EN ISO 1797-3-2013 en Dentistry - Shanks for rotary instruments - Part 3 Shanks made of ceramics《牙科 旋转仪器用柄 第3部分 陶瓷制柄》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationDentistry Shanks for rotary instruments Part 3: Shanks made of ceramicsBS EN ISO 1797-3:2013National forewordThis British Standard is the UK implementation of EN ISO 1797-3:2013.

2、The UK participation in its preparation was entrusted by Technical CommitteeCH/106, Dentistry, to Subcommittee CH/106/4, Dental Instruments andEquipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all t

3、he necessary provisions of acontract. Users are responsible for its correct application. The British Standards Institution 2013Published by BSI Standards Limited 2013ISBN 978 0 580 70434 5ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standa

4、rd was published under the authority of the StandardsPolicy and Strategy Committee on 30 April 2013.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN ISO 1797-3:2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1797-3 March 2013 ICS 11.060.20 English Vers

5、ion Dentistry - Shanks for rotary instruments - Part 3: Shanks made of ceramics (ISO 1797-3:2013) Mdecine bucco-dentaire - Queues pour instruments rotatifs - Partie 3: Queues en cramique (ISO 1797-3:2013)Zahnheilkunde - Schfte fr rotierende Instrumente - Teil 3: Schfte aus Keramik (ISO 1797-3:2013)

6、This European Standard was approved by CEN on 7 March 2013. 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 refere

7、nces 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 responsibility of a CEN

8、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 of Macedonia,

9、 France, Germany, 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 EUROPISCH

10、ES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 1797-3:2013: EBS EN ISO 1797-3:2013EN ISO 1797-3:2013 (E) 2 Contents Page Foreword 3 BS EN ISO 1797

11、-3:2013EN ISO 1797-3:2013 (E) 3 Foreword This document (EN ISO 1797-3:2013) 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 n

12、ational standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject

13、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 to implement this European Standard: Austria, Belgium, Bulgar

14、ia, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turk

15、ey and the United Kingdom. Endorsement notice The text of ISO 1797-3:2013 has been approved by CEN as EN ISO 1797-3:2013 without any modification. BS EN ISO 1797-3:2013ISO 1797-3:2013(E) ISO 2013 All rights reserved iiiContents Page1 Scope . 12 Normative references 13 Terms, definitions and symbols

16、13.1 Terms and definitions . 13.2 Symbols and terms 24 Classification 25 Requirements 35.1 Material . 35.2 Dimensions . 35.3 Shank cylindricity . 55.4 Surface roughness 55.5 Vickers hardness . 55.6 Marking . 56 Test methods . 66.1 Shank diameter . 66.2 Other dimensions . 66.3 Shank cylindricity . 66

17、.4 Surface roughness 66.5 Vickers hardness . 67 Quality control 67.1 Types of shank . 67.2 Defects 6Annex A (informative) Acceptable quality levels (AQL) . 7Bibliography 8BS EN ISO 1797-3:2013INTERNATIONAL STANDARD ISO 1797-3:2013(E)Dentistry Shanks for rotary instruments Part 3: Shanks made of cera

18、mics1 ScopeThis part of ISO 1797 specifies ceramic shanks of rotary instruments used in dentistry and gives measurement methods for the verification of the dimensions.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable

19、 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 3274, Geometrical Product Specifications (GPS) Surface texture: Profile method Nomina

20、l characteristics of contact (stylus) instrumentsISO 4288, Geometrical Product Specifications (GPS) Surface texture: 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 r

21、otary instruments3 Terms, definitions and symbols3.1 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1.1shankpart of the shaft of a rotary instrument used in dentistry which is designed to fit into the chuck of a straight

22、or contra-angle dental handpiece, a technical handpiece or a dental turbine ISO 2013 All rights reserved 1BS EN ISO 1797-3:2013ISO 1797-3:2013(E)3.2 Symbols and termsSymbols and terms are shown in Figures 1 to 8 with the following key:d1shank diameter;d2diameter in the groove;s maximum distance from

23、 the circumference to the flat portion;l1fitting length;l2shoulder to end length;l3shoulder to groove length;l4width of groove;l5length of conical or rounded end; shank cylindricity.4 ClassificationShanks for rotary instruments are classified into the following types, according to their diameters an

24、d designs: Type 1: RA (right angle) - diameter 2,35 mm with groove and flat; Type 2: HP (handpiece) - diameter 2,35 mm cylindrical; Type 3: FG (friction grip) - diameter 1,6 mm cylindrical with conical or rounded end; Type 4: HP (handpiece) - diameter 3 mm cylindrical.Figure 1 Type 1 shank2 ISO 2013

25、 All rights reservedBS EN ISO 1797-3:2013ISO 1797-3:2013(E)Figure 2 Type 2 and Type 4 shankFigure 3 Type 3 shank5 Requirements5.1 MaterialShanks shall be made of ceramic materials. The exact type of material and the treatment given to it are at the discretion of the manufacturer.5.2 DimensionsThe di

