DIN EN ISO 3630-2-2013 Dentistry - Endodontic instruments - Part 2 Enlargers (ISO 3630-2 2013) German version EN ISO 3630-2 2013《牙科 牙根管器械 第2部分 扩大器(ISO 3630-2-2013 德文版本EN ISO 3630-2.pdf

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1、August 2013 Translation by DIN-Sprachendienst.English price group 12No 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

2、 11.060.25!%(1“2052914www.din.deDDIN EN ISO 3630-2Dentistry Endodontic instruments Part 2: Enlargers (ISO 3630-2:2013);English version EN ISO 3630-2:2013,English translation of DIN EN ISO 3630-2:2013-08Zahnheilkunde Endodontische Instrumente Teil 2: Erweiterer (ISO 3630-2:2013);Englische Fassung EN

3、ISO 3630-2:2013,Englische bersetzung von DIN EN ISO 3630-2:2013-08Mdecine bucco-dentaire Instruments dendodontie Partie 2: largisseurs (ISO 3630-2:2013);Version anglaise EN ISO 3630-2:2013,Traduction anglaise de DIN EN ISO 3630-2:2013-08SupersedesDIN EN ISO 3630-2:2001-09www.beuth.deDocument compris

4、es pagesIn case of doubt, the German-language original shall be considered authoritative.2308.13 DIN EN ISO 3630-2:2013-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 3630-2:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC,

5、Canada) in collaboration with Technical Committee CEN/TC 055 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-04 AA Rotierende Instrumente. The DIN Standards co

6、rresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1797-1 DIN EN ISO 1797-1 ISO 1797-2 DIN EN ISO 1797-2 ISO 1942 DIN EN ISO 1942 ISO 3630-1 DIN EN ISO 3630-1 ISO 15223-1 DIN EN ISO 15223-1 DIN EN ISO 3630 consists of the following parts, under th

7、e general title Dentristy Endodontic instruments: Part 1: General requirements and test methods Part 2: Enlargers Part 3: Condensers, pluggers and spreaders Part 4: Auxiliary instruments Part 5: Shaping and cleaning instruments Amendments This standard differs from DIN EN ISO 3630-2:2001-09 as follo

8、ws: a) the general instrument designation and title “Dental root-canal instruments” have been changed to read “Endodontic instruments”; b) the tolerances for diameter measurements have been aligned; c) the test procedures have been aligned with ISO 3630-1; d) marking requirements have been updated b

9、y reference to ISO 3630-1. Previous editions DIN EN 23630-2: 1992-01 DIN EN ISO 3630-2: 2001-09 DIN EN ISO 3630-2:2013-08 3 National Annex NA (informative) Bibliography DIN EN ISO 1797-1, Dentistry Shanks for rotary instruments Part 1: Shanks made of metals DIN EN ISO 1797-2, Dental rotary instrumen

10、ts Shanks Part 2: Shanks made of plastics DIN EN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 3630-1, Dentistry Root-canal instruments Part 1: General requirements and test methods DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supp

11、lied Part 1: General requirements DIN EN ISO 3630-2:2013-08 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-2 April 2013 ICS 11.060.20 Supersedes EN ISO 3630-2:2000English Version Dentistry - Endodontic instruments - Part 2: Enlargers Mdecine bucco-de

12、ntaire - Instruments dendodontie - Partie 2: largisseurs (ISO 3630-2:2013) Zahnheilkunde - Endodontische Instrumente - Teil 2: Erweiterer (ISO 3630-2:2013) This European Standard was approved by CEN on 11 April 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which sti

13、pulate 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 the CEN-CENELEC Management Centre or to any CEN member. This European

14、 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are th

15、e national standards bodies of Austria, 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, Romani

16、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means res

17、erved worldwide for CEN national Members. Ref. No. EN ISO 3630-2:2013: E(ISO 3630-2:2013) Contents Page DIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 2 Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms, definitions and symbols .5 3.1 Terms and definitions .5 3.2 Symbols 6 4 Cl

18、assification 6 4.1 Enlarger Type B1 .6 4.2 Enlarger Type B2 .6 4.3 Enlarger Type G .6 4.4 Enlarger Type M .6 4.5 Enlarger Type P 6 5 Requirements .6 5.1 Materials .6 5.2 Dimensions, designation and number of blades 7 5.3 Mechanical requirements 13 6 Sampling .14 7 Testing 14 7.1 General 14 7.2 Dimen

