SANS 3107-2008 Dentistry - Dental zinc oxide eugenol cements and zinc oxide non-eugenol cements《牙科 牙科用氧化锌丁香粉和非丁香粉粘合剂》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21437-1 SANS 3107:2008Edition 1 and ISO tech. corr. 1 ISO 3107:2004Edition 3 and tech. corr. 1 SOUTH AFRICAN NATIONAL STANDARD Dentistry Z

4、inc oxide/eugenol and zinc oxide/non-eugenol cements This national standard is the identical implementation of ISO 3107:2004 and ISO technical corrigendum 1, and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Ro

5、ad Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 3107:2008 Edition 1 and ISO tech. corr. 1 ISO 3107:2004 Edition 3 and tech. corr. 1 Table of changes Change No. Date Scope ISO tech. corr. 1 2006 Corrected to replace “1,5” by “N/A*” in the

6、 disintegration after 24 h column (column 6) for Type III and Type IV, respectively (table 1). National foreword This South African standard was approved by National Committee SABS SC 106B, Dental equipment and materials Dental materials, in accordance with procedures of the SABS Standards Division,

7、 in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in November 2008. ICS 11.060.10 Ref. No. ISO 3107:2004/Cor.1:2006(E) ISO 2006 All rights reserved Published in Switzerland INTERNATIONAL STANDARD ISO 3107:2004 TECHNICAL CORRIGENDUM 1 Published 2006-03-01 INTERNAT

8、IONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATIONDentistry Zinc oxide/eugenol and zinc oxide/non-eugenol cements TECHNICAL CORRIGENDUM 1 Art dentaire Ciments dentaires base doxyde de zinc-eugnol et base doxyde de zinc sans eugnol RECTIFICATIF TECHNIQUE 1 Technical C

9、orrigendum 1 to ISO 3107:2004 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. Page 2 Table 1 Column 6 (Disintegration after 24 h), rows 4 and 5 (Type III and Type IV respectively) replace “1,5” by “N/A*” in each case. SANS 3107:2008Thi

10、s s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .Reference numberISO 3107:2004(E)ISO 2004INTERNATIONAL STANDARD ISO3107Third edition2004-10-01Dentistry Zinc oxide/eugenol and zinc oxide/non-eugenol cements Art dentaire Ciments dentaires base doxy

11、de de zinc-eugnol et base doxyde de zinc sans eugnol SANS 3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this

12、file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretari

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14、that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2004 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized

15、in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41

16、22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2004 All rights reservedSANS 3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword

17、 iv Introduction v 1 Scope 1 2 Normative references . 1 3 Classification. 1 4 Requirements 2 4.1 Performance requirements 2 4.2 Biocompatibility 2 5 Sampling 2 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

18、Determination of film thickness 6 6.5 Determination of disintegration. 8 6.6 Determination of acid-soluble arsenic content 12 7 Packaging and marking 12 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 SANS

19、3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) iv ISO 2004 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodi

20、es). 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

21、non-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, P

22、art 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 casti

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

24、ling and restorative materials. This third edition cancels and replaces the second edition (ISO 3107:1988), which has been technically revised, including extensive revision and simplification of the classification system, and removal of the disintegration limit as a requirement for temporary cements

25、. SANS 3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) ISO 2004 All rights reserved vIntroduction Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this Interna

26、tional Standard, but it is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405. SANS 3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 31

27、07:2004(E) ISO 2004 All rights reserved 1Dentistry 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

28、cementation, 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 documen

29、ts 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 diethyldithiocar

30、bamate 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 c

31、ements 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. SANS 3107:2008This s tandard may onl

32、y be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) 2 ISO 2004 All rights reserved4 Requirements 4.1 Performance requirements When tested in accordance with the appropriate test methods specified in Clause 6, cements shall comply with the performance

33、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 contentmg/kg min. max. min. max. max. max. max. Type I, Class 1 4 10 35 N/A* 25 2 Type I,

34、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 of pa

35、ckages 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 at (

36、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 completed f

37、rom 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. SANS 3107:2008This s tandard may only be used and print

38、ed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) ISO 2004 All rights reserved 36.2.1.2.1 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 has a flat en

39、d 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 circular hol

40、e 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 Condi

41、tion the metal block (6.2.1.4) and indenter needle (6.2.1.2) in the cabinet (6.2.1.1) at (37 1) C. Place the metal mould (6.2.1.3), conditioned at (23 1) C, on a flat glass plate (6.2.1.5) and fill with the cement to give a level top surface. At (120 10) s after the start of mixing for Type III ceme

42、nts, or (180 10) s from the start of mixing for other cements, place the specimen on the metal block in the cabinet. As soon as possible after placing the specimens in the cabinet, carefully lower the indenter needle vertically onto the surface of the cement. Make indentations at 15 s intervals with

43、 no superimposition of indentations until the time of setting 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

44、 completely the 2 mm depth of cement. SANS 3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) 4 ISO 2004 All rights reservedType I Class 2 materials are non-setting. To verify this property, use the (100,0 0,5) g indent

45、er needle and test every 15 min for 1 h. Penetration can be confirmed by holding the specimen up to the light and examining visually. For Type I Class 2 cements, record presence or absence of penetration at 1 h. 6.2.3 Compliance Results are required to pass the limits given in Table 1. 6.3 Determina

46、tion of compressive strength 6.3.1 Apparatus 6.3.1.1 Split moulds and plates, such as shown in Figure 2, 6 mm high and with an internal diameter of 4 mm, made of stainless steel or other material that is not attacked or corroded by the cement. Dimensions in millimetres Figure 2 Mould for preparation

47、 of compressive strength test specimens SANS 3107:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 3107:2004(E) ISO 2004 All rights reserved 56.3.1.2 Five individual screw clamps, such as those shown in Figure 3. Figure 3 Clamp for pre

48、paration of compressive strength test specimens 6.3.1.3 Cabinet, as specified in 6.2.1.1. 6.3.1.4 Micrometer or similar measuring device, accurate to 1 m. 6.3.1.5 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. 6.3.2 Pre

49、paration of test specimens Condition the moulds (6.3.1.1), screw clamps (6.3.1.2) and top and bottom plates (6.3.1.1) at (23 1) C. Five satisfactory specimens are required for this test. After mixing in accordance with the manufacturers instructions, pack the cement, to a slight excess, into the split moulds within 1 min after the completion of mixing. In order to consolidate the cement and to avoid trapp