EN ISO 14457-2017 Dentistry - Handpieces and motors.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Handpieces and motorsBS EN ISO 14457:2017National forewordThis British Standard is the UK implementation of EN ISO 14457:2017. It is identical to ISO 14457:2017. It supersedes BS EN ISO 14457:2012, which is

2、withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provision

3、s of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 87563 2ICS 11.060.25Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published un

4、der the authority of the Standards Policy and Strategy Committee on 28 February 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 14457:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14457December 2017ICS 11.060.25 Supersedes EN ISO 14457:2012E

5、UROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 14457:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersD

6、entistry - Handpieces and motors (ISO 14457:2017)Mdecine bucco-dentaire - Pices main et moteurs (ISO 14457:2017)Zahnheilkunde - Handstcke und Motoren (ISO 14457:2017)This European Standard was approved by CEN on 17 August 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations

7、 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-CENELEC Management Centre or to any CEN member.This

8、 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 Centre has the same status as the official versions.CEN member

9、s 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal

10、 Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 14457:2017 (E)European forewordThis document (EN ISO 14457:2017) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Den

11、tistry” 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 June 2018, and conflicting national standards shall be withdrawn at the latest by June 2018.Attentio

12、n is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 14457:2012.According to the CEN-CENELEC Internal Regulations, the national sta

13、ndards organizations 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 Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

14、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 14457:2017 has been approved by CEN as EN ISO 14457:2017 without any modification.2BS EN ISO 14457:2017ISO 14457:

15、2017(E)Foreword 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 Drop test . 55.4 Noise level . 55.5 Surfaces . 55.6 Power supply 55.6.1 Electrical power supply . 55.6.2 Air supply .

16、55.6.3 Water supply . 65.7 Air and water pressure 65.8 Temperature 65.8.1 General 65.8.2 Temperature rise of housing . 75.8.3 Excessive temperature 75.9 Vibrations 85.10 Resistance to reprocessing . 85.11 Leakage and/or ingress of water 85.12 Electromagnetic compatibility 85.13 Operating controls .

17、85.14 Usability 85.15 Connection and supply . 85.15.1 General 85.15.2 Connections for high-speed air turbine handpiece and air motor connectors 95.15.3 Connection for handpieces and motors . 95.16 Chuck system for shanks . 115.16.1 Metallic chuck system.115.16.2 Non-metallic chuck system 115.17 Test

18、 mandrel 115.18 Speed 135.19 Eccentricity . 135.20 Stall torque 135.21 Dimensions of head and nose 135.22 Output power of high-speed air turbine handpiece 145.23 Handpieces with light 156 Sampling .157 Testing 157.1 General test conditions . 157.2 Visual inspection 157.3 Power supply Electrical . 15

19、7.4 Power supply Air . 157.4.1 Apparatus 157.4.2 Procedure 157.5 Spray air supply . 167.5.1 Apparatus 167.5.2 Procedure 167.6 Water supply 16 ISO 2017 All rights reserved iiiContents PageBS EN ISO 14457:2017ISO 14457:2017(E)7.6.1 Apparatus 167.6.2 Procedure 167.7 Air and water pressure . 167.7.1 App

20、aratus 167.7.2 Procedure 177.8 Motor cooling air 177.8.1 Apparatus 177.8.2 Procedure 177.9 Handpiece cooling air 177.9.1 Apparatus 177.9.2 Procedure 187.10 Connection for handpieces and motors 197.11 Connection and supply 197.11.1 Apparatus 197.11.2 Procedure 197.12 Test mandrels 197.13 Chuck for sh

21、anks 197.13.1 Extraction test .197.13.2 Torque test . 197.14 Dimensions of head and nose 207.14.1 Apparatus 207.14.2 Procedure 207.15 Eccentricity . 207.15.1 Apparatus 207.15.2 Procedure 207.16 Stall torque 207.16.1 Apparatus 207.16.2 Procedure 207.17 Noise level 217.17.1 Apparatus 217.17.2 Test con

22、ditions217.17.3 Procedure 217.18 Speed 217.18.1 Apparatus 217.18.2 Procedure 217.19 Temperature rise of housing 217.19.1 Temperature rise of motors 217.19.2 Temperature rise for handpieces 217.20 Excessive temperature 227.20.1 Excessive temperature for motors.227.20.2 Excessive temperature for handp

23、ieces .227.21 Resistance to reprocessing 237.22 Output power of high-speed air turbine handpieces 237.22.1 Apparatus 237.22.2 Procedure 237.23 Handpieces with light 247.23.1 Apparatus 247.23.2 Procedure 248 Instructions for use, maintenance and service 259 Technical description .2610 Marking .2610.1

