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1、BRITISH STANDARD BS EN ISO 3107:2004 Dentistry Zinc oxide/eugenol and zinc oxide/non-eugenol cements The European Standard EN ISO 3107:2004 has the status of a British Standard ICS 11.060.10 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
2、BS EN ISO 3107:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 October 2004 BSI 13 October 2004 ISBN 0 580 44588 7 National foreword This British Standard is the official English language version of EN ISO 3107:2004. It is identical w
3、ith ISO 3107:2004. It supersedes BS 7214:1989 which is withdrawn.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 t
4、his subcommittee can be obtained 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
5、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 British Standard does not of itself confer immunit
6、y 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 the UK interests informed; monitor related international and European developments and promulgate them in
7、 the UK. Summary of pages 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 14, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicate
8、s when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3107 October 2004 ICS 11.060.10 Supersede
9、s EN 23107:1991 English version Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements (ISO 3107:2004) Art dentaire - Ciments dentaires base doxyde de zinc- eugnol et base doxyde de zinc sans eugnol (ISO 3107:2004) Zahnheilkunde - Zinkoxideugenolzemente und eugenolfreie Zinkoxidzemente (I
10、SO 3107:2004) This European Standard was approved by CEN on 23 September 2004. 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 bib
11、liographical references concerning such national standards may be obtained on application to the Central Secretariat 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
12、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 standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
13、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels
14、 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3107:2004: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I NESO 13:7002( 40E) 2 Foreword This document (EN ISO
15、 3107:2004) 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
16、 by endorsement, at the latest by April 2005, and conflicting national standards shall be withdrawn at the latest by April 2005. This document supersedes EN 23107:1991. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to imp
17、lement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdo
18、m. Endorsement notice The text of ISO 3107:2004 has been approved by CEN as EN ISO 3107:2004 without any modifications. EN ISO 3107:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 3107:2004(E) OSI 4002 INTERNATIONAL
19、 STANDARD ISO 3107 Third edition 2004-10-01 Dentistry Zinc oxide/eugenol and zinc oxide/non-eugenol cements Art dentaire Ciments dentaires base doxyde de zinc-eugnol et base doxyde de zinc sans eugnol EN ISO 3107:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Un
20、controlled Copy, (c) BSI IS:7013 O4002(E) DPlcsid Fremia ihTs PDF file may ctnoian emdebt dedyfepcaes. In ccaocnadrw eith Aebods licensilop gnic,y this file mairp eb ynted iv roweb detu slahl ton ide ebtlnu deess the typefaces whice era hml era deddebicsnede to i dnanstlaled t noeh computfrep reormi
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22、ile cna f ebi dnuon tlareneG eh Info leratit evo the file; tP ehDc-Frtaeion marapterew setpo erimizde for irpnti.gn Evyre caer neeb sah taken to sneeru that the file is suitlbae fosu re yb ISO memdob rebeis. In tlnu ehikletneve y ttah lborp aem leratit gno it is f,dnuo plsaee inform ttneC ehlar Secr
23、teiraat ta the serddaig sleb nevwo. ISO 4002 All irthgs erse.devr lnUeto sswrehise specified, on trap fo this lbupictaion maeb y cudorperro de tuilizi den yna form ro na ybm ynae,s lecetrinoc ro mecinahcal, inclidung tohpcoiypodna gn micrfoilm, wittuoh repmissii non writign from ietI rehSa Ot tsserd
24、da eh ebolw or ISOs memreb i ydobn the cnuotrfo y ttseuqer ehe.r ISO cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mail coirypthgiso.o gr We bwww.is.o gro Pulbisdehi n Switlrez dna ii ISO 4002 Allr ithgsr esedevr EN ISO 3107:2004 Licensed Copy: s
25、heffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:7013 O4002(E) I SO 4002 All irthgs ersedevr iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Classification.1 4 Requirements 2 4.1 Performance requirements 2 4.2 Biocompatibi
26、lity 2 5 Sampling2 6 Test methods.2 6.1 Preparation of test specimens.2 6.2 Determination of setting time 2 6.3 Determination of compressive strength.4 6.4 Determination of film thickness 6 6.5 Determination of disintegration.8 6.6 Determination of acid-soluble arsenic content12 7 Packaging and mark
27、ing12 7.1 Packaging 12 7.2 Manufacturers instructions.12 7.3 Marking of containers.13 7.4 Capsule or single-dose container .13 Bibliography .14 EN ISO 3107:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:7013 O4002(E) iv I SO 4002 Al
