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1、BRITISH STANDARD BS EN ISO 3630-2:2001 Dental root-canal instruments Part 2: Enlargers The European Standard EN ISO 3630-2:2000 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Thu No
2、v 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 3630-2:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 2001 BSI 03-20
3、01 ISBN 0 580 37007 0 National foreword This British Standard is the official English language version of EN ISO 3630-2:2000. It is identical with ISO 3630-2:2000. It supersedes BS EN 23630-2:1992 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/52,
4、 Dental instruments, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to intern
5、ational publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facili
6、ty of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligati
7、ons. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of p
8、ages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 15, the annex ZA page, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates wh
9、en the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-2 December 2000 ICS 11.060.20Supersedes
10、EN 23630-2:1991 English version Dental root-canal instruments - Part 2: Enlargers (ISO 3630- 2:2000) Instruments pour canaux radiculaires utiliss en art dentaire - Partie 2: Elargisseurs (ISO 3630-2:2000) Wurzelkanalinstrumente - Teil 2: Erweiterer (ISO 3630- 2:2000) This European Standard was appro
11、ved by CEN on 1 December 2000. 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 references concerning such national
12、 standards may be obtained on application to the 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 member into its own language and notified
13、 to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and Uni
14、ted Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3630-2
15、:2000 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard ISO 3630-2:2000 has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dent
16、istry“, the secretariat of which is held by DIN. This European Standard supersedes EN 23630-2:1991. 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 June 2001, and conflicting national standards sh
17、all be withdrawn at the latest by June 2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland
18、, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 3630-2:2000 was approved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards
19、are listed in annex ZA (normative). EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 3630-2:2000(E) INTERNATIONAL STANDARD ISO 3630-2 Second edition 2000-12-01 Dental root-canal instruments Part 2: Enlar
20、gers Instruments pour canaux radiculaires utiliss en art dentaire Partie 2: largisseurs EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GM
21、T+00:00 2006, Uncontrolled Copy, (c) BSI ISO -03632:(0002)E iii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Term, definition and symbols.1 3.1Term and definition .1 3.2Symbols2 4Requirements.2 4.1Materials .2 4.2Dimensions, designation and number of blades2 4.3Mechanical
22、 requirements3 5Sampling.3 6Testing4 6.1General4 6.2Dimensions.4 6.3Resistance to fracture.4 6.4Resistance to bending 4 6.5Resistance to fatigue.4 6.6Position of fracture5 7Marking of the shank.5 8Packaging.5 9Labelling.5 Bibliography15 EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, T
23、hu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -03632:(0002)E iv Foreword ISO (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 thro
24、ugh 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collabor
25、ates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are ci
26、rculated 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 part of ISO 3630 may be the subject of patent rights. ISO shall not be he
27、ld responsible for identifying any or all such patent rights. International Standard ISO 3630-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This second edition cancels and replaces the first edition (ISO 3630-2:1986), which has been technically r
28、evised, including the following changes: addition of requirements for enlarger type M; addition of requirements and test methods for resistance to fracture in torque and angular deflection; specification of requirements for resistance to bending for enlarger types G and B2; specification of requirem
29、ents for resistance to fatigue for enlarger types G and B1. ISO 3630 consists of the following parts, under the general title Dental root-canal instruments: Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches Part 2: Enlargers Part 3: Condensers, pluggers an
30、d spreaders EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -03632:(0002)E v Introduction This part of ISO 3630 covers significant features of hand- and power-operated dental root-canal instruments which are used by the
31、 dentist for the preparation of root canals for treatment. In dentistry these instruments are also referred to as endodontic instruments. This part of ISO 3630 describes enlargers which are used for gaining access to the root canal and enlarging the opening of the coronal portion of the root canal.
