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1、Reference number ISO 4049:2000(E) ISO 2000 INTERNATIONAL STANDARD ISO 4049 Third edition 2000-07-15 Dentistry Polymer-based filling, restorative and luting materials Art dentaire Produits dobturation, de restauration et de scellement base de polymres Copyright International Organization for Standard
2、ization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 4049:2000(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with
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5、 care 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
6、 may be 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
7、 Tel. + 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 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04
8、/12/2007 21:26:14 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 4049:2000(E) ISO 2000 All rights reservediii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .1 4Classification2 5Requirements.2 5.1Biocompatibility.2 5.2Phy
9、sical and chemical properties2 5.3Shade, filling and restorative materials.4 5.4Colour stability after irradiation and water sorption4 5.5Radio-opacity.4 6Sampling.5 7Test methods5 7.1General reagent water.5 7.2Test conditions 6 7.3Inspection.6 7.4Preparation of test specimens .6 7.5Measurement of f
10、ilm thickness of luting materials6 7.6Working time, Class 1 and Class 3 filling and restorative materials9 7.7Working time, Class 1 and Class 3 luting materials.11 7.8Setting time, Class 1 and Class 3 materials11 7.9Sensitivity to ambient light, Class 2 materials .13 7.10Depth of cure, Class 2 mater
11、ials14 7.11Flexural strength15 7.12Water sorption and solubility.18 7.13Shade and colour stability after irradiation and water sorption.21 7.14Radio-opacity.22 8Packaging, marking and information to be supplied by the manufacturer.24 8.1Packaging.24 8.2Marking.24 8.3Manufacturers instructions and in
12、formation for the user25 Bibliography27 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 404
13、9:2000(E) iv ISO 2000 All rights reserved Foreword 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 through ISO technical committees. Each member
14、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 collaborates closely with the International Electr
15、otechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
16、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 of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any o
17、r all such patent rights. International Standard ISO 4049 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This third edition cancels and replaces the second edition (ISO 4049:1988), which has been technically revised to include those p
18、olymer-based restorative materials (inlay/onlay materials) that are processed outside the mouth, in either the dental operatory or laboratory. These have been added as Class 2, group 2 materials in a redesigned Classification (see clause 4). Materials that cure by both chemical means and external en
19、ergy application (dual cure materials) have also been added to the Classification as Class 3 materials. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo reproductio
20、n or networking permitted without license from IHS -,-,- ISO 4049:2000(E) ISO 2000 All rights reservedv Introduction This International Standard now includes requirements for materials intended for the restoration of occlusal surfaces (type 1 materials). It does not cover materials intended to preve
21、nt caries (see ISO 6874) or those used for veneering metal sub-frames (see ISO 10477). The broad group of polymeric restorative materials that is covered by this standard is subject to rapid developments and during the drafting of this standard several new types of material have been marketed. These
22、 include “condensable” and “flowable” composites and “ormocers”. The manufacturers of such materials have the option of claiming compliance with this standard but it should be noted that the materials were not included in any collaborative testing during the preparation of this standard. Also, this
23、International Standard now includes requirements for polymer-based luting materials that are intended for cementing of restorations and appliances such as inlays, onlays, crowns and bridges. This has resulted in new tests and requirements for the working time and film thickness of luting materials.
