SANS 861-2008 Dentistry - Denture base polymers《牙科 义齿基托聚合物》.pdf

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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 978-0-626-21778-5 SANS 861:2008Edition 1 and ISO amdt 1ISO 1567:1999Edition 3 and amdt 1 SOUTH AFRICAN NATIONAL STANDARD Dentistry Denture base poly

4、mers This national standard is the identical implementation of ISO 1567:1999 and ISO amendment No. 1, and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12

5、428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 861:2008 Edition 1 and ISO amdt 1 ISO 1567:1999 Edition 3 and amdt 1 Table of changes Change No. Date Scope ISO amdt 1 2003 Amended to extend the scope to include denture base polymer for which the manufacturer claims that the material is a high

6、 impact polymer and to specify the requirement and test method to be used, to update referenced standards, to modify packing plasticity requirements for unpolymerized material (5.1.3) and residual methyl methacrylate monomer requirements for polymerized material (5.2.10), to add impact strength requ

7、irements for polymerized material (5.2.13), to modify the expression of results for the flexural strength and flexural modulus test method (8.5.3.5.2.5) and for the pass/fail determination of water solubility (8.8.5.4), to correct a cross reference in 8.7.3.3.2, and to add an impact strength test me

8、thod (8.9). 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 Divison, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was publish

9、ed in December 2008. Reference numberISO 1567:1999/Amd.1:2003(E)ISO 2003INTERNATIONAL STANDARD ISO1567Third edition1999-02-15AMENDMENT 12003-09-01Dentistry Denture base polymers AMENDMENT 1 Art dentaire Polymres pour base de prothses dentaires AMENDEMENT 1 SANS 861:2008This s tandard may only be use

10、d and printed by approved subscription and freemailing clients of the SABS .ISO 1567:1999/Amd.1:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are e

11、mbedded 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 Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporat

12、ed. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a p

13、roblem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and micr

14、ofilm, 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 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2

15、003 All rights reservedSANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 1567:1999/Amd.1:2003(E) ISO 2003 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of nat

16、ional 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 subject for which a technical committee has been established has the right to be represented on that committee. Interna

17、tional organizations, governmental and 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 r

18、ules 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 committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by a

19、t 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 held responsible for identifying any or all such patent rights. Amendment 1 to ISO 1567:1999 was prepared by Techni

20、cal Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing cl

21、ients of the SABS .ISO 1567:1999/Amd.1:2003(E) ISO 2003 All rights reserved 1Dentistry Denture base polymers AMENDMENT 1 Page 1, Scope Add to paragraph 1.1 Furthermore, it applies to denture base polymers for which the manufacturer claims that the material is a high impact polymer. It also specifies

22、 the requirement and the test method to be used. Page 1, Normative references Add the following reference: ISO 179:1993, Plastics Determination of Charpy impact strength Page 4, subclause 5.1.3 First line, delete Type 1 class 2 and Type 2 class 2. Page 5, subclause 5.2.10 Last paragraph, last line a

23、fter 0,2 % add “mass fraction”. After subclause 5.2.12 add the following subclause: 5.2.13 Impact strength When the manufacturer claims that the material is a high impact polymer, the impact strength shall not be less than 2,0 kJ/m2when tested in accordance with 8.9. Page 14, subclause 8.5.3.5.2.5 B

24、efore 5.2.7 and 5.2.8 add “requirements of”. Page 16, subclause 8.7.3.3.2 Replace 8.7.3.1.1.1 with 8.7.3.1.1. Page 22, subclause 8.8.5.4 Second paragraph replace two with three to read: “If at least three of the”. After subclause 8.8.5.5 add the following subclause: SANS 861:2008This s tandard may o

25、nly be used and printed by approved subscription and freemailing clients of the SABS .ISO 1567:1999/Amd.1:2003(E) 2 ISO 2003 All rights reserved8.9 Impact strength 8.9.1 Materials This consists of two specimen plates, freshly formed and processed in accordance with the manufacturers instructions, ea

26、ch from a separate mix. Use the material, the apparatus (8.5.1.1) and the mould (8.5.1.1.2) (except that the dimensions of the plates shall be (50 2) mm long, (50 2) mm wide and (4 0,2) mm in height). 8.9.2 Apparatus 8.9.2.1 See 8.5.3.2.1, 8.5.3.2.2 and 8.5.3.2.4. 8.9.2.2 Standard metallographic gri

27、nding papers, progressively finer grades using a grain size of approximately 26 m (600 FEPA) for the final finishing stage. 8.9.2.3 Containers of water, for storing the specimen strips at (23 2) C and (37 1) C for pre-test conditioning. 8.9.2.4 Pendulum impact testing machine, conforming to ISO 179:

28、1993. A test capacity of 0,5 J is suitable. 8.9.3 Procedure Within (24 2) h of the beginning of the curing cycle of the denture base polymer, cut each plate lengthways into seven to eight equal strips, (50 2) mm long (l), (6 0,2) mm wide (w) and (4 0,2) mm in height (h). Machine the strips in a mill

