EN ISO 22374-2005 Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips《牙科 牙钻手柄 电动刮器和刮器梢头》.pdf

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1、BRITISH STANDARDBS EN ISO 22374:2005Dentistry Dental handpieces Electrical-powered scalers and scaler tipsThe European Standard EN ISO 22374:2005 has the status of a British StandardICS 11.060.25g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g3

2、8g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 22374:2005This British St

3、andard was published under the authority of the Standards Policy and Strategy Committee on 16 January 2006 BSI 16 January 2006ISBN 0 580 47541 7National forewordThis British Standard is the official English language version of EN ISO 22374:2005. It is identical with ISO 22374:2005.The UK participati

4、on in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards whic

5、h implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publicati

6、on does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/E

7、uropean committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, t

8、he EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 10, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsCopyright European Committee for

9、Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22374September 2005ICS 11.060.25English VersionDentistry - Dental handpieces - Electrical-powered scalers and

10、scaler tips (ISO 22374:2005)Art dentaire - Pices main dentaires - Instruments pourdtartrage lectriques et parties actives des instrumentspour dtartrage (ISO 22374:2005)Zahnheilkunde - Zahnrztliche Handstcke - Elektrischbetriebene Scaler und Spitzen (ISO 22374:2005)This European Standard was approved

11、 by CEN on 13 August 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstanda

12、rds may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the

13、 Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

14、Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means

15、 reservedworldwide for CEN national Members.Ref. No. EN ISO 22374:2005: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Foreword This document (EN ISO 22374:2005) has been prepa

16、red 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 be given the status of a national standard, either by publication of an identical text or by endorsement, at the la

17、test by March 2006, and conflicting national standards shall be withdrawn at the latest by March 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Rep

18、ublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22374:2005 has been approved

19、 by CEN as EN ISO 22374:2005 without any modifications. EN ISO 22374:2005Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Reference numberISO 22374:2005(E)INTERNATIONAL STANDARD I

20、SO22374First edition2005-09-01Dentistry Dental handpieces Electrical-powered scalers and scaler tipsArt dentaire Pices main dentaires Instruments pour dtartrage lectriques et parties actives des instruments pour dtartrage EN ISO 22374:2005Copyright European Committee for Standardization Provided by

21、IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ii Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-iiiContents Page F

22、oreword iv 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Requirements 2 4.1 General design of handpiece connection 2 4.2 Scaler tip 2 4.3 Performance 2 4.4 Supply of cooling liquid . 3 4.5 Noise level . 3 4.6 Resistance to sterilization . 3 4.7 Energy for light source (if appli

23、cable) 3 4.8 Electrical power supply 3 5 Sampling 3 6 Test methods. 3 6.1 General. 3 6.2 Visual inspection 3 6.3 Scaler tip 4 6.4 Frequency 4 6.5 Amplitude, unloaded scaler tip . 5 6.6 Amplitude, loaded scaler tip 5 6.7 Supply of cooling liquid . 6 6.8 Noise level . 6 6.9 Resistance to sterilization

24、 . 7 6.10 Energy for light supply (if applicable) 7 7 Instructions for use, maintenance and service .8 8 Marking 9 9 Labelling 9 10 Packaging 9 Annex A (informative) Performance and general design . 10 EN ISO 22374:2005Copyright European Committee for Standardization Provided by IHS under license wi

25、th CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-iv Foreword ISO (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

26、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 part in the work. ISO

27、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/IEC Directives, Part 2. The main task of technical committees is to prepare Internationa

28、l 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 member bodies casting a vote. Attention is drawn to the possibility that some of the eleme

29、nts 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 22374 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. EN ISO 22374:2005Copyright European Committee for Sta

30、ndardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1Dentistry Dental handpieces Electrical-powered scalers and scaler tips 1 Scope This International Standard specifies requirements and test methods for electrical-pow

31、ered scalers and scaler tips, including piezo, ferrostrictive 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 references Th

32、e 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 1942, Dentistry Vocabulary ISO 7494-1, Dentistr

