DIN EN ISO 3107-2011 Dentistry - Zinc oxide eugenol cements and zinc oxide non-eugenol cements (ISO 3107 2011) German version EN ISO 3107 2011《牙科 氧化锌 丁香酚和氧化锌 非丁香酚粘固粉(ISO 3107-2011).pdf

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1、June 2011 Translation by DIN-Sprachendienst.English price group 10No 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 1

2、1.060.10!$s)e“1800666www.din.deDDIN EN ISO 3107Dentistry Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements(ISO 3107:2011)English translation of DIN EN ISO 3107:2011-06Zahnheilkunde Zinkoxid-Eugenolzemente und eugenolfreie Zinkoxidzemente (ISO 3107:2011)Englische bersetzung von DIN EN ISO

3、 3107:2011-06Mdecine bucco-dentaire Ciments dentaires base doxyde de zinc-eugnol et base doxyde de zinc sanseugnol (ISO 3107:2011)Traduction anglaise de DIN EN ISO 3107:2011-06SupersedesDIN EN ISO 3107:2005-01 andDIN EN ISO 3107 1:2006-11www.beuth.deDocument comprises 16 pagesIn case of doubt, the G

4、erman-language original shall be considered authoritative.Corrigendum 06.11 DIN EN ISO 3107:2011-06 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Comm

5、ittee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). 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 referre

6、d to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN ISO 3107:2005-01 and DIN EN ISO 3107 Corrigendum 1:2006-11 as follows: a) the cement classification types have been consolidated into two; b) the co

7、mpressive strength limit has been reduced to reflect materials in current use; c) the text on the interpretation of compressive test results has been modified; d) the lower setting time limit has been lowered to reflect materials in current use. Previous editions DIN 13924-1: 1978-10 DIN 13924-2: 19

8、78-10 DIN EN 23107: 1992-05 DIN EN ISO 3107: 2005-01 DIN EN ISO 3107 Corrigendum 1: 2006-11 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 8601, Data elements and interchange

9、 formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3107 March 2011 ICS 11.060.10 Supersedes EN ISO 3107:2004English Version Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011) Mdecine bucco

10、-dentaire - Ciments dentaires base doxyde de zinc-eugnol et base doxyde de zinc sans eugnol (ISO 3107:2011) Zahnheilkunde - Zinkoxid-Eugenolzemente und eugenolfreie Zinkoxidzemente (ISO 3107:2011) This European Standard was approved by CEN on 28 February 2011. CEN members are bound to comply with th

11、e 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 standards may be obtained on application to the CEN-CENELEC Managemen

12、t 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 to the CEN-CENELEC Management Centre has the same status

13、as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, R

14、omania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserv

15、ed worldwide for CEN national Members. Ref. No. EN ISO 3107:2011: EContents DIN EN ISO 3107:2011-06 EN ISO 3107:2011 (E) 2 Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Classification5 5 Requirements.5 5.1 Performance requirements .5 5.2 Biocompatibil

16、ity.6 6 Sampling.6 7 Test methods6 7.1 Preparation of test specimens .6 7.2 Determination of setting time .6 7.3 Determination of compressive strength7 7.4 Determination of film thickness .10 7.5 Determination of acid-soluble arsenic fraction 12 8 Marking, labelling and packaging 12 8.1 Packaging .1

17、2 8.2 Marking and instructions for use.12 Bibliography 14 Foreword The text of ISO 3107:2011 has been prepared by Technical Committee ISO/TC 106 Dentistry” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 3107:2011 by Technical Committee CEN/TC 55 “Dentis

18、try” 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 by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011.

19、 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 identifying any or all such patent rights. This document supersedes EN ISO 3107:2004. According to the CEN/CENELEC Internal Regu

20、lations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Ma

21、lta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 3107:2011 has been approved by CEN as a EN ISO 3107:2011 without any modification. “DIN EN ISO 3107:2011-06 EN ISO 3107:2011 (E) 3 Introducti

22、on Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is intended that in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405. DIN EN ISO 3107:2011-06 EN ISO 3

23、107:2011 (E) 4 1 Scope This International Standard specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. This International Standard also specifies requirements for non-eugen

24、ol cements containing zinc oxide and aromatic oils suitable for temporary cementation. 2 Normative references 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

25、 the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 2590, General method for the determination of arsenic Silver diethyldithiocarbamate photometric method ISO 3696, Water for analytical laboratory use Specification and test methods ISO 8601, Data elements

26、and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 apply. 4 Classification For the purposes of this International Standard, the following classification for cements i

27、s used, based on their intended use: a) type I: for temporary cementation; b) type II: for bases and temporary restorations. 5 Requirements 5.1 Performance requirements When tested in accordance with the appropriate test methods specified in Clause 7, type I and type II cements shall comply with the

28、 performance requirements specified in Table 1. DIN EN ISO 3107:2011-06 EN ISO 3107:2011 (E) 5 Table 1 Requirements Type Setting time at 37 C Compressive strength at 24 h Film thickness Acid-soluble arsenic mass fraction min MPa m mg/kga min. max. min. max. max. max. Type I 1,5 10 35 25 2 Type II 1,

29、5 10 5 N/A 2 N/A: not applicable amg/kg is the equivalent of ppm; ppm is a deprecated unit. 5.2 Biocompatibility For guidance on biocompatibility, see ISO 10993-1 and ISO 7405. 6 Sampling The test sample shall consist of packages prepared for retail sale from the same batch containing enough materia

30、l to carry out the specified tasks plus an allowance for repeats. 50 g should be sufficient. 7 Test methods 7.1 Preparation of test specimens Prepare the test material in accordance with the manufacturers instructions (see 8.2). 7.1.1 Ambient conditions Prepare and test all specimens at (23 2) C and