29、ing machine (8.5.3.2.2) on the edges and equally from both moulded surfaces so that the dimensions remain slightly oversized. Take care to avoid overheating the specimen strips. Wet-grind all faces and edges smooth and flat with metallographic grinding papers (8.9.2.2). Cut a notch (type A) (see Fig

30、ure 4) in the middle of each specimen strip as described in ISO 179:1993. Cut the notch edgewise to a depth of (1,2 0,1) mm leaving a residual depth beneath the notch of (4,8 0,1) mm. The radius of the notch base (tip) shall be (0,25 0,05) mm (see Figure 5). aDirection of blow. bSee Figure 5. Figure

31、 4 Charpy edgewise impact test, with single-notched specimen SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 1567:1999/Amd.1:2003(E) ISO 2003 All rights reserved 3Radius of notch base rn= (0,25 0,05) mm. Figure 5 Part of sing

32、le-notched specimen strip with type A notch Measure and record, the height, h, nominal (4 0,2) mm of each specimen strip near the notch and the residual depth, b, nominal (4,8 0,1) mm beneath the notch using a measuring instrument (8.2.1.5 or 8.5.3.2.4). Use only specimen strips which are of good qu

33、ality and fall within the correct size range. Store 12 selected specimen strips in the container of water at (37 1) C for 7 d 2 h. Condition the specimen strips in the container of water at (23 2) C for (60 15) min prior to testing. After conditioning, remove a specimen strip from the water and plac

34、e it on the specimen supports of the testing apparatus (8.9.2.4). Set the specimen supports at a separation of (40,0 0,2) mm. Place the specimen strip with the notch facing away from the point of impact of the pendulum. Ensure that the specimen strip is centred with regard to the position of the not

35、ch and the point of impact of the pendulum. As soon as possible after removing each separate specimen strip from the water bath, release the pendulum in order to fracture the specimen. Record the value of energy absorbed, J1. Re-zero the instrument and allow the pendulum to swing again with no speci

36、men strip in place. (The energy recorded, J2, gives an indication of the friction in the system.) 8.9.4 Calculation and expression of results Calculate the impact strength of notched specimen, a, in kilojoules per square metre (kJ/m2) using the formula: ()31210JJbhwhere J1is the value of energy, in

37、joules, absorbed by the specimen strip; J2is the friction energy, in joules, of the system; h is the height, in millimetres, of the specimen strip; b is the depth, in millimetres, behind the notch. SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clie

38、nts of the SABS .ISO 1567:1999/Amd.1:2003(E) 4 ISO 2003 All rights reserved8.9.5 Pass/fail determination of impact strength If results obtained for at least nine of the twelve specimen strips conform to the requirement stated in 5.2.13, the material fulfils the requirement of a high impact denture b

39、ase polymer. If five or fewer of the twelve specimen strips conform to the requirement stated in 5.2.13, the polymer fails. If only six to eight of the twelve specimen strips conform to the requirement stated in 5.2.13, repeat the test. If at least ten of the second series of specimen strips conform

40、 to the requirement stated in 5.2.13, the polymer passes. 8.9.6 Expression of results Report the number of specimens evaluated, all results for impact strength with the number of specimens conforming to 5.2.13 and whether the material passes. Page 22, After subclause 9.2.1 k) add the following item:

41、 l) the term “high impact” if the manufacturer wishes to claim that the material is a high impact polymer. If claimed, the polymer shall conform to the requirement of 5.2.13 when tested in accordance with 8.9. Page 23, After subclause 9.2.2 k) add the following item: l) the term “high impact” if the

42、 manufacturer wishes to claim that the material is a high impact polymer. If claimed, the polymer shall conform to the requirement of 5.2.13 when tested in accordance with 8.9. Page 24, After subclause 9.3 m) add the following item. n) the term “high impact” if the manufacturer wishes to claim that

43、the material is a high impact polymer. If claimed, the polymer shall conform to the requirement of 5.2.13 when tested in accordance with 8.9. SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 861:2008This s tandard may only be

44、 used and printed by approved subscription and freemailing clients of the SABS .ISO 1567:1999/Amd.1:2003(E) ICS 11.060.10 Price based on 4 pages ISO 2003 All rights reserved SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ARefere

45、nce numberISO 1567:1999(E)INTERNATIONALSTANDARDISO1567Third edition1999-02-15Dentistry Denture base polymersArt dentaire Polymres pour base de prothses dentairesSANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 1567:1999(E) ISO

46、 1999All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronicor mechanical, including photocopying and microfilm, without permission in writing from the publisher.International Organization for StandardizationC

47、ase postale 56 CH-1211 Genve 20 SwitzerlandInternet isoiso.chPrinted in SwitzerlandiiContents1 Scope 12 Normative references 13 Definitions 24 Classification35 Requirements.36 Sampling.67 Preparation of test specimens .68 Test methods69 Requirements for labelling, marking, packaging and instructions

48、 supplied by manufacturer .22Annex A HPLC method for determination of MMA content.25Annex B Bibliography .27SANS 861:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS . ISOISO 1567:1999(E)iiiForewordISO (the International Organization for St

49、andardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely