SANS 14356-2008 Dentistry - Duplicating material《牙科 复制材料》.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 978-0-626-21433-3 SANS 14356:2008Edition 1 ISO 14356:2003Edition 1 SOUTH AFRICAN NATIONAL STANDARD Dentistry Duplicating material This national stan

4、dard is the identical implementation of ISO 14356:2003 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 www.sabs.co.za SA

5、BS SANS 14356:2008 Edition 1 ISO 14356:2003 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 Standards Division, i

6、n compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in September 2008. Reference numberISO 14356:2003(E)ISO 2003INTERNATIONAL STANDARD ISO14356First edition2003-03-01Dentistry Duplicating material Art dentaire Produits pour duplication SANS 14356:2008This s tandard m

7、ay only be used and printed by approved subscription and freemailing clients of the SABS .ISO 14356:2003(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 a

8、re 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 Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorp

9、orated. 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

10、 a problem 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

11、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 copyrightiso.org Web www.iso.org Published in Switzerland ii I

12、SO 2003 All rights reservedSANS 14356:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 14356:2003(E) ISO 2003 All rights reserved iiiContents Page Foreword iv 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Classifica

13、tion by types . 4 5 Material characteristics and properties Requirements 4 5.1 General. 4 5.2 Melting temperature Type 1 materials 4 5.3 Pouring temperature Type 1 materials. 4 5.4 Component colours Type 2 materials 4 5.5 Detail reproduction . 4 5.6 Compatibility with refractory investment (and gyps

14、um if applicable) 5 5.7 Elastic recovery. 5 5.8 Tear strength . 5 5.9 Resistance to fungal growth Type 1 materials only . 5 6 Sampling 5 7 Test methods General 5 7.1 Laboratory conditions 5 7.2 Verification of apparatus function. 5 7.3 Specimen preparation and testing 5 7.4 Pass/fail determinations.

15、 6 7.5 Expression of test results 6 8 Specific specimen preparation and test procedures 6 8.1 Melting temperature test Type 1 materials only 6 8.2 Detail reproduction test 7 8.3 Test for compatibility with refractory investment (and gypsum if applicable). 8 8.4 Elastic recovery test . 9 8.5 Tear str

16、ength test 12 8.6 Fungal growth resistance test Type 1 agar materials only 15 9 Requirements for packaging 15 10 Requirements for labelling. 15 11 Instructions for use Required information 16 Annex A (informative) Optional procedure for tear test . 27 SANS 14356:2008This s tandard may only be used a

17、nd printed by approved subscription and freemailing clients of the SABS .ISO 14356:2003(E) iv ISO 2003 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

18、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-governmental, in liaison with ISO, al

19、so 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 2. The main task of technical committ

20、ees 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 vote. Attention is drawn to the poss

21、ibility 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 14356 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. SANS 14356:2008Thi

22、s s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 14356:2003(E) ISO 2003 All rights reserved 1Dentistry Duplicating material 1 Scope This International Standard specifies requirements and tests for the duplicating materi

23、als used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated re

24、ferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942 (all parts), Dental vocabulary ISO 6873, Dental gypsum products ISO 7490, Dental gypsum-bonded casting investments ISO 9694, Dental phosphate-b

25、onded casting investments ISO 11245, Dental restorations Phosphate-bonded refractory die materials ISO 11246, Dental ethyl silicate bonded casting investments 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 block out

26、 to flow or mould waxes and/or materials such as cements, clays and polymeric materials into undercut areas on a master model, and then shape them so as to leave only those undercuts that are essential to the subsequent steps in producing a prosthesis that will fit and function optimally NOTE A bloc

27、ked-out master model may also include other surface modifications needed relative to construction of a prosthesis. 3.2 double boiler container system, usually in three parts, in which the upper container fits into the lower container such that boiling water in the lower container heats the contents

28、of the lid-covered upper container SANS 14356:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 14356:2003(E) 2 ISO 2003 All rights reserved3.3 duplicating material elastic material used to make flexible negative copy impressions or mou

29、lds of objects (models or casts) into which a mix of a refractory investment, or another mixture intended for a similar purpose, can be poured to produce a positive copy of the original object 3.4 non-reversible duplicating material material which converts from a pourable consistency to a gel or rub

30、ber-like state and which thereafter cannot be returned to the pourable consistency for repeated use 3.5 reversible duplicating material material which can be recycled for more than one use by changing it, by means of heating, from an elastic gel state to a pourable consistency, and then returning it

