EN 1639:2009
(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, 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
Relations
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
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
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 14Bibliography . 15
The following changes were made: a) Normative references: 1) Addition of new relevant product standards, issued after 2004: EN 13060, EN ISO 8325, EN ISO 11135-1, EN ISO 11137-1, EN ISO 11607-1, EN ISO 11607-2, EN ISO 14155-1, EN ISO 14155-2, EN ISO 14971, EN ISO 15883-1, EN ISO 17664, EN ISO 17665-1 and EN ISO 21571; 2) Deletion of the following withdrawn standards: EN 550, EN 552, EN 554, EN 26360-2 and EN 28325. b) 4.7 Clinical evaluation: Clarification of requirement for a clinical evaluation; c) 4.10.6 Instructions for use: Clarification of requirement that information may be provided in an electronic format; d) Annex ZA: Actualisation of correspondence between this European Standard and Directive 93/42/EEC, as amended by Directive 2007/47/EC. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 1639:2010
(ISO 3630-1:2008) 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 7153-1, Surgical instruments — Metallic materials — Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999) SIST EN 1639:2010
(ISO 7711-3:2004) 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 8325, Dentistry — Test methods for rotary instruments (ISO 8325:2004) EN ISO 9173-1, Dentistry — Extraction forceps — Part 1: General requirements and test methods
(ISO 9173-1:2006) 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 11135-1 Sterilizat
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