ISO-4823-2000.pdf
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1、Reference number ISO 4823:2000(E) ISO 2000 INTERNATIONAL STANDARD ISO 4823 Third edition 2000-12-15 Dentistry Elastomeric impression materials Art dentaire Produits pour empreintes, base dlastomres ISO 4823:2000(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe
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4、has been taken to ensure 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 2000 All rights reserved. Unless otherwise specified, no part of this publication may b
5、e reproduced or utilized 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.
6、+ 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2000 All rights reserved -,-,- ISO 4823:2000(E) ISO 2000 All rights reservediii ContentsPage Foreword.iv 1Scope 1 2Normative references1 3Terms and definitions .1 4Classification2 5Biocompatib
7、ility advisory.3 6Requirements for characteristics and properties 3 6.1Component colours.3 6.2Mixing time (hand-spatulated or hand-kneaded mixes).3 6.3Working time3 6.4Compatibility with gypsum.3 7Sampling.4 8Test methods General 4 8.1Laboratory conditions.4 8.2Apparatus function verification4 8.3Ma
8、terial manipulation and specimen preparation4 8.4Pass/fail determinations .4 8.5Expression of test results.5 9Test methods Specific5 9.1Mixing-time test5 9.2Consistency test5 9.3Working-time test.7 9.4Detail reproduction test 8 9.5Linear dimensional change test.9 9.6Test for compatibility with gypsu
9、m .11 9.7Elastic recovery test12 9.8Strain-in-compression test.14 10Requirements for information in manufacturers instructions.15 10.1General15 10.2Identifying information15 10.3Specific instructions for use 15 11Requirements for packaging and labelling.16 11.1Packaging requirements.16 11.2Labelling
10、 requirements .17 Annex A (informative) Working-time test instrument components Possible sources32 Bibliography33 -,-,- ISO 4823:2000(E) iv ISO 2000 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO membe
11、r 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. International organizations, governmenta
12、l 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 rules given in the ISO/IEC Directi
13、ves, Part 3. 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 eleme
14、nts of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 4823 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This third e
15、dition cancels and replaces the second edition (ISO 4823:1992), which has been revised to reflect the following technical differences: the 60 s limit on Mixing time (5.4, second edition) has been eliminated; the Consistency test requirement for Type 1 and Type 2 impression materials has been relaxed
16、 (see Table 1, both editions); a more realistic approach for making pass/fail determinations (8.4); apparatus and procedures specified for the Working-time test (9.3) and the Elastic recovery tests (9.7) provide for more objective test results than those specified in 7.4 and 7.6 of the second editio
17、n; Figure 2 illustrates how the instrument depicted in Figure 4 of the second edition can be modified to make it suitable for use in the Consistency test as well as for the Strain-in-compression test; Figure 15 illustrates how the split mould shown in Figure 5 of the second edition can be modified t
18、o provide for more uniformly shaped specimens. Annex A of this International Standard is for information only. -,-,- INTERNATIONAL STANDARDISO 4823:2000(E) ISO 2000 All rights reserved1 Dentistry Elastomeric impression materials 1Scope This International Standard specifies requirements and tests for
19、 evaluating elastomeric dental impression materials. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these p
20、ublications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred t
21、o applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1942, Dental vocabulary. ISO 6873, Dental gypsum products. 3Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 1942 and the following apply.
22、 3.1 consistency degree of firmness with which particles of a material, prepared for use, cohere so as to allow the material to flow, or resist flow, as required to achieve the purpose for which it is intended 3.2 elastic recovery test compression set (deprecated) permanent deformation (deprecated)
23、recovery from deformation (deprecated) ?elastic impression materials?method of determining whether the materials possess the elastic properties required to recover adequately after deformation occurring when the materials, used for forming impressions, are removed from the mouth 3.3 extrusion mixing
24、 method by which two or more material components are extruded from their separate immediate containers through a special mixing tip, from which the components emerge as a homogeneous mixture 3.4 hand mixing method of mixing the components of a material by means of manual kneading or spatulation ISO
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