24、 General 2610.2 Handpieces 2610.3 Motors 2611 Labelling .2612 Packaging 27iv ISO 2017 All rights reservedBS EN ISO 14457:2017ISO 14457:2017(E)Annex A (informative) Handpiece and motor category tree .28Annex B (informative) Test report form 30Bibliography .35 ISO 2017 All rights reserved vBS EN ISO 1

25、4457:2017ISO 14457:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested i

26、n a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commis

27、sion (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents sho

28、uld be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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 id

29、entifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the conve

30、nience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Tech

31、nical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This second edition cancels and replaces the first edition (ISO 14457:2012), which has been technically re

32、vised.The main changes compared to the previous edition are as follows: use of terms for handpieces and motors has been clarified; output power for high-speed air turbine handpieces has been added; light for handpieces has been added; a few technical data have been corrected; an example for the test

33、 report has been added in Annex B.vi ISO 2017 All rights reservedBS EN ISO 14457:2017Dentistry - Handpieces and motors1 ScopeThis document specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their con

34、struction. It also specifies requirements for manufacturers information, marking and packaging.This document is applicable to the following:a) straight and angle handpieces;b) high-speed air turbine handpieces;c) air motors;d) electrical motors;e) prophy handpieces.This document is not applicable to

35、 the following: intraoral camera handpieces; powered polymerization handpieces; air-powered scalers; electrical-powered scalers; powder jet handpieces; multifunction handpieces (syringes).NOTE See Annex A for clarification of handpieces and motor types covered by this document.2 Normative references

36、The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applie

37、s.ISO 1797, Dentistry Shanks for rotary and oscillating instrumentsISO 1942, Dentistry VocabularyISO 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indicationsISO 2768-2, General tolerances Part 2: Geometrical tolerances for features with

38、out individual tolerance indicationsISO 3964, Dentistry Coupling dimensions for handpiece connectorsISO 5349-1, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirementsINTERNATIONAL STANDARD ISO 14457:2017(E) ISO 2017 All rights res

39、erved 1BS EN ISO 14457:2017ISO 14457:2017(E)ISO 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 7494-1, Denti

40、stry Dental units Part 1: General requirements and test methodsISO 9168, Dentistry Hose connectors for air driven dental handpiecesISO 9687, Dentistry Graphical symbols for dental equipmentISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management p

41、rocessISO 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 1: General requirementsISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for th

42、e processing of resterilizable medical devicesISO 21531, Dentistry Graphical symbols for dental instrumentsIEC 60601-1:2005+AMD1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 61672-1, Electroacoustics Sound level meters Part 1: Specific

43、ationsIEC 62366-1, Medical devices Part 1: Application of usability engineering to medical devicesIEC 80601-2-60:2012, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment3 Terms and definitionsFor the purposes of this documen

44、t, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1a

45、ir motormotor (3.14) powered by compressed air, which is supplied by a dental unit3.2powder jet handpiecehandpiece (3.10) powered by compressed air, designed to deliver powder to the patients oral cavity at high velocity3.3air-powered scalerhandpiece (3.10) powered by compressed air, with an oscilla

46、ting working part3.4angle handpiecehandpiece (3.10) with an angle between the input and output axes, driven by an air motor (3.1) or an electrical motor (3.7) or with an internal power supply, including extension part of a handpiece designed to hold a working part (3.9) 2 ISO 2017 All rights reserve

47、dBS EN ISO 14457:2017ISO 14457:2017(E)3.5contra-angle handpieceangle handpiece (3.4) with one or more additional angles placed so as to bring the working part (3.9) of the instrument or tool approximately into line with the main axis of the handpiece (3.10) 3.6non-metallic chuckhandpiece (3.10) chuc

48、k with non-metallic material on the contact surface of the shank holding mechanism3.7electrical motormotor (3.14) powered by electrical energy, which is supplied by a dental unit3.8electrical-powered scalerhandpiece (3.10) powered by electrical energy, with an oscillating working part3.9working part

49、part of a fixed or interchangeable instrument connected to a dental handpiece3.10handpiecepowered handheld instrument used to operate a rotary, oscillating or reciprocating working part (3.9) 3.11handpiece chuckpart of the handpiece (3.10) designed to securely hold the shank of a working part (3.9) 3.12high-speed air turbine handpiecehandpiece (3.10) 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