DIN EN ISO 3630-3-2015 Dentistry - Endodontic instruments - Part 3 Compactors pluggers and spreaders (ISO 3630-3 2015) German version EN ISO 3630-3 2015《牙医学 根管器械 第3部分 充盈冷凝器、充盈充填器和充.pdf

1、December 2015 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!%KEnglish version EN

2、ISO 3630-3:2015,English translation of DIN EN ISO 3630-3:2015-12Zahnheilkunde Endodontische Instrumente Teil 3: Kompaktoren: Stopfer und Verteiler (ISO 3630-3:2015);Englische Fassung EN ISO 3630-3:2015,Englische bersetzung von DIN EN ISO 3630-3:2015-12Mdecine bucco-dentaire Instruments dendodontie P

3、artie 3: Compacteurs axiaux et latraux (ISO 3630-3:2015);Version anglaise EN ISO 3630-3:2015,Traduction anglaise de DIN EN ISO 3630-3:2015-12SupersedesDIN EN ISO 3630-3:1996-08www.beuth.deDocument comprises 18 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original sha

4、ll be considered authoritative.01.16DIN EN ISO 3630-3:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 3630-3:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: CNN, Canada) in collaboration with Technical Committee CEN/TC 55 “

5、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 to the International Standards referred to in

6、Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3630-1 DIN EN ISO 3630-1 DIN EN ISO 3630 consists of the following parts, under the general title Dentristy Endodontic instruments: Part 1: General requirements and test methods Part 2: Enlargers Part 3: Compactors: pluggers and

7、spreaders Part 4: Auxiliary instruments Part 5: Shaping and cleaning instruments Amendments This standard differs from DIN EN ISO 3630-3:1996-08 as follows: a) the name and definition of “condenser” (in the German version “Fllungsverdichter”) has been changed to “compactor” (in the German version “K

8、ompaktor”); b) in Clauses 5 and 7, a differentiation has been made between finger instruments and hand instruments; c) plugger sizes 015 and 020 have been deleted from Table 1; d) reprocessing requirements have been added. Previous editions DIN EN ISO 3630-3: 1996-08 DIN EN ISO 3630-3:2015-12 3 Nati

9、onal Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 3630-1, Dentistry Root-canal instruments Part 1: General requirements and test methods DIN EN ISO 3630-3:2015-12 4 Page intentionally left blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-3 S

10、eptember 2015 ICS 11.060.20 Supersedes EN ISO 3630-3:1996English Version Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015) Mdecine bucco-dentaire - Instruments dendodontie -Partie 3: Compacteurs axiaux et latraux(ISO 3630-3:2015) Zahnheilkunde - Endodo

11、ntische Instrumente - Teil 3: Verdichter: Stopfer und Spreizer This European Standard was approved by CEN on 16 August 2015. 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 wi

12、thout 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, French, German). A version in any othe

13、r 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, Bulgaria, Croatia, Cyprus, Czech Republic,

14、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 andUnited Kingdom. EUROPEAN COMMIT

15、TEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3630-3:2015 E(ISO 3630-

16、3:2015) Contents Page European foreword. 3 Foreword 41 Scope . 52 Normative references 53 Terms and definitions . 54 Types . 65 Classification 66 Requirements 66.1 Material . 66.2 Dimensional requirements . 66.2.1 General 66.2.2 Diameters . 66.2.3 Length 66.2.4 Hand compactors 96.3 Mechanical requir

17、ements 106.3.1 Stiffness (resistance to bending), finger compactors . 106.3.2 Stiffness (resistance to bending), hand compactors . 106.3.3 Stiffness (resistance to bending), heat carrier instruments. 106.3.4 Handle security . 106.3.5 Surface finish . 106.4 Resistance to reprocessing . 106.5 Colour c

18、oding . 107 Sampling 108 Testing . 118.1 General . 118.1.1 Size . 118.1.2 Stiffness (resistance to bending), finger instruments . 118.1.3 Stiffness (resistance to bending), hand instruments 128.1.4 Bending (stiffness), heat carrier instruments 139 Designation, marking, and identification . 1310 Pack

19、aging . 1311 Manufacturers instructions for use . 1312 Labelling 13Bibliography .142 EN ISO 3630-3:2015 (E) DIN EN ISO 3630-3:2015-12European foreword This document (EN ISO 3630-3:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 5

20、5 “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 March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016

21、. 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. This document supersedes EN ISO 3630-3:1996. According to the CEN-CENELEC Internal R

22、egulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland

23、, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 3630-3:2015 has been approved by CEN as EN ISO 3630-3:2015 without any modification. 3EN IS

24、O 3630-3:2015 (E)DIN EN ISO 3630-3:2015-12ForewordISO (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 member b

25、ody 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 Electro

26、technical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of I

27、SO 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/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 r

28、esponsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in 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 g

29、iven for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the follow

30、ing URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This second edition cancels and replaces the first edition (ISO 3630-3:1994), which has been technically revised with the following changes:a) name

31、 and definition of “condenser” was changed to “compactor”;b) differentiation between finger instruments and hand instruments was made in Clause 5 and Clause 7;c) plugger sizes 015 and 020 were deleted from Table 1;d) reprocessing requirements were added.ISO 3630 consists of the following parts, unde