24、In comparison with ISO 4049:1988, alterations have been made to the requirements for flexural properties (see 5.2.9) and water sorption (see 5.2.10). These requirements have been changed following collaborative testing and review of published data. Changes have been made to the test methods for wate
25、r sorption and solubility (see 7.12) and radio-opacity (see 7.14.) in order to clarify simplify and improve the accuracy of these tests. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that w
26、hen assessing possible biological or toxicological hazards reference should be made to ISO 10993-1 and ISO 7405. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo re
27、production or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo reproduction or networking permitted without lice
28、nse from IHS -,-,- INTERNATIONAL STANDARDISO 4049:2000(E) ISO 2000 All rights reserved1 Dentistry Polymer-based filling, restorative and luting materials 1Scope This International Standard specifies requirements for dental polymer-based filling and restorative materials and polymer-based luting mate
29、rials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth. The luting materials covered by this International Standard are intended for
30、use in the cementing or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This International Standard does not cover requirements for polymeric materials intended for veneering indirectly restoration metal sub-frames (see ISO 10477) and materials intended t
31、o prevent caries (see ISO 6874). 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 publications do not a
32、pply. 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 to applies. Members o
33、f ISO and IEC maintain registers of currently valid International Standards. ISO 3665:1996, Photography Intra-oral dental radiographic film Specification. ISO 3696:1987, Water for analytical use Specification and test methods. ISO 7491:1999, Dental materials Determination of colour stability of dent
34、al materials. ISO 8601:1988, Data elements and interchange formats Information interchange Representation of dates and times. 3Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 opaquer luting material intensely pigmented polymer-bas
35、ed luting material intended to mask underlying tooth structure 3.2 opaque shade of a polymer-based restorative material intended to be less translucent than a non-opaque shade Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Stan
36、dards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 4049:2000(E) 2 ISO 2000 All rights reserved 4Classification For the purposes of this International Standard, dental polymer-based restorative materials are categorized
37、 as one of the following types. a)Type 1: polymer-based filling and restorative materials claimed by the manufacturer as suitable for restorations involving occlusal surfaces; b)Type 2: all other polymer-based filling and restorative materials. NOTE 1It is not necessary to classify polymer-based lut
38、ing materials into types. The three classes of dental polymer-based filling, restorative and luting materials are as follows. ?Class 1: materials whose setting is effected by mixing an initiator and activator (“self-curing” materials). ?Class 2: materials whose setting is effected by the application
39、 of energy from an external source, such as blue light or heat (“external-energy-activated” materials). They are subdivided as follows: 1)Group 1: materials whose use requires the energy to be applied intra-orally; 2)Group 2: materials whose use requires the energy to be applied extra-orally. When f
40、abricated, these materials will be luted into place. Certain materials may be claimed by manufacturers to be both Group 1 and Group 2. In this event the material should fulfil the requirements for both groups. NOTE 2Class 2 luting materials will fall into Group 1 only. ?Class 3: materials that are c
41、ured by the application of external energy and also have a self-curing mechanism present “dual cure” materials; see 8.3 e). 5Requirements 5.1Biocompatibility See the Introduction for guidance on biocompatibility. See ISO 7405 and ISO 10993-1 for further information. 5.2Physical and chemical properti
42、es 5.2.1General If a filling and restorative material is supplied by the manufacturer in various shades, each shade, including opaque shades, shall be capable of satisfying all the requirements for sensitivity to ambient light (5.2.7), depth of cure (5.2.8), shade (5.3) and colour stability (5.4) ap
43、propriate to the material type and class. If the material is supplied such that it can be “tinted” or “blended” to the users specification, the material shall comply with the requirements both when used alone and when used with the maximum recommended proportion of tint or blender see 8.3 d). Simila
44、rly, if the manufacturer supplies a luting material in various shades, each shade, including opaquer luting materials, shall be capable of satisfying all the requirements for depth of cure (5.2.8). Colour stability (5.4) of luting materials shall not be tested unless the manufacturer claims such a p
45、roperty. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 21:26:14 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 4049:2000(E) ISO 2000 All rights r
46、eserved3 In respect of the other requirements of 5.2 and those of 5.5, only one representative shade of luting, filling and restorative materials shall be tested. This representative shade shall be either that classified by the manufacturer as “universal” or, in the event that no shade is so classif
47、ied, that shade corresponding to “A3” in the Vita?1) classification of shade. 5.2.2Film thickness of luting materials The film thickness of luting materials when determined in accordance with 7.5 shall be no more than 10 ?m above any value claimed by the manufacturer and in any event shall be no gre
48、ater than 50 ?m. 5.2.3Working time, Class 1 and Class 3 filling and restorative materials The working time for Class 1 and Class 3 filling and restorative materials, determined in accordance with 7.6, shall be not less than 90 s. 5.2.4Working time, Class 1 and Class 3 luting materials When tested in accordance with 7.7, the material shall be capable of forming a thin layer; during its formation there shall be no detectable change in its homogeneity. 5.2.5Setting time, Class 1 material