28、l irthgs ersedevr 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 sub
29、ject 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 collaborates closely with the International Electrotechnical Commission (I
30、EC) on 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 commit
31、tees are 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
32、 held responsible for identifying any or all such patent rights. ISO 3107 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This third edition cancels and replaces the second edition (ISO 3107:1988), which has been technically revised, i
33、ncluding extensive revision and simplification of the classification system, and removal of the disintegration limit as a requirement for temporary cements. EN ISO 3107:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:7013 O4002(E) I
34、SO 4002 All irthgs ersedevr v Introduction 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 biological or toxicological hazards, reference be made to ISO 10993-1 an
35、d ISO 7405. EN ISO 3107:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank EN ISO 3107:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS:7013 O40
36、02(E) I SO 4002 All irthgs ersedevr 1 Dentistry Zinc oxide/eugenol and zinc oxide/non-eugenol cements 1 Scope This International Standard specifies the requirements and performance test methods for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cem
37、entation, for permanent cementation, for cavity liners and bases and as temporary restorations. This International Standard is also applicable to non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation. 2 Normative references The following referenced documents
38、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 2590, General method for the determination of arsenic Silver diethyldithiocarbam
39、ate photometric method ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Classification For the purposes of this document, the following classification for ceme
40、nts is used, based on their intended use: a) Type I: for temporary cementation; 1) Class 1: setting cement; 2) Class 2: non-setting cement. b) Type II: for permanent cementation; c) Type III: for bases and temporary restorations; d) Type IV: for cavity liners. EN ISO 3107:2004 Licensed Copy: sheffie
41、ldun sheffieldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:7013 O4002(E) 2 I SO 4002 All irthgs ersedevr 4 Requirements 4.1 Performance requirements When tested in accordance with the appropriate test methods specified in Clause 6, cements shall comply with the performan
42、ce requirements specified in Table 1. Table 1 Requirements Type and Class Setting time at 37 C min Compressive strength at 24 h MPa Disintegration after 24 h % (mass fraction) Film thickness m Acid-soluble arsenic content mg/kg min. max. min. max. max. max. max. Type I, Class 1 4 10 35 N/A* 25 2 Typ
43、e I, Class 2 Penetration at 1 h N/A* N/A* N/A* 25 2 Type II 4 10 35 1,5 25 2 Type III 3 10 25 1,5 N/A* 2 Type IV 4 10 5 1,5 N/A* 2 N/A* not applicable. 4.2 Biocompatibility Guidance on biocompatibility is given in ISO 10993-1 and ISO 7405 (see Bibliography). 5 Sampling The test sample shall consist
44、of packages prepared for retail sale from the same batch containing enough material to carry out the specified tasks plus an allowance for repeats. 6 Test methods 6.1 Preparation of test specimens Prepare the test material in accordance with the manufacturers instructions (7.2) Prepare all specimens
45、 at (23 1) C and a relative humidity of (50 5) %. Before the start of mixing, condition the test samples and apparatus in these conditions for at least 1 h. Prepare the cement according to the manufacturers instructions. Mix sufficient cement to ensure that the preparation of each specimen is comple
46、ted from one mix. Prepare a fresh mix for each specimen. 6.2 Determination of setting time 6.2.1 Apparatus 6.2.1.1 Cabinet, capable of being maintained at a temperature of (37 1) C and a relative humidity not less than 95 %. 6.2.1.2 Indenter needle. EN ISO 3107:2004 Licensed Copy: sheffieldun sheffi
47、eldun, na, Fri Nov 17 09:53:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:7013 O4002(E) I SO 4002 All irthgs ersedevr 3 6.2.1.2.1 For Type I Class 1, Type II and Type III materials, an indenter needle of mass (400 2) g with a tip which is cylindrical for a distance of approximately 5 mm, which ha
48、s a flat end of diameter (1,0 0,1) mm. 6.2.1.2.2 For Type I Class 2 and Type IV materials, an indenter needle similar to that of 6.2.1.2.1 but of mass (100,0 0,5) g and having a flat end of diameter (2,0 0,1) mm. 6.2.1.3 Mould, made of non-corrodible metal, consisting of a rectangular plate with a c
49、ircular hole conforming to the dimensions given in Figure 1. Dimensions in millimetres Figure 1 Mould for use in determination of setting time 6.2.1.4 Metal block, of minimum dimensions 8 mm 20 mm 10 mm. 6.2.1.5 Flat glass plate, approximately 1 mm thick (for example, a microscope slide). 6.2.2 Procedure Condition the metal block (6.2.1.4) and indenter needle (6.2.1.2) in the cabinet (6.2.1.1