BS EN ISO 7786-2001 Dental rotary instruments Laboratory abrasive instruments《牙科用旋转器械 实验室研磨器械》.pdf

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1、BRITISH STANDARD BS EN ISO 7786:2001 Incorporating Corrigendum No. 1 Dental rotary instruments Laboratory abrasive instruments The European Standard EN ISO 7786:2001 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN ISO 778

2、6:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 June 2001 BSI 07-2001 ISBN 0 580 37648 6 National foreword This British Standard is the offi

3、cial English language version of EN ISO 7786:2001. It is identical with ISO 7786:2001. It supersedes BS EN 27786:1992 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/52, Dental instruments, which has the responsibility to: A list of organizations r

4、epresented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using t

5、he “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity fro

6、m legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the

7、UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 9, the annex ZA page, an inisde back cover and a back cover. The BSI copyright date displayed in this docume

8、nt indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 13334 Corrigendum No.1 July 2001 Incorporation of annex ZAEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7786 April 2001 ICS 11.060.20 Supersedes EN 27786:1991 English version Dental

9、rotary instruments - Laboratory abrasive instruments (ISO 7786:2001) Instruments rotatifs dentaires - Instruments abrasifs de laboratoire (ISO 7786:2001) Rotierende Dentalinstrumente - Laborschleifinstrumente (ISO 7786:2001) This European Standard was approved by CEN on 1 April 2001. CEN members are

10、 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 references concerning such national standards may be obtained on application to t

11、he 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 member into its own language and notified to the Management Centre has the same status

12、as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZ

13、ATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7786:2001 EForeword Corrected 2001-06-13 The text o

14、f the International Standard ISO 7786:2001 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 supersedes EN 27786:1991. This European Standard shall be given

15、the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2001, and conflicting national standards shall be withdrawn at the latest by October 2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations

16、 of 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 and the United Kingdom. Endorsement notice The text o

17、f the International Standard ISO 7786:2001 was approved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 7786:2001Reference number ISO 7786:2001(E) INTERNATIONAL STANDARD ISO 7786 Third edition 20

18、01-04-01 Dental rotary instruments Laboratory abrasive instruments Instruments rotatifs dentaires Instruments abrasifs de laboratoire EN ISO 7786:2001ii iii Contents Page Foreword.iv Introduction.v 1 Scope 1 2 Normative references 1 3 Symbols 1 4 Requirements.1 4.1 Materials .1 4.2 Shapes 2 4.3 Dime

19、nsions.2 4.4 Specifications for dental laboratory abrasive instruments.2 4.5 Run-out .7 5 Test procedures.7 5.1 Shapes 7 5.2 Dimensions.7 5.3 Run-out .7 6 Sampling and acceptance level (AQL) 7 7 Manufacturers instructions8 8 Marking on abrasive instruments 8 9 Labelling .8 10 Packaging.8 Bibliograph

20、y9 EN ISO 7786:2001 Annex ZA (normative) Normative references to international publications with their relevant European publications.41 .10iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of pre

21、paring 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, governmental and non-governmental, in

22、 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/IEC Directives, Part 3. Draft Interna

23、tional 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 elements of this International

24、Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 7786 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This third edition cancels and replaces the

25、 second edition (ISO 7786:1990), which has been technically revised as follows: addition of new shape: Spherical; truncated conical: Nominal size 031; addition of requirement for manufacturers instructions; addition of requirement for marking; addition of requirement for labelling. EN ISO 7786:2001

26、v Introduction This International Standard is one of a series of standards relating to dental rotary instruments. This International Standard contains the specifications for laboratory abrasive instruments. The various dimensional and other requirements specified for laboratory abrasive instruments

27、are those considered important to ensure the interchangeability and safe usage of these grinding instruments in the dental laboratory. The nominal diameters of the working part listed in Tables 1 to 10 comply with the diameters specified in ISO 2157. Attention is drawn to the ISO 6360 series, which

28、specifies a 15-digit numbering system for the indentification of dental rotary instruments of all types. EN ISO 7786:2001blank 1 Dental rotary instruments Laboratory abrasive instruments 1 Scope This International Standard specifies dimensional and other relevant requirements for the six most common

29、ly available shapes of ceramic bonded abrasive instruments used for grinding in the dental laboratory, including a quality control and specifications for labelling of these instruments. 2 Normative references The following normative documents contain provisions which, through reference in this text,

30、 constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recen

31、t editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of m

32、etals. ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection. ISO 6360-2, Dental rotary instruments Number coding system Part 2: Shape and specific characteristics. ISO 8325:1985, Dental rotary instru

33、ments Test methods. 3 Symbols For the purposes of this International Standard, the following symbols apply. d diameter of working part, head diameter; l 1 length of working part, head length; l 2 overall length; angle of the working part. 4 Requirements 4.1 Materials 4.1.1 Working part The working p

34、art shall be made of abrasive materials. The selection of the type and the treatment of the abrasive material shall be left to the discretion of the manufacturer. EN ISO 7786:20012 4.1.2 Shank The material of the shank shall comply with ISO 1797-1. 4.2 Shapes The shapes of the working part shall be