31、 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. 7.1.2 Procedure for mixing Mix sufficient cement to ensure that the preparation of each specimen is completed from one mix. Prepare a fresh mix for each specim

32、en. 7.2 Determination of setting time 7.2.1 Apparatus 7.2.1.1 Cabinet, capable of being maintained at a temperature of (37 1) C and a relative humidity of (95 5) %. 7.2.1.2 Indenter needle 7.2.1.2.1 For type I materials, an indenter needle of mass (100 0,5) g with a tip which is cylindrical for a di

33、stance of approximately 5 mm and has a flat end of diameter (2,0 0,1) mm. 7.2.1.2.2 For type II materials, a similar indenter needle of mass (400 5) g with a tip which is cylindrical for a distance of approximately 5 mm, and which has a flat end of diameter (1,0 0,1) mm. 7.2.1.3 Mould, made of non-c

34、orrodible metal, consisting of a rectangular plate with a circular hole conforming to the dimensions given in Figure 1. DIN EN ISO 3107:2011-06 EN ISO 3107:2011 (E) 6 Dimensions in millimetres Figure 1 Mould for use in determination of setting time 7.2.1.4 Metal block, of minimum dimensions 8 mm 20

35、mm 10 mm. 7.2.1.5 Flat glass plate, approximately 1 mm thick (for example, a microscopic slide). 7.2.2 Procedure Condition the metal block (7.2.1.4) and indenter needle (7.2.1.2) in the cabinet (7.2.1.1) at (37 1) C. Place the metal mould (7.2.1.3), conditioned at (23 1) C, on the flat glass plate (

36、7.2.1.5) and fill to a level surface with the cement. After (60 10) s from the start of mixing for all cements, place the specimen, mould and glass plate on to the metal block. 30 s before the setting time given by the manufacturer, carefully lower the indenter needle vertically on to the surface of

37、 the cement. Make indentations at 15 s intervals with no superimposition of indentations until the setting time has been reached. Maintain the needle tip in a clean condition between indentations. Record the setting time, to the nearest 15 s, as the period of time which elapses from the start of mix

38、ing to the time when the needle fails to penetrate completely the 2 mm depth of cement. 7.2.3 Treatment of results The result shall either be one of the limit values or lie between the limits given in Table 1. 7.3 Determination of compressive strength 7.3.1 Apparatus 7.3.1.1 Split moulds and plates,

39、 for example as shown in Figure 2, suitable for the preparation of a cylindrical specimen with a height of 6 mm and a diameter of 4 mm, and made of a material that is neither attacked nor corroded by the cement, such as stainless steel. DIN EN ISO 3107:2011-06 EN ISO 3107:2011 (E) 7 Dimensions in mi

40、llimetres Figure 2 Mould and plates for preparation of compressive strength test specimens 7.3.1.2 Screw clamp, of dimensions such that it can clamp the mould and plates together, such as is shown in Figure 3. Figure 3 Clamp for preparation of compressive strength test specimens DIN EN ISO 3107:2011

41、-06 EN ISO 3107:2011 (E) 8 7.3.1.3 Cabinet, as specified in 7.2.1.1. 7.3.1.4 Micrometer or similar measuring device, accurate to 1 m. 7.3.1.5 Mechanical tester, capable of being operated at a cross-head speed of (0,75 0,30) mm/min or at a loading rate of (50 16) N/min. 7.3.2 Preparation of test spec

42、imens Condition the moulds (7.3.1.1), screw clamps (7.3.1.2) and top and bottom plates (7.3.1.1) at (23 1) C. After mixing in accordance with the manufacturers instructions, pack the cement, to a slight excess, into the split moulds within 1 min of the completion of mixing. In order to consolidate t

43、he cement and to avoid trapping air, it is advisable to convey the largest convenient portions of mixed cement to the mould and apply to one side with a suitable instrument. Fill the mould to excess in this manner and then place the mould on the bottom plate and pack the cement, such that the excess

44、 is expressed. To facilitate the removal of the hardened cement specimen, the internal surface of the mould may be evenly coated, prior to filling, with a 3 % solution of micro-crystalline or paraffin wax in pure toluene. Alternatively, a thin film of silicone grease or polytetrafluoroethylene (PTFE

45、) dry film lubricant may be used. Remove any extruded cement, place the top metal plate in position and squeeze together. Put the mould and plates in the clamp (7.3.1.2) and screw tightly together. Not later than 2 min after completion of mixing, transfer the whole assembly to the cabinet (7.3.1.3),

46、 maintained at (37 1) C. One hour after completion of mixing, remove the plates, and prepare the surface of the ends of the specimen plane, at right angles to its long axis, using a small amount of 45 m silicon carbide powder or similar abrasive, mixed with water (ISO 3696, grade 2) on a flat glass

47、plate. Keep the specimen wet during preparation. Alternatively, use an equivalent grade of abrasive coated paper and water (ISO 3696, grade 2). Keep the ends of the specimen flat by rotating the specimen one quarter turn every few strokes. Remove the specimen from the mould immediately after surfaci

48、ng and examine for air voids or chipped edges. Discard any specimens with these defects. Immerse each specimen in distilled or deionized water (ISO 3696, grade 2) and maintain at (37 1) C for 24 h, after which condition in distilled or deionized water at (23 1) C for (15 1) min prior to testing. The

49、n, measure the diameter of the cylinder with the micrometer (7.3.1.4) to the nearest micrometre. Proceed immediately to testing. The testing procedure requires five specimens. 7.3.3 Procedure Immediately after the end of the conditioning period, place the specimen with the flat ends between the platens of the mechanical testing apparatus (7.3.1.5) so that the load is applied in the long axis of the specimen. Use a cross head speed of (0,75 0,30) mm/min or a loading rate of (50