BS EN ISO 1797-2017 Dentistry Shanks for rotary and oscillating instruments《牙科学 旋转和摆动器械用直柄》.pdf

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1、Dentistry Shanks for rotary and oscillating instrumentsBS EN ISO 1797:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 1797:2017. It is identical to ISO 1797:2017. It supersedes BS EN ISO 17

2、97-2:1995, BS EN ISO 1797-1:2011 and BS EN ISO 1797-3:2013, which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on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.Th

3、is publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 84564 2ICS 11.060.20; 11.060.25Compliance with a British Standard can

4、not confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS EN ISO 1797:2017EUROPEAN STANDARDNORME EUROPENNEEUROPI

5、SCHE NORMEN ISO 1797May 2017ICS 11.060.20 Supersedes EN ISO 1797-2:1995, EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 1797:2017: EAll rights of exploitation

6、in any form and by any means reserved worldwide for CEN national MembersDentistry - Shanks for rotary and oscillating instruments (ISO 1797:2017) Mdecine bucco-dentaire - Queues pour instruments rotatifs et oscillants (ISO 1797:2017) Zahnheilkunde - Schfte fr rotierende und oszillierende Instrumente

7、 (ISO 1797:2017) This European Standard was approved by CEN on 1 March 2017.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 biblio

8、graphical references concerning 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 responsib

9、ility 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 members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic

10、 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 1797:2017 (E)European forewordThis d

11、ocument (EN ISO 1797:2017) 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.This European Standard shall be given the status of a national standard, either by publication of an iden

12、tical text or by endorsement, at the latest by November 2017, and conflicting national standards shall be withdrawn at the latest by November 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 hel

13、d responsible for identifying any or all such patent rights.This document supersedes EN ISO 1797-1:2011 , EN ISO 1797-2:1995 and EN ISO 1797-3:2013 .According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European

14、 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, Serbia, Slovakia,

15、 Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 1797:2017 has been approved by CEN as EN ISO 1797:2017 without any modification.iiBS EN ISO 1797:2017ISO 1797:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms, definitions and symbols 1

16、3.1 Terms and definitions . 13.2 Symbols . 24 Classification 35 Requirements 45.1 Dimensions . 45.1.1 Dimensions of shanks made of metal, tungsten carbide or ceramic material 45.1.2 Dimensions of Type 1 plastic shanks . 55.1.3 Shank cylindricity . 65.1.4 Surface roughness . 75.1.5 Location of markin

17、g 75.1.6 Colour code of plastic shanks . 75.2 Material requirements 75.2.1 Shanks made of metal or tungsten carbide . 75.2.2 Shanks made of ceramic materials . 75.2.3 Shanks made of plastic materials 86 Sampling and pass/fail evaluation 87 Measurement and test methods . 87.1 Shank diameter . 87.2 Ot

18、her dimensions . 97.3 Shank cylindricity . 97.4 Surface roughness 97.5 Vickers hardness . 97.6 Tensile strength (only for shanks made of plastic materials) 97.7 Heat resistance, colour stability and stability against swelling (only for shanks made of plastic materials) . 97.7.1 Apparatus . 97.7.2 Pr

19、ocedure . 97.7.3 Swelling resistance during reprocessing 9Annex A (informative) Quality control 10Bibliography .11 ISO 2017 All rights reserved iiiContents PageBS EN ISO 1797:2017ISO 1797:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national st

20、andards 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. International o

21、rganizations, 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 those intended for i

22、ts 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 (see www.iso.org/d

23、irectives).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 document will be in

24、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 voluntary nature of standards, the meaning of ISO

25、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.This document was prepared by Technical Committe

26、e ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This third edition cancels and replaces ISO 1797-1 , ISO 1797-2 , and ISO 1797-3 , which have been technically revised with the following changes:a) combination of three material parts into one International Standard;b) reprocessing req

27、uirements for plastic shanks have been added;c) AQL-values have been deleted;d) quality control concept was moved to Annex A.iv ISO 2017 All rights reservedBS EN ISO 1797:2017Dentistry Shanks for rotary and oscillating instruments1 ScopeThis document specifies the requirements for dimensions and mat

28、erial properties of shanks used in dentistry for rotary or oscillating instruments. It describes the measurement methods for the verification of the requirements.This document is not applicable to tips fixed to the handpiece with a screw, e.g. scaler tips.Information about the location of marking is

29、 also given. Annex A on quality control is included in order to ensure a high quality level.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cite

30、d applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 527-2 , Plastics Determination of tensile properties Part 2: Test conditions for moulding and extrusion plasticsISO 1101 , Geometrical product specifications (GPS) Geometrical tole

31、rancing Tolerances of form, orientation, location and run-outISO 1942 , Dentistry Vocabulary ISO 3274 , Geometrical Product Specifications (GPS) Surface texture: Profile method Nominal characteristics of contact (stylus) instrumentsISO 4288 , Geometrical Product Specifications (GPS) Surface texture:

32、 Profile method Rules and procedures for the assessment of surface textureISO 6507-1 , Metallic materials Vickers hardness test Part 1: Test methodISO 8325 , Dentistry Test methods for rotary instrumentsISO 14457 , Dentistry Handpieces and motors 3 Terms, definitions and symbols3.1 Terms and definit

33、ionsFor the purposes of this document, the terms and definitions given in ISO 1942 , ISO 14457 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing p

