard ne velja za noben vir energije, s katerim mora biti instrument povezan. Vire energije vključuje standard EN 1640. Preskusi za dokazovanje skladnosti s tem evropskim 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: 11.060.25 - Dental instruments
• 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: 02-Dec-2019
• Completion Date: 02-Dec-2019
• 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 1639:2010 - Dentistry - Medical devices for dentistry - Instruments

Relations

• Replaces: EN 1639:2004 - Dentistry - Medical devices for dentistry - Instruments
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.QWLZahnheilkunde - Medizinprodukte für die Zahnheilkunde - InstrumenteArt dentaire - Dispositifs médicaux pour l'art dentaire - InstrumentsDentistry - Medical devices for dentistry - Instruments11.060.25Dental instrumentsICS:Ta slovenski standard je istoveten z:EN 1639:2009SIST EN 1639:2010en,fr,de01-januar-2010SIST EN 1639:2010SLOVENSKI
STANDARDSIST EN 1639:20051DGRPHãþD



SIST EN 1639:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1639
October 2009 ICS 11.060.25 Supersedes EN 1639:2004English Version
Dentistry - Medical devices for dentistry - Instruments
Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Instrumente 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 1639:2009: ESIST EN 1639:2010



EN 1639:2009 (E) 2 Contents page Foreword . 3Introduction . 41Scope . 52Normative references . 53Terms and definitions . 74Requirements . 84.1General . 84.2Chemical and physical properties . 84.2.1General . 84.2.2Contaminants and residues . 84.2.3Contact with substances . 94.3Control of contamination . 94.3.1General . 94.3.2Instruments supplied sterile . 94.3.3Instruments supplied non-sterile . 94.4Construction and environmental properties . 94.5Instruments connected to or equipped with an energy source . 104.6Protection against electrical risks .
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