EN ISO 13295-2007 en Dentistry - Mandrels for rotary instruments《牙科学 旋转器械用心轴》.pdf

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1、BRITISH STANDARDBS EN ISO 13295:2007Dentistry Mandrels for rotary instrumentsThe European Standard EN ISO 13295:2007 has the status of a British StandardICS 11.060.20g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53

2、g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 13295:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2007 BSI 2007ISBN 978 0 580 54290 9National forewordThis British Standard is the UK implementation

3、 of EN ISO 13295:2007. It supersedes BS EN ISO 13295:1997 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments and equipment.A list of organizations represented on this committee can be obtain

4、ed on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date

5、CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 13295July 2007ICS 11.060.20English VersionDentistry - Mandrels for rotary instruments (ISO 13295:2007)Art dentaire - Mandrins pour instruments rotatifs (ISO13295:2007)Zahnheilkunde - Trger fr rotierende Instrumente (ISO13295:2007)This Eur

6、opean Standard was approved by CEN on 13 June 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references conce

7、rning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own l

8、anguage and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L

9、uxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rig

10、hts of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 13295:2007: EForeword This document (EN ISO 13295:2007) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secr

11、etariat 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 January 2008, and conflicting national standards shall be withdrawn at the latest by January 2008. According to the

12、 CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani

13、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 13295:2007 has been approved by CEN as a EN ISO 13295:2007 without any modification. EN ISO 13295:2007 Reference numberISO 1

14、3295:2007(E)INTERNATIONAL STANDARD ISO13295Second edition2007-07-01Dentistry Mandrels for rotary instruments Art dentaire Mandrins pour instruments rotatifs EN ISO 13295:2007 ii iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodie

15、s (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 organizations,

16、 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. International Standards are drafted in accordance with the rules given in the ISO

17、/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the m

18、ember 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 held responsible for identifying any or all such patent rights. ISO 13295 was prepared by Technical Committee ISO/TC 106, Dentistry, Sub

19、committee SC 4, Dental instruments. This second edition cancels and replaces the first edition (ISO 13295:1994) which has been technically revised by the addition of three additional types and the clarification of labelling requirements. EN ISO 13295:2007 iv Introduction Mandrels are used for the su

20、pport of rotary instruments. To achieve a general application, independent of the type of instrument, the standardization of mandrels is desirable. This will ease the usage of rotary instruments in dentistry. EN ISO 13295:2007 1Dentistry Mandrels for rotary instruments 1 Scope This International Sta

21、ndard specifies the requirements, the packaging and marking characteristics for mandrels suitable for discs and polishers used in dentistry. This International Standard uses the system of coding laid down in ISO 6360, which specifies a 15-digit number for the identification of dental rotary instrume

22、nts of all types. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1797

23、-1, Dental rotary instruments Shanks Part 1: Shanks made of metals ISO 1942, Dentistry Vocabulary ISO 6360 (all parts), Dentistry Number coding system for rotary instruments ISO 6892, Metallic materials Tensile testing Method of testing at ambient temperature ISO 8325:2004, Dentistry Test methods fo

24、r rotary instruments 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 mandrel rotary shaft for holding dental rotary instruments 4 Classification For the purposes of this document, mandrels are classified according to

25、 their mechanical properties and the application for which they are recommended as follows: Type 1: mandrel, standard; Type 2: mandrel, reinforced; Type 3: mandrel with cylindrical thread for fixing unmounted polishers; Type 4: mandrel with conical thread for fixing unmounted polishers; Type 5: mand

26、rel on which polishers can be snapped. EN ISO 13295:2007 2 5 Requirements 5.1 Material 5.1.1 Proof strength, Rp0,2Mandrel Type 1, mandrel Type 2, screw for Type 1 and Type 2, mandrel Type 3 and mandrel Type 4 shall be made of a material with a proof strength of at least 600 MPa. Type and treatment s

27、hall be left to the discretion of the manufacturer. Testing shall be carried out in accordance with 6.1. 5.1.2 Vickers hardness Mandrel Type 5 shall be made of a material with a minimum Vickers hardness of 250 N/mm2. Type and treatment shall be left to the discretion of the manufacturer. 5.2 Dimensi

28、ons 5.2.1 General The dimensions and their tolerances are given in millimetres. Angles are given in degrees. The dimensions shall be as shown in Figures 1 to 6. This International Standard specifies only mandrels with a diameter of the plate and the screw head of 5 mm. Other diameters are possible.

