DIN EN ISO 17509-2017 Dentistry - Torque transmitter for handpieces (ISO 17509 2016) German version EN ISO 17509 2016《牙科 手机用力矩式发送器(ISO 17509-2016) 德文版本EN ISO 17509-2016》.pdf

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1、February 2017 English price group 9No 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!%ang“2627568www.din.de

2、DIN EN ISO 17509Dentistry Torque transmitter for handpieces (ISO 17509:2016);English version EN ISO 17509:2016,English translation of DIN EN ISO 17509:2017-02Zahnheilkunde Drehmomentbertragung fr Handstcke (ISO 17509:2016);Englische Fassung EN ISO 17509:2016,Englische bersetzung von DIN EN ISO 17509

3、:2017-02Mdecine buccodentaire Transmetteur de couple pour pices main (ISO 17509:2016);Version anglaise EN ISO 17509:2016,Traduction anglaise de DIN EN ISO 17509:2017-02www.beuth.deDocument comprises 12 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be co

4、nsidered authoritative.02.17 DIN EN ISO 17509:2017-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17509:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, German

5、y). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Group NA 014-00-21-02 AK Instrumente fr die dentale Implantologie in Working Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to the Inte

6、rnational Standards referred to in Clause 2 of this standard are as follows: IEC 62366-1 DIN EN 62366-1 (VDE 0750-241-1) ISO 1797-1 DIN EN ISO 1797-1 ISO 1942 DIN EN ISO 1942 ISO 3274 DIN EN ISO 3274 ISO 4288 DIN EN ISO 4288 ISO 6507-1 DIN EN ISO 6507-1 ISO 10664 DIN EN ISO 10664 ISO 13504:2012 DIN

7、EN ISO 13504:2012-10 ISO 16443 DIN EN ISO 16443 National Annex NA (informative) Bibliography DIN EN 62366-1 (VDE 0750-241-1), Medical devices Part 1: Application of usability engineering to medical devices DIN EN ISO 1797-1, Dentistry Shanks for rotary instruments Part 1: Shanks made of metals DIN E

8、N ISO 1942, Dentistry Vocabulary DIN EN ISO 3274, Geometrical product specifications (GPS) Surface texture: Profile method Nominal characteristics of contact (stylus) instruments DIN EN ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and procedures for the as

9、sessment of surface texture DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methods DIN EN ISO 10664, Hexalobular internal driving feature for bolts and screws DIN EN ISO 13504:2012-10, Hydraulic fluid power General requirements for instruments and related accessories used i

10、n dental implant placement and treatment (ISO 13504:2012) DIN EN ISO 16443, Dentistry Vocabulary for dental implants systems and related procedure EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17509 October 2016 ICS 11.060.20 English Version Dentistry - Torque transmitter for handpieces(I

11、SO 17509:2016) Mdecine bucco-dentaire - Transmetteur de couple pour pices main (ISO 17509:2016) Zahnheilkunde - Drehmomentbertragungsschaft fr Chirurgiewinkelstcke (ISO 17509:2016) This European Standard was approved by CEN on 3 September 2016. CEN members are bound to comply with the CEN/CENELEC In

12、ternal 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 the CEN-CENELEC Management Centre or to a

13、ny 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 Centre has the same status as the official

14、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, Lithuania, Luxembourg, Malta, Netherlands, Norw

15、ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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 explo

16、itation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17509:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Classification 75 Intended performance . 76 Performance attributes . 76.1 Dimensions . 76.2

17、Performance 76.3 Material selection . 77 Performance evaluation . 98 Manufacturing . 99 Resistance to reprocessing 910 Information to be supplied by the manufacturer . 911 Testing . 911.1 Inspection of technical product file . 911.2 Dimensions . 911.3 Stall torque 1011.3.1 Apparatus 1011.3.2 Procedu

18、re 10Contents PageDIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E) 2Foreword .4European foreword This document (EN ISO 17509:2016) 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. Th

19、is 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 April 2017, and conflicting national standards shall be withdrawn at the latest by April 2017. Attention is drawn to the possibility that some of the

20、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 countries are bound to implement thi

21、s 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, Norway, Poland, Portugal, Romania, Slovaki

22、a, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17509:2016 has been approved by CEN as EN ISO 17509:2016 without any modification. DIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E)3 ForewordISO (the International Organization for Standardizatio

23、n) 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 in a subject for which a technical committee has been established has the right to be rep

24、resented 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 Commission (IEC) on all matters of electrotechnical standardization.The procedures used to dev

25、elop 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 should be noted. This document was drafted in accordance with the editorial rules of the IS

