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1、BRITISH STANDARD BS EN ISO 6877:2006 Dentistry Root-canal obturating points The European Standard EN ISO 6877:2006 has the status of a British Standard ICS 11.060.10 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 6877:2006 This
2、British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 April 2006 BSI 2006 ISBN 0 580 48157 3 National foreword This British Standard is the official English language version of EN ISO 6877:2006. It is identical with ISO 6877:2006. It supersedes BS EN
3、 ISO 6877:1998 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/1, Restorative and orthodontic materials, which has the responsibility to: A list of organizations represented on this subcommittee can be obtaine
4、d on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of
5、the BSI Electronic Catalogue or of British Standards Online. This 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 does not of itself confer immunity from legal obligations. aid e
6、nquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This docu
7、ment 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 11 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued si
8、nce publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6877 April 2006 ICS 11.060.10Supersedes EN ISO 6877:1998 English Version Dentistry Root-canal obtu
9、rating points (ISO 6877:2006) Art dentaire Cnes dobturation dentaires pour canaux radiculaires (ISO 6877:2006) Zahnheilkunde - Wurzelkanalfllstifte (ISO 6877:2006) This European Standard was approved by CEN on 23 January 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations
10、 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 standards may be obtained on application to the Central Secretariat or to any CEN member. This European
11、 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 to the Central Secretariat has the same status as the official versions. CEN members are the national
12、 standards bodies of Austria, Belgium, 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
13、. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6877:2006: E Lice
14、nsed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 6877:2006) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which i
15、s 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 October 2006, and conflicting national standards shall be withdrawn at the latest by October 2006. This document supersedes EN ISO 68
16、77:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L
17、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 6877:2006 has been approved by CEN as EN ISO 6877:2006 without any modifications. EN ISO 6877:2006 Licensed Copy:
18、 sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 6877:2006(E) INTERNATIONAL STANDARD ISO 6877 Second edition 2006-04-01 Dentistry Root-canal obturating points Art dentaire Cnes dobturation dentaires pour canaux radiculaires EN ISO 6877
19、:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative referenc
20、es. 1 3 Terms and definitions. 1 4 Requirements 2 4.1 Points. 2 4.2 Biocompatibility 2 4.3 Length 2 4.4 Size designation and taper 2 4.5 Physical integrity 4 4.6 Radio-opacity 4 4.7 Colour coding 4 5 Procurement of samples 5 6 Test methods. 5 6.1 Test conditions . 5 6.2 Visual examination . 5 6.3 Le
21、ngth 5 6.4 Size designation 6 6.5 Physical integrity 7 6.6 Radio-opacity for polymeric points 8 7 Packaging 9 8 Marking and information to be supplied by manufacturer. 9 Bibliography. 11 EN ISO 6877:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Cop
22、y, (c) BSI 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 through ISO technical committees. Each member body interested in a subject fo
23、r 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 Electrotechnical Commission (IEC) on
24、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 adopted by the technical committees ar
25、e 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 rights. ISO shall not be held r
26、esponsible for identifying any or all such patent rights. ISO 6877 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This second edition cancels and replaces the first edition (ISO 6877:1995), which has been technically revised and a typ
27、ographical error relating to the size of the specimen required to measure the radio-opacity has been corrected. iv EN ISO 6877:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction The working group, who have prepared this Inte
28、rnational Standard have addressed the question of cadmium in polytransisoprene (gutta-percha) points and on the data obtained have concluded that the amount of cadmium in polytransisoprene (gutta-percha) points is most likely not intentionally added either as an aesthetic (colour) agent for the enha
29、ncement of the chemical or physical integrity of the points. It has likely resulted from the contamination of the chemical components in the manufacturing process. Based on the data obtained this trace amount of cadmium has no health implications. EN ISO 6877:2006 Licensed Copy: sheffieldun sheffiel
30、dun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Dentistry Root-canal obturating points 1 Scope This International Standard specifies the dimensions and compositi
