SIST EN 1640:2005
(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 pieces 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, a l'emballage, au marquage, a l'étiquetage, ainsi qu'aux informations fournies par le fabricant.
La présente Norme européenne ne comporte pas d'exigences relatives au matériel a rayons X utilisé dans la pratique de l'art dentaire.
La présente Norme européenne ne s'applique pas aux instruments dentaires connectés a une piece de matériel dentaire. Ceux-ci sont traités dans les normes de niveaux 2 et 3 sur les instruments dentaires.
Les essais destinés a établir la conformité a 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
4.8 Protection against mechanical and thermal risks.8
4.8.1 Mechanical stability.8
4.8.2 Vibration.8
4.8.3 Noise.8
4.8.4 Electricity, gas, hydraulic and pneumatic energy .8
4.8.5 Surface temperature.8
4.9 Controls and indicators .8
4.10 Marking, labelling and information supplied by the manufacturer .8
4.10.1 General.8
4.10.2 Symbols.9
4.10.3 Marking.9
4.10.4 Labelling.9
4.10.5 Detachable components.9
4.10.6 Instructions for use .9
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC.11
Bibliography .12
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SIST EN 1640:2005
EN 1640:2004 (E)
Foreword
This document (EN 1640:2004) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the secretariat
of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by December 2004, and conflicting national standards shall be withdrawn at the latest
by December 2004.
This document supersedes EN 1640:1996.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC.
For relationship with EU Directive 93/42/EEC, see informative annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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.
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SIST EN 1640:2005
EN 1640:2004 (E)
Introduction
There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows:
— Level 1: General requirements for medical devices;
— Level 2: Particular requirements for families of medical devices used in dentistry;
— Level 3: Specific requirements for types of medical devices used in dentistry.
There are no level 1 standards written exclusively in respect of medical devices used in dentistry.
This standard is a level 2 standard and details requirements that apply to those items of dental equipment which
are medical devices. For energy sources to be connected to dental instruments, this standard should be used in
conjunction with EN 1639, which is applicable for dental instruments. This standard also indicates that there are
additional requirements in the level 3 standards. Where available, these are included as normative references. To
cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level.
In the Bibliography a reference for guidance on the classification of dental devices and accessories [3] is given.
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SIST EN 1640:2005
EN 1640:2004 (E)
1 Scope
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.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1041, Information supplied by the manufacturer with medical devices.
EN 1639, Dentistry — Medical devices for dentistry — Instruments.
EN 21942-1, Dental vocabulary — Part 1: General and clinical terms.
EN 21942-4, Dental vocabulary — Part 4: Dental equipment (ISO 1942-4:1989).
EN 60601-1, Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-1:1988).
EN 60601-2-22, Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and
therapeutic laser equipment (IEC 60601-2-22:1995).
EN 60825-1, Safety of laser products — Part 1: Equipment classification, requirements and user's guide (IEC
60825-1:1993)
EN ISO 6875, Dental equipment - Dental patient chair (ISO 6875:1995)
EN ISO 7488, Dental amalgamators (ISO 7488:1991).
EN ISO 7494, Dental unit (ISO 7494:1996).
EN ISO 7494-2, Dentistry — Dental units — Part 2: Water and air supply (ISO 7494-2:2003).
EN ISO 9680, Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995).
EN ISO 9687, Dental equipment — Graphical symbols (ISO 9687:1993).
EN ISO 10637, Dental equipment — High- and medium-volume suction systems (ISO 10637:1999).
EN ISO 11143, Dental equipment — Amalgam separators (ISO 11143:1999).
EN ISO 11498, Dental handpieces — Dental low-voltage electrical motors (ISO 11498:1997).
EN ISO 13294, Dental handpieces — Dental air-motors (ISO 13294:1997).
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