1、September 2016 English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.25!%Zso“2558076www.din.
2、deDIN EN ISO 18397Dentistry Powered scaler (ISO 18397:2016);English version EN ISO 18397:2016,English translation of DIN EN ISO 18397:2016-09Zahnheilkunde Angetriebener Scaler (ISO 18397:2016);Englische Fassung EN ISO 18397:2016,Englische bersetzung von DIN EN ISO 18397:2016-09Mdecine bucco-dentaire
3、 Instruments pour le dtartrage (ISO 18397:2016);Version anglaise EN ISO 18397:2016,Traduction anglaise de DIN EN ISO 18397:2016-09SupersedesDIN EN ISO 15606:2000-07 andDIN EN ISO 22374:2005-12www.beuth.deDocument comprises 27 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-langu
4、age original shall be considered authoritative.08.16 DIN EN ISO 18397:2016-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 18397:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Commit
5、tee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Group NA 014-00-05-06 AK HKL-Systeme in Working Committee NA 014-00-05 AA Dentale Ausrstung. The DIN Standards co
6、rresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 5349-1 DIN EN ISO 5349-1 ISO 5349-2 DIN EN ISO 5349-2 ISO 7494-1 DIN EN ISO 7494-1 ISO 9168 DIN EN ISO 9168 ISO 9687 DIN EN ISO 9687 ISO 10993-1 DIN EN ISO 10993-1 ISO 14457 DIN EN IS
7、O 14457 ISO 15223-1 DIN EN ISO 15223-1 ISO 17664 DIN EN ISO 17664 ISO 21531 DIN EN ISO 21531 IEC 60601-1 DIN EN 60601-1 IEC 60601-1-2 DIN EN 60601-1-2 IEC 61672-1 DIN EN 61672-1 IEC 62366-1 DIN EN 62366-1 IEC 80601-2-60 DIN ISO 80601-2-60 Amendments This standard differs from DIN EN ISO 15606:2000-0
8、7 and DIN EN ISO 22374:2005-12 as follows: a) the two standards have been combined so that air-powered and electric-powered scalers are covered in one standard; b) terms and definitions are more precise (e.g. in the German version, the term “Scaler is used instead of “Zahnsteinentferner); c) provisi
9、ons for marking have been revised; d) scaler tips are now to be marked (Subclause 10.3); e) an example for calculating the power output of scaler tips is given in Annex A. Previous editions DIN EN ISO 15606: 2000-07 DIN EN ISO 22374: 2005-12 DIN EN ISO 18397:2016-08 3 National Annex NA (informative)
10、 Bibliography DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbance
11、s Requirements and tests DIN EN 61672-1, Electroacoustics Sound level meters Part -1: Specifications DIN EN 62366-1, Medical devices Part 1: Application of usability engineering to medical devices DIN EN 80601-2-60, Medical electrical equipment Part 2-60: Particular requirements for basic safety and
12、 essential performance of dental equipment DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 5349-1, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General rules DIN EN ISO 5349-2, Mechanical vibration Measurement and evaluation of human exposu
13、re to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplace DIN EN ISO 7494-1, Dentistry Dental units Part 1: General requirements and test methods DIN EN ISO 9168, Dentistry Hose connectors for air driven dental handpieces DIN EN ISO 9687, Dentistry Graphical symbol
14、s for dental instruments DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 14457, Dentistry Handpieces and motors DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and info
15、rmation to be supplied Part 1: General rules DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices DIN EN ISO 21531, Dentistry Graphical symbols for dental instruments DIN EN ISO 18397:2016-08 4 This pag
16、e is intentionally blank EUROPEAN 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 - Instruments pour le dtartrage (ISO 18397:2016) Zahnh
17、eilkunde - Angetriebener Scaler(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 this European Standard the status of a national standard without any alte
18、ration. 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 versions (English, French, German). A version in any other language mad
19、e 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 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Eston
20、ia, 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, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STAND
21、ARDIZATION 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 national Members. Ref. No. EN ISO 18397:2016 EForeword 5Introduction .
