1、BRITISH STANDARDBS EN ISO 3630-1:2008Dentistry Root-canal instruments Part 1: General requirements and test methodsICS 11.060.25g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g
2、60g53g44g42g43g55g3g47g36g58BS EN ISO 3630-1:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 February 2008 BSI 2008ISBN 978 0 580 54310 4National forewordThis British Standard is the UK implementation of EN ISO 3630-1:2008. It supersed
3、es BS EN ISO 3630-1:1995 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments and equipment.A list of organizations represented on this committee can be obtained on request to its secretary.Th
4、is publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments/corrigenda issued since publicationDate CommentsEUROPEAN STANDARDNORME
5、EUROPENNEEUROPISCHE NORMEN ISO 3630-1February 2008ICS 11.060.20 Supersedes EN ISO 3630-1:1994 English VersionDentistry - Root-canal instruments - Part 1: Generalrequirements and test methods (ISO 3630-1:2008)Art dentaire - Instruments pour canaux radiculaires - Partie1: Exigences gnrales et mthodes
6、dessai (ISO 3630-1:2008)Zahnheilkunde - Wurzelkanalinstrumente - Teil 1:Allgemeine Anforderungen und Prfverfahren (ISO 3630-1:2008)This European Standard was approved by CEN on 7 January 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
7、 giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official v
8、ersions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium
9、, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STAND
10、ARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 3630-1:2008: EForeword This document (EN ISO 3630-1
11、:2008) 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, either by publication of an identical text or by e
12、ndorsement, at the latest by August 2008, and conflicting national standards shall be withdrawn at the latest by August 2008. 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 ide
13、ntifying any or all such patent rights. This document supersedes EN ISO 3630-1:1994. 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, Cyprus, Czech Republic, D
14、enmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 3630-1:2008 has been ap
15、proved by CEN as a EN ISO 3630-1:2008 without any modification. BS EN ISO 3630-1:2008Reference numberISO 3630-1:2008(E)INTERNATIONAL STANDARD ISO3630-1Second edition2008-02-01Dentistry Root-canal instruments Part 1: General requirements and test methods Art dentaire Instruments pour canaux radiculai
16、res Partie 1: Exigences gnrales et mthodes dessai BS EN ISO 3630-1:2008ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms, definitions and symbols 1 3.1 Terms and definitions. 1 3.2 Symbols . 3 4 Classification. 3 5 Requirements 3 5.1 General. 3 5.2 Type 1:
17、 standard-sized instruments . 3 5.3 Type 2: taper-sized instruments 5 5.4 Type 3: shape-sized instruments 6 5.5 Type 4: non-taper-sized instruments 7 5.6 Type 5: non-uniform taper-sized instruments . 8 5.7 Material 9 5.8 Dimensions 9 5.9 Mechanical requirements. 9 5.10 Chemical requirements 10 6 Sam
18、pling 10 7 Testing . 10 7.1 Visual inspection 10 7.2 Test conditions . 10 7.3 Measurement of dimensions . 11 7.4 Resistance to fracture by twisting and angular deflection. 11 7.5 Stiffness. 13 7.6 Handle and shank security 14 7.7 Corrosion test . 14 7.8 Heat effects of sterilization 15 8 Designation
19、, marking and identification 16 8.1 General. 16 8.2 Identification symbols 16 9 Packaging 16 10 Manufacturers instructions for use 16 11 Labelling 17 Bibliography . 18 BS EN ISO 3630-1:2008iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national stan
20、dards 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 org
21、anizations, 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. International Standards are drafted in accordance with the rules given
22、 in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75
23、 % 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 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 3630-1 was prepared by Technical Committee ISO/TC 106, De
24、ntistry, Subcommittee SC 4, Dental instruments. This second edition cancels and replaces the first edition (ISO 3630-1:1992), which has been technically revised. ISO 3630 consists of the following parts, under the general title Dentistry Root-canal instruments: Part 1: General requirements and test
25、methods Part 2: Enlargers Part 3: Condensers, pluggers and spreaders Part 4: Auxiliary instruments BS EN ISO 3630-1:2008vIntroduction The reorganization of ISO 3630 is intended to present the requirements and test methods for root-canal instruments in an orderly manner. This part of ISO 3630 defines
26、 general requirements and test methods. Subsequent parts provide the specific requirements and test methods, if applicable, for two areas of endodontic procedures. These parts are enlargers, condensers and auxiliary instruments. With current use of nickel-titanium (Ni-Ti) alloys for manufacture of r
27、oot canal instruments a need for adequate expertise in their safe use is recommended. Instruments made of Ni-Ti can be easily broken near the tip if manufacturers cautions are not understood and practiced. This part of ISO 3630 does not attempt to provide information for proper use of any instrument
28、s. The sizes of the root-canal obturating points (cones) specified in ISO 68774have to be aligned with the corresponding sizes for root-canal instruments specified in ISO 3630. BS EN ISO 3630-1:2008blank1Dentistry Root-canal instruments Part 1: General requirements and test methods 1 Scope This part
29、 of ISO 3630 specifies general requirements and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments. In addition it covers general size designations, colour coding, packaging and identification
