DIN EN ISO 7711-1-2009 Dental rotary instruments - Diamond instruments - Part 1 Dimensions requirements marking and packaging (ISO 7711-1 1997 + Amd 1 2009)(includes Amendment A1 2.pdf

1、October 2009DEUTSCHE NORM English price group 22No 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!$ZCc“1553264

2、www.din.deDDIN EN ISO 7711-1Dental rotary instruments Diamond instruments Part 1: Dimensions, requirements, marking and packagingEnglish version of DIN EN ISO 7711-1:2009-10Zahnrztliche rotierende Instrumente Diamantinstrumente Englische Fassung DIN EN ISO 7711-1:2009-10SupersedesDIN EN ISO 7711-1:1

3、998-11www.beuth.deTeil 1: Mae, Anforderungen, Kennzeichnung und Verpackung .Document comprises 54 pages(ISO 7711-1:1997+Amd 1:2009) (enthlt nderung A1:2009)(ISO 7711-1:1997 + Amd 1:2009) (includes Amendment A1:2009)DIN EN ISO 7711-1:2009-10 2 National foreword This standard has been prepared by Tech

4、nical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-04 AA Rotierende I

5、nstrumente. Amendment 1:2009 to ISO 7711-1:1998 has been incorporated in this standard. The start and finish of text The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1797-1 DIN EN ISO 1797-1 ISO 2157 DIN EN ISO 2157 ISO 3696 DIN ISO 3696

6、 ISO 6360-1 DIN EN ISO 6360-1 ISO 6360-2 DIN EN ISO 6360-2 ISO 7711-3 DIN EN ISO 7711-3 ISO 8325 DIN EN ISO 8325 Amendments This standard differs from DIN EN ISO 7711-1:1998-11 as follows: a) A new subclause 7.3 “General product information” has been added after subclause 7.2. Previous editions DIN

7、13956: 1985-08, 1990-09 DIN EN ISO 7711-1: 1998-11 National Annex NA (informative) Bibliography DIN EN ISO 8325, Dentistry Test methods for rotary instruments DIN EN ISO 6360-1, Dentistry Number coding system for rotary instruments Part 1: General characteris-tics DIN EN ISO 6360-2, Dentistry Number

8、 coding system for rotary instruments Part 2: Shapes DIN EN ISO 1797-1, Dentistry Shanks for rotary instruments Part 1: Shanks made of metals DIN EN ISO 2157, Dental rotary instruments Nominal diameters and designation code number DIN EN ISO 7711-3, Dentistry Diamond rotary instruments Part 3: Grit

9、sizes, designation and colour code DIN ISO 3696, Water for analytical laboratory use Specification and test methods introduced or altered by amendment is indicated in the text by tags !“. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7711-1 November 1998 +A1 May 2009 ICS 11.060.20 English

10、 version Dental rotary instruments Diamond instruments Part 1: Dimensions, requirements, marking and packaging (ISO 7711-1:1997+Amd. 1:2009) Instruments rotatifs dentaires Instruments diamants Partie 1: Dimensions, exigences, marquage et emballage (ISO 7711-1:1997+Amd. 1:2009) Zahnrztliche rotierend

11、e Instrumente Diamantinstrumente Teil 1: Mae, Anforderungen, Kennzeichnung und Verpackung (ISO 7711-1:1997+Amd. 1:2009) EN ISO 7711-1:1998 was approved by CEN on 1998-05-01 and Amendment A1:2009 on 2009-04-20. Standard the status of a national standard without any alteration. Up-to-date lists and bi

12、bliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of

13、 a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,

14、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 NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-

15、1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7711-1:1998+A1:2009 ECEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European DIN EN IS

16、O 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E) 2 Contents Page !Foreword to EN ISO 7711-1:1998/A1:2009“.3 Introduction .4 1 Scope .5 2 Normative references .5 3 Symbols .5 4 Requirements 6 4.1 Materials 6 4.2 Shapes 6 4.3 Dimensions.6 4.4 Run-out .44 4.5 Corrosion resistance.45 4.6 Neck strength.45

17、 5 Testing .45 5.1 Dimensions.45 5.2 Run-out .45 5.3 Corrosion resistance.45 5.4 Neck strength.46 6 Quality control .51 6.1 Sampling.51 6.2 Compliance.51 7 Marking 51 7.1 Marking on diamond instruments51 7.2 Labelling on the package51 7.3 !General product information“.52 8 Packaging 52 Foreword to E