26、mensions and tolerances shall be as shown in Figure 4 to Figure 7 and as given in Table 1.Dimensions are given in millimetres, surface roughness in micrometres.The end of the shank for Types 1, 2 and 4 shall be either flat, conical or rounded. The end of the shank for Type 3 shall be either conical

27、or rounded.The shape of the shank end shall be at the discretion of the manufacturer.Dimensions in millimetresFigure 4 Dimensions Type 1 shank ISO 2013 All rights reserved 3BS EN ISO 1797-3:2013ISO 1797-3:2013(E)Dimensions in millimetresFigure 5 Dimensions Type 2 shankDimensions in millimetresFigure

28、 6 Dimensions Type 3 shankDimensions in millimetresFigure 7 Dimensions Type 4 shankTable 1 Fitting length of shankDimensions in millimetresShank DiameterFitting length, l1min.miniature, short standard, long extra longType 1a2,35 11 12Type 2 2,35 15 30 30Type 3 1,6 9 11 12Type 4 3 30 30aThe start of

29、any enlargement on a Type 1 shank (e.g. by marking or the working head) shall be outside l1= 13,5 mm.4 ISO 2013 All rights reservedBS EN ISO 1797-3:2013ISO 1797-3:2013(E)5.3 Shank cylindricityThe shank cylindricity, (see Figure 8) shall be within the tolerances of the acceptable shank diameter.Key1

30、upper limit of d12 lower limit of d1Figure 8 Shank cylindricityThe requirement for the shank cylindricity covers the fitting length, l1, of the shank with the exception of the shank end geometry.Test in accordance with 6.3.5.4 Surface roughnessThe surface roughness, Ra, shall be fora) Type 1, Type 2

31、, and Type 4: 1 m,b) Type 3: 0,5 m,as it is located and shown in Figure 4 to Figure 7.Test in accordance with 6.4.5.5 Vickers hardnessThe Vickers hardness for shanks made of ceramic material, shall be not less than 1 400 HV0,5.5.6 MarkingMarking, if envisaged, should be outside the fitting length, l

32、1.If the marking is applied within the fitting length, l1, the outside diameter of the shank with the marking shall not exceed the effective diameter of the shank.Marking shall be resistant to reprocessing procedures such as disinfection, cleaning and sterilization according to the manufacturers ins

33、tructions. ISO 2013 All rights reserved 5BS EN ISO 1797-3:2013ISO 1797-3:2013(E)6 Test methods6.1 Shank diameterMeasurements of the shank diameter shall be made in accordance with ISO 8325 with suitable measuring devices with an accuracy of 0,001 mm. The accuracy of the measuring device shall be ver

34、ified.The shank diameter, d1,shall be measured by traversing the length, l1.6.2 Other dimensionsMeasurements shall be made in accordance with ISO 8325 with suitable measuring devices with an accuracy of 0,01 mm. The accuracy of the measuring device shall be verified.6.3 Shank cylindricityThe test me

35、thod is left to the discretion of the manufacturer.6.4 Surface roughnessTest the surface roughness in accordance with ISO 3274 and ISO 4288.6.5 Vickers hardnessTest the hardness in accordance with ISO 6507-1.7 Quality control7.1 Types of shankFor the purpose of quality control, the shanks of the ins

36、truments shall be classified as given in Clause 4.7.2 Defects7.2.1 Major defectsMajor defects shall be those deviations from the specifications listed in Table 2. Major defects include only those items which prevent an instrument from operating.7.2.2 Minor defectsMinor defects shall be all deviation

37、s in fitting dimensions not listed in Table 2. Minor defects include all other deviations from the specification which lower the quality of the instrument.Acceptable quality levels are given in Annex A.Table 2 Major defectsShank d1d2l3l4sType 1 2,35 1,45 1,80Type 2 2,35 Type 3 1,60 3 6 ISO 2013 All

38、rights reservedBS EN ISO 1797-3:2013ISO 1797-3:2013(E)Annex A (informative) Acceptable quality levels (AQL)The acceptable quality level (AQL) expressed in terms of the number of defects per 100 pieces, for each type of instrument, should be as shown in Table A.1.Table A.1 Acceptable quality levelSha

39、nkAQLMajor defects Minor defectsType 1 1 2,5Type 2 1 2,5Type 3 1 2,0Type 4 1 2,5 ISO 2013 All rights reserved 7BS EN ISO 1797-3:2013ISO 1797-3:2013(E)Bibliography1 ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-

40、by-lot inspection8 ISO 2013 All rights reservedBS EN ISO 1797-3:2013This page deliberately left blankBSI is the independent national body responsible for preparing British Standards and other standards-related publications, information and services. It presents the UK view on standards in Europe and

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