SANS 22112-2008 Dentistry - Artificial teeth for dental prostheses《牙科 牙修复术用假牙》.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 978-0-626-21436-4 SANS 22112:2008Edition 1ISO 22112:2005Edition 1 SOUTH AFRICAN NATIONAL STANDARD Dentistry Artificial teeth for dental prostheses T

4、his national standard is the identical implementation of ISO 22112:2005 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 12 428 7911 Fax: +27 12 344 1568

5、www.sabs.co.za SABS SANS 22112:2008 Edition 1 ISO 22112:2005 Edition 1 Table of changes Change No. Date Scope 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 Stan

6、dards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in September 2008. Reference numberISO 22112:2005(E)ISO 2005INTERNATIONAL STANDARD ISO22112First edition2005-11-01Dentistry Artificial teeth for dental prostheses Art dentaire Dents artificielles po

7、ur prothses dentaires SANS 22112:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22112:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed

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10、 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 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

11、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 22 749 09 47 E-mail copyright

12、iso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reservedSANS 22112:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22112:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv 1 Scope . 1 2 Normative

13、 references . 1 3 Terms and definitions. 1 4 Classification. 2 5 Requirements 2 5.1 General. 2 5.2 Ceramic teeth 3 5.3 Synthetic polymer teeth . 3 6 Sampling 3 7 Inspection and test methods . 4 7.1 Visual inspection 4 7.2 Dimensions of teeth 4 7.3 Comparison with shade guide. 4 7.4 Surface finish of

14、 ceramic teeth . 5 7.5 Surface finish of synthetic polymer teeth 5 7.6 Porosity of ceramic teeth. 6 7.7 Porosity of synthetic polymer teeth and other defects 7 7.8 Radioactivity of ceramic teeth. 9 7.9 Anchorage of ceramic teeth to denture base polymers . 9 7.10 Resistance of ceramic teeth to therma

15、l shock 9 7.11 Quality of bonding of synthetic polymer teeth to denture-base polymers. 10 7.12 Resistance to blanching, distortion and crazing of synthetic polymer teeth. 12 7.13 Colour stability of synthetic polymer teeth 13 7.14 Dimensional stability of synthetic polymer teeth 13 8 Marking, labell

16、ing, packaging, and information to be supplied by the manufacturer. 14 8.1 Marking, labelling and packaging . 14 8.2 Information to be supplied by manufacturer . 14 8.3 Manufacturers instructions 15 Bibliography . 16 SANS 22112:2008This s tandard may only be used and printed by approved subscription

17、 and freemailing clients of the SABS .ISO 22112:2005(E) iv ISO 2005 All rights reservedForeword 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 t

18、hrough 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-governmental, in liaison with ISO, also take part in the work. ISO colla

19、borates 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 2. The main task of technical committees is to prepare International Sta

20、ndards. 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 vote. Attention is drawn to the possibility that some of the elements o

21、f this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22112 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This first edition cancels and replaces ISO 3336:1993

22、, ISO 4824:1993 and ISO 4824:1993/Amd. 1:1997 which have been technically revised. SANS 22112:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 22112:2005(E) ISO 2005 All rights reserved 1Dentistry Artificial teet

23、h for dental prostheses 1 Scope This International Standard specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry. 2 Normative references The following referenced documents are indispensable

24、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 483 1), Plastics Small enclosures for conditioning and testing using aqueous solutions to maintain

25、 the humidity at a constant value ISO 1567:1999, Dentistry Denture base polymers ISO 1942 2), Dentistry Vocabulary ISO 3950:1984, Dentistry Designation system for teeth and areas of the oral cavity ISO 6873:1998, Dental gypsum products ISO 7491:2000, Dental materials Determination of colour stabilit

26、y 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 diatoric teeth teeth designed to be retained by anchorage slots and/or holes 3.2 pin teeth teeth designed to be retained by headed pins 3.3 set set of six anterior te

27、eth or eight posterior teeth, as received from the manufacturer 1) To be published. (Revision of ISO 483:1988) 2) To be published. Revision of ISO 1942 (all parts):1989 SANS 22112:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22112:

28、2005(E) 2 ISO 2005 All rights reserved3.4 half-set three teeth on one side of a set of anterior teeth or four teeth on one side of a set of posterior teeth 3.5 mould chart chart representing the form, shape and dimensions of all individual teeth of a set 4 Classification Artificial teeth are grouped

29、 in accordance with the following classification: a) Type 1: anterior teeth; b) Type 2: posterior teeth. 5 Requirements 5.1 General 5.1.1 Biocompatibility Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is

30、recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405. 5.1.2 Dimensions of teeth The dimensions of the teeth when examined in accordance with 7.2 shall not differ by more than 5 % for synthetic polymer teeth and 7 % for ceramic tee

31、th from the values shown in the manufacturers mould chart. 5.1.3 Colour and blending of shades When tested in accordance with 7.3, sets of anterior and posterior teeth shall exhibit no perceptible colour difference compared with the manufacturers shade guide (8.2.2) or nominated shade guide. Blended

