EN ISO 17509-2016 en Dentistry - Torque transmitter for handpieces《牙科-手机扭矩变送器(ISO 17509 2016)》.pdf

1、BS EN ISO 17509:2016Dentistry Torque transmitterfor handpieces (ISO17509:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 17509:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 17509:2016.The UK participatio

2、n 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 provisions of a contract. Users are re

3、sponsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82777 8 ICS 11.060.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the St

4、andards Policy and Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17509 October 2016 ICS 11.060.20 English Version Dentistry - Torque transmitter for handpieces (ISO 17509:2016)

5、 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 Internal Regulat

6、ions 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.

7、 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 versions. CEN

8、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, Norway, Poland, Po

9、rtugal, 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 exploitation in any

10、 form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17509:2016 EBS EN ISO 17509:2016EN ISO 17509:2016 (E) 3 European foreword This document (EN ISO 17509:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CE

11、N/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 latest by April 2017, and conflicting national standards shall be withdrawn at the latest by Apri

12、l 2017. 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, the national standards orga

13、nizations 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, Luxembourg,

14、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, 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. ISO 2016Dentistry Torque transmitter for handpi

15、ecesMdecine bucco-dentaire Transmetteur de couple pour pices mainINTERNATIONAL STANDARDISO17509First edition2016-10-01Reference numberISO 17509:2016(E)ISO 17509:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise

16、specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

17、or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS EN ISO 17509:2016ISO 17509:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13

18、 Terms and definitions . 14 Classification 25 Intended performance . 26 Performance attributes . 26.1 Dimensions . 26.2 Performance 26.3 Material selection . 27 Performance evaluation . 48 Manufacturing . 49 Resistance to reprocessing 410 Information to be supplied by the manufacturer . 411 Testing

19、. 411.1 Inspection of technical product file . 411.2 Dimensions . 411.3 Stall torque . 511.3.1 Apparatus . 511.3.2 Procedure . 5 ISO 2016 All rights reserved iiiContents PageBS EN ISO 17509:2016ISO 17509:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federatio

20、n 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 represented on that committee.

21、 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 develop this document and thos

22、e 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 ISO/IEC Directives, Part 2 (s

23、ee 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 the development of the docu

24、ment 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 of ISO specific terms and

25、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 document is ISO/TC 106, Dentistr

26、y, Subcommittee SC 4, Dental instruments.iv ISO 2016 All rights reservedBS EN ISO 17509:2016ISO 17509:2016(E)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 dental

27、implants or their connecting parts. ISO 2016 All rights reserved vBS EN ISO 17509:2016BS EN ISO 17509:2016Dentistry Torque transmitter for handpieces1 ScopeThis International Standard specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiec

28、e as an accessory in the placement of dental implants and 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

29、having torque control mechanism, but does not apply to the 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 perfor

30、mance, performance attributes, material selection, performance 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 applic

31、ation. 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 1797-1, Dentistry Shanks for rotary instruments Part 1: Shanks made of metalsISO 3274, Geometrical P

32、roduct Specifications (GPS) Su rface texture: Profile method No minal characteristics of contact (stylus) instrumentsISO 4288, Geometrical Product Specifications (GPS) Su rface texture: Profile method Ru les and procedures for the assessment of surface textureISO 6507-1, Metallic materials Vickers h

33、ardness test Part 1: Test methodISO 10664, Hexalobular internal 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 rel

34、ated procedureIEC 62366-1, Medical devices Part 1: Application 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

35、and treatmentnon-invasive surgical device used with a transient 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 partsINTERNATIONAL STANDARD ISO 17509:2016(E) ISO 2016 All rights reserved 1BS EN ISO 17509:

36、2016ISO 17509:2016(E)3.2torque transmitternon-invasive surgical device designed to transmit a rotary movement from a dental 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

37、.Table 1 Classification of torque transmitterISO 13504, SubclauseClassification requirementsSelection Description4.1 Intended 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, C

38、lause 5 a) and b) and IEC 62366-1 apply.6 Performance attributesISO 13504:2012, Clause 6 applies.6.1 DimensionsThe dimensions 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

39、 roughness, as determined by the methods described in ISO 3274 and ISO 4288, shall be as specified in ISO 1797-1.Test in 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

40、 dental implants.Shape and dimensions of engaging part of applicable implant bodies or connecting parts shall be contained 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 t

41、orque transmitters shall provide for their safe and reliable operation in connection with dental handpieces in accordance 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.2

42、ISO 2016 All rights reservedBS EN ISO 17509:2016ISO 17509:2016(E)The hardness for shanks made from steel, as determined by the method specified 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 i

43、mplant bodies or connecting parts in torque transmitter: Concave-shapedFigure 3 Shapes of engaging part with implant bodies or connecting parts in torque transmitter: Square-shaped ISO 2016 All rights reserved 3BS EN ISO 17509:2016ISO 17509:2016(E)Figure 4 Shapes of engaging part with implant bodies

44、 or connecting parts in torque transmitter: Hexalobular-shaped (star-shaped)7 Performance evaluationISO 13504:2012, Clause 8 applies.8 ManufacturingISO 13504:2012, Clause 9 applies.Torque transmitters shall be manufactured in accordance with the requirements specified in Clauses 6 and 7.Test in acco

45、rdance 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 sh

46、all include the recommended methods of cleaning, disinfection and sterilization.10 Information to be supplied by the manufacturerISO 13504:2012, Clause 11 applies.Shape and dimensions of engaging part of applicable implant bodies or connecting parts shall be contained at least in the labelled inform

47、ation.Instruments and related accessories shall be marked with name or registered trademark of manufacturer, where appropriate.11 Testing11.1 Inspection of technical product fileVisually inspect the technical product file to determine compliance with the requirements.11.2 DimensionsTesting shall be

48、carried out by visual inspection and measurement of all dimensions described by the manufacturer by using appropriate measuring instruments.4 ISO 2016 All rights reservedBS EN ISO 17509:2016ISO 17509:2016(E)11.3 Stall torque11.3.1 Apparatusa) Chuck system, in accordance with ISO 1797-1.b) Torque wat

49、ch or dynamometer, capable of measuring the torque, in Newton metres, with an accuracy of 10 %.11.3.2 ProcedureInsert and fix the torque transmitter in the chuck system and connect the torque measuring device to the outer end of the torque transmitter. Rotate the torque; watch slowly until it reaches the maximum allowed torque. No sign of deformation shall be observed. ISO 2016 All rights reserved 5BS EN ISO 17509:2016ISO 17509:2016(E) ISO 2016 All rights reservedICS 11.060.20Price bas