31、onal requirements for prefabricated metal or polymeric points or cones suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. It also specifies numerical systems and a colour coding system for designating the sizes. Dental root-canal obturating poi
32、nts are marketed sterilized or unsterilized. This International Standard covers the physical attributes expected of such products as supplied. Requirements for sterility are not included, and any claim that the product is sterile is the responsibility of the manufacturer see 8 f). 2 Normative refere
33、nces 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 3665, Photography Intra-oral dental radi
34、ographic film Specification ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 point prefabricated metal or polymeric material for
35、 use in the obturation of the root-canal NOTE For the purposes of this International Standard the term “root-canal obturating point” is abbreviated as “point”. 3.2 unit pack smallest pack of points distributed, containing one or more sizes of point 3.3 standard taper point point having uniform 2 % t
36、aper throughout all the ranges of sizes available 3.4 greater taper point point having a taper greater than 2 % 3.5 size designation numerical indication, “000”, of the projected tip diameter, measured in hundredths of a millimetre EN ISO 6877:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov
37、 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 4 Requirements 4.1 Points Throughout their tapered length, the points shall be smooth and uniform in appearance. Testing shall be carried out in accordance with 6.2. 4.2 Biocompatibility Specific qualitative and quantitative requirements for
38、freedom from biological hazard are not included in this International Standard but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to lSO 10993-1 and ISO 7405. 4.3 Length Unless otherwise stated by the manufacturer, the overall length shall
39、 be not less than 28 mm. If some other length is stated, the points shall not be less than the stated length. Testing shall be carried out in accordance with 6.3. 4.4 Size designation and taper 4.4.1 General 4.4.1.1 The designation shall be in the form of a five-digit numerical set, having two parts
40、: 000 XX where 000 corresponds to the size designation; XX corresponds to the 2 significant figures of the taper. 4.4.1.2 For all types of points a diameter tolerance of 0,02 mm for metallic points, 0,05 mm for polymeric points of sizes 010 to 025, and 0,07 mm for polymeric points of sizes 030 to 14
41、0 is permissible. 4.4.2 Standard taper points The size designation of standardized points shall be in accordance with the numbering system shown in Table 1. The taper of the points shall be uniform for a minimum of 16 mm from the tip as illustrated in Figure 1. Testing shall be carried out in accord
42、ance with 6.4.2.1 and the taper calculated as shown in 6.4.3. 4.4.3 Greater taper points Testing shall be in accordance with 6.4.2.2.The taper of the points shall be uniform up to 1 mm from the end of the taper. The calculated taper shall be within 10 % of the stated tapers. This is calculated as sh
43、own in 6.4.3. The tip diameter and the taper or tapers of the points shall be designated by the manufacturer (8.c). EN ISO 6877:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 Table 1 Size designation for standardized points Dimension
44、s in millimetres Size designation Diameter d1 Diameter d2 Diameter d3 010 0,10 0,16 0,42 015 0,15 0,21 0,47 020 0,20 0,26 0,52 025 0,25 0,31 0,57 030 0,30 0,36 0,62 035 0,35 0,41 0,67 040 0,40 0,46 0,72 045 0,45 0,51 0,77 050 0,50 0,56 0,82 055 0,55 0,61 0,87 060 0,60 0,66 0,92 070 0,70 0,76 1,02 08
45、0 0,80 0,86 1,12 090 0,90 0,96 1,22 100 1,00 1,06 1,32 110 1,10 1,16 1,42 120 1,20 1,26 1,52 130 1,30 1,36 1,62 140 1,40 1,46 1,72 EN ISO 6877:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 Dimensions in millimetres Key 1 optional fl
46、attened end l overall length NOTE 1 The diameters d1, d2 and d3 are expressed in hundredths of a millimetre. NOTE 2 Table 1 gives values of d1, d2 and d3 for each size. NOTE 3 The taper is 0,02 mm per 1 mm length, therefore d3 = d1 + 0,32 mm. a Datum line. b Projected diameter d1 at tip. c The exact
47、 shape of the tip is left to the option of the manufacturer. Figure 1 Diagrammatic representation of standard points 4.5 Physical integrity None of the five samples tested shall show any sign of fracture when tested in accordance with 6.5.2. 4.6 Radio-opacity The material from which polymeric points
48、 are made shall have a radio-opacity equivalent to at least 6 mm aluminium when tested in accordance with 6.6.2. 4.7 Colour coding The use of colour coding on the packaging or the individual points to indicate the nominal size designation is optional; if used the colours shall conform to Table 2. Wi
49、th regard to taper identification the colour scheme shall be light to dark to indicate the increasing taper of the various points, e.g. a brand may have tapers of 2 %, 4 %, 6 %, 8 %, and 10 % and the colours would be consecutively white, yellow, red, blue and green. EN ISO 6877:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 5 Table 2 Colour code for size designation Size designation Colour code Abbrevia