BS EN ISO 8325-2004 Dentistry - Test methods for rotary instruments《牙科 旋转器械试验方法》.pdf

1、BRITISH STANDARD BS EN ISO 8325:2004 Dentistry Test methods for rotary instruments The European Standard EN ISO 8325:2004 has the status of a British Standard ICS 11.060.20 BS EN ISO 8325:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 2

2、4 September 2004 BSI 24 September 2004 ISBN 0 580 44514 3 National foreword This British Standard is the official English language version of EN ISO 8325:2004. It is identical with ISO 8325:2004. It supersedes BS 6828-9:1987 which is withdrawn. The UK participation in its preparation was entrusted b

3、y Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or Europe

4、an publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all

5、 the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on

6、 the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the

7、 ISO title page, pages ii to v, a blank page, pages 1 to 9 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO8325 September20

8、04 ICS11.060.20 SupersedesEN28325:1990 Englishversion DentistryTestmethodsforrotaryinstruments(ISO8325:2004) ArtdentaireMthodesdessaipourinstrumentsrotatifs (ISO8325:2004) ZahnheilkundePrfverfahrenfrrotierendeInstrumente (ISO8325:2004) ThisEuropeanStandardwasapprovedbyCENon2September2004. CENmembers

9、areboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember.

10、 ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgi

11、um,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EURO

12、PISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO8325:2004:E I NESO 38:5202( 40E) 2 Foreword This document (EN ISO 8325:2004) has been prepared by Technical Committee ISO/T

13、C 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 2005, and conflict

14、ing national standards shall be withdrawn at the latest by March 2005. This document supersedes EN 28325:1990. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, C

15、zech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 8325:2004 has been a

16、pproved by CEN as EN ISO 8325:2004 without any modifications. ENISO8325:2004 Reference number ISO 8325:2004(E) OSI 4002INTERNATIONAL STANDARD ISO 8325 Second edition 2004-09-15 Dentistry Test methods for rotary instruments Art dentaire Mthodes dessai pour instruments rotatifs ENISO8325:2004IS:5238 O

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21、 the cnuotfo yr ttseuqer ehe.r ISO cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o groii ISO 4002 Allr ithgsr esedevrENISO8325:2004IS:5238 O4002(E) I SO 4002 All irthgs ersedevr iiiContents Page Foreword iv Intro

22、duction v 1 Scope 1 2 Normative references. 1 3 Terms and definitions. 1 4 Test methods. 1 4.1 General. 1 4.2 Atmospheric conditions. 2 4.3 Measurement instruments. 2 5 Measuring of single characteristics of instruments 2 5.1 Shape of the working part 2 5.2 Diameter of the working part . 3 5.3 Neck

23、diameter 3 5.4 Dimensions of the shank and the mandrel. 4 5.5 Length of the working part. 4 5.6 Overall length 4 5.7 Angle of the taper of the working part 5 5.8 Run-out of the working part. 5 5.9 Neck strength 7 5.10 Surface roughness 8 Bibliography . 9 ENISO8325:2004IS:5238 O4002(E) iv I SO 4002 A

24、ll irthgs ersedevrForeword ISO (the International Organization 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 sub

25、ject for which a technical committee has been established has the 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 (I

26、EC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical commit

27、tees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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

28、 held responsible for identifying any or all such patent rights. ISO 8325 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This second edition cancels and replaces the first edition (ISO 8325:1985), which has been technically revised. ENISO8325:2004IS

29、:5238 O4002(E) I SO 4002 All irthgs ersedevr vIntroduction To check the conformity of dental rotary instruments against relevant product standards, it is indispensable to conduct tests on the basis of harmonised test methods in order to achieve comparable test results. In the respective product stan

30、dards for dental rotary instruments, reference is made to the test methods specified in this International Standard. ENISO8325:2004INTENRATIONAL TSANDADR IS:5238 O4002(E)I SO 4002 All irthgs ersedevr 1Dentistry Test methods for rotary instruments 1 Scope This International Standard specifies methods

31、 for measuring the dimensional characteristics, neck strength and surface roughness of dental rotary instruments, such as burs, cutters, polishers, diamond and abrasive instruments. This International Standard does not provide test methods for the characteristics of materials used for dental rotary

32、instruments. NOTE For testing of these characteristics, see the respective product standards. This International Standard is not applicable to dental root-canal instruments (see ISO 3630-1). 2 Normative references The following referenced documents are indispensable for the application of this docum

