EN ISO 3630-2-2013 en Dentistry - Endodontic instruments - Part 2 Enlargers《牙科 牙根管器械 第2部分 扩大器》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 3630-2:2013Dentistry Endodontic instrumentsPart 2: EnlargersBS EN ISO 3630-2:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN

2、ISO 3630-2:2013. It supersedes BS EN ISO 3630-2:2001,which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 0 6 / 4 , D e n t a l I n s t r u m e n t s a n d E q u i p m e n t .A list of organizations represented on this committee can

3、be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013.ISBN 978 0 580 65529 6 ICS 11.060.20 Com

4、pliance with a British Standard cannot confer immunityfrom legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPI

5、SCHE NORM EN ISO 3630-2 April 2013 ICS 11.060.20 Supersedes EN ISO 3630-2:2000English Version Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013) Mdecine bucco-dentaire - Instruments dendodontie - Partie 2: largisseurs (ISO 3630-2:2013) Zahnheilkunde - Endodontische Instrumente

6、- 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 stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-

7、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, French, German). A version in any other language made by transl

8、ation 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland

9、, 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION

10、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 reserved worldwide for CEN national Members. Ref. No. EN ISO 3630-2:2013: EBS EN ISO 3630-2:2013 EN ISO 3630-2:2013 (E)

11、3 Foreword This document (EN ISO 3630-2:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” incollaboration 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 pub

12、lication of an identicaltext or by endorsement, at the latest by October 2013, and conflicting national standards shall be withdrawn atthe latest by October 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC s

13、hall not be held responsible for identifying 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 followingcountries are bound to implement this European Standard: Austria, Belgium,

14、Bulgaria, Croatia, Cyprus, CzechRepublic, 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 the United Kingdom. Endorsement notice The text of ISO 3630-2:2013 has been approved by CEN as EN ISO 3630-2:2013 without any modification. BS EN ISO 3630-2:2013ISO 3630-2:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Ter

16、ms, definitions and symbols 13.1 Terms and definitions . 13.2 Symbols . 24 Classification 24.1 Enlarger Type B1 24.2 Enlarger Type B2 24.3 Enlarger Type G 24.4 Enlarger Type M . 24.5 Enlarger Type P 25 Requirements 25.1 Materials . 25.2 Dimensions, designation and number of blades 35.3 Mechanical re

17、quirements 96 Sampling .107 Testing 107.1 General 107.2 Dimensions 107.3 Resistance to fracture by twisting and angular deflection .117.4 Resistance to bending 117.5 Resistance to fatigue . 117.6 Fracture location 118 Designation, marking and identification .139 Packaging 1410 Labelling .14Bibliogra

18、phy .15BS EN ISO 3630-2:2013ISO 3630-2:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each memb

19、er 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. ISO collaborates closely with the International Ele

20、ctrotechnical 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 International Standards. Draft International Standards adopte

21、d 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 document may be the subject of patent

22、rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 3630-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This third edition cancels and replaces the second edition (ISO 3630-2:2000), which has been technically

23、 revised.The following changes were made:a) tolerances for diameter measurements were aligned;b) test procedures were aligned with ISO 3630-1.ISO 3630 consists of the following parts, under the general title Dentistry Endodontic instruments: Part 1: General requirements and test methods Part 2: Enla

24、rgers Part 3: Condensers, pluggers and spreaders Part 4: Auxiliary instruments Part 5: Shaping and cleaning instrumentsiv ISO 2013 All rights reservedBS EN ISO 3630-2:2013ISO 3630-2:2013(E)IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazard are not inclu

25、ded in this International Standard 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

26、all types. ISO 2013 All rights reserved vBS EN ISO 3630-2:2013BS EN ISO 3630-2:2013Dentistry Endodontic instruments Part 2: Enlargers1 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 require

27、ments for size, marking, product designation, safety considerations, and their labelling and packaging, 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 da

28、ted references, only the edition cited applies. For undated references, the latest edition of the referenced 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 o

29、f plasticsISO 1942, Dentistry VocabularyISO 3630-1:2008, Dentistry Root-canal instruments Part 1: General 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

30、 and symbols3.1 Terms and definitionsFor the purposes of this document, the terms and definitions given 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 openingINTERNATIONAL

31、 STANDARD ISO 3630-2:2013(E) ISO 2013 All rights reserved 1BS EN ISO 3630-2:2013ISO 3630-2:2013(E)3.2 SymbolsFor the purposes of this document, the following symbols apply. All dimensions are in millimetres (see Figures 1 to 5 and Tables 1 to 10).d1diameter of working part (head diameter);d2neck dia

32、meter, 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 to section A-A (at maximum diameter d1);l2maximum length of working end and the measuring distance of d2(head length);l3minimum length of oper

33、ative 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 it.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 dril

34、l.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 Materials5.1.1 Shank or handleThe material(s) of the shank or handle shall be left to the discretion of the manufacturer but shall meet the requirem

35、ent 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 1797-2.2 ISO 2013 All rights reservedBS EN ISO 3630-2:2013ISO 3630-2:2013(E)5.1.2 Working partThe working part of the instrument shall be made of stainless steel, corrosion-resistant metal,

36、 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 millimetres, all angles in degrees. The linear dimensions in millimetres shall comply with Figures 1 to 5 and Tables 1 to 10

37、.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 with ISO 3630-1. ISO 3630-1:2008, Table 1, gives the series of nominal diameters for the working part and the corresponding

38、 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 the limits of the dimensions and the subclass titles are permitted.5.2.2 Enlarger types5.2.2.1 Enlarger Type B1Requirement

39、s 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 4.5.2.2.3 Enlarger Type GRequirements for enlargers of Type G are given in Figure 3 and Tables 5 and 6.5.2.2.4 Enlarger Type MRequi

40、rements 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. ISO 2013 All rights reserved 3BS EN ISO 3630-2:2013ISO 3630-2:2013(E)Dimensions in millimetresNOTE The shank shown is an exa

41、mple 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 d1d2d3l1l2Number of bladesColour Ring marking 0,05+0050, +0005, 0,05 min. min.090 0,90 0,75 0,75 4,5010,04 white I10

42、0 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 Type B1: Lengths l3and l4Dimensions in millimetresShank(ISO 1797-1)l3min.l4Type 1 13 34 0,5Type 2 26 65

43、1,04 ISO 2013 All rights reservedBS EN ISO 3630-2:2013ISO 3630-2:2013(E)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 Enlarger Type B2: Dimensions and designationDimensions in millimetresNominal size d1d2d3l

44、1l2Colour 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 0,80 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

45、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 1,0 ISO 2013 All rights reserved 5BS EN ISO 3630-2:2013ISO 3630-2:2013(E)Dimensions in millimetresNOTE The shank shown is an example of Type 1 of ISO 1797-1 with

46、 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.050 0,50 0,38 0,38 0,25 1,50 2,3 3 white I070 0,70 0,48 0,48 0,30 1,

47、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 III6 ISO 2013 All rights reservedBS EN ISO 3630-2:2013ISO 3630-2:2013(E)Table 6 Enlarger Type G: Length

48、s 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: Dimensions and designationDimensions in millimet

49、resNominal 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 I ISO 2013 All rights reserved 7BS EN ISO 3630-2:2013ISO 3630-2:2013(E)Table 8 Enlarger Type M: Lengths l3and l4Dimensions in millimetresShank(ISO 1797-1)l3min.l4Type 1 19 33 0,5Dimensions in millimetresNOTE The shank shown is an example of T