1、March 2010 Translation by DIN-Sprachendienst.English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.060.10!$a.A“1621130www.din.deDDIN EN ISO 4049Dentistry Polymer-based restorative materials (ISO 4049:2009)English translation of DIN EN ISO 4049:2010-03Zahnheilkunde Polymerbasierende Restaurationsmaterialien (ISO 4049:2009)Englische bersetzung von DIN EN ISO 4049:2010-03Art dentaire Produits de
3、restauration base de polymres (ISO 4049:2009)Traduction anglaise de DIN EN ISO 4049:2010-03SupersedesDIN EN ISO 4049:2001-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 34 pages03.10 DIN EN ISO 4049:2010-03 2 A comma is used as the d
4、ecimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Norme
5、nausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-01 AA Fllungswerkstoffe. The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN are as follows: ISO 1942 E DIN EN ISO 1942 ISO 3665 DIN EN ISO 3665 ISO 3696 DIN ISO 3696 ISO 7491
6、DIN EN ISO 7491 ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN ISO 4049:2001-01 as follows: a) The test method for radio-opacity (see 7.14) has been revised. b) The specifications for marking and manufacturers instructions have been updated. Previous editions DIN 13922: 1979-02 D
7、IN EN 24049: 1994-03 DIN EN ISO 4049: 2001-01 National Annex NA (informative) Bibliography E DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 3665, Photography Intra-oral dental radiographic film Specification DIN EN ISO 7491, Dental materials Determination of colour stability DIN ISO 3696, Water f
8、or analytical laboratory use Specification and test methods DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 4049 October 2009 ICS 11.060.10 Supersedes EN ISO 4049:2000English Versio
9、n Dentistry - Polymer-based restorative materials (ISO 4049:2009) Art dentaire - Produits de restauration base de polymres (ISO 4049:2009) Zahnheilkunde - Polymerbasierende Restaurationsmaterialien (ISO 4049:2009) This European Standard was approved by CEN on 24 September 2009. CEN members are bound
10、 to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN
11、 Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same statu
12、s as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
13、 Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worl
14、dwide for CEN national Members. Ref. No. EN ISO 4049:2009: EContents DIN EN ISO 4049:2010-03 2 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 Classification .6 5 Requirements.6 5.1 Biocompatibility.6 5.2 Physical and chemical properties .6 5.3 Shade, re
15、storative materials 8 5.4 Colour stability after irradiation and water sorption .8 5.5 Radio-opacity.8 6 Sampling 9 7 Test methods .9 7.1 General reagent Water .9 7.2 Test conditions10 7.3 Inspection.10 7.4 Preparation of test specimens .10 7.5 Measurement of film thickness of luting materials10 7.6
16、 Working time, Class 1 and Class 3 restorative materials, excluding luting materials.13 7.7 Working time, Class 1 and Class 3 luting materials 15 7.8 Setting time, Class 1 and Class 3 materials .15 7.9 Sensitivity to ambient light, Class 2 materials .17 7.10 Depth of cure, Class 2 materials18 7.11 F
17、lexural strength .19 7.12 Water sorption and solubility.22 7.13 Shade and colour stability after irradiation and water sorption.25 7.14 Radio-opacity.26 8 Packaging, marking and instructions and information to be supplied by the manufacturer29 8.1 Packaging.29 8.2 Marking.29 8.3 Manufacturers instru
18、ctions and information for the user31 Bibliography32 EN ISO 4049:2009 (E) Foreword DIN EN ISO 4049:2010-03 3 EN ISO 4049:2009 (E) collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national stand
19、ard, either by publication of an identical text or by endorsement, at the latest by April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN
20、 and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 4049:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Au
21、stria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorse
22、ment notice The text of ISO 4049:2009 has been approved by CEN as a EN ISO 4049:2009 without any modification. This document (EN ISO 4049:2009) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in Introduction Specific qualitative and quantitative requirements for freedom from biologic
23、al hazard are not included in this International Standard, but it is recommended that when assessing possible biological or toxicological hazards, reference should be made to ISO 10993-1 and ISO 7405. DIN EN ISO 4049:2010-03 4 EN ISO 4049:2009 (E) 1 Scope This International Standard specifies requir
