DIN EN ISO 13295-2007 Dentistry - Mandrels for rotary instruments (ISO 13295 2007) English version of DIN EN ISO 13295 2007-09《牙科学 旋转器械用心轴(ISO 13295 2007)》.pdf

1、September 2007DEUTSCHE NORM English price group 9No part of this standard 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!$I3R“138164

2、7www.din.deDDIN EN ISO 13295Dentistry Mandrels for rotary instruments (ISO 13295:2007)English version of DIN EN ISO 13295:2007-09Zahnheilkunde Trger fr rotierende Instrumente (ISO 13295:2007)Englische Fassung DIN EN ISO 13295:2007-09SupersedesDIN EN ISO 13295:1996-10www.beuth.deDocument comprises 13

3、 pages11.07DIN EN ISO 13295:2007-09 2 National foreword This standard 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, Germany. The responsible German body involved in its prepara

4、tion was the Normenausschuss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-04 AA Rotierende Instrumente. The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN ISO are as follows: ISO 1797-1 DIN EN ISO 1797-1 ISO 1942 E DIN EN ISO 194

5、2 ISO 6360 DIN EN ISO 6360 ISO 6892 E DIN EN ISO 6892 ISO 8325 DIN EN ISO 8325 Amendments This standard differs from DIN EN ISO 13295:1996-10 as follows: a) Three additional types (type 3 to type 5) have been included. b) The proof strength for the different types of material has been specified. c)

6、The labelling requirements have been clarified. Previous editions DIN EN ISO 13295: 1996-10 National Annex NA (informative) Bibliography DIN EN ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of metals E DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 6360 (all Parts), Dentistry N

7、umber coding system for rotary instruments E DIN EN ISO 6892, Metallic materials Tensile testing Method of testing at ambient temperature DIN EN ISO 8325, Dentistry Test methods for rotary instruments EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 13295July 2007ICS 11.060.20English VersionDen

8、tistry - Mandrels for rotary instruments (ISO 13295:2007)This European 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

9、alteration. Up-to-date lists and bibliographical references concerning 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 t

10、ranslationunder the responsibility of a CEN member into its own language 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, German

11、y, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManage

12、ment Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 13295:2007: E(ISO 13295:2007)Art dentaire - Mandrins pour instruments rotatifs(ISO 13295:2007)Zahnheilkunde - Trger fr rotieren

13、de InstrumenteEN ISO 13295:2007 (E) 2 Foreword 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 secretariat of which is held by DIN. This European Standard shall be given the status o

14、f 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 CEN/CENELEC Internal Regulations, the national standards organizations of the foll

15、owing 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slo

16、venia, 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. Introduction Mandrels are used for the support of rotary instruments. To achieve a general application, independent of the

17、 type of instrument, the standardization of mandrels is desirable. This will ease the usage of rotary instruments in dentistry. EN ISO 13295:2007 (E)31 Scope This International Standard specifies the requirements, the packaging and marking characteristics for mandrels suitable for discs and polisher

18、s 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 instruments of all types. 2 Normative references The following referenced documents are indispensable for the application of thi

19、s document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of metals ISO 1942, Dentistry Vocabulary ISO 6360 (all parts),

20、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 for rotary instruments 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1

21、942 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 their mechanical properties and the application for which they are recommended as follows: Type 1: mandrel, standard; T

22、ype 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: mandrel on which polishers can be snapped. EN ISO 13295:2007 (E)45 Requirements 5.1 Material 5.1.1 Proof strength, Rp0,2Mand

23、rel 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 shall be left to the discretion of the manufacturer. Testing shall be carried out in accordance with 6.1. 5.1.2 Vickers

24、 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 Dimensions 5.2.1 General The dimensions and their tolerances are given in millimetres. Angles are given in degrees. The dimen

25、sions 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. See 7 f). Testing shall be carried out in accordance with 6.2. EN ISO 13295:2007 (E)55.2.2 Mandrel, Type 1 l Shank, Ty

26、pe 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 with the screw head diameter. bRadius at discretion of manufacturer. cCountersunk at the discretion of the manufactu

27、rer. dTesting of run-out in accordance with ISO 8325:2004, 5.8. Figure 1 Mandrel, Type 1 EN ISO 13295:2007 (E)65.2.3 Mandrel, Type 2 l Shank Type 1 Shank Type 2 min. 30 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 di

28、ameter 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 ISO 8325:2004, 5.8. Figure 2 Mandrel, Type 2 EN ISO 13295:2007 (E)75.2.4 Screw for Type 1 and Type 2 Key 1 undercu

29、t aRadius at the discretion of manufacturer. Figure 3 Screw for Type 1 and Type 2 EN ISO 13295:2007 (E)85.2.5 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, Type 2 aRadius at the discretion of the manufacturer. bTip at the discretion of the manufacturer. cThread

30、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 13295:2007 (E)95.2.6 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

31、 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 at the discretion of the manufacturer. dThickness at the discretion of the manufacturer. eTesting of run-o

32、ut in accordance with ISO 8325:2004, 5.8. Figure 5 Mandrel, Type 4 EN ISO 13295:2007 (E)105.2.7 Mandrel, Type 5 Key 1 shank according to ISO 1797-1 or screw thread M1,8 0,35 2 disc, dimensions (L and X) at the discretion of the manufacturer L thickness of the disc aDimension only applicable for scre

33、w 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 available test devices of adequate accuracy. 6.2 Dimensions The dimensions shall be tested in accordance wit

34、h 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 distributor; b) lot number; c) type of shank in accordance with ISO 1797-1, if applicable; d) general charac

35、teristics 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 Packaging Packaging of mandrels shall be at the discretion of the manufacturer. EN ISO 13295:2007 (E)11