29、See 7 f). Testing shall be carried out in accordance with 6.2. EN ISO 13295:2007 35.2.2 Mandrel, Type 1 l Shank, Type 1 Shank, Type 2 min. 20 44,5 0,5 Key 1 plate 2 shank, in accordance with ISO 1797-1, Type 1 or Type 2 NOTE The screw of Figure 3 can be used. aThe plate diameter shall be identical w

30、ith the screw head diameter. bRadius at discretion of manufacturer. cCountersunk at the discretion of the manufacturer. dTesting of run-out in accordance with ISO 8325:2004, 5.8. Figure 1 Mandrel, Type 1 EN ISO 13295:2007 4 5.2.3 Mandrel, Type 2 l Shank Type 1 Shank Type 2 min. 30 44,5 0,5 Key 1 pla

31、te 2 shank, in accordance with ISO 1797-1, Type 1 or Type 2 NOTE The screw of Figure 3 can be used. aThe plate diameter shall be identical with the screw head diameter. bRadius at discretion of manufacturer. cCountersunk at the discretion of the manufacturer. dTesting of run-out in accordance with I

32、SO 8325:2004, 5.8. Figure 2 Mandrel, Type 2 EN ISO 13295:2007 55.2.4 Screw for Type 1 and Type 2 Key 1 undercut aRadius at the discretion of manufacturer. Figure 3 Screw for Type 1 and Type 2 EN ISO 13295:2007 6 5.2.5 Mandrel, Type 3 l1 0,2 l2min. D 0,1 8 46,0 2,3 12 46,0 2,3 Key 1 shank, ISO 1797-1

33、, Type 2 aRadius at the discretion of the manufacturer. bTip at the discretion of the manufacturer. cThread profile at the discretion of the manufacturer. dThickness at the discretion of the manufacturer. eTesting of run-out in accordance with ISO 8325:2004, 5.8. Figure 4 Mandrel, Type 3 EN ISO 1329

34、5:2007 75.2.6 Mandrel, Type 4 l1 0,2 l2min. Type 1 l2min. Type 2 l3min. D1 0,1 D2 0,1 8 28,0 46,0 3,0 1,6 2,4 12 28,0 46,0 3,0 1,8 2,7 12 28,0 46,0 3,0 1,8 3,1 Key 1 shank, ISO 1797-1, Type 2 aRadius at the discretion of the manufacturer. bTip at the discretion of the manufacturer. cThread profile a

35、t the discretion of the manufacturer. dThickness at the discretion of the manufacturer. eTesting of run-out in accordance with ISO 8325:2004, 5.8. Figure 5 Mandrel, Type 4 EN ISO 13295:2007 8 5.2.7 Mandrel, Type 5 Key 1 shank according to ISO 1797-1 or screw thread M1,8 0,35 2 disc, dimensions (L an

36、d X) at the discretion of the manufacturer L thickness of the disc aDimension only applicable for screw thread. Figure 6 Mandrel, Type 5 6 Testing 6.1 Material For mandrels Type 1, Type 2, Type 3 and Type 4 the proof strength, Rp0,2, in accordance with ISO 6892 shall be measured with commonly availa

37、ble test devices of adequate accuracy. 6.2 Dimensions The dimensions shall be tested in accordance with ISO 8325:2004, 5.4. 7 Labelling on the package The labelling on the package of mandrels shall contain at least the following information: a) name and/or trademark of the manufacturer or the distri

38、butor; b) lot number; c) type of shank in accordance with ISO 1797-1, if applicable; d) general characteristics encoded in accordance with ISO 6360-1, if applicable; e) shape and specific characteristics encoded in accordance with ISO 6360-2, if applicable; f) diameter of the plate, if applicable. 8

39、 Packaging Packaging of mandrels shall be at the discretion of the manufacturer. EN ISO 13295:2007 blankBS EN ISO 13295:2007BSI389 Chiswick High RoadLondonW4 4ALBSI British Standards InstitutionBSI is the independent national body responsible for preparing British Standards. It presents the UK view

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