DIN EN ISO 7787-1-2016 Dentistry - Laboratory cutters - Part 1 Steel laboratory cutters (ISO 7787-1 2016) German version EN ISO 7787-1 2016《牙科 实验室刀具 第1部分 钢制实验室刀具(ISO 7787-1-2016) 德.pdf

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1、November 2016 English price group 11No part of this translation 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!%p“2587795www.din.deD

2、IN EN ISO 7787-1Dentistry Laboratory cutters Part 1: Steel laboratory cutters (ISO 77871:2016);English version EN ISO 77871:2016,English translation of DIN EN ISO 7787-1:2016-11Zahnheilkunde Laborfrser Teil 1: Laborfrser aus Stahl (ISO 77871:2016);Englische Fassung EN ISO 77871:2016,Englische berset

3、zung von DIN EN ISO 7787-1:2016-11Mdecine buccodentaire Fraises de laboratoire Partie 1: Fraises de laboratoire en acier (ISO 77871:2016);Version anglaise EN ISO 77871:2016,Traduction anglaise de DIN EN ISO 7787-1:2016-11SupersedesDIN 139541:199009www.beuth.deDocument comprises sy pagesDTranslation

4、by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.16DIN EN ISO 7787-1:2016-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 7787-1:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in colla

5、boration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-04 AA Rotierende Instrumente. The DIN Standards corresponding t

6、o the International Standards referred to in this document are as follows: ISO 1797 E DIN EN ISO 1797 ISO 1942 DIN EN ISO 1942 ISO 2157 DIN EN ISO 2157 ISO 2859-1 DIN ISO 2859-1 ISO 6360-3 DIN EN ISO 6360-3 ISO 8325 DIN EN ISO 8325 Amendments This standard differs from DIN 13954-1:1990-09 as follows

7、: a) normative references have been updated; b) terms and definitions have been included; c) details of sampling have been modified; d) requirements for marking have been included. Previous editions DIN 13954-1: 1986-10, 1990-09 DIN EN ISO 7787-1:2016-11 3 National Annex NA (informative) Bibliograph

8、y E DIN EN ISO 1797, Dentistry Shanks for rotary and oscillating instruments DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 2157, Dentistry Nominal diameters and designation code numbers for rotary instruments DIN EN ISO 6360-3, Dentistry Number coding system for rotary instruments Part 3: Specifi

9、c characteristics of burs and cutters DIN EN ISO 8325, Dentistry Test methods for rotary instruments DIN ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection DIN EN ISO 7787-1:2016-11 4 This page is

10、intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7787-1 May 2016 ICS 11.060.20 Supersedes EN 27787-1:1990English Version Dentistry Laboratory cutters Part 1: Steel laboratory cutters (ISO 7787-1:2016) Mdecine bucco-dentaire Fraises de laboratoire Partie 1: Fraises de labo

11、ratoire en acier (ISO 7787-1:2016) Zahneilkud Laborfrser Teil 1: Laborfrser aus Stahl (ISO 7787-1:2016) This European Standard was approved by CEN on 15 April 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stand

12、ard 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 the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English

13、, 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bul

14、garia, 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, T

15、urkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members

16、. Ref. No. EN ISO 7787-1:2016 EEN ISO 7787-1:2016 (E) 2 Contents Page European foreword . 3 Foreword 4 Introduction 5 1 Scope 6 2 Normative references . 6 3 Terms, definitions and symbols . 6 3.1 Terms and definitions . 6 3.2 Symbols . 7 4 Material . 7 5 Dimensions and number of blades . 7 5.1 Round

17、 (spherical) . 7 5.2 Cylindrical, double domed . 8 5.3 Egg . 8 5.4 Oval, transverse . 8 5.5 Bud, rounded 9 5.6 Bud 9 5.7 Pear . 10 5.8 Bud, slender . 10 5.9 Wheel 11 6 Run-out 11 7 Sampling 11 8 Designation code number . 12 9 Marking 12 Bibliography . 13 DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016

18、(E) 3 European foreword This document (EN ISO 7787-1:2016) 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 national standard,

19、 either by publication of an identical text or by endorsement, at the latest by November 2016, and conflicting national standards shall be withdrawn at the latest by November 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. C

20、EN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 27787-1:1990. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: A

21、ustria, Belgium, Bulgaria, 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, Sw

22、eden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 7787-1:2016 has been approved by CEN as EN ISO 7787-1:2016 without any modification. DIN EN ISO 7787-1:2016-11 ForewordISO (the International Organization for Standardization) is a worldwide federation of national s

23、tandards bodies (ISO member bodies). The work of preparing 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

24、organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for

25、its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/

26、directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be i

27、n the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions r

28、elated to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instr

29、uments.This second edition cancels and replaces the first edition (ISO 7787-1:1984), which has been technically revised.ISO 7787 consists of the following parts, under the general title Dentistry Laboratory cutters: Part 1: Steel laboratory cutters Part 2: Carbide laboratory cutters Part 3: Tungsten

30、 carbide cutters for milling machines Part 4: Miniature carbide laboratory cutters4DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) IntroductionThis part of ISO 7787 is one of a series of International Standards relating to dental rotary instruments.The various dimensional and other requirements spe

