EN ISO 1797-1-2011 en Dentistry - Shanks for rotary instruments - Part 1 Shanks made of metals《牙科学 旋转仪器柄 第1部分 金属制成的柄(ISO 1797-1-2011)》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 1797-1:2011Dentistry Shanks for rotaryinstrumentsPart 1: Shanks made of metals (ISO1797-1:2011)BS EN ISO 1797-1:2011 BRITISH STANDARDNational forewordThis British Stand

2、ard is the UK implementation of EN ISO1797-1:2011. It supersedes BS EN ISO 1797-1:1995 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on requ

3、est to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 65528 9ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Stand

4、ard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1797-1 August 2011 ICS 11.060.20 Supersedes EN ISO 1797-1:1995English Version Dentistry

5、- Shanks for rotary instruments - Part 1: Shanks made of metals (ISO 1797-1:2011) Mdecine bucco-dentaire - Queues pour instruments rotatifs - Partie 1: Queues en matriaux mtalliques (ISO 1797-1:2011) Zahnheilkunde - Schfte fr rotierende Instrumente - Teil 1: Schfte aus Metall (ISO 1797-1:2011) This

6、European Standard was approved by CEN on 14 August 2011. 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 reference

7、s 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 mem

8、ber 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, France, Germany, Greece, Hungary, Iceland

9、, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Ma

10、rnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 1797-1:2011: EBS EN ISO 1797-1:2011EN ISO 1797-1:2011 (E) 3 Foreword This document (EN ISO 1797-1:2011) has been prepared by Technical Committee ISO/

11、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 identical text or by endorsement, at the latest by February 2012, and confl

12、icting national standards shall be withdrawn at the latest by February 2012. 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 held responsible for identifying any or all such patent rights. This docu

13、ment supersedes EN ISO 1797-1:1995. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, German

14、y, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 1797-1:2011 has been approved by CEN as a EN ISO 1797-1:2011 wi

15、thout any modification. BS EN ISO 1797-1:2011ISO 1797-1:2011(E) ISO 2011 All rights reserved iiiForeword 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 carr

16、ied 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, governmental and non-governmental, in liaison with ISO, also take part in the work.

17、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/IEC Directives, Part 2. The main task of technical committees is to prepare Internat

18、ional 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 member bodies casting a vote. Attention is drawn to the possibility that some of the e

19、lements 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 1797-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This second edition cancels and replaces the fir

20、st edition (ISO 1797-1:1992) and ISO 1797-1:1992/ Amd.1:1997, which has been technically revised. The following changes were made: a) addition of a maximum value for the end of the shank for Type 3; b) addition of a definition for shank; c) clarification of symbols and figures. ISO 1797 consists of

21、the following parts, under the general title Dentistry Shanks for rotary instruments: Part 1: Shanks made of metals Part 2: Shanks made of plastics BS EN ISO 1797-1:2011ISO 1797-1:2011(E) iv ISO 2011 All rights reservedIntroduction This International Standard is one of a series of basic standards on

22、 dental rotary instruments. It constitutes an important link between the standards on dental rotary instruments and those on dental handpieces. BS EN ISO 1797-1:2011INTERNATIONAL STANDARD ISO 1797-1:2011(E) ISO 2011 All rights reserved 1Dentistry Shanks for rotary instruments Part 1: Shanks made of

23、metals 1 Scope This International Standard specifies shanks for rotary instruments used in dentistry and gives measurement methods for the verification of dimensions. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated reference

24、s, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 3274, Geometrical Product Specifications (GPS) Surface texture: Profile method Nominal characteristics of contact (stylus) i

25、nstruments ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and procedures for the assessment of surface texture ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method ISO 8325, Dentistry Test methods for rotary instruments 3 Terms, definitio

26、ns, symbols and abbreviated terms 3.1 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1.1 shank part of a rotary instrument used in dentistry which is designed to fit into the chuck of a straight or geared dental handpie

27、ce, a technical handpiece or a dental turbine 3.2 Symbols and abbreviated terms Symbols and terms are shown in Figures 1 to 8 with the following key: d1shank diameter; d2diameter in the groove; BS EN ISO 1797-1:2011ISO 1797-1:2011(E) 2 ISO 2011 All rights reserveds maximum distance from the circumfe

28、rence to the flat portion; l1fitting length; l2shoulder to end length; l3shoulder to groove length; l4width of groove; l5length of conical or rounded end; cylindricity of shank cylinder. 4 Classification Shanks for rotary instruments are classified into the following types, according to their diamet