33、ent. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of metals ISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks

34、made of plastics ISO 1942, Dentistry Vocabulary ISO 3274, Geometrical Product Specification (GPS) Surface texture: Profile method Nominal characteristics of contact (stylus) instruments ISO 4288, Geometrical Product Specification (GPS Surface texture: Profile method Rules and procedures for the asse

35、ssment of surface texture 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 apply. 4 Test methods 4.1 General The test methods specified in this International Standard refer to the main dimensional characteristics of dental rotary instruments. The

36、y are demonstrated by describing the measurement procedures for the single characteristics of instruments. ENISO8325:2004IS:5238 O4002(E) 2 I SO 4002 All irthgs ersedevrIn addition to the test methods specified below, other equivalent methods and test devices exist and may be used, provided they ren

37、der similar results. In case of dispute, however, the test methods specified in this International Standard become reference. For evaluation of test results, see the relevant product standard. 4.2 Atmospheric conditions Tests shall be conducted at room temperature (20 C to 25 C). 4.3 Measurement ins

38、truments A list of measurement instruments is provided as follows: a) micrometer; b) vernier calliper; c) dial gauge; d) comparator; e) toolmakers microscope, workshop microscope, measuring microscope; f) shadowgraph (e.g. profile projector); g) ring gauge; h) pneumatic gauge; i) goniometer; j) lase

39、r scanner. Other precision instruments may equally be applicable, and may be used at the discretion of the manufacturer. Measurement instruments with reasonable accuracy shall be chosen in respect to the characteristics of the instruments to be measured. Lengths and diameters shall be measured and c

40、alculated in millimetres, angles in degrees. 5 Measuring of single characteristics of instruments 5.1 Shape of the working part 5.1.1 Measurement instrument Any suitable instrument of those listed in 4.3 shall be used, having an accuracy of u 0,01 mm. The applied measuring force shall not exceed 1,5

41、 N. 5.1.2 Measurement location The measurement location shall cover the whole representative integral shape of the test piece. ENISO8325:2004IS:5238 O4002(E) I SO 4002 All irthgs ersedevr 35.1.3 Procedure Determine the shape of the working part visually or by using an instrument specified in 5.1.1.

42、Conduct one measurement. 5.2 Diameter of the working part 5.2.1 Measurement instrument Any suitable instrument of those listed in 4.3 shall be used, having an accuracy of u 0,01 mm. The applied measuring force shall not exceed 1,5 N. In case of dispute, the reference method shall be that using a dia

43、l gauge. 5.2.2 Measurement location The measurement point shall be as follows, unless specified otherwise in the respective product standard: a) for cylindrical instruments: the middle of the working part; b) for non-cylindrical instruments: the largest diameter of the working part. 5.2.3 Procedure

44、Measure the diameter of the working part using an instrument as specified in 5.2.1. Conduct one measurement on the peripheral surface, i.e. on the top surface. For diamond instruments, conduct three measurements at angles 120 apart on the circumference of the test piece. Lift the blade before rotati

45、ng the test piece to the next measurement point. Record the three measuring results as d 1 , d 2and d 3 . 5.2.4 Evaluation of test results for diamond instruments For diamond instruments, calculate the average diameter by using the following formula: 1233 dd d d + =(1) where d 1is the diameter given

46、 by measurement 1; d 2is the diameter given by measurement 2; d 3is the diameter given by measurement 3. 5.3 Neck diameter 5.3.1 Measurement instrument Any suitable instrument of those listed in 4.3 shall be used, having an accuracy of 0,01 mm. ENISO8325:2004IS:5238 O4002(E) 4 I SO 4002 All irthgs e

47、rsedevrIf mechanical instruments are used, they shall be equipped with knife-edged tungsten carbide blades of u 0,3 mm thickness. The applied measurement force shall not exceed 1,5 N. 5.3.2 Measurement location The measurement point shall be the smallest diameter just behind the working part, or jus

48、t behind the collar, where applicable. 5.3.3 Procedure Measure the neck diameter using an instrument as specified in 5.3.1. Conduct one measurement. 5.4 Dimensions of the shank and the mandrel The dimensions of the shank and the mandrel shall be determined in accordance with ISO 1797-1 and ISO 1797-2. ISO 13295 should also be consulted. The applied measuring force shall not exceed 1,5 N. 5.5 Length of the working part 5.5.1 Measurement instrument Any suitable instrument of those listed in 4.3 shall be