31、cified for steel cutters are those considered important to ensure the interchangeability of these instruments.5 DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) 1 ScopeThis part of ISO 7787 specifies dimensional and other requirements for the nine most commonly used steel cutters which are predomina

32、ntly used in the dental laboratory.Other characteristics of laboratory cutters, for example, spiralled blades or cross-cut, are not covered by this part of ISO 7787.NOTE These cutters are also used in podiatry.2 Normative referencesThe following documents, in whole or in part, are normatively refere

33、nced in this document and are indispensable 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 17971), Dentistry Shanks for rotary and oscillating instrumentsISO 1942,

34、 Dentistry VocabularyISO 2157, Dentistry Nominal diameters and designation code numbers for rotary instrumentsISO 6360-3, Dentistry Number coding system for rotary instruments Part 3: Specific characteristics of burs and cuttersISO 8325, Dentistry Test methods for rotary instruments3 Terms, definiti

35、ons and symbolsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 6360-3, and the following apply.3.1 Terms and definitions3.1.1laboratory cuttercutter designed for use with dental materials in the dental laboratory3.1.2dental laboratoryfacility where dental technica

36、l procedures complementing dental clinical treatment are carried outSOURCE: ISO 1942:2009, 2.77 1) To be published.6DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) 3.2 SymbolsFor the purposes of this part of ISO 7787, the following symbols apply:d diameter of the working part, head diameter;l lengt

37、h of the working part, head length.4 MaterialThe shaft and the working part shall be made of steel.The selection of the type of steel and the treatment given to it shall be left to the discretion of the manufacturer.5 Dimensions and number of bladesAll dimensions are in millimetres.The dimensions, m

38、easured as described in ISO 8325, shall be as specified in Tables 1 to 9 and as shown in Figures 1 to 9.The shank shall be Type 2 of ISO 1797.The shank length shall be (38 1) mm.In this part of ISO 7787, the laboratory cutters are differentiated according to the shape of the head of the laboratory c

39、utters.5.1 Round (spherical)Figure 1 RoundTable 1 Round Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l 0,25Number of blades min.040 4 3,7 8050 5 4,7 10060 6 5,8 12070 7 6,8 14080 8 7, 8 167 DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) 5.2 Cylindrical, double

40、domedFigure 2 CylindricalTable 2 Cylindrical Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l 0,25Number of blades min.040 4 9 8050 5 10 10060 6 11 12070 7 12 14080 8 13 165.3 EggFigure 3 EggTable 3 Egg Dimensions and number of bladesDimensions in millimetresNomina

41、l size d +0,15 -0,25l 0,25Number of blades min.040 4 9 8050 5 10 10060 6 11 12070 7 12 14080 8 13 165.4 Oval, transverseFigure 4 Oval, transverse8DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) Table 4 Oval, transverse Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,

42、25l 0,25Number of blades min.040 4 2,5 8050 5 3,0 10060 6 3,5 12070 7 4,0 14080 8 4,5 165.5 Bud, roundedNOTE = 14 to 18.Figure 5 Bud, roundedTable 5 Bud, rounded Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l 0,25Number of blades min.040 4 8 8050 5 9,5 10060 6 11

43、,0 12070 7 12,5 14080 8 14,0 165.6 BudNOTE A small flat area is allowed at the tip of no more than 0,1 mm.Figure 6 Bud9 DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) Table 6 Bud Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l0,25Number of blades min.040 4 7 805

44、0 5 8 10060 6 9 12070 7 10 14080 8 11 165.7 PearNOTE = 14 to 18.Figure 7 PearTable 7 Pear Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l 0,25Number of blades min.040 4 9 8050 5 10 10060 6 11 12070 7 12 14080 8 13 165.8 Bud, slenderNOTE A small flat area is allowe

45、d at the tip of no more than 0,1 mm.Figure 8 Bud, slender10DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) Table 8 Bud, slender Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l 0,25Number of blades min.040 4 10 8050 5 11 10060 6 12 12070 7 13 13080 8 14 145.9 Whee

46、lFigure 9 WheelTable 9 Wheel Dimensions and number of bladesDimensions in millimetresNominal size d +0,15 -0,25l 0,25Number of blades min.100 10 3,5 18125 12,5 3,5 22140 14 4,0 26160 16 4,0 306 Run-outThe total indicated run-out determined as described in ISO 8325 shall not exceed 0,12 mm.Record for

47、 each cutting edge the readings and sort the highest and the lowest for further analysis.7 SamplingTake randomly 10 instruments from validation batch and test them according to the method described in Clause 6. If eight or less samples pass, the product fails.If nine samples pass, test 10 additional

48、 samples. When 10 additional samples are to be tested, all 10 shall pass for the product to comply.11 DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) 8 Designation code numberThe designation code numbers for laboratory cutters shall be in accordance with ISO 2157.9 MarkingLaboratory cutters shall b

49、e marked with the following information:a) trade name and/or trade mark of the manufacturer;b) nominal size designation.12DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E) Bibliography1 ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection13 DIN EN ISO 7787-1:2016-11 EN ISO 7787-1:2016 (E)

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