EN ISO 18397-2016 en Dentistry - Powered scaler《牙科 电刮器(ISO 18397 2016)》.pdf

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1、BSI Standards PublicationBS EN ISO 18397:2016Dentistry Powered scalerBS EN ISO 18397:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 18397:2016. It supersedes BS EN ISO 15606:2000 and BS EN ISO 22374:2005 which are withdrawn.BSI, as a member of CEN, is

2、obliged to publish EN ISO 18397 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the UK Committee voted against its approval as a European Standard.This is because the UK Committee has concerns about two requirements in the standar

3、d.Clause 5.19.2, Extraction force (non-screw tip only), requires that an insert shall withstand, without displacement, a minimum axial tension force of 20 N. Recent data suggests that this force would be excessive for magnetostrictive inserts which rely on an O-ring for retention, to the point that

4、the user would find it difficult to remove the insert after use.Clause 7.14, Resistance to reprocessing, requires that 250 reprocessing cycles are carried out as specified in the manufacturers instruction. If the manufacturer states a lower number of permitted reprocessing cycles then the device is

5、to withstand this number multiplied by 1,5. The UK committee has concerns that this is excessive.The UK Committee will be seeking a solution to these issues for the next revision of the standard.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcom

6、mittee CH/106/4, Dental Instruments and Equipment.A list of 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 Briti

7、sh Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 81000 8ICS 11.060.25Compliance 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 31 March

8、 2016.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18397 February 2016 ICS 11.060.25 Supersedes EN ISO 15606:1999, EN ISO 22374:2005English Version Dentistry - Powered scaler (ISO 18397:2016) Mdecine bucco-dentaire - Instrum

9、ents pour le dtartrage (ISO 18397:2016) Zahnheilkunde - Zahnreiniger (Scaler) und dazugehrige Spitzen (ISO 18397:2016) This European Standard was approved by CEN on 24 October 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving th

10、is 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 European Standard exists in three official

11、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 members are the national standards bodies of Aust

12、ria, 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, Romania, Slovakia, Slovenia, Spain, Swede

13、n, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN

14、 national Members. Ref. No. EN ISO 18397:2016 E3 European foreword This document (EN ISO 18397:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall b

15、e given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2016, and conflicting national standards shall be withdrawn at the latest by August 2016. This document supersedes EN ISO 22374:2005, EN ISO 15606:1999. Attention is drawn

16、 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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following

17、 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, Luxembourg, Malta, Netherlands, Norwa

18、y, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 18397:2016 has been approved by CEN as EN ISO 18397:2016 without any modification. Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and d

19、efinitions . 24 Classification of scaler handpieces 35 Requirements and performance 35.1 General . 35.2 Materials . 35.3 Drop test . 35.4 Noise level . 35.5 Surfaces . 45.6 Electrical power supply (if applicable) 45.7 Energy for light source (if applicable) 45.8 Air supply . 45.9 Supply of cooling l

20、iquid . 45.10 Air and water pressure 45.11 Temperature 45.11.1 Temperature rise of housing . 45.11.2 Temperature, excessive 55.12 Vibrations 55.13 Resistance to reprocessing . 55.14 Leakage and/or ingress of water 55.15 Electromagnetic compatibility 55.16 Operating controls . 55.17 Usability 55.18 C

21、onnection 65.18.1 General 65.18.2 Connections for air-powered scaler handpieces 65.18.3 Connector for electrical-powered scaler handpieces . 65.19 Scaler tip performance . 65.19.1 Scaler tip connection 65.19.2 Extraction force (for non-screw tips only) 65.19.3 Holding torque (for screw-in-tips only)

22、 65.19.4 Insertion force (for non-screw-tips only) . 75.19.5 Tightening torque (for screw-in-tips only) . 75.19.6 Stall effort . 75.19.7 Power output, scaler tips 75.19.8 Breakage resistance 75.20 Frequency 75.21 Amplitude 76 Sampling 77 Testing . 87.1 General test conditions 87.2 Visual inspection

23、. 87.3 Power supply Electrical 87.4 Air supply . 87.4.1 Apparatus . 87.4.2 Procedure . 87.5 Supply of cooling liquid . 87.5.1 Apparatus . 87.5.2 Procedure . 8 ISO 2016 All rights reserved iiiContents PageBS EN ISO 18397:2016EN ISO 18397:2016 (E)Foreword vIntroduction vi1 Scope . 12 Normative referen

24、ces 13 Terms and definitions . 24 Classification of scaler handpieces 35 Requirements and performance 35.1 General . 35.2 Materials . 35.3 Drop test . 35.4 Noise level . 35.5 Surfaces . 45.6 Electrical power supply (if applicable) 45.7 Energy for light source (if applicable) 45.8 Air supply . 45.9 S

25、upply of cooling liquid . 45.10 Air and water pressure 45.11 Temperature 45.11.1 Temperature rise of housing . 45.11.2 Temperature, excessive 55.12 Vibrations 55.13 Resistance to reprocessing . 55.14 Leakage and/or ingress of water 55.15 Electromagnetic compatibility 55.16 Operating controls . 55.17