22、61 Scope .72 Normative references 73 Terms and definitions .84 Classification of scaler handpieces 95 Requirements and performance 95.1 General .95.2 Materials .95.3 Drop test .95.4 Noise level .95.5 Surfaces 105.6 Electrical power supply (if applicable) .105.7 Energy for light source (if applicable
23、) .105.8 Air supply 105.9 Supply of cooling liquid 105.10 Air and water pressure .105.11 Temperature .105.11.1 Temperature rise of housing 105.11.2 Temperature, excessive .115.12 Vibrations .115.13 Resistance to reprocessing 115.14 Leakage and/or ingress of water .115.15 Electromagnetic compatibilit
24、y .115.16 Operating controls 115.17 Usability .115.18 Connection .125.18.1 General.125.18.2 Connections for air-powered scaler handpieces .125.18.3 Connector for electrical-powered scaler handpieces 125.19 Scaler tip performance 125.19.1 Scaler tip connection .125.19.2 Extraction force (for non-scre
25、w tips only) .125.19.3 Holding torque (for screw-in-tips only) .125.19.4 Insertion force (for non-screw-tips only) 135.19.5 Tightening torque (for screw-in-tips only) 135.19.6 Stall effort 135.19.7 Power output, scaler tips .135.19.8 Breakage resistance .135.20 Frequency .135.21 Amplitude .136 Sampl
26、ing .137 Testing 147.1 General test conditions .147.2 Visual inspection 147.3 Power supply Electrical .147.4 Air supply 147.4.1 Apparatus 147.4.2 Procedure 14Contents Page2EN ISO 18397:2016 (E)DIN EN ISO 18397:2016-08 European foreword .47.6 Air and water pressure . 147.6.1 Apparatus 147.6.2 Procedu
27、re 147.7 Measuring device for dimensions 157.8 Scaler tips . 157.8.1 Extraction force (for non-screw-tips only). 157.8.2 Holding torque (for screw-in-tips only) . 157.8.3 Insertion force (for non-screw-tips only) 157.8.4 Tightening torque (for screw-in-tips only) 157.8.5 Stall effort 167.8.6 Power o
28、utput, scaler tips . 167.8.7 Breakage resistance .187.9 Frequency . 187.9.1 Apparatus 187.9.2 Procedure 187.10 Amplitude . 187.10.1 Apparatus 187.10.2 Procedure 197.11 Noise level 197.11.1 Apparatus 197.11.2 Test conditions207.11.3 Procedure 207.12 Temperature rise of housing 207.13 Temperature, exc
29、essive . 207.14 Resistance to reprocessing 208 Instructions for use, maintenance and service 209 Technical description .2110 Marking .2110.1 General 1210.2 Scaler handpieces 2110.3 Scaler tips . 2211 Labelling .2212 Packaging 22Annex A (informative) Calculation example for power output 233EN ISO 183
30、97:2016 (E)DIN EN ISO 18397:2016-08 7.5 Supply of cooling liquid 147.5.1 Apparatus 147.5.2 Procedure 14European 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 o
31、f 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 August 2016, and conflicting national standards shall be withdrawn at the latest by August 2016. This document supersedes EN
32、 ISO 22374:2005, EN ISO 15606:1999. 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. According to the CEN-CENELEC Internal Regulations,
33、 the national standards 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, La
34、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, 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. 4EN ISO 18397:2016
35、(E)DIN EN ISO 18397:2016-08 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
36、 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 Electrotechnical Comm
37、ission (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 s
38、hould 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
39、 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 for the c
40、onvenience 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 URL: Forew
41、ord - 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.5EN ISO 18397:2016 (E)DIN EN ISO 1839
42、7:2016-08 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, bo
43、th of the individual devices and in combination, is at an appropriate level.6EN ISO 18397:2016 (E)DIN EN ISO 18397:2016-08 1 ScopeThis International Standard specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrict
44、ive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers instructions, marking and packaging.2 Normative referencesThe following documents, in whole or in part, are normatively
45、referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 5349-1, Mechanical vibration Measure
46、ment and evaluation of human exposure to hand-transmitted vibration Part 1: General requirementsISO 5349-2, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplaceISO 7494-1, Dentistry Dental units Pa
47、rt 1: General requirements and test methodsISO 9168, Dentistry Hose connectors for air driven dental handpiecesISO 9687, Dental equipment Graphical symbols for dental equipmentISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 144
48、57, Dentistry Handpieces and motorsISO 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 the processing of resteri
49、lizable medical devicesISO 21531, Graphical symbols for dental instrumentsIEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and testsIEC 61672-1, Ele
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