19、sions .14 7.3 Resistance to fracture by twisting and angular deflection .15 7.4 Resistance to bending 15 7.5 Resistance to fatigue .15 7.6 Fracture location 15 8 Designation, marking and identification .17 9 Packaging .18 10 Labelling .18 Bibliography 19 Foreword This document (EN ISO 3630-2:2013) h

20、as 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, either by publication of an identical text or by endorsemen

21、t, at the latest by October 2013, and conflicting national standards shall be withdrawn at the latest by October 2013. 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 identifyin

22、g any or all such patent rights. This document supersedes EN ISO 3630-2:2000. 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,

23、 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, Turkey and the United Kingdom. Endorseme

24、nt notice The text of ISO 3630-2:2013 has been approved by CEN as EN ISO 3630-2:2013 without any modification. DIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 3 IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazard are not included in this International S

25、tandard but it is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.Attention is drawn to ISO 6360 (all parts) which specifies a 15-digit number for the identification of dental rotary instruments of all types.DIN EN ISO 3630-2

26、:2013-08 EN ISO 3630-2:2013 (E) 4 1 ScopeThis part of ISO 3630 specifies requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4 or ISO 3630-5.This part of ISO 3630 specifies requirements for size, marking, product designation, safety considerations, and their labelling and packag

27、ing, including the instructions for use.2 Normative referencesThe following documents, in whole or in part, are normatively referenced 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 r

28、eferenced document (including any amendments) applies.ISO 1797-1, Dentistry Shanks for rotary instruments Part 1: Shanks made of metalsISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks made of plasticsISO 1942, Dentistry VocabularyISO 3630-1:2008, Dentistry Root-canal instruments Part 1: G

29、eneral requirements and test methodsISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements3 Terms, definitions and symbols3.1 Terms and definitionsFor the purposes of this document, the terms and definitions g

30、iven in ISO 1942, ISO 3630-1 and the following apply.3.1.1enlargerhand- or power-operated endodontic instrument used for improving access to the root canal by enlarging its coronal openingDIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 5 3.2 SymbolsFor the purposes of this document, the following s

31、ymbols apply. All dimensions are in millimetres (see Figures 1 to 5 and Tables 1 to 10).d1diameter of working part (head diameter);d2neck diameter, measured at the proximal end of the working part;d3neck diameter, measured at the proximal end of the operative end;d4tip diameter;l1distance from tip t

32、o section A-A (at maximum diameter d1);l2maximum length of working end and the measuring distance of d2(head length);l3minimum length of operative end and the measuring distance of d3;l4total length of the instrument.4 Classification4.1 Enlarger Type B1This enlarger has no other name attributed to i

33、t.4.2 Enlarger Type B2This enlarger has no other name attributed to it.4.3 Enlarger Type GThis enlarger is also known as a Gates-Glidden drill.4.4 Enlarger Type MThis enlarger has no other name attributed to it.4.5 Enlarger Type PThis enlarger is also known as a Peeso drill.5 Requirements5.1 Materia

34、ls5.1.1 Shank or handleThe material(s) of the shank or handle shall be left to the discretion of the manufacturer but shall meet the requirement in ISO 3630-1:2008, 5.7.The shank or handle of the enlarger shall be Type 1 or Type 2 of ISO 1797-1 or ISO 1797-2.DIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2

35、013 (E) 6 5.1.2 Working partThe working part of the instrument shall be made of stainless steel, corrosion-resistant metal, or any other material, provided it meets the requirements given in 5.2 and 5.3.5.2 Dimensions, designation and number of blades5.2.1 GeneralAll linear dimensions are given in m

36、illimetres, all angles in degrees. The linear dimensions in millimetres shall comply with Figures 1 to 5 and Tables 1 to 10.The lengths of the working part and the operative part shall be specified by the manufacturer and shall be within 0,5 mm of the specified lengths.Test compliance in accordance

37、with ISO 3630-1. ISO 3630-1:2008, Table 1, gives the series of nominal diameters for the working part and the corresponding designation to be used, for all Types of dental endodontic instruments specified in ISO 3630-2, ISO 3630-3, ISO 3630-4 and ISO 3630-5.NOTE Variations in shape and design within

38、 the limits of the dimensions and the subclass titles are permitted.5.2.2 Enlarger types5.2.2.1 Enlarger Type B1Requirements for enlargers of Type B1 are given in Figure 1 and Tables 1 and 2.5.2.2.2 Enlarger Type B2Requirements for enlargers of Type B2 are given in Figure 2 and Tables 3 and 4.5.2.2.

