SIST EN 1639:2010

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 . 104.7Protection against mechanical and thermal risks . 104.7.1Vibration . 104.7.2Noise . 104.7.3Electricity, gas or hydraulic and pneumatic energy . 104.7.4Surface temperature . 104.8Controls and indicators . 114.9Clinical evaluation . 114.10Marking, labelling and information supplied by the manufacturer . 114.10.1General . 114.10.2Symbols . 114.10.3Marking . 114.10.4Label . 124.10.5Detachable components . 124.10.6Instructions for use . 12Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 14Bibliography . 15
SIST EN 1639:2010



EN 1639:2009 (E) 3 Foreword This document (EN 1639:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1639:2004. 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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



EN 1639:2009 (E) 4 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: 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 European 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 European Standard should be used in conjunction with EN 1640, which is applicable for dental equipment. This European 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. SIST EN 1639:2010



EN 1639:2009 (E) 5 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, 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. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 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, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 1640, Dentistry — Medical devices for dentistry — Equipment EN 13060, Small steam sterilizers EN 21942-1:1991, Dental vocabulary — Part 1: General and clinical terms (ISO 1942-1:1989) EN 21942-3:1993, Dental vocabulary — Part 3: Dental instruments (ISO 1942-3:1989) EN 23964, Dentistry — Dental handpieces — Coupling dimensions (ISO 3964:1982) EN 29168, Dental handpieces — Hose connectors (ISO 9168:1991) EN 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) 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 plastics (ISO 1797-2:1992) EN ISO 2157, Dental rotary instruments — Nominal diameters and designation code number (ISO 2157:1992) EN ISO 3630-1, Dentistry — Root-canal instruments — Part 1: General requirements and test methods
(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



EN 1639:2009 (E) 6 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, Dentistry— Diamond rotary instruments — Part 3: Grit sizes, designation and colour code
(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 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) EN ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) EN ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) EN ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) EN ISO 13295, Dentistry — Mandrels for rotary instruments (ISO 13295:2007) EN ISO 13397-1, Periodontal curettes, dental scalers and excavators — Part 1: General requirements
(ISO 13397-1:1995) EN ISO 13397-2, Dentistry — Periodontal curettes, dental scalers and excavators — Part 2: Periodontal curettes of Gr-type (ISO 13397-2:2005) 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 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
(ISO 14155-1:2003) SIST EN 1639:2010



EN 1639:2009 (E) 7 EN ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 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) EN ISO 15087-3, Dental elevators — Part 3: Cryer elevators (ISO 15087-3:2000) EN ISO 15087-4, Dental elevators — Part 4: Coupland elevators (ISO 15087-4:2000) EN ISO 15087-5, Dental elevators — Part 5: Bein elevators (ISO 15087-5:2000) EN ISO 15087-6, Dental elevators — Part 6: Flohr elevators (ISO 15087-6:2000) EN ISO 15098-1, Dental tweezers — Part 1: General requirements (ISO 15098-1:2000) EN ISO 15098-2, Dental tweezers — Part 2: Meriam types (ISO 15098-2:2000) EN ISO 15098-3, Dental tweezers — Part 3: College types (ISO 15098-3:2000) EN ISO 15606, Dental handpieces — Air-powered scalers and scaler
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