29、ers and designs: Type 1: diameter 2,35 mm with groove and flat (for contra-angle-connection); Type 2: diameter 2,35 mm cylindrical; Type 3: diameter 1,6 mm cylindrical with conical or rounded end; Type 4: diameter 3 mm cylindrical. Figure 1 Type 1 shank Figure 2 Type 2 and Type 4 shank Figure 3 Type

30、 3 shank BS EN ISO 1797-1:2011ISO 1797-1:2011(E) ISO 2011 All rights reserved 35 Requirements 5.1 Material Shanks shall be made of metallic materials (e.g. steel or tungsten carbide). The exact type of material and the treatment given to it are at the discretion of the manufacturer. 5.2 Dimensions T

31、he dimensions and tolerances shall be as shown in Figures 4 to 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

32、 or rounded. The shape of the shank end shall be at the discretion of the manufacturer. Dimensions in millimetres Figure 4 Dimensions Type 1 shank Dimensions in millimetres Figure 5 Dimensions Type 2 shank BS EN ISO 1797-1:2011ISO 1797-1:2011(E) 4 ISO 2011 All rights reservedDimensions in millimetre

33、s Figure 6 Dimensions Type 3 shank Dimensions in millimetres Figure 7 Dimensions Type 4 shank Table 1 Fitting length of shank Dimensions in millimetres Shank Diameter Fitting length, l1min. miniature, short standard, long extra long Type 1a 2,35 11 12Type 2 2,35 15 30 30 Type 3 1,6 9 11 12 Type 4 3

34、30 30 aThe start of any enlargement on a Type 1 shank (e.g. by marking or the working head) shall be outside l1= 13,5 mm. 5.3 Shank cylindricity The shank cylindricity (see Figure 8) shall be within the tolerances of the acceptable shank diameter. BS EN ISO 1797-1:2011ISO 1797-1:2011(E) ISO 2011 All

35、 rights reserved 5Key 1 upper limit of d12 lower limit of d1Figure 8 Shank cylindricity The 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 roughness The surface roughness, Ra, s

36、hall be for a) Type 1, Type 2, 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 hardness The Vickers hardness for shanks made of metallic material, shall be not less than 250 HV5. Test in accordance with 6.5. 5.6 Marking

37、Marking, if envisaged, should be outside the fitting length, l1. 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 as disinfection, cl

38、eaning and sterilization according to the manufacturers instructions. BS EN ISO 1797-1:2011ISO 1797-1:2011(E) 6 ISO 2011 All rights reserved6 Test methods 6.1 Shank diameter Measurements of the shank diameter shall be made with suitable measuring devices that have an accuracy of 0,001 mm. The accura

39、cy of the measuring device shall be verified. The shank diameter, d1,shall be measured by traversing the length, l1. 6.2 Other dimensions Measurements 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

40、verified. 6.3 Shank cylindricity The test method is left to the discretion of the manufacturer. 6.4 Surface roughness Test the surface roughness in accordance with ISO 3274 and ISO 4288. 6.5 Vickers hardness Test the hardness in accordance with ISO 6507-1. 7 Quality control 7.1 Types of shank For th

41、e purpose of quality control, the shanks of the instruments shall be classified as given in Clause 4. 7.2 Defects 7.2.1 Major defects Major defects shall be those deviations from the specifications listed in Table 2. Major defects include only those items which prevent an instrument from operating.

42、7.2.2 Minor defects Minor defects shall be all deviations 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. BS EN ISO 1797-1:2011ISO 1797-1:2011(E)

43、ISO 2011 All rights reserved 7Table 2 Major defects Shank d1d2l3l4s Type 1 2,35 1,45 1,80 0,85 1,80 Type 2 2,35 Type 3 1,60 1,59 Type 4 3 BS EN ISO 1797-1:2011ISO 1797-1:2011(E) 8 ISO 2011 All rights reservedAnnex A (informative) Acceptable quality levels (AQL) The acceptable quality level (AQL) exp

44、ressed 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 level Shank AQL Major defects Minor defects Type 1 2,5 6,5 Type 2 2,5 6,5 Type 3 1,5 4,0 Type 4 2,5 6,5 BS EN ISO 1797-1:2011ISO 1797-1:2011(E) ISO 2011

45、 All rights reserved 9Bibliography 1 ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection This page deliberately left blankThis page deliberately left blankBSI is the independent national body responsi

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