EN ISO 14457-2012 en Dentistry - Handpieces and motors《牙科 电动牙钻手柄》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14457:2012Dentistry - Handpieces and motorsIncorporating corrigendum February 2013BS EN ISO 14457:2012 BRITISH STANDARDNational forewordThis British Standard is the UK

2、implementation of EN ISO 14457:2012. It supersedes BS EN ISO 11498:2000, BS EN ISO 13294:1997, BS EN ISO 7785-1:1999 and BS EN ISO 7785-2:1998 which are withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental A list o

3、f organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards

4、Limited 2013ISBN 978 0 580 81107 4 ICS 11.060.25 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2012.Amendments/corrigenda issued since publication

5、Date Text affectedImplementation of CEN correction notice 17October 2012: Supersession information addedto CEN forewordInstruments and Equipment.31 May 2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14457 September 2012 ICS 11.060.25 Supersedes EN ISO 11498:1999, EN ISO 13294:1997, EN

6、ISO 7785-1:1999, EN ISO 7785-2:1997English Version Dentistry - Handpieces and motors (ISO 14457:2012) Mdecine bucco-dentaire - Pices main et moteurs (ISO 14457:2012) Zahnheilkunde - Handstcke und Motoren (ISO 14457:2012) This European Standard was approved by CEN on 14 September 2012. CEN members ar

7、e 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

8、the CEN-CENELEC 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-CENELEC Management Ce

9、ntre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithua

10、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels

11、 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14457:2012: EForeword This document (EN ISO 14457:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “

12、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 March 2013, and conflicting national standards shall be withdrawn at the latest by March 2013. A

13、ttention 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 ISO 7785-1:1999, EN ISO 7785-2:1997, EN ISO 11498:1999, EN

14、ISO 13294:1997. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedo

15、nia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 14457:2012 has been approved by CEN

16、as a EN ISO 14457:2012 without any modification. BS EN ISO 14457:2012 EN ISO 14457:2012 (E)iiiiiContents PageForeword . vIntroduction . vi1 Scope 12 Normative references . 13 Terms and definitions . 24 Classification of handpieces 45 Requirements and performance 45.1 General . 45.2 Materials . 45.3

17、Drop test 45.4 Noise level . 45.5 Surfaces . 45.6 Power supply 55.7 Air and water pressure . 65.8 Temperature 65.9 Vibrations 65.10 Resistance to reprocessing 65.11 Leakage and/or ingress of water . 65.12 Electromagnetic compatibility . 65.13 Operating controls 65.14 Usability . 75.15 Connection and

18、 supply 75.16 Chuck system for shanks . 95.17 Test mandrel . 95.18 Speed 115.19 Eccentricity . 115.20 Torque . 115.21 Dimensions of head and nose . 116 Sampling 127 Testing 127.1 General test conditions .127.2 Visual inspection .137.3 Power supply Electrical 137.4 Power supply Air 137.5 Spray air su

19、pply .137.6 Spray water supply .137.7 Air and water pressure .147.8 Motor cooling air .147.9 Connector for handpiece attachment and for air-powered handpiece .147.10 Connection and supply 147.11 Test mandrels .147.12 Chuck for shanks 157.13 Dimensions (of head and nose) .157.14 Eccentricity .167.15

20、Torque .167.16 Noise level .167.17 Speed 177.18 Temperature rise of housing 177.19 Temperature, excessive .177.20 Resistance to reprocessing 178 Instructions for use, maintenance and service .17BS EN ISO 14457:2012 EN ISO 14457:2012 (E) ISO 2013iv 9 Technical description .1810 Marking .1810.1 Genera

21、l .1810.2 Handpieces .1810.3 Motors .1811 Labelling 1912 Packaging 19Annex A (informative) Handpiece categories 20Bibliography .22BS EN ISO 14457:2012 EN ISO 14457:2012 (E) ISO 2013ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

22、 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations,

23、governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/I

24、EC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the memb

25、er bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 14457 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommi

26、ttee SC 4, Dental instruments.ISO 14457 cancels and replaces ISO 7785-1:1997, ISO 7785-2:1995, ISO 11498:1997 and ISO 13294:1997, which have been technically revised.vBS EN ISO 14457:2012 EN ISO 14457:2012 (E) ISO 2013IntroductionDental handpieces and dental motors have been used in dental treatment

27、 procedures for many years.Technical development creates handpieces and motors that are better and easier to use. The combination of these items is very important for good performance.This International Standard combines the content of the following four ISO standards, which have now been withdrawn.

