EN ISO 17937-2015 en Dentistry - Osteotome《牙科 骨凿(ISO 17937 2015)》.pdf

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1、BSI Standards PublicationBS EN ISO 17937:2015Dentistry - OsteotomeBS EN ISO 17937:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 17937:2015.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equ

2、ipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015.Published by BSI St

3、andards Limited 2015ISBN 978 0 580 78550 4ICS 11.060.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued since publicati

4、onDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17937 September 2015 ICS 11.060.01 English Version Dentistry - Osteotome (ISO 17937:2015) Mdecine bucco-dentaire - Ostotome (ISO 17937:2015) Zahnheilkunde - Osteotome (ISO 17937:2015) This European Standard was approved by

5、CEN on 22 August 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 alteration. Up-to-date lists and bibliographical references concerning such national standar

6、ds 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 made by translation under the responsibility of a CEN member into its own language and noti

7、fied 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, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ic

8、eland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, 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 Man

9、agement Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17937:2015 EEN ISO 17937:2015 (E) 3 European foreword This document (EN ISO 17937:2015) has been prepared by Technical Commi

10、ttee 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 latest by March 2016, and

11、 conflicting national standards shall be withdrawn at the latest by March 2016. 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. Accord

12、ing to the CEN-CENELEC Internal Regulations, 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,

13、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17937:2015 has been approved by CEN as EN ISO 17937:2015 w

14、ithout any modification. BS EN ISO 17937:2015BS EN ISO 17937:2015 ISO 2015Dentistry OsteotomeMdecine bucco-dentaire OstotomeINTERNATIONAL STANDARDISO17937First edition2015-09-15Reference numberISO 17937:2015(E)BS EN ISO 17937:2015ISO 17937:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DO

15、CUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise 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 writte

16、n permission. Permission can be requested from either ISO at the address below 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 17937:201

17、5ISO 17937:2015(E)Foreword ivIntroductionv1 Scope. 12 Normative references 13 Terms, definitions, and symbols 13.1 Terms and definitions . 13.2 Symbols . 24 Classification 25 Shapes 25.1 Sinutome 25.2 Condenser . 35.3 Chisel . 46 Material 56.1 Material of the working end 56.2 Material for the handle

18、. 57 Requirements 57.1 Dimensions . 57.1.1 Diameter of the working end (D1, D2) . 57.1.2 Overall length 57.2 Marking on the working end . 67.2.1 General 67.2.2 Thickness of scale line . 67.3 Surface finish 67.4 Resistance to reprocessing . 67.5 Hardness of the working end . 67.6 Connection of shank

19、and handle 68 Test method . 68.1 Measurement of length and diameter . 68.2 Test on surface finish . 68.3 Test on resistance to reprocessing . 68.4 Hardness test 68.5 Connection of shank . 78.5.1 Test under tensile force 78.5.2 Test under torque 79 Marking, labelling, and instructions for use . 79.1

20、Marking on the osteotome 79.2 Labelling on the package 7Bibliography9.3 Instructions for use . 78 ISO 2015 All rights reserved iiiContents PageForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep

21、aring 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. International organizations, governmental and non-governmental, in

22、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 those intended for its further maintenance are described in the ISO/IEC

23、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 (see www.iso.org/directives).Attention is drawn to the possibility tha

24、t 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 document will be in the Introduction and/or on the ISO list of patent de

25、clarations 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 expressions related to conformity assessment, as well as information

26、 about ISOs adherence to 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.iv ISO 2015 All rights reservedBS EN ISO 17937:2

27、015ISO 17937:2015(E)IntroductionOsteotomes are instruments generally used in orthopaedic surgery. However, in dentistry, and more specific, when preparing the implant site for dental implants, certain types of osteotomes are used for bone compaction, sinus floor elevation, and jaw bone cleaving. The

28、se types of osteotomes are addressed in this International Standard. ISO 2015 All rights reserved vBS EN ISO 17937:2015ISO 17937:2015(E)BS EN ISO 17937:2015BS EN ISO 17937:2015Dentistry Osteotome1 ScopeThis International Standard specifies requirements and their test methods for osteotomes used in d

29、entistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving. It also specifies the requirements for their marking and labelling.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its applic

30、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 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1, Metallic materials R

31、ockwell hardness test Part 1: Test methodISO 13504, Dentistry General requirements for instruments and related accessories used in dental implant placement and treatmentISO 15087-1, Dental elevators Part 1: General requirementsISO 16443, Dentistry Vocabulary for dental implants systems and related p

32、rocedure3 Terms, definitions, and symbols3.1 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 13504, ISO 16443 and the following apply.3.1.1osteotomehandheld dental instrument designed for bone compaction, internal sinus floor elevation, or jaw

33、 bone cleavingNote 1 to entry: Osteotomes consist of a working tip, a shank, and a handle.3.1.2condenserbone-condenserworking endhandheld dental instrument, with conical shaped (3.1.5), used for compacting the maxillary bone surrounding the implant socket to improve the primary stability of the impl

34、ant3.1.3chiselhandheld dental instrument designed for cleaving the jaw bone into a buccal and lingual or buccal and palatinal bone lamelle in order to insert an implant in betweenNote 1 to entry: Chisels can also be used selectively to remove bone for procedures such as grafting and transplantation.

