EN ISO 3107-2011 en Dentistry - Zinc oxide eugenol cements and zinc oxide non-eugenol cements《牙科学 氧化锌 丁香酸和氧化锌 非丁香酸粘固粉》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 3107:2011Dentistry Zinc oxide/eugenolcements and zinc oxide/non-eugenol cements (ISO3107:2011)BS EN ISO 3107:2011 BRITISH STANDARDNational forewordThis British Standard

2、 is the UK implementation of EN ISO 3107:2011.It supersedes BS EN ISO 3107:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can beobtained o

3、n request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 59574 5ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British

4、 Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3107 March 2011 ICS 11.060.10 Supersedes EN ISO 3107:2004English Version Dentistry

5、- Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011) Mdecine bucco-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 Europ

6、ean Standard was approved by CEN on 28 February 2011. 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 c

7、oncerning such national standards 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

8、 into its own language and notified 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, France, Germany, Greece, Hungary, Iceland, I

9、reland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marni

10、x 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3107:2011: EBS EN ISO 3107:2011EN ISO 3107:2011 (E) 3 Foreword The text of ISO 3107:2011 has been prepared by Technical Committee ISO/TC 106 “Dentistry“

11、 of the International Organization for Standardization (ISO) and has been taken over as EN ISO 3107:2011 by 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 identica

12、l text or by endorsement, at the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. 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

13、 responsible for identifying any or all such patent rights. This document supersedes EN ISO 3107:2004. 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

14、, 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 the United Kingdom. Endorsement notice The text of

15、ISO 3107:2011 has been approved by CEN as a EN ISO 3107:2011 without any modification. BS EN ISO 3107:2011ISO 3107:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification .1 5 Requirements.1 5.1 Per

16、formance requirements.1 5.2 Biocompatibility.2 6 Sampling 2 7 Test methods .2 7.1 Preparation of test specimens .2 7.2 Determination of setting time.2 7.3 Determination of compressive strength .3 7.4 Determination of film thickness.6 7.5 Determination of acid-soluble arsenic fraction8 8 Marking, lab

17、elling and packaging8 8.1 Packaging.8 8.2 Marking and instructions for use.8 Bibliography10 BS EN ISO 3107:2011ISO 3107:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

18、 The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-

19、governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part

20、2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees 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

21、 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 responsible for identifying any or all such patent rights. ISO 3107 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling

22、 and restorative materials. This fourth edition cancels and replaces the third edition (ISO 3107:2004), which has been technically revised. It also incorporates the Technical Corrigendum ISO 3107:2004/Cor.1:2006. The main changes are that the a) classification types have been consolidated into two,

23、b) compressive strength limit has been reduced to reflect materials in current use, c) text on interpretation of compressive test results has been modified, and d) lower setting time limit has been lowered to reflect materials in current use. BS EN ISO 3107:2011ISO 3107:2011(E) ISO 2011 All rights r

24、eserved vIntroduction 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. BS EN ISO 310

25、7:2011BS EN ISO 3107:2011INTERNATIONAL STANDARD ISO 3107:2011(E) ISO 2011 All rights reserved 1Dentistry Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements 1 Scope This International Standard specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restora

26、tive dentistry for temporary cementation, for bases and as temporary restorations. This International Standard also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation. 2 Normative references The following referenced documents are

27、 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 1942, Dentistry Vocabulary ISO 2590, General method for the determination of arseni

28、c Silver diethyldithiocarbamate photometric method ISO 3696, Water for analytical laboratory use Specification and test methods ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the ter

29、ms and definitions given in ISO 1942 apply. 4 Classification For the purposes of this International Standard, the following classification for cements is used, based on their intended use: a) type I: for temporary cementation; b) type II: for bases and temporary restorations. 5 Requirements 5.1 Perf

30、ormance requirements When tested in accordance with the appropriate test methods specified in Clause 7, type I and type II cements shall comply with the performance requirements specified in Table 1. BS EN ISO 3107:2011ISO 3107:2011(E) 2 ISO 2011 All rights reservedTable 1 Requirements Type Setting

31、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 1,5 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

32、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 material to carry out the specified tasks plus an allowance for repeats. 50 g should be sufficient. 7 Test methods 7.1 Preparation of te

33、st 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 a relative humidity of (50 5) %. Before the start of mixing, condition the test samples and apparatus in these conditions for at

34、 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 specimen. 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 a

35、nd 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 distance 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 nee

36、dle 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-corrodible metal, consisting of a rectangular plate with a circular hole conforming to the dimensions given in Figure 1. BS EN ISO

37、 3107:2011ISO 3107:2011(E) ISO 2011 All rights reserved 3Dimensions in millimetres Figure 1 Mould for use in determination of setting time 7.2.1.4 Metal block, of minimum dimensions 8 mm 20 mm 10 mm. 7.2.1.5 Flat glass plate, approximately 1 mm thick (for example, a microscopic slide). 7.2.2 Procedu

38、re 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 (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

39、, 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 the cement. Make indentations at 15 s intervals with no superimposition of indentations until the setting tim

40、e 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 mixing to the time when the needle fails to penetrate completely the 2 mm depth of cement. 7.2.3 Treatment of res

41、ults 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, for example as shown in Figure 2, suitable for the preparation of a cylindrical specimen with a height of 6 m

42、m and a diameter of 4 mm, and made of a material that is neither attacked nor corroded by the cement, such as stainless steel. BS EN ISO 3107:2011ISO 3107:2011(E) 4 ISO 2011 All rights reservedDimensions in millimetres Figure 2 Mould and plates for preparation of compressive strength test specimens

43、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 BS EN ISO 3107:2011ISO 3107:2011(E) ISO 2011 All rights reserved 57.3.1.3 Cabinet, as specified in 7.2.1.1. 7.3

44、.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 specimens Condition the moulds (7.3.1.1), screw clamps (7.3.1.2) and top and

45、 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 the cement and to avoid trapping air, it is advisable to convey the large

46、st 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 is expressed. To facilitate the removal of the hardened cement specimen

47、, 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) dry film lubricant may be used. Remove any extruded cement, place the

48、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), maintained at (37 1) C. One hour after completion of mixing, remove the

49、 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 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 s