28、ISO 7785-1:1997, Dental handpieces Part 1: High-speed air turbine handpiecesISO 7785-2:1995, Dental handpieces Part 2: Straight and geared angle handpiecesISO 11498:1997, Dental handpieces Dental low-voltage electrical motorsISO 13294:1997, Dental handpieces Dental air-motorsvi BS EN ISO 14457:2012

29、EN ISO 14457:2012 (E) ISO 2013Dentistry Handpieces and motors1 ScopeThis International Standard is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturers information, marking and packaging.Th

30、is International Standard is applicable to:a) straight and geared-angle handpieces, including handpiece attachments;b) high-speed air turbine handpieces;c) air motors;d) electrical motors;e) prophy handpieces.This International Standard is not applicable to:1) intraoral camera handpieces;2) powered

31、polymerization handpieces;3) air-powered scalers;4) electrical powered scalers;5) air-powder polishing handpieces;6) multifunction handpieces (syringes).NOTE See Annex A for clarification of the handpieces, attachments and motor types covered by this International Standard.2 Normative referencesThe

32、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.ISO 1797-1, Dentistry Shanks for rotary instruments Pa

33、rt 1: Shanks made of metalsISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks made of plasticsISO 1942, Dentistry VocabularyISO 3964, Dental handpieces Coupling dimensionsISO 5349-1, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: Gene

34、ral requirementsISO 5349-2, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplaceISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 7405, Dentistry Evaluation of biocompatib

35、ility of medical devices used in dentistryINTERNATIONAL STANDARD 1BS EN ISO 14457:2012 EN ISO 14457:2012 (E) ISO 2013ISO 7494-1, Dentistry Dental units Part 1: General requirements and test methodsISO 9168, Dentistry Hose connectors for air driven dental handpiecesISO 9687, Dental equipment Graphica

36、l symbolsISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 13295, Dentistry Mandrels for rotary instrumentsISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part

37、1: General requirementsISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesISO 21531, Dentistry Graphical symbols for dental instrumentsIEC 60601-1:2005, Medical electrical equipment Part 1: General requiremen

38、ts for basic safety and essential performanceIEC 61672-1, Electroacoustics Sound level meters Part 1: SpecificationsIEC 62366, Medical devices Application of usability engineering to medical devicesIEC 80601-2-60:2012, Medical electrical equipment Part 2-60: Particular requirements for basic safety

39、and essential performance of dental equipment3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1air motormotor powered by compressed air, which is supplied by a dental unit3.2air-powered powder jet handpiecehandpiece power

40、ed by air, designed to transfer powder to the patient3.3air-powered scalerhandpiece powered by air, with an oscillating working part3.4angle handpiecehandpiece with an angle between the input and output axes, driven by an air motor or an electrical motor or with an internal power supply3.5contra-ang

41、le handpieceangle handpiece with one or more additional angles placed so as to bring the working part of the instrument or tool approximately into line with the main axis of the handpiece3.6non-metallic chuckhandpiece chuck with non-metallic material on the contact surface of the shank holding mecha

42、nism3.7electrical motormotor powered by electrical energy, which is supplied by a dental unit2 BS EN ISO 14457:2012 EN ISO 14457:2012 (E) ISO 20133.8electrical powered scalerhandpiece powered by electrical energy, with an oscillating working part3.9working partpart of a fixed or interchangeable inst

43、rument connected to a handpiece3.10handpiecepowered handheld instrument used to operate a rotary, oscillating or reciprocating working part3.11handpiece attachmentextension part of a handpiece designed to hold a working part3.12handpiece chuckpart of the handpiece designed to securely hold the shank

44、 of a working part3.13high-speed air turbine handpiecehandpiece propelled by a small air-powered turbine (or rotor), capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with the turbine3.14intraoral camera handpiecehandpiece designed to take op

45、tical images in the oral cavity of the patient3.15motordevice, powered by air or electricity supplied by a dental unit, designed to transform energy into movement3.16polymerization handpiecehandpiece producing light that is applied directly to polymerizable dental materials in the oral cavity of a p

46、atient3.17prophy handpieceangle handpiece used for dental prophylaxis, driven by an air motor or an electrical motor3.18rotary instrumentrotating instrument used in a high-speed air turbine handpiece or in a straight and geared-angle handpiece, consisting of a shank and a working end used for dental

47、 procedures3.19reciprocating instrumentoscillating instrument used in a high-speed air turbine handpiece, or in a straight and geared-angle handpiece, consisting of a shank and a working end used for dental procedures3.20straight handpiecehandpiece with the input and output axes in alignment, driven

48、 by an air motor or an electrical motor or with an internal power supply3.21transmission partsmall tool (rotary or reciprocating) designed to transmit energy from the shank to the working end3BS EN ISO 14457:2012 EN ISO 14457:2012 (E) ISO 20133.22working enddistal end of a rotary or oscillating inst

49、rument intended for direct use in the oral cavity of the patient4 Classification of handpiecesHandpieces are classified according to their gear ratio into three types as given in Table 1.Table 1 Gear ratios for handpiecesType Gear ratio Resulting rotating speed Resulting torque Colour1 1:1 lower higher green2 1:1 constant constant blue3 1:1 higher lower red5 Requirements and performance5.1 GeneralThe construction of handpieces shall provide for their safe and reliable operation. Their use and manipu