35、as specified in Figures 1 to 10. Variations of the shapes within the limited dimensions and the descriptions used in the subclause titles are permitted. Testing shall be carried out in accordance with 5.1. 4.3 Dimensions Dimensions in tables and figures are given in millimetres and angles are given

36、in degrees. 4.3.1 Working part and overall length The dimensions of the working part and the overall length shall be as specified in Figures 1 to 10 as appropriate and Tables 1 to 10 as appropriate. Testing shall be carried out in accordance with 5.2. 4.3.2 Shank The shank shall be Type 2 in accorda

37、nce with ISO 1797-1. 4.4 Specifications for dental laboratory abrasive instruments 4.4.1 Spherical (round) Figure 1 Spherical (round) Table 1 Dimensions Spherical (round) Designation of nominal diameter (Nominal size) d +0,5 0 l 2 3 031 3,1 45 040 44 6 050 54 7 060 64 8 EN ISO 7786:2001 3 4.4.2 Inve

38、rted truncated, conical 4.4.2.1 Inverted truncated, conical, short, l 1 d Figure 2 Inverted truncated, conical, short Table 2 Dimensions Inverted truncated, conical, short Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +1 0,5 l 2 3 040 424 2 050 52 , 54 2 060 634 2 070 73 , 54 2 50 to 9

39、0 4.4.2.2 Inverted truncated, conical, standard, l 1 = d Figure 3 Inverted truncated, conical, standard Table 3 Dimensions Inverted truncated, conical, standard Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +0,5 0 l 2 3 065 6,5 6,5 48 20 to 30 EN ISO 7786:20014 4.4.3 Inverted conical (

40、hyperboloidal-inverted) Figure 4 Inverted conical (hyperboloidal-inverted) Table 4 Dimensions Inverted conical (hyperboloidal-inverted) Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +0,5 0 l 2 3 070 754 6 4.4.4 Cylindrical 4.4.4.1 Cylindrical, short, l 1 d Figure 5 Cylindrical, short T

41、able 5 Dimensions Cylindrical, short Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +1 0,5 l 2 3 060 634 4 060 654 4 100 10 2 44 100 10 3 44 100 10 4 44 EN ISO 7786:20015 4.4.4.2 Cylindrical, regular, l 1 d Figure 6 Cylindrical, regular Table 6 Dimensions Cylindrical, regular Designatio

42、n of nominal diameter (Nominal size) d +0,5 0 l 1 +1 0,5 l 2 3 021 2,1 6 44 031 3,1 6 44 040 464 4 050 564 4 4.4.4.3 Cylindrical, long, l 1 W 2d Figure 7 Cylindrical, long Table 7 Dimensions Cylindrical, long Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +1 0,5 l 2 3 050 51 24 8 065 6,

43、5 13 50 EN ISO 7786:20016 4.4.5 Knife-edge (conico, inverted hyperboloidal) Figure 8 Knife-edge (conico, inverted hyperboloidal) Table 8 Dimensions Knife-edge (conico, inverted hyperboloidal) Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +0,5 0 l 2 3 090 944 6 4.4.6 Truncated conical 4

44、.4.6.1 Truncated conical, regular, l 1 d Figure 9 Truncated conical, regular Table 9 Dimensions Truncated conical, regular Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +1 0,5 l 2 3 021 2,1 6 44 031 3,1 6 44 040 464 4 050 564 4 8 to 14 EN ISO 7786:2001 7 4.4.6.2 Truncated conical, long

45、, l 1 2 d Figure 10 Truncated conical, long Table 10 Dimensions Truncated conical, long Designation of nominal diameter (Nominal size) d +0,5 0 l 1 +1 0,5 l 2 3 031 3,1 7 46 035 3,5 10,5 53 6 to 10 4.5 Run-out The run-out shall not exceed 0,3 mm. Testing shall be carried out in accordance with 5.3.

46、5 Test procedures 5.1 Shapes Determine the shapes by using a shadowgraph or measuring the relevant dimensions in accordance with ISO 8325. 5.2 Dimensions Measure the dimensions in accordance with ISO 8325. 5.3 Run-out Determine the run-out in accordance with ISO 8325. Measurement shall be made at th

47、e largest diameter or, for the cylindrical form, at the middle of the working part. 6 Sampling and acceptance quality level (AQL) The acceptance quality level (AQL) determined in accordance with ISO 2859-1 shall be 6,5. EN ISO 7786:20018 7 Manufacturers instructions The manufacturer shall provide in

48、formation on maximum rotational speed. 8 Marking on abrasive instruments Marking on abrasive instrument may contain information on the abrasive material. 9 Labelling Labelling on the package of abrasive instruments shall contain at least the following information: a) name and/or trade mark of manufa

49、cturer or distributor; b) material of the working part, identification of abrasive material; c) type of shank, in accordance with ISO 1797-1; d) shape number, in accordance with ISO 6360-2; e) specific characteristics; f) nominal diameter, nominal size; g) lot number. The information should preferably be given in accordance with the