32、Attention is drawn to the International Standard series ISO 6360 on a number coding system which specifies a 15-digit number for the identification of dental rotary instruments of all types. EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolle
33、d Copy, (c) BSI EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADRISO -03632:(0002)E 1 Dental root-canal instruments Part 2: Enlargers 1Scope This part of ISO 3630 specifies requirements for dental root-
34、canal enlargers of the following types: ?Type G; ?Type P; ?Type B1; ?Type B2; ?Type M. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 3630. For dated references, subsequent amendments to, or
35、revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 3630 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normati
36、ve document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of metals. ISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks made of plastics. ISO 3630-1:1992, Dental roo
37、t-canal instruments Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches. ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times. 3Term, definition and symbols 3.1Term and definition For the purposes of this
38、part of ISO 3630, the following term and definition applies. 3.1.1 dental root-canal enlarger hand- and power-operated endodontic instrument used for gaining access to the root canal and for enlarging the opening of the coronal portion of the root canal EN ISO 36302:2000 Licensed Copy: sheffieldun s
39、heffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -03632:(0002)E 2 3.2Symbols For the purposes of this part of ISO 3630, the following symbols apply (see Figures 1 to 5 and Tables 1 to 10): d1diameter of working part; head diameter; d2neck diameter, measured at the e
40、nd of the working part; d3neck diameter, measured at the end of the operative end; d4tip diameter; l1distance from tip to section A-A (at maximum diameter d1); l2length of working part; head length; l3length of operative end; l4overall length. 4Requirements 4.1Materials 4.1.1Shank The material of th
41、e shank shall be left to the discretion of the manufacturer (see ISO 1797-1 and ISO 1797-2). 4.1.2Working part The working part of the instruments shall be made of tool steel or corrosion-resistant metal produced to meet the requirements given in 4.2 and 4.3 of this part of ISO 3630. 4.2Dimensions,
42、designation and number of blades 4.2.1General All linear dimensions are given in millimetres, all angles in degrees. 4.2.2Shank The shank shall be Type 1 or Type 2 of ISO 1797-1 or ISO 1797-2. 4.2.3Working part 4.2.3.1General The linear dimensions of the enlargers shall comply with Figures 1 to 5 an
43、d Tables 1 to 10. Variations in shape and design within the limited dimensions and the description in the subclause titles are permitted. Compliance shall be tested in accordance with ISO 3630-1. Table 1 of ISO 3630-1:1992 gives the series of nominal diameters for the working part, and the correspon
44、ding designation to be used, for all types of dental root-canal instruments specified in ISO 3630-1, ISO 3630-2 and ISO 3630-3. EN ISO 36302:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:02:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -03632:(0002)E 3 4.2.3.2Enlarger type G Req
45、uirements for enlargers of type G are given in Figure 1 and Tables 1 and 2. 4.2.3.3Enlarger type P Requirements for enlargers of type P are given in Figure 2 and Tables 3 and 4. 4.2.3.4Enlarger type B1 Requirements for enlargers of type B1 are given in Figure 3 and Tables 5 and 6. 4.2.3.5Enlarger ty
46、pe B2 Requirements for enlargers of type B2 are given in Figure 4 and Tables 7 and 8. 4.2.3.6Enlarger type M Requirements for enlargers of type M are given in Figure 5 and Tables 9 and 10. 4.3Mechanical requirements 4.3.1Resistance to fracture in torque and angular deflection When tested in accordan
47、ce with 6.3, the instrument shall not fracture at less than the minimum value for the resistance to fracture in torque and the minimum angular deflection given in Table 11, and shall meet the requirements of 4.3.4. 4.3.2Resistance to bending When tested in accordance with 6.4, the instrument shall n
48、ot fracture and shall not exceed the values specified in Table 11. 4.3.3Resistance to fatigue When tested in accordance with 6.5, the instrument shall meet the requirements of 4.3.4. The minimum number of test revolutions shall be the value given in Table 11. 4.3.4Position of fracture point When tes
49、ted for requirements 4.3.1 and 4.3.3, the instruments shall fracture within 4 mm of the junction of the operative end of the shank, as shown in Figures 1 to 4. 5Sampling For each test, unless otherwise specified, more than 90 % of the samples tested shall comply with the requirements. The sampling plan is as follows: Test ten enlarger of each size. If all ten enlarger pass, the product passes. If eight or fewer enlarger pass, the product fails. If nine enlargers pass, test five additional enlargers. If five additional enlargers need to be
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