35、INTERNATIONAL STANDARD ISO 17937:2015(E) ISO 2015 All rights reserved 1BS EN ISO17937:2015ISO 17937:2015(E)3.1.4sinutomehandheld dental instrument for performing an internal sinus floor elevation, where the sinus floor is elevated cranially through the oral cavity with different sized instrumentsNot

36、e 1 to entry: Another term for internal sinus floor elevation is sinus floor elevation according to Summer.3.1.5working endpart of the osteotome (3.1.1) consisting of a working tip (3.1.6) and a shank connected to the handle (3.1.7)3.1.6working tipthe most frontal area of the instrument which is use

37、d for working3.1.7handlearea used for holding the instrument during operation3.1.8impact surfacebackward area of the instrument used for receiving the hitting of the malletNote 1 to entry: Another term for mallet is hammer.3.2 SymbolsThe symbols used in Figure 1 to Figure 8 are the following:L1total

38、 length;D1diameter or width of the active area;D2maximum diameter at the beginning of the active area.4 ClassificationFor the purposes of this International Standard, osteotomes shall be classified according to the shapes into the following types: Type 1: sinutome Type 2: condenser Type 3: chiselFor

39、 the purposes of this International Standard, osteotomes shall be classified according to the shape of the shanks into the following forms: Form A: straight shank Form B: offset shank5 Shapes5.1 SinutomeWorking tip: cylindricalWorking area: preferable as shown in detail Z, Figure 3.2 ISO 2015 All ri

40、ghts reservedDimensions in millimetresL1816D1ZFigure 1 Type 1, Form A: Sinutome, straightDimensions in millimetresFigure 2 Type 1, Form B: Sinutome, offset shapedaPlane.bConcave.Figure 3 Detail Z, working tips of sinutome5.2 CondenserWorking tip: conicalWorking area: preferable as shown in detail Z,

41、 Figure 6.Dimensions in millimetresFigure 4 Type 2, Form A: Condenser, straight ISO 2015 All rights reserved 3BS EN ISO 17937:2015ISO 17937:2015(E)Dimensions in millimetresFigure 5 Type 2, Form B: Condenser, offsetaConvex.bPlane.Figure 6 Detail Z, working tips of condenser5.3 Chisela) Working tip: p

42、ointed, straightWorking area: preferable as shown in detail Z, Figure 8.Dimensions in millimetresFigure 7 Type 3, Form A: Chisel, straight with straight working tipaStraight with doublesided cutting edge/polished section to the point.bStraight with singlesided cutting edge to the tip.Figure 8 Detail

43、 Z, working tips of chisel4 ISO 2015 All rights reservedBS EN ISO 17937:2015ISO 17937:2015(E)b) Working tip: pointed, curved or angledWorking area: Preferable as shown in detail Z, Figure 10.Dimensions in millimetresFigure 9 Type 3, Form A: Chisel, straight with curved or angled working tipaCurved.b

44、Angled.Figure 10 Detail Z, working tips of chisel6 Material6.1 Material of the working endThe materials of the working end of the osteotome shall be in accordance with ISO 13504.6.2 Material for the handleThe material of the handle of the osteotome shall be in accordance with ISO 13504.NOTE Some ost

45、eotomes consist of a handle with interchangeable working ends.7 Requirements7.1 Dimensions7.1.1 Diameter of the working end (D1, D2)The diameter of the working end shall be within 0,1 mm of the manufacturers stated dimensions.7.1.2 Overall lengthThe overall length of the osteotome including the hand

46、le and the working end shall not exceed 175 mm. ISO 2015 All rights reserved 5BS EN ISO 17937:2015ISO 17937:2015(E)BS EN ISO17937:2015ISO 17937:2015(E)7.2 Marking on the working end7.2.1 GeneralMarking shall be marked or carved from the tip of the working end at intervals as per the manufacturers in

47、structions in 2 mm steps, in order to indicate the depth of introduction of the osteotome into osseous tissue. The length from the working tip to the marking shall be within 0,1 mm of the manufacturers dimensions, measuring from the working tip to one of the two marking lines, whichever is nearer to

48、 the working tip, and at least the area between 8 mm and 16 mm shall be marked.7.2.2 Thickness of scale lineThe fine scale line or markings used in single dimension shall be visible without magnification.7.3 Surface finishThe surfaces of the instruments shall be free of visible surface defects when

49、tested in accordance with 8.2.7.4 Resistance to reprocessingThere shall be no visible signs of deterioration, and the requirement for 7.5 and 7.6 shall be met when tested in accordance with 8.3.7.5 Hardness of the working endThe hardness of the osteotome shall be equal or greater than 480 HV1 or 48 HRC.7.6 Connection of shank and handleThe osteotome assembled with the shank and the handle shall not loosen when tested at the tensile force and torque as stated under 8.5.1 and 8.5.2 hereafter.