31、 to the gel state by cooling 3.6 duplicating process for making metal and ceramic objects method for making positive copies of master models from a negative mould NOTE 1 The process is carried out according to the following steps: master model is blocked out, duplicating material is poured around bl

32、ocked-out master model and allowed to gel or set, master model is separated from the duplicating material, leaving a flexible mould having surfaces that constitute a negative copy of the surfaces of the master model, an investment mixture is poured into the mould to form a refractory model on which

33、polymeric or wax patterns, or both, can be laid down to form the shapes desired in metal or ceramic castings or on which slurries of porcelain can be applied for forming desired shapes. NOTE 2 Gypsum product mixtures or other mixtures may be poured into the moulds to form copies of master models nee

34、ded for other purposes. 3.7 effective setting time for materials setting at or near oral or room temperature time measured from the commencement of mixing components of a material together, or otherwise activating the chemistry involved, to the time at which the activated material has developed the

35、properties (elasticity, hardness, etc.) that will permit it to be used with optimal effectiveness in a subsequent step or for its intended purpose 3.8 functional life reversible duplicating material number of times a material can be recycled for use, if handled and used according to the manufacturer

36、s instructions, without loss of the properties required to ensure that the material is fit for the purpose intended 3.9 gelation agar duplicating material transition of a material from a relatively fluid consistency to a gel state in which the material has developed the elastic properties needed for

37、 its intended purpose 3.10 immediate container packaging component having internal surfaces in direct contact with the material contained SANS 14356:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 14356:2003(E) ISO 2003 All rights res

38、erved 3NOTE An immediate container may be a unlabelled container protected by more durable outer packaging, such as a can, carton or drum. If strong enough to protect its contents without outer packaging, an immediate container can serve as a primary container on which labelling may be required. 3.1

39、1 initial setting time time measured from the commencement of mixing components of a material together, or otherwise activating the chemistry involved, to the time at which a test procedure, conducted at a specified temperature, indicates that the mixture has begun to set at a relatively rapid rate,

40、 thus indicating that the effective setting time will be reached at some predictable time thereafter NOTE Initial setting times stated in the manufacturers instructions are useful to test operators, users, and standards developers because: they can often be used for determining whether a product is

41、of a quality suitable for testing or use. For example, if the initial setting time found by the test operator or user corresponds closely to that stated in the instructions, it can usually be assumed that the product is suitable for testing or use. they can be helpful in the development of standards

42、 for certain materials if there is a need for a standard to identify a reference point in time that can be used as a basis for specifying when certain subsequent procedures should begin. 3.12 investment casting powdered refractory material containing a binder, to be mixed with a specified liquid to

43、form a slurry that can be poured into a mould made of duplicating material where it is allowed to harden to form a heat-resistant positive copy of a master model, or which can be poured around patterns to form a heat-resistant mould used for forming ceramic or metal objects 3.13 master model definit

44、ive cast fixed and removable denture construction positive copy of the hard and/or soft tissues of a dental arch, usually made by pouring a gypsum product slurry into an impression made of a dental arch 3.14 melt agar reversible duplicating material change a material, by heating, from a gel state to

45、 a pourable fluid state 3.15 outer package wrapping or carton which is used to cover one or more immediate or primary containers in preparation for retail marketing and which may be required by law or International Standard to bear specified labelling information 3.16 pouring temperature duplicating

46、 material temperature of the material designated in the manufacturers instructions for pouring the material around an object to be duplicated 3.17 primary container retail marketing packaging component which may or may not be covered by an outer package and which may be required by law or Internatio

47、nal Standard to bear specified labelling information EXAMPLE Bottle, carton, drum, jar, or tube, etc. NOTE A primary container may also be an immediate container, and vice versa. SANS 14356:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .

48、ISO 14356:2003(E) 4 ISO 2003 All rights reserved3.18 refractory material that retains its effective shape and composition when heated to the maximum temperature required for its use 3.19 slurry ceramic, gypsum or refractory investment mixture, consisting of a powder and water, or a powder and anothe

49、r liquid, having a consistency that will allow it to be poured around patterns or into moulds, or to be otherwise applied, and then be allowed or caused to harden so as to form a desired shape 3.20 storage holding of a material in an immediate container in a protected environment before the container is opened for the first use, and between subsequent openings of the container 3.21 store, verb melted agar reversible duplicating material to hold a material at the temperature specified in the