1、October 2012 Translation by DIN-Sprachendienst.English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.060.10!$-“1919210www.din.deDDIN EN ISO 6876Dentistry Root canal sealing materials (ISO 6876:2012);English version EN ISO 6876:2012,English translation of DIN EN ISO 6876:2012-10Zahnheilkunde Wurzelkanalversiegelungswerkstoffe (ISO 6876:2012);Englische Fassung EN ISO 6876:2012,Englische bersetzun
3、g von DIN EN ISO 6876:2012-10Mdecine bucco-dentaire Matriaux de scellement des canaux radiculaires (ISO 6876:2012);Version anglaise EN ISO 6876:2012,Traduction anglaise de DIN EN ISO 6876:2012-10SupersedesDIN EN ISO 6876:2003-06www.beuth.deIn case of doubt, the German-language original shall be cons
4、idered authoritative.Document comprises 15 pages09.12 DIN EN ISO 6876:2012-10 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Ge
5、rmany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-01 AA Fllungswerkstoffe. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DI
6、N EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 6873 DIN EN ISO 6873 ISO 7405 DIN EN ISO 7405 ISO 8601 DIN ISO 8601 ISO 10993-1 DIN EN ISO 10993-1 Amendments This standard differs from DIN EN ISO 6876:2003-06 as follows: a) the test procedures for flow (5.3), working time (5.3) and solubility (5.6) have bee
7、n revised and a new limit value has been specified; b) the test to determine the dimensional change following setting (former 7.6) has been deleted; c) information on marking (6.3) and instructions for use (6.4) has been updated. Previous editions DIN 13946: 1990-10 DIN EN ISO 6876: 2003-06 National
8、 Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6873, Dental gypsum products DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry DIN ISO 8
9、601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6876 July 2012 ICS
10、 11.060.10 Supersedes EN ISO 6876:2002English Version Dentistry - Root canal sealing materials (ISO 6876:2012) Mdecine bucco-dentaire - Matriaux de scellement des canaux radiculaires (ISO 6876:2012) Zahnheilkunde - Wurzelkanalversiegelungswerkstoffe (ISO 6876:2012) This European Standard was approve
11、d by CEN on 16 June 2012. 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 stan
12、dards 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 member into its own language and n
13、otified 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, France, Germany, Greece, Hungary,
14、 Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any m
15、eans reserved worldwide for CEN national Members. Ref. No. EN ISO 6876:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references 5 3 Terms and definitions 5 4 Requirements
16、 . 6 4.1 Components . 6 4.2 Microbiological hazard 6 4.3 Physical and mechanical properties 6 4.4 Sampling . 7 4.5 Test conditions . 7 4.6 Preparation of material for testing . 7 5 Test methods 7 5.1 Extraneous matter 7 5.2 Flow . 7 5.3 Working time . 8 5.4 Setting time . 8 5.5 Film thickness 9 5.6
17、Solubility . 9 5.7 Radio-opacity 10 6 Packaging, marking and information to be supplied by the manufacturer 11 6.1 General 11 6.2 Packaging . 11 6.3 Marking 11 6.4 Manufacturers information and instructions for use 11 Bibliography 13 2DIN EN ISO 6876:2012-10 EN ISO 6876:2012 (E) Foreword This docume
18、nt (EN ISO 6876:2012) has been prepared by Technical Committee ISO/TC 106 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
19、 endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. 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