32、r the general title Dentistry Endodontic instruments: Part 1: General requirements and test methods Part 2: Enlargers Part 3: Compactors: pluggers and spreaders Part 4: Auxiliary instruments Part 5: Shaping and cleaning instruments4 EN ISO 3630-3:2015 (E) DIN EN ISO 3630-3:2015-121 ScopeThis part of

33、 ISO 3630 specifies requirements and test methods for endodontic instruments used as pluggers and spreaders, used to compact endodontic filling materials not cited in ISO 3630-1, ISO 3630-2, ISO 3630-4, or ISO 3630-5.This part of ISO 3630 specifies requirements for size, marking, product designation

34、, safety considerations, and their labelling and packaging.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 late

35、st edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3630-1:2008, Dentistry Root-canal instruments Part 1: General requirements and test methods3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942,

36、 ISO 3630-1, and the following apply.3.1compactorinstrument whose working part is cylindrical or tapered, and circular in cross-section which is designed to condense the filling material in a root canal in the axial and/or lateral directionNote 1 to entry: See Figure 3.3.2pluggerfinger or hand instr

37、ument whose working part is cylindrical or tapered, circular in cross-section and has a flat tip end which is designed to compact filling materials in a root canal mainly in an axial directionNote 1 to entry: See Figure 13.3spreaderfinger or hand instrument whose working part is cylindrical or taper

38、ed, circular in cross-section and has a pointed tip end which is designed to compact filling materials in a root canal mainly in a lateral directionNote 1 to entry: See Figure 2.3.4heat carrier instrumenthand instrument used for transferring heat to a root canal instrument used for transferring heat

39、 to the filling material in a root canal5EN ISO 3630-3:2015 (E)DIN EN ISO 3630-3:2015-123.5thermomechanical compactorinstrument that may be heated or rotary for compacting obturation material in the root canal4 TypesFor the purposes of this International Standard, endodontic compactors are categoriz

40、ed as Type 1, Type 2, and Type 4 as specified in ISO 3630-1:2008, Clause 4.5 ClassificationThe definitions in Clause 3 specify the classification of endodontic compactors and instruments which can be used in a lateral or axial direction or as thermomechanical or heat carrier instrument.6 Requirement

41、s6.1 MaterialThe material for the working part of the instrument as well as design of the handle or the shank is left to the discretion of the manufacturer but shall meet the requirements in ISO 3630-1:2008, 5.7.6.2 Dimensional requirements6.2.1 GeneralThe nominal diameter and taper dimensions of th

42、e compactors, when stated, shall meet the requirements in ISO 3630-1:2008, Clause 5 except as specified. The instruments shall comply with the appropriate tables and figures. Within the dimensional requirements, variations in shape and design are at manufacturers discretion.Working part length, oper

43、ative part length, overall length and tip end are left to the discretion of the manufacturer.The manufacturer shall specify working part length as a minimum and operative part length shall be within 0,5 mm of the length specified. When provided by the manufacturer, the stated overall length shall be

44、 within 1,0 mm of the stated length.6.2.2 DiametersThe diameter designated as d1for Type 1, Type 2, and Type 4 instruments is the reference for the nominal size of the instrument, as shown in Figures 1 and 2, when tested as specified in ISO 3630-1:2008, 7.3. The diameter designated as d1for Type 4 i

45、nstruments is the functional diameter. All other dimensions identified in the figures or tables of that International Standard are used for the purpose of calculation of the taper for the working part of Type 2 instruments, the calculation for d1, and for determination of instrument diameter test lo

46、cations.6.2.3 LengthMeasure the length in accordance with ISO 3630-1:2008, 7.3.6.2.3.1 Type 1Length of working part shall be a minimum of 16 mm. The operative part and overall length shall be left to the discretion of the manufacturer.6 EN ISO 3630-3:2015 (E) DIN EN ISO 3630-3:2015-126.2.3.2 Type 2

47、and Type 4The manufacturer shall specify working part as a minimum and operative part length shall be within 0,5 mm of the length specified.The tip shall be flat and perpendicular to the axis of the instrument. The working part shall be either Type 1 (standard sized), Type 2 (tapered size), or Type

48、4 (non-tapered) along l1, based on d1and d2of Table 1.The neck shall be either cylindrical or tapered. The diameter d1shall not exceed d2, when non-tapered.Key1 handled1diameter of the working part at the tip end (nominal size)d2diameter at the end of working partl1length for measuring point, d2, an

49、d minimum length of working partl2length of operative endl3neck portionFigure 1 PluggerDimensions in millimetresTable 1 Diameters and designation of pluggersNominal size d10,02d20,02Colourdesignation025 0,25 0,57 red030 0,30 0,62 blue035 0,35 0,67 green040 0,40 0,72 black045 0,45 0,77 white050 0,50 0,82 yellow055 0,55 0,87 red060 0,60 0,92 blue070 0,70 1,02 green080 0,80 1,12 black090 0,90 1,22 white100 1,00 1,32 yellow110 1,10 1,42 red120 1,20 1,52 blue7EN ISO 3630-3:2015 (E)DIN EN ISO 3630-3:2015-12Nominal size d10,02d2