18、N ISO 7711-1:1998-11 .3 Foreword to EN ISO 7711-1:1998-11 International Standard ISO 7711-1:1997 “Dental rotary instruments Diamond instruments Part 1: Dimensions, requirements, marking and packaging” which was prepared by ISO/TC 106 “Dentistry” of the International Organization for Standardization,

19、 has been adopted by Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany) as a European Standard. 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 1999, and conflicting na

20、tional standards shall be withdrawn at the latest by February 1999. ISO 7711 consists of the following parts, under the general title Dental rotary instruments Diamond instruments: Part 1: Dimensions, requirements, marking and packaging Part 2: Discs Part 3: Grit sizes, designation and colour code I

21、n accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland a

22、nd United Kingdom. Endorsement notice The text of the International Standard ISO 7711-1:1997 was approved by CEN as a European Standard without any modification. !Foreword to EN ISO 7711-1:1998/A1:2009 This document (EN ISO 7711-1:1998/A1:2009) has been prepared by Technical Committee ISO/TC 106 “De

23、ntistry” 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 November 2009, and conflicting nat

24、ional standards shall be withdrawn at the latest by November 2009. 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. According to the CE

25、N/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, Lithuania,

26、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 7711-1:1997/Amd. 1:2009 has been approved by CEN as a European Standard EN ISO 7711-1:1998/A1:2009 without any modification.“ 3

27、 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E) Introduction This part of IS0 7711 is one of a series of standards relating to dental rotary instruments. This first edition of IS0 771 l-l contains the updated specifications for diamond instruments given in IS0 7711:1984. It was also aligne

28、d in several details with the other International Standards on dental rotary instruments. The various dimensional and other requirements specified for diamond instruments are those considered important to ensure the interchange- ability and safe usage of these instruments in the practice of dentistr

29、y. The nominal diameters of the working part listed in tables 1 to 48 comply with the diameters specified in IS0 2157. The diameters listed in the first column (preferred diameters) should be used in preference. Attention is drawn to IS0 6360, which specifies a 15-digit number coding system for the

30、identification of dental rotary instruments of all types. 4 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E)1 Scope This part of IS0 7711 specifies dimensional and other relevant requirements for the 14 most commonly used shapes of dental diamond instruments, including a quality control for

31、these instruments. It is envisaged to update this part of IS0 7711 at each periodical revision to cover at that time the commonly used shapes and other specifications. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of th

32、is part of IS0 7711. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 7711 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Mem

33、bers of IEC and IS0 maintain registers of currently valid International Standards. IS0 1797-l :I 992, Dental rotary instruments - Shanks - Part I: Shanks made of metals. IS0 2157:1992, Dental rotary instruments - Nominal diameters and designation code number. IS0 3696: 1987, Water for analytical lab

34、oratory use - Specification and test methods. IS0 6360-I :I 985, Dental rotary instruments - Number coding system - Part 1: General characteris tics. IS0 6360-2: 1986, Dental rotary instruments - Number coding system - Part 2: Shape and specific characteristics. IS0 771 l-3:1 992, Dental rotary inst

35、ruments - Diamond instruments - Part 3: Grit sizes, designation and co/our code. IS0 8325: 1985, Dental rotary instruments - Test methods. 3 Symbols For the purposes of this part of IS0 7711, the following symbo 1s aPP IY . . dl diameter of working part; head diameter 5 DIN EN ISO 7711-1:2009-10 EN

36、ISO 7711-1:1998+A1:2009 (E) head length /2 overall length a angle of the working part 4 Requirements 4.1 Materials 4.1.1 Shank The material of the shank shall comply with IS0 1797-1. 4.1.2 Working part The working part shall be made of diamond grit, bound in either metal, plastics or other suitable

37、material at the discretion of the manufacturer. Grit sizes shall comply with IS0 771 l-3. 4.2 Shapes The shape of the working part shall be as specified in the appropriate figures 1 to 48. Variations of shape within the limited dimensions and the descriptions in the subclause titles are permitted. T

38、esting shall be carried out in accordance with 5.1. 4.3 Dimensions 4.3.1 Overall length The overall length of the instrument, 12, is the sum of the fitting length of the shank and the length of the working part. In tables 1 to 48, “Standard” refers to instruments with standard fitting lengths of sha

39、nk. For instruments with longer or shorter shank lengths, the overall length, 12, will vary accordingly. See IS0 1797-l :I 992, table 1, for fitting lengths of shanks. 4.3.2 Shank The shank shall be Type 1, 2 or 3 of IS0 1797-l. 4.3.3 Working part The dimensions of the working part shall be as speci

