DIN EN ISO 17937-2016 Dentistry - Osteotome (ISO 17937 2015) German version EN ISO 17937 2015《牙科 骨凿 (ISO 17937-2015) 德文版本EN ISO 17937-2015》.pdf

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1、January 2016 English price group 11No 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!%KXR“2405347www.din.de

2、DIN EN ISO 17937Dentistry Osteotome (ISO 17937:2015);English version EN ISO 17937:2015,English translation of DIN EN ISO 17937:2016-01Zahnheilkunde Osteotome (ISO 17937:2015);Englische Fassung EN ISO 17937:2015,Englische bersetzung von DIN EN ISO 17937:2016-01Mdecine bucco-dentaire Ostotome (ISO 179

3、37:2015);Version anglaise EN ISO 17937:2015,Traduction anglaise de DIN EN ISO 17937:2016-01SupersedesDIN 13988:2013-01www.beuth.deDocument comprises 17 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.01.16 DIN EN ISO 17937:2016

4、-01 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17937:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its pr

5、eparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committees NA 014-00-21 Dentalimplantate and NA 014-00-21-02 AK Instrumente fr die dentale Implantologie. The DIN Standards corresponding to the International Standards referred to in this document are as follows:

6、ISO 1942 DIN EN ISO 1942 ISO 6507-1 DIN EN ISO 6507-1 ISO 6508-1 DIN EN ISO 6508-1 ISO 13504 DIN EN ISO 13504 ISO 15087-1 DIN EN ISO 15087-1 ISO 16443 DIN EN ISO 16443 ISO 17664 DIN EN ISO 17664 Amendments This standard differs from DIN 13988:2013-01 as follows: a) the term “osteotome” is now used a

7、s a generic term (formerly only used in connection with chisels); b) chisels with angled working tip have been included (Figure 10). Previous editions DIN 13988: 2013-01 DIN EN ISO 17937:2016-01 3 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6507-1, M

8、etallic materials Vickers hardness test Part 1: Test method DIN EN ISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test method DIN EN ISO 13504, Dentistry General requirements for instruments and related accessories used in dental implant placement and treatment DIN EN ISO 15087-1, Den

9、tal elevators Part 1: General requirements DIN EN ISO 16443, Dentistry Vocabulary for dental implants systems and related procedure 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 17937:

10、2016-01 4 This page is intentionally blank EUROPEAN 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 Sta

11、ndard was approved by 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

12、 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 made by translation under the responsibility of a CEN member into its

13、 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, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, German

14、y, 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR N

15、ORMUNG CEN-CENELEC Management 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 EForeword .4Introduction 51 Scope . 62 Normative references 63 Terms, definitions, and symb

16、ols 63.1 Terms and definitions . 63.2 Symbols . 74 Classification 75 Shapes 75.1 Sinutome 75.2 Condenser . 85.3 Chisel . 96 Material . 106.1 Material of the working end . 106.2 Material for the handle 107 Requirements . 107.1 Dimensions 107.1.1 Diameter of the working end (D1, D2) 107.1.2 Overall le

17、ngth . 107.2 Marking on the working end 117.2.1 General. 117.2.2 Thickness of scale line 117.3 Surface finish . 117.4 Resistance to reprocessing 117.5 Hardness of the working end 117.6 Connection of shank and handle. 118 Test method 118.1 Measurement of length and diameter 118.2 Test on surface fini

18、sh 118.3 Test on resistance to reprocessing 118.4 Hardness test . 118.5 Connection of shank 128.5.1 Test under tensile force . 128.5.2 Test under torque . 129 Marking, labelling, and instructions for use 129.1 Marking on the osteotome . 129.2 Labelling on the package . 129.3 Instructions for use 12B

19、ibliography 13Contents PageDIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 2European foreword 3European foreword This document (EN ISO 17937:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which i

20、s 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 conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility

21、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 organizations of the following countries are bound

22、 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, Malta, Netherlands, Norway, Poland, Portugal,

23、 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 without any modification. DIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 3 ForewordISO (the International Organization

24、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 in a subject for which a technical committee has been established has t

25、he 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 Commission (IEC) on all matters of electrotechnical standardization.The proc

26、edures 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 should be noted. This document was drafted in accordance with the editori

27、al 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 identifying any or all such patent rights. Details of any patent rights

28、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 convenience of users and does not constitute an endorsement.For an explanat

29、ion 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: Foreword - Supplementary informationThe committee responsible for this document

30、 is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.DIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 4 IntroductionOsteotomes are instruments generally used in orthopaedic surgery. However, in dentistry, and more specific, when preparing the implant site for dental implants, certain types

31、 of osteotomes are used for bone compaction, sinus floor elevation, and jaw bone cleaving. These types of osteotomes are addressed in this International Standard.DIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 5 1 ScopeThis International Standard specifies requirements and their test methods for oste

32、otomes used in dentistry 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 indispensabl

33、e 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 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1, Meta

34、llic materials Rockwell 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 syste

35、ms and related procedure3 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 e

36、levation, or jaw bone cleavingNote 1 to entry: Osteotomes consist of a working tip, a shank, and a handle.3.1.2condenserbone-condenserhandheld dental instrument, with conical shaped working end (3.1.5), used for compacting the maxillary bone surrounding the implant socket to improve the primary stab

37、ility of the implant3.1.3chiselhandheld 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

38、 transplantation.DIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 6 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 instrumentsNote 1 to entry: Another term for internal s

39、inus 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 used for working3.1.7handlearea used for hol

40、ding 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 length;D1diameter or width of the active

41、 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 the purposes of this International Stand

42、ard, 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.DIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 7 Dimension

43、s 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, Figure 6.Dimensions i

44、n millimetresFigure 4 Type 2, Form A: Condenser, straightDIN EN ISO 17937:2016-01 EN ISO 17937:2015 (E) 8 Dimensions in millimetresFigure 5 Type 2, Form B: Condenser, offsetaConvex.bPlane.Figure 6 Detail Z, working tips of condenser5.3 Chisela) Working tip: pointed, straightWorking area: preferable

45、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 Z, working tips of chiselDIN EN ISO 1793

46、7:2016-01 EN ISO 17937:2015 (E) 9 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.bAngled.Figure 10 Detail Z, working tips of chisel6 Material

47、6.1 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 osteotomes 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