26、 Usability 55.18 Connection 65.18.1 General 65.18.2 Connections for air-powered scaler handpieces 65.18.3 Connector for electrical-powered scaler handpieces . 65.19 Scaler tip performance . 65.19.1 Scaler tip connection 65.19.2 Extraction force (for non-screw tips only) 65.19.3 Holding torque (for s

27、crew-in-tips only) 65.19.4 Insertion force (for non-screw-tips only) . 75.19.5 Tightening torque (for screw-in-tips only) . 75.19.6 Stall effort . 75.19.7 Power output, scaler tips 75.19.8 Breakage resistance 75.20 Frequency 75.21 Amplitude 76 Sampling 77 Testing . 87.1 General test conditions 87.2

28、Visual inspection . 87.3 Power supply Electrical 87.4 Air supply . 87.4.1 Apparatus . 87.4.2 Procedure . 87.5 Supply of cooling liquid . 87.5.1 Apparatus . 87.5.2 Procedure . 8 ISO 2016 All rights reserved iiiContents PageBS EN ISO 18397:2016ISO 18397:2016(E)7.6 Air and water pressure 87.6.1 Apparat

29、us . 87.6.2 Procedure . 87.7 Measuring device for dimensions . 97.8 Scaler tips 97.8.1 Extraction force (for non-screw-tips only) 97.8.2 Holding torque (for screw-in-tips only) 97.8.3 Insertion force (for non-screw-tips only) . 97.8.4 Tightening torque (for screw-in-tips only) . 97.8.5 Stall effort

30、107.8.6 Power output, scaler tips . 107.8.7 Breakage resistance .127.9 Frequency . 127.9.1 Apparatus 127.9.2 Procedure 127.10 Amplitude . 127.10.1 Apparatus 127.10.2 Procedure 137.11 Noise level 137.11.1 Apparatus 137.11.2 Test conditions147.11.3 Procedure 147.12 Temperature rise of housing 147.13 T

31、emperature, excessive . 147.14 Resistance to reprocessing 148 Instructions for use, maintenance and service 149 Technical description .1510 Marking .1510.1 General 1510.2 Scaler handpieces 1510.3 Scaler tips . 1611 Labelling .1612 Packaging 16Annex A (informative) Calculation example for power outpu

32、t 17iv ISO 2016 All rights reserved 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 in

33、terested in 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 Electrotechni

34、cal Commission (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 doc

35、uments should 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 respons

36、ible for identifying 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 f

37、or the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following UR

38、L: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This first edition of ISO 18397 cancels and replaces ISO 15606:1999 and ISO 22374:2005, which have been technically revised. ISO 2016 All rights reserved

39、 vBS EN ISO 18397:2016ISO 18397:2016(E)7.6 Air and water pressure 87.6.1 Apparatus . 87.6.2 Procedure . 87.7 Measuring device for dimensions . 97.8 Scaler tips 97.8.1 Extraction force (for non-screw-tips only) 97.8.2 Holding torque (for screw-in-tips only) 97.8.3 Insertion force (for non-screw-tips

40、only) . 97.8.4 Tightening torque (for screw-in-tips only) . 97.8.5 Stall effort 107.8.6 Power output, scaler tips . 107.8.7 Breakage resistance .127.9 Frequency . 127.9.1 Apparatus 127.9.2 Procedure 127.10 Amplitude . 127.10.1 Apparatus 127.10.2 Procedure 137.11 Noise level 137.11.1 Apparatus 137.11

41、.2 Test conditions147.11.3 Procedure 147.12 Temperature rise of housing 147.13 Temperature, excessive . 147.14 Resistance to reprocessing 148 Instructions for use, maintenance and service 149 Technical description .1510 Marking .1510.1 General 1510.2 Scaler handpieces 1510.3 Scaler tips . 1611 Label

42、ling .1612 Packaging 16Annex A (informative) Calculation example for power output 17iv ISO 2016 All rights reserved ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standar

43、ds 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, governmental and non-governmental, in liaison with ISO, also take

44、 part in the work. ISO collaborates closely with the International Electrotechnical Commission (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 part

45、icular the different approval criteria needed for the different types of ISO documents should 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

46、this document may be the subject of patent rights. ISO shall not be held responsible for identifying 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 w

47、ww.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to

48、the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This first edition of ISO 18397 cancels and replaces ISO 15606:1999 and I

49、SO 22374:2005, which have been technically revised. ISO 2016 All rights reserved vBS EN ISO 18397:2016ISO 18397:2016(E)IntroductionDental scaler handpieces and scaler tips have been used in dental treatment procedures for many years.As technical development has resulted in improved scaler handpieces and tips, this revised International Standard is necessary to ensure the level of safety and performance, both of the individual devices and in combination, is at an appropriate level.vi ISO 2016 All rights reserved Dentistry Powered scaler1 ScopeT