20、 identifying any or all such patent rights. This document supersedes EN ISO 6876:2002. 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, Croatia, Cyprus, Czech
21、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, the United Kingdom and Turkey.
22、Endorsement notice The text of ISO 6876:2012 has been approved by CEN as a EN ISO 6876:2012 without any modification. “Dentistry” 3DIN EN ISO 6876:2012-10 EN ISO 6876:2012 (E) Introduction)ROORZLQJWKHSXEOLFDWLRQRIWKHVHFRQGHGLWLRQRIWKLV,QWHUQD WLRQDO6WDQGDUG ISO 6876:2001 WHVWKRXVHVUHSRUWHGGLIFXOWLHV
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25、OHLQWKHFRXQWULQZKLFKWKHVHDOHULVPDUNHWHGRUZLWKVXFKQDWLRQDOUHJXODWLRQVDVDUHDSSOLFDEOHWRSXULWDQGVWHULOLWRISKDUPDFHXWLFDOSURGXFWV 6SHFLFTXDOLWDWLYHDQGTXDQWLWDWLYHWHVWPHWKRGVIRUGHPRQVW UDWLQJIUHHGRPIURPXQDFFHSWDEOHELRORJLFDOULVNVDUHQRWLQFOXGHGLQWKLV,QWHUQDWLRQDO6WDQGDUGEXWLWLVUHFRPPHQGHGWKDWIRUWKHDVVHVVP
26、HQWRIVXFKELRORJLFDOULVNVUHIHUHQFHEHPDGHWR,62DQG,624DIN EN ISO 6876:2012-10 EN ISO 6876:2012 (E) 1 Scope7KLV ,QWHUQDWLRQDO 6WDQGDUG VSHFLHV UHTXLUHPHQWV DQG WHVW PHWKRGV IRU URRW FDQDO HQGRGRQWLF VHDOLQJPDWHULDOVZKLFKVHWZLWKRUZLWKRXWWKHDVVLVWDQFHRIPRLVWXUHDQGDUHXVHGIRUSHUPDQHQWREWXUDWLRQRIWKHURRWFDQD
27、OZLWKRUZLWKRXWWKHDLGRIREWXUDWLQJSRLQWVFRQHV,WRQOFRYHUVVHDOHUVLQWHQGHGIRURUWKRJUDGHXVHLHDURRWOOLQJSODFHGIURPWKHFRURQDODVSHFWRIDWRRWK6SHFLFTXDOLWDWLYHDQGTXDQWLWDWLYHWHVWPHWKRGVIRUGHPRQVWUDWLQJIUHHGRPIURPXQDFFHSWDEOHELRORJLFDOULVNVDUHQRWLQFOXGHGLQWKLV,QWHUQDWLRQDO6WDQGDUGEXWLWLVUHFRPPHQGHGWKDWIRUWKHDVV
28、HVVPHQWRIVXFKELRORJLFDOULVNVUHIHUHQFHEHPDGHWR,62DQG,622 Normative references7KHIROORZLQJUHIHUHQFHGGRFXPHQWVDUHLQGLVSHQVDEOHIRUWKHDSSOLFDWLRQ RI WKLV GRFXPHQW )RU GDWHGUHIHUHQFHVRQOWKHHGLWLRQFLWHGDSSOLHV)RUXQGDWHGUHIHUHQFHVWKHODWHVWHGLWLRQRIWKHUHIHUHQFHGGRFXPHQW LQFOXGLQJDQDPHQGPHQWV DSSOLHV,62Dentis
29、try Vocabulary,623KRWRJUDSK,QWUDRUDOGHQWDOUDGLRJUDSKLFOPDQGOPSDFNHW V0DQXIDFWXUHUVSHFLFDWLRQV,62:DWHUIRUDQDOWLFDOODERUDWRUXVH6SHFLFDWLRQDQGWHVWPHW KRGV,62Dentistry Gypsum productsISO 8601DWDHOHPHQWVDQGLQWHUFKDQJHIRUPDWV,QIRUPDWLRQLQWHUFKDQJH 5HSUHVHQWDWLRQRIGDWHVDQGWLPHV 7HUPVDQGGHQLWLRQV)RUWKHSXUSR
30、VHVRIWKLVGRFXPHQWWKHWHUPVDQGGHQLWLRQVJLYHQLQ,62DQGWKHIROORZLQJDSSO3.1root canal sealing materialHQGRGRQWLFPDWHULDOLQWHQGHGWRSHUPDQHQWOVHDOWKHURRWFDQDOOOLQJPDWHULDOLQWRWKHFDYLWLHVSUHYLRXVORFFXSLHGEWKHUHPRYHGSXOS3.2URRWFDQDOOOLQJPDWHULDOHQGRGRQWLFPDWHULDOLQWHQGHGWRSHUPDQHQWOREWXUDWHWKHFDYLWLHVSUHYLRXV
31、ORFFXSLHGEWKHSXOS3.3mixing timeWKDWSDUWRIWKHZRUNLQJWLPHUHTXLUHGLQRUGHUWRREWDLQDVDWLVIDFWRUPLRIWKHFRPSRQHQWV3.4working timeSHULRGRIWLPHPHDVXUHGIURPWKHVWDUWRIPLLQJGXULQJZKLFKLWLVSRVVLEOHWRPDQLSXODWHWKHURRWFDQDOVHDOHUZLWKRXWDQDGYHUVHHIIHFWRQLWVSURSHUWLHV5DIN EN ISO 6876:2012-10 EN ISO 6876:2012 (E) 3.5
32、setting timeSHULRGRIWLPHPHDVXUHGIURPWKHHQGRIPLLQJXQWLOWKHVHDOHUKDVVHWDFFRUGLQJWRWKHFULWHULDDQGFRQGLWLRQVGHVFULEHGLQ127( )RUWKHSXUSRVHVRIWKLV,QWHUQDWLRQDO6WDQGDUGWKHVHWWLQJWLPHLVGHWHUPLQHGIURPWKHHQGRIPLLQJEHFDXVHRIWKHZLGHYDULDWLRQLQPLLQJWLPHV4 Requirements4.1 Components7KHFRPSRQHQWVRIWKHVHDOHUVKDOOEH
33、IUHHIURPHWUDQHRXVPDWWHUZKHQWHVWHGDFFRUGLQJWR7KHFRPSRQHQWVVKDOOZKHQXVHGLQDFFRUGDQFHZLWKWKHPDQXIDFWXUHUVLQVWUXFWLRQVIRUPDVHDOHUZKLFKFRPSOLHVZLWKWKHUHTXLUHPHQWVRIWKLV,QWHUQDWLRQDO6WDQGDUG4.2 Microbiological hazard6SHFLFTXDOLWDWLYHDQGTXDQWLWDWLYHUHTXLUHPHQWVIRUWKHGHWHUPLQDWLRQRIPLFURELRORJLFDOJURZWKDUHQRWLQFOXGHGLQWKLV,QWHUQDWLRQDO6WDQGDUG4.3 Physical and mechanical properties4.3.1 Flow:KHQGHWHUPLQHGLQDFFRUGDQFHZLWKHDFKGLVFVKDOOKDYHDGLDPHWHURIQRWOHVVWKDQPP4.3.2 Working time)RUVHDOHUVWKDWDUHFODLPHGEWKHPDQXIDFWXUHUWRKDYHDVWD
