EN 1639:2004
(Main)Dentistry - Medical devices for dentistry - Instruments
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, sterilization, 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 the level 2 and level 3 standards, for dental equipment.
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 vorgesehene Leistung, die Konstruktionsmerkmale, die Bauteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung der Instrumente und die Informationen durch den Hersteller.
Diese Norm gilt nicht für irgendeine notwendige Energiequelle, an die ein Instrument angeschlossen werden muss. Für diese gelten die Normen der Ebenen 2 und 3 für zahnärztliche Ausrüstungen.
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 stérilisation, 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 les normes de niveaux 2 et 3, relatives au matériel dentaire.
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
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 1639:2005
01-januar-2005
1DGRPHãþD
SIST EN 1639:2000
=RER]GUDYVWYR0HGLFLQVNLSULSRPRþNL]D]RER]GUDYVWYR,QVWUXPHQWL
Dentistry - Medical devices for dentistry - Instruments
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Instrumente
Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
Ta slovenski standard je istoveten z: EN 1639:2004
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN 1639:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 1639:2005
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SIST EN 1639:2005
EUROPEAN STANDARD
EN 1639
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2004
ICS 11.060.25 Supersedes EN 1639:1996
English version
Dentistry - Medical devices for dentistry - Instruments
Art dentaire - Dispositifs médicaux pour l'art dentaire - Zahnheilkunde - Medizinprodukte für die Zahnheilkunde -
Instruments Instrumente
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 1639:2004: E
worldwide for CEN national Members.
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SIST EN 1639:2005
EN 1639:2004 (E)
Contents
page
Foreword.3
1 Scope.5
2 Normative references.5
3 Terms and definitions .7
4 Requirements.7
4.1 General.7
4.2 Chemical and physical properties .8
4.2.1 General.8
4.2.2 Contaminants and residues.8
4.2.3 Contact with substances .8
4.3 Control of contamination .8
4.3.1 General.8
4.3.2 Instruments supplied sterile.8
4.3.3 Instruments supplied non-sterile.9
4.4 Construction and environmental properties.9
4.5 Instruments connected to or equipped with an energy source.
...
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