33、y Dental units Part 1: General requirements and test methods ISO 9687, Dental equipment Graphical symbols ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 17664, Sterilization of medical devices Information to be provided by the m

34、anufacturer for the processing of resterilizable medical devices IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety IEC 61012, Filters for the measurement of audible sound in the presence of ultrasound IEC 61672-1, Electroacoustics Sound level meters Part 1: Speci

35、fications 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 electrical powered scaler instrument with a oscillating scaler tip used in dental treatment consisting of a combination of a dental unit, a handpiece, the tub

36、ing connecting the handpiece to the dental unit, and an interchangeable scaler tip NOTE The system also includes a connection to a supply of cooling liquid. EN ISO 22374:2005Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networ

37、king permitted without license from IHS-,-,-2 3.2 scaler insert system interchangeable instrument used in an electrical-powered scaler and consisting of a working part and a transducer for dental scaling 3.3 scaler tip fixed or interchangeable instrument used in an electrical-powered scaler and cons

38、isting of a shaft and a working part for dental procedures 3.4 operating area of the scaler tip area for use, as described by the manufacturer for different scaler tips 4 Requirements 4.1 General design of handpiece connection The configuration, dimensions and tolerances of hose connections, tested

39、in accordance with 6.2, shall be in accordance with the manufacturers instructions for use. 4.2 Scaler tip 4.2.1 Extraction force When installed in accordance with the manufacturers instructions for use, the scaler tip, tested in accordance with 6.3.1, shall withstand, without displacement, a minimu

40、m axial tension force of 20 N. 4.2.2 Torque (for screw-in-tips only) The following requirement is only applicable for screw-in-tips. When installed in accordance with the manufacturers instructions, the scaler tip, tested in accordance with 6.3.2, shall withstand, without rotation displacement, a mi

41、nimum torque of 200 N.mm. 4.2.3 Insertion of the scaler tip The force required to insert and secure the scaler tip in the handpiece shall not exceed 30 N when tested in accordance with 6.3.3. 4.3 Performance 4.3.1 Frequency When operated at the settings recommended by the manufacturer, the frequency

42、 of the scaler tip, tested in accordance with 6.4, shall be between 18 000 Hz and 60 000 Hz. 4.3.2 Amplitude, unloaded scaler tip When operated at the maximum power recommended by the manufacturer, the maximum unloaded peak to peak excursion of the scaler tip, tested in accordance with 6.5, shall no

43、t exceed 200 m. EN ISO 22374:2005Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-34.3.3 Amplitude, loaded scaler tip When operated with the maximum power recommended by the manuf

44、acturer, in a direction perpendicular to the plane of vibration (or to the vibration direction) and under a load of 1 N, the maximum amplitude of the working tip, tested in accordance with 6.6, shall not exceed 200 m. 4.4 Supply of cooling liquid When operated at the maximum power recommended by the

45、 manufacturer, the liquid cooling capability to the operating area of the scaler tip, tested in accordance with 6.7, shall be less than 50 ml/min. 4.5 Noise level When operated at the maximum power recommended by the manufacturer, the A-weighted sound pressure value generated, tested in accordance w

46、ith 6.8, shall not exceed 70 dB. 4.6 Resistance to sterilization Electrically powered scaler handpieces and scaler tips shall be capable of withstanding a minimum of 250 sterilization cycles as defined in the manufacturers instructions for use without deterioration in appearance or performance. Sing

47、le use handpieces or the disposable (non-reusable) parts of other handpieces, tested in accordance with 6.9, shall be supplied sterile or be capable of withstanding one sterilization cycle, as defined in the manufacturers instructions, without deterioration in appearance or performance. 4.7 Energy f

48、or light source (if applicable) The voltage of the light source in the handpiece, tested in accordance with 6.10, shall not exceed a nominal value of 25 V a.c. or 60 V d.c. on the transformer or converter, between conductors in an earth-free circuit which is isolated from the supply main by a safety transformer or by a device with an equivalent separation. 4.8 Electrical power supply This shall be as specified by the manufacturer and complying with ISO 7494-1. 5 Sampling At least one handpiece or insert (scaler tip type) for each model