SIST EN 1639:2005
(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, a la stérilisation, a l’emballage, au marquage, a 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 etre raccordés. Ces sources d’énergie sont traitées dans les normes de niveaux 2 et 3, relatives au matériel dentaire.
Les essais destinés a établir la conformité a la présente Norme européenne sont décrits, le cas échéant, dans les normes de niveau 3.
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Instrumenti
General Information
Relations
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.9
4.6 Protection against electrical risks .9
4.7 Protection against mechanical and thermal risks.10
4.7.1 Vibration.10
4.7.2 Noise.10
4.7.3 Electricity, gas or hydraulic and pneumatic energy .10
4.7.4 Surface temperature.10
4.8 Controls and indicators .10
4.9 Marking, labelling and information supplied by the manufacturer .10
4.9.1 General.10
4.9.2 Symbols.10
4.9.3 Marking.11
4.9.4 Labelling.11
4.9.5 Detachable components.11
4.9.6 Instructions for use .11
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC.13
Bibliography .14
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SIST EN 1639:2005
EN 1639:2004 (E)
Foreword
This document (EN 1639:2004) 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 1639:1996.
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 1639:2005
EN 1639:2004 (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 instruments used in the practice of
dentistry. For instruments to be connected to an energy source, this standard should be used in conjunction with
EN 1640, which is applicable for dental equipment. 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 1639:2005
EN 1639:2004 (E)
1 Scope
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.
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 550, Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization.
EN 552, Sterilization of medical devices — Validation and routine control of sterilization by irradiation.
EN 554, Sterilization of medical devices — Validation and routine control of sterilization by moist heat.
EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" —
Part 1: Requirements for terminally sterilized medical devices.
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1041, Information supplied by the manufacturer with medical devices.
EN 1640, Dentistry — Medical devices for dentistry — Equipment.
EN 21942-1, Dental vocabulary — Part 1: General and clinical terms.
EN 21942-3, Dental vocabulary — Part 3: Dental instruments (ISO 1942-3:1989).
EN 23964, Dentistry - Dental handpieces - Coupling dimensions (ISO 3964:1982)
EN 26360-2, Dentistry — Dental rotary instruments — Number coding system — Part 2: Shape and specific
characteristics.
EN 28325, Dentistry — Dental rotary instruments — Test methods (ISO 8325:1985).
EN 28601, Data elements and interchange formats - Information interchange - Representation of dates and times
(ISO 8601:1988)
EN 29168, Dental handpieces - Hose connectors (ISO 9168:1991)
EN 60601-1, Medical electrical equipment — Part 1: General requirements for safety.
EN ISO 1797-1, Dental rotary instruments — Shanks — Part 1: Shanks made of metals (ISO 1797-1:1992).
EN ISO 1797-2, Dental rotary equipment — Shanks — Part 2: Shanks made of plastic (ISO 1797-2:1992).
EN ISO 2157, Dental rotary instruments — Nominal diameters and designation code number (ISO 2157:1992).
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SIST EN 1639:2005
EN 1639:2004 (E)
EN ISO 3630-1, Dental root-canal instruments — Part 1: Files, reamers, barbed broaches, rasps, paste carriers,
explorers and cotton broaches (ISO 3630-1:1992).
EN ISO 3630-2, Dental root-canal instruments — Part 2: Enlargers (ISO 3630-2:2000).
EN ISO 3630-3, Dental root-canal instruments — Part 3: Condensers, pluggers and spreaders (ISO 3630-3:1994).
EN ISO 3823-1, Dental rotary instruments — Burs — Part 1: Steel and carbide burs (ISO 3823-1:1997).
EN ISO 3823-2, Dentistry — Rotary bur instruments — Part 2: Finishing burs (ISO 3823-2:2003).
EN ISO 6360-1, Dentistry - Number coding system for rotary instruments - Part 1: General characteristics (ISO
6360-1:2004)
EN ISO 7153-1, Surgical instruments — Metallic materials — Part 1: Stainless steel (ISO 7153-1:1991).
EN ISO 7492, Dental explorers (ISO 7492:1997).
EN ISO 7711-1, Dental rotary instruments — Diamond instruments — Part 1: Dimensions, requirements, marking
and packaging (ISO 7711-1:1997).
EN ISO 7711-2, Dental rotary instruments — Diamond instruments — Part 2: Discs (ISO 7711-2:1992).
EN ISO 7711-3, Dental rotary instruments — Diamond instruments — Part 3: Grit sizes, designation and colour
code (ISO 7711-3:1992).
EN ISO 7785-1, Dental handpieces — Part 1: High-speed air turbine handpieces (ISO 7785-1:1997).
EN ISO 7785-2, Dental handpieces — Part 2: Straight and geared angle handpieces (ISO 7785-2:1995).
EN ISO 7885, Sterile dental injection needles for single use (ISO 7885:2000)
EN ISO 9173-1, Dental extraction forceps — Part 1: Screw and pin joint types (ISO 9173-1:1991).
EN ISO 9687, Dental equipment — Graphical symbols (ISO 9687:1993).
EN ISO 9873, Dental hand instrument — Reusable mirrors and handles (ISO 9873:1998).
EN ISO 9997, Dental cartridge syringes (ISO 9997:1999).
EN ISO 10323, Dental rotary instruments — Bore diameters for discs and wheels (ISO 10323:1991).
EN ISO 13295, Dental rotary instruments — Mandrels (ISO 13295:1994).
EN ISO 13397-1, Periodontal curettes, dental scalers and excavators — Part 1: General requirements (ISO 13397-
1:1995).
EN ISO 13397-2, Periodontal curettes, dental scalers and excavators — Part 2: Periodontal curettes - GR-type
(ISO 13397-2:1996).
EN ISO 13397-3, Periodontal curettes, dental scalers and excavators — Part 3: Dental scalers: H-type (ISO 13397-
3:1996).
EN ISO 13397-4, Periodontal curettes, dental scalers and excavators — Part 4: Dental excavators — Discoid-type
(ISO 13397-4:1997).
EN ISO 13402, Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion
and thermal exposure (ISO 13402:1995).
EN ISO 15087-1, Dental elevators — Part 1: General requirements (ISO 15087-1:1999).
EN ISO 15087-2, Dental elevators — Part 2: Warwick James elevators (ISO 15087-2:2000).
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