1、BRITISH STANDARDBS EN ISO 6877:2006Dentistry Root-canal obturating pointsThe European Standard EN ISO 6877:2006 has the status of a British StandardICS 11.060.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g4
2、4g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 6877:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 April 2006 BSI 2006ISBN 0 580 48157 3National forewordThis British Standard is the official English language ve
3、rsion of EN ISO 6877:2006. It is identical with ISO 6877:2006. It supersedes BS EN ISO 6877:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/1, Restorative and orthodontic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 responsib
4、ility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “Inter
5、national Standards Correspondence Index”, or by using the “Search” facility of 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 Bri
6、tish Standard does not of itself confer immunity from legal obligations. aid enquirers 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 E
7、uropean developments and promulgate them in the UK.Summary of pagesThis 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 11 and a back cover.The BSI copyright notice displayed in this
8、 document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 6877April 2006ICS 11.060.10 Supersedes EN ISO 6877:1998 English VersionDentistry Root-canal obturating points (ISO 6877:2006)Art dentai
9、re Cnes dobturation dentaires pour canauxradiculaires (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 which stipulate the conditions for giving t
10、his 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 Central Secretariat or to any CEN member.This European Standard exists in three official versions (En
11、glish, 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 Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Cze
12、ch 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 STANDARDIZATIONCOMIT EUROPEN
13、 DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 6877:2006: EForeword This document (EN ISO 6877:2006) has been prepared by
14、 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 endorsement, at the latest b
15、y October 2006, and conflicting national standards shall be withdrawn at the latest by October 2006. This document supersedes EN ISO 6877:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stan
16、dard: 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. Endorsement n
17、otice The text of ISO 6877:2006 has been approved by CEN as EN ISO 6877:2006 without any modifications. EN ISO 6877:2006Reference numberISO 6877:2006(E)INTERNATIONAL STANDARD ISO6877Second edition2006-04-01Dentistry Root-canal obturating pointsArt dentaire Cnes dobturation dentaires pour canaux radi
18、culaires EN ISO 6877:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 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 codin
19、g 4 5 Procurement of samples 5 6 Test methods. 5 6.1 Test conditions . 5 6.2 Visual examination . 5 6.3 Length 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
20、 6877:2006Foreword 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 for
21、 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 a
22、ll 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 are
23、 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 re
24、sponsible 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 typo
25、graphical error relating to the size of the specimen required to measure the radio-opacity has been corrected. iv EN ISO 6877:2006vIntroduction The working group, who have prepared this International Standard have addressed the question of cadmium in polytransisoprene (gutta-percha) points and on th
26、e 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 enhancement of the chemical or physical integrity of the points. It has likely resulted from the contamination of
27、the chemical components in the manufacturing process. Based on the data obtained this trace amount of cadmium has no health implications. EN ISO 6877:2006blank1Dentistry Root-canal obturating points 1 Scope This International Standard specifies the dimensions and compositional requirements for prefa
28、bricated 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 points are marketed sterilized
29、 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 references The following referenc
30、ed 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 radiographic film Specification
31、 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 use in the obturation of t
32、he 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 % taper throughout all the ran
33、ges 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 6877:20062 4 Requirements 4.1 Points Throughout their tapered length, the points shall b
34、e smooth and uniform in appearance. Testing shall be carried out in accordance with 6.2. 4.2 Biocompatibility Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard but it is recommended that, in assessing possible biolog
35、ical 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 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
36、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: 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
37、 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 140 is permissible. 4.4.2 Standard taper points The size designation of standardized points shall be in accordance with the numbering sys
38、tem 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 accordance 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.Th
39、e 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 shown 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 6877:20063Ta
40、ble 1 Size designation for standardized points Dimensions in millimetres Size designation Diameter d1Diameter d2Diameter d3010 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,
41、55 0,61 0,87 060 0,60 0,66 0,92 070 0,70 0,76 1,02 080 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 6877:20064 Dimensions in millimetres Key 1 optional flattened end l overall length NOTE 1 The diameters d1, d
42、2and d3are expressed in hundredths of a millimetre. NOTE 2 Table 1 gives values of d1, d2and d3for each size. NOTE 3 The taper is 0,02 mm per 1 mm length, therefore d3= d1+ 0,32 mm. aDatum line. bProjected diameter d1at tip. cThe exact shape of the tip is left to the option of the manufacturer. Figu
43、re 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 are made shall have a radio-opacity equivalent to at least 6 mm
44、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. With regard to taper identification the colour scheme shall be ligh
45、t 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 6877:20065Table 2 Colour code for size designation Size designation Colour code Abbreviatio
46、n 010 purple pur 015 white wh 020 yellow yel 025 red red 030 blue blu 035 green grn 040 black blk 045 white wh 050 yellow yel 055 red red 060 blue blu 070 green grn 080 black blk 090 white wh 100 yellow yel 110 red red 120 blue blu 130 green grn 140 black blk 5 Procurement of samples Samples for tes
47、ting for compliance with this International Standard shall be procured on the open market. Sufficient numbers shall be obtained so that all tests can be carried out on at least five sizes of points from each manufacturer, or the maximum numbers of sizes manufactured if less than five. 6 Test methods
48、 6.1 Test conditions Conduct all tests at (23 2) C and a relative humidity of (50 5) %. Condition the points at this temperature and humidity for 24 h prior to testing. 6.2 Visual examination Choose ten points at random. Visual examination without magnification shall be used to determine the charact
49、eristics of the points as specified in 4.1 and Clause 7. The observer shall be of normal visual acuity. 6.3 Length Choose ten points of any size and taper at random. Place the point on a scale rule marked in 0,5 mm graduations and measure the overall length to the nearest 0,5 mm. If all ten points pass the requirement, the product passes. If eight or fewer points pass, the product fails. If nine points pass, test five additional points. When the five additional points are tested all five shall comply for the product to pass. EN ISO 68