26、O/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 identifying any or all such patent rights. Details of any patent rights identified during

27、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 convenience of users and does not constitute an endorsement.For an explanation on the meaning

28、 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 Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this docum

29、ent is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.DIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E) 4 IntroductionBased on ISO 13504, this International Standard describes accessories that are inserted into dental handpieces and that impart rotational forces from a dental handpiece to

30、 dental implants or their connecting parts.DIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E)5 1 ScopeThis International Standard specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and

31、the further manipulation of connecting parts in the craniofacial area.This International Standard applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the

32、 power-driven systems themselves.This International Standard does not include the dental implant nor parts that would be connected to it.With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, perform

33、ance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applie

34、s. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 1797-1, Dentistry Shanks for rotary instruments Part 1: Shanks made of metalsISO 3274, Geometrical Product Specifications (GPS) Surface texture: Profile metho

35、d Nominal characteristics of contact (stylus) instrumentsISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and procedures for the assessment of surface textureISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 10664, Hexalobular interna

36、l driving feature for bolts and screwsISO 13504:2012, Dentistry General requirements for instruments and related accessories used in dental implant placement and treatmentISO 16443, Dentistry Vocabulary for dental implants systems and related procedureIEC 62366-1, Medical devices Part 1: Application

37、 of usability engineering to medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 13504, ISO 16443 and the following apply.3.1accessory used in dental implant placement and treatmentnon-invasive surgical device used with a transien

38、t usage in direct or indirect contact to the human body to be used in the placement of dental implants and the further manipulation of connecting partsDIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E) 6 3.2torque transmitternon-invasive surgical device designed to transmit a rotary movement from a dent

39、al handpiece to a dental implant or a dental implant connecting parts4 ClassificationTorque transmitters are classified according to ISO 13504:2012, 4.1 to 4.3 as given in Table 1.Table 1 Classification of torque transmitterISO 13504, SubclauseClassification requirementsSelection Description4.1 Inte

40、nded usage Type 1 Energized or motor-driven instrument4.2 Tissue contact Class 3 Without tissue contact4.3 Reprocessing Group 1 Multiple use5 Intended performanceISO 13504:2012, Clause 5 a) and b) and IEC 62366-1 apply.6 Performance attributesISO 13504:2012, Clause 6 applies.6.1 DimensionsThe dimens

41、ions and tolerances of the shank shall be in accordance with ISO 1797-1, Type 1 shank and the shape and dimensions of the head is at the discretion of the manufacturer.The surface roughness, as determined by the methods described in ISO 3274 and ISO 4288, shall be as specified in ISO 1797-1.Test in

42、accordance with 11.1.6.2 PerformanceTorque transmitters connected to an appropriate dental handpiece shall be designed to transmit a torque of at least 0,8 Nm for the insertion of dental implants.Shape and dimensions of engaging part of applicable implant bodies or connecting parts shall be containe

43、d at least in the labelled information.Test in accordance with 11.3.NOTE The measure detail is a limiting value on technical data and not a medical statement.The construction of torque transmitters shall provide for their safe and reliable operation in connection with dental handpieces in accordance

44、 with IEC 62366-1.6.3 Material selectionISO 13504:2012, Clause 7 applies.The manufacturer of the torque transmitter shall use a material as specified in ISO 13504:2012, Annex A.DIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E)7 The hardness for shanks made from steel, as determined by the method specif

45、ied in ISO 6507-1, shall be not less than 500 HV 5.Dimensions in millimetresFigure 1 Torque transmitter: Convex hexagonalFigure 2 Shapes of engaging part with implant bodies or connecting parts in torque transmitter: Concave-shapedFigure 3 Shapes of engaging part with implant bodies or connecting pa

46、rts in torque transmitter: Square-shapedDIN EN ISO 17509:2017-02 EN ISO 17509:2016 (E) 8 Figure 4 Shapes of engaging part with implant bodies or connecting parts in torque transmitter: Hexalobular-shaped (star-shaped)7 Performance evaluationISO 13504:2012, Clause 8 applies.8 ManufacturingISO 13504:2

47、012, Clause 9 applies.Torque transmitters shall be manufactured in accordance with the requirements specified in Clauses 6 and 7.Test in accordance with 11.1.9 Resistance to reprocessingISO 13504:2012, Clause 10 applies.All instruments intended for multiple use shall withstand 100 reprocessing cycles, as defined by the manufacturers instructions, without deterioration in performance or showing signs of corrosion.The reprocessing cycle shall include the recommended methods of cleaning, disinfection and sterilization.10 Information to be supplied by