32、 teeth shall show no line of demarcation between incisal and cervical portions on the facial aspects of the teeth. NOTE This requirement is not intended to disallow especially designed demarcations placed to simulate borders of restorations or enamel imperfections found in natural teeth. 5.1.4 Surfa

33、ce finish When inspected visually in accordance with 7.1, the teeth as received (excluding retention areas) shall have a smooth, lustrous, non-porous surface. When ceramic teeth are tested in accordance with 7.4, the processing shall not have impaired the original finish of the teeth, and the teeth

34、shall be capable of being ground and polished. When synthetic polymer teeth are tested in accordance with 7.5, the teeth shall be capable of being polished to restore the original finish. 5.1.5 Freedom from porosity and other defects Ceramic teeth shall not show more than a total of 16 pores of diam

35、eter greater than 30 m on the four test surfaces when tested in accordance with 7.6. No more than six of those pores shall have diameters ranging from W 40 m and u 150 m. There shall be no pores of diameter greater than 150 m. SANS 22112:2008This s tandard may only be used and printed by approved su

36、bscription and freemailing clients of the SABS .ISO 22112:2005(E) ISO 2005 All rights reserved 3Synthetic polymer teeth, when examined in accordance with 7.7, shall exhibit no porosity or defect, such as rough trimming, rough finish or visible impurities, on the coronal surfaces. 5.2 Ceramic teeth 5

37、.2.1 Radioactivity When tested in accordance with 7.8, ceramic teeth shall have an activity concentration of no more than 1,0 Bqg1of uranium238. 5.2.2 Anchorage All ceramic diatoric teeth, examined in accordance with 7.9, shall provide a means of positive retention and have holes all of which shall

38、be open and unsealed. 5.2.3 Resistance to thermal shock Ceramic teeth shall, when tested in accordance with 7.10, show no signs of cracking. 5.3 Synthetic polymer teeth 5.3.1 Bonding to denture base polymers All synthetic polymer teeth shall be capable of being bonded to heat-polymerized denture-bas

39、e materials (Type 1), which conform to ISO 1567:1999. For five out of the six test specimens, the bond formed between the ridge lap portion of the teeth and the denture base polymer shall pass the test described in 7.11. 5.3.2 Resistance to blanching, distortion and crazing When tested in accordance

40、 with 7.12, no teeth shall exhibit blanching or distortion. No teeth shall exhibit crazing with the exception of the ridge lap surfaces and the cervical portion of the teeth up to the cervical line. 5.3.3 Colour stability When tested in accordance with 7.13, there shall be no perceptible colour chan

41、ge between the exposed and unexposed halves of the tooth and the unexposed tooth. 5.3.4 Dimensional stability When tested in accordance with 7.14, the dimensional change of a tooth shall be within 2 % of its original mesio-distal dimension. 6 Sampling The sample shall consist of six groups, each com

42、prising sets of mandibular and maxillary anterior and posterior teeth (if available). For comparisons with the manufacturers shade guide, all available shades of anterior teeth and five shades of available posterior teeth shades shall be included. Five mould sizes shall be included covering the rang

43、e of mould sizes shown by the manufacturers mould chart. The teeth shall be representative of the physical dimensions of the brand and type. SANS 22112:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22112:2005(E) 4 ISO 2005 All right

44、s reserved7 Inspection and test methods 7.1 Visual inspection Visually examine without magnification all the teeth in each set for compliance with the requirements given in 5.1.3 and 5.1.4. 7.2 Dimensions of teeth 7.2.1 Apparatus 7.2.1.1 Micrometer, accurate to 0,01 mm and fitted with parallel steel

45、 face pieces. 7.2.2 Procedure Measure the maximum mesio-distal dimension of each upper (l1, l5) and lower (l3, l7) set of teeth (see Clause 6) in the in-line plane for conformity to the mould chart dimensions (see 5.1.2). Measure the maximum mesio-distal (l2, l4) and cervico-incisal (h1, h2) dimensi

46、ons of the upper and lower left central incisors (21, 31), and the overall facio-lingual (l6, l8) dimensions of the crowns of the upper and lower left first molars (26, 36), using a micrometer (7.2.1.1). See Figure 1 for these dimensions given in parentheses. The numerical tooth designations given i

47、n parentheses are in accordance with ISO 3950:1984. a) Dimensions of Type 1 teeth b) Dimensions of Type 2 teeth Figure 1 Dimensions of teeth to be measured 7.3 Comparison with shade guide Select a maxillary central incisor of all available anterior shades and/or a maxillary premolar tooth (see Claus

48、e 6) from each of the five different posterior tooth shades for evaluation. Evaluate in accordance with ISO 7491:2000, 3.2.3. Compare the labial surfaces of each tooth to be tested to the shade guide by holding the tooth alongside and in the same plane as the corresponding shade guide tooth, with th

49、e test tooth first on one side of the shade guide tooth and then on the other. The tooth complies with 5.1.3 if there is no perceptible colour difference. SANS 22112:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22112:2005(E) ISO 2005 All rights reserved 57.4 Surface finish of ceramic teeth 7.4.1 Apparatus and materials 7.4.1.1 Denture base polymer, Type 1, complying with ISO 1567:1999. 7.4.1.2 Dental laboratory equipment, for denture flaski