40、fied in the appropriate tables 1 to 48. Testing shall be carried out in accordance with 5.1. 6 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E)4.3.3.1 Round head (spherical) Figure I! Table 1 - Dimensions (see figure 1) Dimensions in millimetres Designation of nominal diameter Preferred diam

41、eters 4 cf;! 4 &2 rf:o,5 Shank Shank Shank Shank nom. tol. max. min. TVpe 1 TYPe 2 TYPe 3 TVpe 3 Standard Standard Standard Short 7 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E) 4.3.3.2 Round head (with collar) Figure 2 Table 2 - Dimensions (see figure 2) 009 09 010 LO &0,08 lwl r- 012 1

42、I IL I 1,4 12 014 016 15 018 18 021 u 023 23 025 2,5 033 3,3 + 0,lO Dimensions in millimetres Shank Shank Shank Shank Type1 Type2 Type3 Type3 Standard Standard Standard Short 22,0 44,5 19,o 16,5 12 IL 0,5 8 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E)4.3.3.3 Inverted cone head (inverted,

43、 truncated conical) Figure 3 Table 3 - Dimensions (see figure 3) Dimensions in millimetres, angles in degrees Designation of nominal diameter 4 d2 a h 12 + 0,5 Preferred diameters nom. max. Shank Shank Shank Shank min. TVpe 1 TVpe 2 Type 3 Type 3 Standard Standard Standard Short 9 DIN EN ISO 7711-1:

44、2009-10 EN ISO 7711-1:1998+A1:2009 (E) 4.3.3.4 Inverted cone head (with collar) Figure 4 Table 4 - Dimensions (see figure 4) Dimensions in millimetres, angles in degrees Designation of nominal diameter Preferred diameters 4 d2 d3 4 a 12 + 0,5 Shank Shank Shank Shank min. nom. tol. max. + 0,l Type 1

45、Type 2 Type 3 Type 3 Standard Standard Standard Short 017 0,68 0,60 008 03 0,78 0,68 2,0 8” to 14 +0,08 009 019 0,84 0,74 010 LO 0,96 0,78 012 12 1 ,oo 0,88 IO” to 18” 014 1,4 I,04 0,98 22,0 44,5 19,0 16,5 22 016 13 I,10 I,04 018 13 +0,10 I,18 I,35 10”t022” 021 21 I,26 I,40 023 2,3 I,32 I,70 2,5 025

46、 2,5 I,44 I,90 10 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E)4.3.3.5 Wheel Figure 5 Table 5 - Dimensions (see figure 5) Dimensions in millimetres Designation of nominal diameter 12 + 0,5 Shank Shank Shank Shank TYPe 1 Type 2 TYPe 3 Type 3 Standard Standard Standard Short 22,0 44,5 19,o

47、16,5 d2 4 min. Preferred diameters max. 0,73 013 0,83 014 114 016 116 0,93 0,4 I 118 I,03 018 I I,05 0,5 021 211 023 2,3 I,23 I 025 1 215 I,25 I 027 I 2,7 I,43 I,45 I,53 I 033 I 313 I,63 I,67 053 I 035 1 3,5 I,77 I 037 1 3,7 I 040 1 4,o I,91 2,Ol 2,Ol 2,09 2,17 I 042 I 4,2 I 045 1 4,5 11 DIN EN ISO

48、7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E) 4.3.3.6 Wheel with collar Figure 6 Table 6 - Dimensions (see figure 6) Dimensions in millimetres Shank TYPe 3 Short 4.3.3.7 Cylindrical working part 4.3.3.7.1 Head length 3,0 mm * 4 * 4 m w Figure 7 Table 7 - Dimensions (see figure 7) Dimensions in milli

49、metres I Designation I 4 12 of nominal diameter + 0,5 1 nom. 1 tol. / max. 1 + 0,3 1 j!/ia!d 1 j!/ia:d / j!:ia!d 008 018 1 030 1 I - 1 009 09 + 0,08 0,90 3,O 010 10 1 ,oo I 22,0 44,5 I 19,o 012 12 k 0,lO I,20 Shank Type 3 Short 16,5 12 DIN EN ISO 7711-1:2009-10 EN ISO 7711-1:1998+A1:2009 (E)4.3.3.7.2 Head length 4,0 mm (2 Figure 8 Table 8 - Dimensions (see figure 8) Dimensions in millimetres 010 LO +0,08 1 ,oo 012 12 I,20 - 014 410 114 I,35 22,o 44,5 19,o 1615 fO,lO 016 116 I,50 018 118 I,60 4.3.3.7.3 Head leng