30、symbols. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 554, Standard
31、 atmospheres for conditioning and/or testing Specifications ISO 1942, Dental vocabulary (all parts) ISO 1797-1:1992, Dental rotary instruments Shanks Part 1: Shanks made of metals ISO 1797-2:1992, Dental rotary instruments Shanks Part 2: Shanks made of plastics ISO 3630-2:2000, Dental root-canal ins
32、truments Part 2: Enlargers ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 6360-2, Dentistry Number coding system for rotary instruments Part 2: Shapes ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO
33、13402, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 3 Terms, definitions and symbo
34、ls 3.1 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. BS EN ISO 3630-1:20082 3.1.1 root-canal instrument endodontic instrument dental instrument designed to explore, shape, clean and fill root canal systems 3.1.2 standard
35、-sized instrument root-canal instrument throughout the range of sizes available having a uniform taper of 0,02 mm per millimetre of length NOTE The nominal size of the root-canal instrument is listed in Table 1. 3.1.3 non standard-sized instrument root-canal instrument which has other tip sizes than
36、 the standard-sized instrument NOTE The nominal size of the root-canal instrument is not listed in Table 1. 3.1.4 taper-sized instrument root-canal instrument the sizes of which are determined by the tip sizes that have tapers other than 0,02 mm per millimetre of length 3.1.5 shape-sized instrument
37、root-canal instrument having a contoured working part with continuously varying profile 3.1.6 non taper-sized instrument root-canal instrument having a cylindrical form along the long axis 3.1.7 non-uniform taper-sized instrument root-canal instrument having more than one taper along the working par
38、t 3.1.8 flexible instrument root-canal instrument whose average test value when tested according to 7.5, shall be 65 %, or less, of the value listed in the appropriate bending or stiffness table of referenced specifications 3.1.9 guided tip instrument root-canal instrument having a tip which guides
39、access within root canal systems 3.1.10 tip portion of the instrument that part of the root-canal instrument which is intended as the point, the shape of which is at the discretion of the manufacturer 3.1.11 working part portion of the root-canal instrument with an active cutting surface 3.1.12 shan
40、k part of the root-canal instrument to be connected to a handpiece 3.1.13 handle part of the root-canal instrument to be manipulated by the user by hand BS EN ISO 3630-1:200833.1.14 operative part portion of the root-canal instrument from the tip to the handle or shank 3.2 Symbols For the purposes o
41、f this document, the following symbols apply. d1diameter of the projection of the working part at the tip end (reference size); d2diameter at length l2; d3diameter at the end of minimum length of working part, length l3; l1tip length; l2length for measuring point d2; l3length for measuring point d3a
42、nd minimum length of working part; l4length of operative part. 4 Classification For the purposes of this document, root-canal instruments are classified according to the shape and taper of the tip size (see Figure 1) as follows. Type 1: standard-sized instruments (taper = 2 %); Type 2: taper-sized i
43、nstruments (taper other than 2 %); Type 3: shape-sized instruments (arc shape); Type 4: non-taper-sized instruments (zero taper); Type 5: non-uniform taper-sized instruments (more than one taper). 5 Requirements 5.1 General Specific root-canal instrument types, such as enlargers, have unique shapes
44、which are not included here. These cases are covered in ISO 3630-2 and ISO 3630-3. 5.2 Type 1: standard-sized instruments 5.2.1 Length The length of the working part, l3, shall be a minimum of 16 mm unless otherwise specified by the manufacturer. The lengths of the working part, when specified, and
45、of the operative part, l4, shall be within 0,5 mm of the specified lengths. Test in accordance with 7.3. BS EN ISO 3630-1:20084 Figure 1 Dimensions and locations for Type 1 (standard-sized instruments; taper = 2 %) 5.2.2 Size designation and diameters Table 1 gives the nominal sizes and dimensions f
46、or the working part to be used for Type 1 (standard-sized instruments). Tip sizes (d1) other than those listed in Table 1 are permitted. Figure 1 shows the position of the diameters and lengths for all Type 1 root-canal instruments. The nominal sizes shall correspond to the values of the extended di
47、ameters at the tip of the working part in hundredths of a millimetre. NOTE The designation (code number) with three digits is part of the 15-digit identification number specified in ISO 6360-1 and ISO 6360-2. 5.2.3 Colour designation Table 1 gives the colour designation for each size of Type 1 instr
48、ument. These colours are used on the handle or shank and specify the size identification of the working part. Colours of sizes not included in Table 1 are at the discretion of the manufacturer. 5.2.4 Tip shape The shape of the tip is at the discretion of the manufacturer. 5.2.5 Tip length and angle
49、The tip length shall be within the limits specified by the minimum and maximum angle (l1min. to l1max.) as shown in Figure 1. BS EN ISO 3630-1:20085Table 1 Dimensions, size designation, and colour designation for Type 1 (standard-sized instruments) Dimensions in millimetres Nominal size d1ref. d2Tolerance d3Tolerance l2l3min. Colour designation 006 0,06 012 0,38 pink 008 0,08 014 0,40 grey 010 0,10 016 0,01 0,42 purple015 0,15 0,21 0,47 white 020 0,20 0,26 0,52 yellow 025 0,25 0,31 0,57 red 030 0,
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