34、latform: available at http:/www.iso.org/obp INTERNATIONAL STANDARD ISO 1797:2017(E) ISO 2017 All rights reserved 1BS EN ISO 1797:2017ISO 1797:2017(E)3.1.1handpiecepowered handheld device used to operate a rotary or oscillating instrument (3.1.3) Note 1 to entry: This definition includes reciprocatin

35、g instruments.SOURCE: ISO 14457:2012, 3.10, modified3.1.2instrumenttool used for rotary or oscillating movements, consisting of working part, neck (if applicable) and shank (3.1.5), which is constructed to fit into a handpiece (3.1.1) Note 1 to entry: This includes continuous rotation or oscillating

36、 instruments (3.1.3).Note 2 to entry: See Figure 1. Key1 working part2 neck3 shankFigure 1 Designation of instrument parts3.1.3oscillating instrumentinstrument (3.1.2) used with an alternate (cyclic) movement, including vibrating, consisting of a shank (3.1.5) and a working part used in a handpiece

37、(3.1.1) for dental proceduresNote 1 to entry: All movements can be combined with axial movements.3.1.4rotary instrumentinstrument (3.1.2) used with a continuous rotation in a handpiece (3.1.1) consisting of a shank (3.1.5) and a working part used for dental procedures3.1.5shankpart of the shaft of a

38、 rotary or oscillating instrument (3.1.3) used in dentistry which is designed to fit into the chuck of a handpiece (3.1.1) or a handpiece for laboratory use3.1.6fitting lengthlength of the shank (3.1.5) that is contained within the chuck of a handpiece (3.1.1) or a handpiece for laboratory use3.2 Sy

39、mbolsd1shank diameterd2diameter in the grooved3second distance for plastic shanks2 ISO 2017 All rights reservedBS EN ISO 1797:2017ISO 1797:2017(E)l1fitting lengthl2shoulder to end lengthl3shoulder to groove lengthl4width of groovel5length of conical or rounded endRa surface roughnesss maximum distan

40、ce from the circumference to the flat area shank cylindricity4 ClassificationShanks for rotary or oscillating instruments are classified into the following types, according to their diameters and designs: Type 1: RA (right angle), CA (contra angle): diameter 2,35 mm, with groove and flat area (see F

41、igure 2); Type 2: HP (handpiece): diameter 2,35 mm, cylindrical (see Figure 3); Type 3: FG (friction grip): diameter 1,6 mm, cylindrical with conical or rounded end (see Figure 4); Type 4: HP (handpiece): diameter 3 mm cylindrical (see Figure 3).NOTE All movements can be combined with axial movement

42、s.Figure 2 Type 1 shankFigure 3 Type 2 and Type 4 shank ISO 2017 All rights reserved 3BS EN ISO 1797:2017ISO 1797:2017(E)Figure 4 Type 3 shank5 Requirements5.1 Dimensions5.1.1 Dimensions of shanks made of metal, tungsten carbide or ceramic materialThe dimensions and tolerances for shanks made of met

43、al, tungsten carbide or ceramic material shall be as shown in Figure 5, Figure 6, Figure 7 and Figure 8 and as given in Table 1.Dimensions are given in millimetres and surface roughness in micrometres.The end of the shank for Type 1, Type 2 and Type 4 shall be flat, conical or rounded. The end of th

44、e shank for Type 3 shall be conical or rounded.Test in accordance with 7.1 to 7.4.Table 1 Fitting length of shankDimensions in millimetresShank DiameterFitting length, l1min.Miniature, short Standard, long Extra longType 1a2,35 9 11 12Type 2 2,35 15 30 30Type 3 1,6 9 11 12Type 4 3 30 30aThe start of

45、 any enlargement on a Type 1 shank (e.g. by marking or the working head) shall be outside the fitting length.Figure 5 Dimensions, tolerances and surface roughness for Type 1 shank4 ISO 2017 All rights reservedBS EN ISO 1797:2017ISO 1797:2017(E)Figure 6 Dimensions, tolerances and surface roughness fo

46、r Type 2 shankFigure 7 Dimensions, tolerances and surface roughness for Type 3 shankFigure 8 Dimensions, tolerances and surface roughness for Type 4 shank5.1.2 Dimensions of Type 1 plastic shanks5.1.2.1 GeneralThe dimensions and tolerances for Type 1 plastic shanks shall be as shown in Figure 9 and

47、Figure 10.Dimensions are given in millimetres and surface roughness in micrometres.The fitting lengths shall be in accordance with Table 1.The end of the shank for Type 1 shall be flat, conical or rounded.Test in accordance with 7.1 to 7.4, if applicable. ISO 2017 All rights reserved 5BS EN ISO 1797

48、:2017ISO 1797:2017(E)Figure 9 Dimensions, tolerances and surface roughness for Type 1 plastic shank5.1.2.2 Permitted shape deviations Flattened portions of plastic shanksSurface irregularities shall comply with the following specifications (see Figure 10). d10050235=,mm ; x = max. 0,04 mm; d 3 d 1;

49、y = max. 0,04 mm.Figure 10 Flattened portions, cross-section B-B of Figure 9 5.1.3 Shank cylindricityThe shank cylindricity for all shanks shall be within the tolerances of the acceptable shank diameter.The definition of cylindricity is given in ISO 1101 .Test in accordance with 7.3.6 ISO 2017 All rights reservedBS EN ISO 1797:2017ISO 1797:2017(E)5.1.4 Surface roughnessThe surface roughness, Ra, for shanks made of metal, tungsten carbide or ceramic material, shall be for the f