1、BSI Standards PublicationBS EN ISO 3630-3:2015Dentistry EndodonticinstrumentsPart 3: Compactors: pluggers and spreadersBS EN ISO 3630-3:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 3630-3:2015. It supersedes BS EN ISO 3630-3:1997 which iswithdrawn.Th
2、e UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contr
3、act. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 78984 7 ICS 11.060.25 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the au
4、thority of the Standards Policy and Strategy Committee on 30 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-3 September 2015 ICS 11.060.20 Supersedes EN ISO 3630-3:1996English Version Dentistry -
5、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 - Endodontische Instrumente - Teil 3: Verdichter: Stopfer und Spreizer (ISO 3630-3:2015) Thi
6、s 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 without any alteration. Up-to-date lists and bibliographical referen
7、ces 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 translation under the responsibility of a CEN m
8、ember 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, Former Yugoslav Republic of Macedonia,
9、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 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES
10、 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 EBS EN ISO 3630-3:2015EN ISO 3630-3:2015 (E) 3 European foreword This documen
11、t (EN ISO 3630-3:2015) has been prepared by Technical Committee ISO/TC 106“Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of whichis held by DIN. This European Standard shall be given the status of a national standard, either by publication of anidentical
12、text or by endorsement, at the latest by March 2016, and conflicting national standards shallbe withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible
13、 for identifying any or all such patentrights. This document supersedes EN ISO 3630-3:1996. According to the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,Croatia, Cyprus, Cze
14、ch 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,Turkey and the United Kingdom.
15、Endorsement notice The text of ISO 3630-3:2015 has been approved by CEN as EN ISO 3630-3:2015 without anymodification. BS EN ISO 3630-3:2015ISO 3630-3:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Types . 25 Classification 26 Requirements 26.1 Material . 26.2 Dime
16、nsional requirements . 26.2.1 General 26.2.2 Diameters . 26.2.3 Length 26.2.4 Hand compactors 56.3 Mechanical requirements 66.3.1 Stiffness (resistance to bending), finger compactors . 66.3.2 Stiffness (resistance to bending), hand compactors . 66.3.3 Stiffness (resistance to bending), heat carrier
17、instruments. 66.3.4 Handle security . 66.3.5 Surface finish . 66.4 Resistance to reprocessing . 66.5 Colour coding . 67 Sampling 68 Testing . 78.1 General . 78.1.1 Size . 78.1.2 Stiffness (resistance to bending), finger instruments . 78.1.3 Stiffness (resistance to bending), hand instruments 88.1.4
18、Bending (stiffness), heat carrier instruments 99 Designation, marking, and identification . 910 Packaging . 911 Manufacturers instructions for use . 912 Labelling 9Bibliography .10 ISO 2015 All rights reserved iiiContents PageBS EN ISO 3630-3:2015ISO 3630-3:2015(E)ForewordISO (the International Orga
19、nization 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 body interested in a subject for which a technical committee has been establis
20、hed 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization
21、.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 ISO documents should be noted. This document was drafted in accordance with th
22、e 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 responsible for identifying any or all such patent rights. Details of any pate
23、nt 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 given for the convenience of users and does not constitute an endorsement.For
24、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 following URL: Foreword - Supplementary informationThe committee responsible for th
25、is 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 and definition of “condenser” was changed to “compactor”;b) differentiation
26、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, under the general title Dentistry Endodontic instruments: Part 1: General require
27、ments and test methods Part 2: Enlargers Part 3: Compactors: pluggers and spreaders Part 4: Auxiliary instruments Part 5: Shaping and cleaning instrumentsiv ISO 2015 All rights reservedBS EN ISO 3630-3:2015INTERNATIONAL STANDARD ISO 3630-3:2015(E)Dentistry Endodontic instruments Part 3: Compactors:
28、pluggers and spreaders1 ScopeThis part of 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 requiremen
29、ts for size, marking, product designation, 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
30、applies. For undated references, the latest 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
31、 terms and definitions given in ISO 1942, 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: Se
32、e Figure 3.3.2pluggerfinger or hand instrument 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 w
33、hose working part is cylindrical or tapered, 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 ca
34、nal instrument used for transferring heat to the filling material in a root canal ISO 2015 All rights reserved 1BS EN ISO 3630-3:2015ISO 3630-3:2015(E)3.5thermomechanical compactorinstrument that may be heated or rotary for compacting obturation material in the root canal4 TypesFor the purposes of t
35、his International Standard, endodontic compactors are categorized 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
36、or as thermomechanical or heat carrier instrument.6 Requirements6.1 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 requireme
37、nts6.2.1 GeneralThe nominal diameter and taper dimensions of the 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 d
38、esign are at manufacturers discretion.Working part length, operative 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 p
39、rovided by the manufacturer, the stated overall length shall be 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
40、ISO 3630-1:2008, 7.3. The diameter designated as d1for Type 4 instruments 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 calculati
41、on for d1, and for determination of instrument diameter test locations.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.2
42、ISO 2015 All rights reservedBS EN ISO 3630-3:2015ISO 3630-3:2015(E)6.2.3.2 Type 2 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 wor
43、king part shall be either Type 1 (standard sized), Type 2 (tapered size), or Type 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 (nomi
44、nal size)d2diameter at the end of working partl1length for measuring point, d2, and 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 red03
45、0 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 blue ISO 2015 All rights reserved 3BS EN ISO 3630-3:2015ISO 3630
46、-3:2015(E)Nominal size d10,02d20,02Colourdesignation130 1,30 1,62 green140 1,40 1,72 blackKey1 handled1diameter of the working part at the tip end (nominal size)d2diameter at fixed length l5d3diameter at length l1l1length for measuring point d3and minimum length of working partl2length of operative
47、endl3neck portionl4length of tipl5fixed length of 3 mm for measuring point d2Figure 2 SpreaderThe taper along l1is specified by d1and d2of Table 2. The neck portion shall be cylindrical, continuously tapered or both. The diameter d1shall not exceed d2, when cylindrical.Table 1 (continued)4 ISO 2015
48、All rights reservedBS EN ISO 3630-3:2015ISO 3630-3:2015(E)Dimensions in millimetresTable 2 Diameters and designation of standard spreadersNominal size d1ref.d20,02d30,02Colourdesignation010 0,10 0,16 0,42 purple015 0,15 0,21 0,47 white020 0,20 0,26 0,52 yellow025 0,25 0,31 0,57 red030 0,30 0,36 0,62
49、 blue035 0,35 0,41 0,67 green040 0,40 0,46 0,72 black045 0,45 0,51 0,77 white6.2.4 Hand compactorsThe symbols and terms in 6.1, 6.2.1, 6.2.2, and 6.2.3 also apply to instruments fitted in handles.The length and the diameter of the handle shall be at the manufacturers discretion but the overall length shall not exceed 175 mm.The compactors shall be either straight or angled as shown in Figure 3. Length l2can be less than 16 mm at the discretion of the manufacturer.The angle, , shown in Figure 3 shall be within the tolerance
