EN 1639-2009 en Dentistry - Medical devices for dentistry - Instruments《牙科学 牙科用医疗器械 仪器》.pdf

1、BS EN 1639:2009ICS 11.060.25NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Medicaldevices for dentistry InstrumentsThis British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009 BSI 2009ISBN 978 0

2、 580 63624 0Amendments/corrigenda issued since publicationDate CommentsBS EN 1639:2009National forewordThis British Standard is the UK implementation of EN 1639:2009. Itsupersedes BS EN 1639:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4,

3、 Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Stand

4、ard cannot confer immunityfrom legal obligations.BS EN 1639:2009EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1639 October 2009 ICS 11.060.25 Supersedes EN 1639:2004English Version Dentistry - Medical devices for dentistry - Instruments Art dentaire - Dispositifs mdicaux pour lart dentaire -

5、Instruments Zahnheilkunde - Medizinprodukte fr 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 n

6、ational 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

7、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, Denmar

8、k, 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 COMIT EUROPEN DE NORMALISATI

9、ON EUROPISCHES KOMITEE FR 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: EBS EN 1639:2009EN 1639:2009 (E) 2 Contents page Foreword 3Introduction . 41 Sco

10、pe 52 Normative references 53 Terms and definitions . 74 Requirements . 84.1 General 84.2 Chemical and physical properties . 84.2.1 General 84.2.2 Contaminants and residues 84.2.3 Contact with substances 94.3 Control of contamination 94.3.1 General 94.3.2 Instruments supplied sterile . 94.3.3 Instru

11、ments supplied non-sterile . 94.4 Construction and environmental properties . 94.5 Instruments connected to or equipped with an energy source 104.6 Protection against electrical risks . 104.7 Protection against mechanical and thermal risks 104.7.1 Vibration . 104.7.2 Noise . 104.7.3 Electricity, gas

12、 or hydraulic and pneumatic energy 104.7.4 Surface temperature 104.8 Controls and indicators 114.9 Clinical evaluation . 114.10 Marking, labelling and information supplied by the manufacturer 114.10.1 General 114.10.2 Symbols 114.10.3 Marking . 114.10.4 Label 124.10.5 Detachable components . 124.10.

13、6 Instructions for use . 12Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 14Bibliography 15BS EN 1639:2009EN 1639:2009 (E) 3 Foreword This document (EN 1639:2009) has been prepared by Technical Committee CEN/TC 55 “Dentis

14、try”, 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. Attent

15、ion 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

16、 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

17、) 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

18、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 corresp

19、ondence 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, Cz

20、ech 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. BS EN 1639:2009EN 1639:2009 (E) 4 Introduct

21、ion 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 devic

22、es 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 so

23、urce, 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 requ

24、irements 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. BS EN 1639:2009EN 1639:2009 (E) 5 1 Scope This European Standard specifies general requ

25、irements 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

26、 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

27、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 de

28、signated “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 steriliz

29、ers 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:

30、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

31、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: Enla

32、rgers (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

33、 3823-2:2003) EN ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999) BS EN 1639:2009EN 1639:2009 (E) 6 EN ISO 7492, Dental explorers (ISO 7492:1997) EN ISO 7711-1, Dental rotary instruments Diamond instruments Part 1: Dimensions,

34、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 Pa

35、rt 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:

36、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 (I

37、SO 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 1113

38、5-1:2007) 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

39、 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

40、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 curette

41、s, 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 auto

42、claving, 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) BS EN 1639:2009EN 1639:2009 (E) 7 EN ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2:

43、 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: Wa

44、rwick 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 elevat

45、ors 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 handpie

46、ces Air-powered scalers and scaler tips (ISO 15606:1999) EN ISO 15883-1, Washer-disinfectors Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resteriliz

47、able medical devices (ISO 17664:2004) EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) EN ISO 21531, Dentistry Graphical symbols for dental instr

48、uments (ISO 21531:2009) EN ISO 21533, Dentistry Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003) EN ISO 21671, Dentistry Rotary polishers (ISO 21671:2006) ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this European Standard, the terms and definitions given in EN 21942-1:1991, EN 21942-3:1993 and the following apply. 3.1 dental instrument any instrument specially designed for use in the practice of dentistry, which may be hand-operated, power-operated or