39、3 Enlarger Type GRequirements for enlargers of Type G are given in Figure 3 and Tables 5 and 6.5.2.2.4 Enlarger Type MRequirements for enlargers of Type M are given in Figure 4 and Tables 7 and 8.5.2.2.5 Enlarger Type PRequirements for enlargers of Type P are given in Figure 5 and Tables 9 and 10.DI

40、N EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 7 Dimensions in millimetresNOTE The shank shown is an example of Type 1 of ISO 1797-1 with six-ring marking.Figure 1 Enlarger Type B1Table 1 Enlarger Type B1: Dimensions, number of blades and designationDimensions in millimetresNominal size d1d2d3l1l2Nu

41、mber of bladesColour Ring marking 0,05+0050, +0005, 0,05 min. min.090 0,90 0,75 0,75 4,5010,04 white I100 1,00 0,85 0,85 4,50 4 yellow II120 1,20 1,05 1,05 4,50 4 red III140 1,40 1,20 1,20 4,75 4 blue III I160 1,60 1,40 1,40 4,75 4 green III II180 1,80 1,60 1,60 4,75 4 black III IIITable 2 Enlarger

42、Type B1: Lengths l3and l4Dimensions in millimetresShank(ISO 1797-1)l3min.l4Type 1 13 34 0,5Type 2 26 65 1,0DIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 8 Dimensions in millimetresNOTE The shank shown is an example of Type 1 of ISO 1797-1 with six-ring marking.Figure 2 Enlarger Type B2Table 3 Enl

43、arger Type B2: Dimensions and designationDimensions in millimetresNominal size d1d2d3l1l2Colour Ring marking 0,05+0050, +0005, 0,05 min.030 0,30 0,20 0,20 0,50 7,5 purple 0035 0,35 0,26 0,26 0,50 8,0 white I045 0,45 0,36 0,36 0,50 8,0 yellow II060 0,60 0,46 0,46 0,70 8,0 red III075 0,75 0,56 0,56 0,

44、80 9,0 blue III I090 0,90 0,66 0,66 1,00 9,0 green III II105 1,05 0,76 0,76 1,10 10,0 black III IIITable 4 Enlarger Type B2: Lengths l3and l4Dimensions in millimetresShank(ISO 1797-1)l3l4Type 1 18 0,5 33 0,5Type 2 min. 25 61 1,0DIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 9 Dimensions in millime

45、tresNOTE The shank shown is an example of Type 1 of ISO 1797-1 with six-ring marking.Figure 3 Enlarger Type GTable 5 Enlarger Type G: Dimensions, number of blades and designationDimensions in millimetresNominal sized1d2d3d4l1l2Number of bladesColour Ring marking 0,05+0005,+0005, 0,05 0,05 min. min.0

46、50 0,50 0,38 0,38 0,25 1,50 2,3 3 white I070 0,70 0,48 0,48 0,30 1,70 2,7 3 yellow II090 0,90 0,58 0,58 0,35 1,90 3,1 3 red III110 1,10 0,68 0,68 0,40 2,10 3,5 3 blue III I130 1,30 0,78 0,78 0,45 2,30 3,9 3 green III II150 1,50 0,87 0,87 0,50 2,50 4,3 3 black III IIIDIN EN ISO 3630-2:2013-08 EN ISO

47、3630-2:2013 (E) 10 Table 6 Enlarger Type G: Lengths l3and l4Dimensions in millimetresShank(ISO 1797)l3min.l4Type 1 15,2 32 0,5Type 2 15,2 60,5 1,0Dimensions in millimetresNOTE The shank shown is an example of Type 1 of ISO 1797-1 with four-ring marking.Figure 4 Enlarger Type MTable 7 Enlarger Type M

48、: Dimensions and designationDimensions in millimetresNominal size d1d2d4l1l2Colour Ring marking 0,05+0050, 0,05 0,05 min.120 1,20 1,00 0,40 4,75 13,0 white I140 1,40 1,15 0,45 4,75 13,0 yellow II165 1,65 1,30 0,50 4,75 13,0 red III190 1,90 1,45 0,55 4,75 13,0 blue III IDIN EN ISO 3630-2:2013-08 EN ISO 3630-2:2013 (E) 11 Table 8 Enlarger Type M: Lengths l3and l4Dimensions in millimetresShank(ISO 1797-1)l3min.l4Type 1 19 33 0,5Dimensions in