24、ements for dental polymer-based restorative materials 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 and for luting. The polymer-ba
25、sed luting materials covered by this International Standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This International Standard does not cover those polymer-based luting materials that have an adhesive co
26、mponent within the structure of the material. This International Standard does not cover materials intended to prevent caries (see ISO 6874) or those used for veneering metal sub-frames (see ISO 10477). 2 Normative references The following referenced documents are indispensable for the application o
27、f 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 1942, Dentistry Vocabulary ISO 3665, Photography Intra-oral dental radiographic film Specification ISO 3696, Water for
28、analytical laboratory use Specification and test methods ISO 7491, Dental materials Determination of colour stability ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms and def
29、initions given in ISO 1942 and the following apply. 3.1 opaque luting material intensely pigmented polymer-based luting material intended to mask underlying materials and tooth structure 3.2 opaque shade of an intensely pigmented polymer-based restorative material DIN EN ISO 4049:2010-03 5 EN ISO 40
30、49:2009 (E) 4 Classification For the purposes of this International Standard, dental polymer-based restorative materials are classified as the following types. a) Type 1: polymer-based restorative materials claimed by the manufacturer as suitable for restorations involving occlusal surfaces; b) Type
31、 2: all other polymer-based restorative materials, and luting materials. The three classes of dental polymer-based restorative 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 ef
32、fected by the application of energy from an external source, such as blue light or heat “external-energy-activated” materials, see also 8.3 e). 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
33、 energy to be applied extra-orally. When fabricated, 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 Class 2 luting materials will fall into Gr
34、oup 1 only. Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present (“dual cure” materials). 5 Requirements 5.1 Biocompatibility See the Introduction for guidance on biocompatibility. Further information is available in ISO 7405 and ISO 1
35、0993-1. 5.2 Physical and chemical properties 5.2.1 General If a 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
36、) and colour stability (5.4) appropriate to the material type and class. If the material is supplied such that it can be “tinted” or “blended” to the users prescription, the material shall comply with the requirements both when used alone and when used with the maximum recommended proportion of tint
37、 or blender see 8.3 d). Similarly, if the manufacturer supplies a luting material in various shades, each shade, including opaque 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
38、 manufacturer claims such a property. In respect of the other requirements of 5.2 and those of 5.5, only one representative shade of restorative material shall be tested. This representative shade shall be either that classified by the manufacturer as DIN EN ISO 4049:2010-03 6 EN ISO 4049:2009 (E) “
39、universal” or, in the event that no shade is so classified, that shade corresponding to “A3” in the Vita 1) classification of shade. However, if the manufacturer claims a higher value for radio-opacity see 5.5 and 8.3 o) for any other shade, this claim shall be tested. The requirements are summarise
40、d in Tables 1, 2 and 3. 5.2.2 Film thickness, 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 greater than 50 m. 5.2.3 Working time, Class 1 and Class 3
41、restorative materials, excluding luting materials The working time for Class 1 and Class 3 restorative materials, excluding luting materials, determined in accordance with 7.6, shall be not less than 90 s. 5.2.4 Working time, Class 1 and Class 3 luting materials When tested in accordance with 7.7, t
42、he material shall be capable of forming a thin layer; during its formation there shall be no detectable change in its homogeneity. 5.2.5 Setting time, Class 1 materials The setting time for Class 1 restorative materials, excluding luting materials, determined in accordance with 7.8, shall be not mor
43、e than 5 min. The setting time for Class 1 luting materials, determined in accordance with 7.8, shall be not more than 10 min. 5.2.6 Setting time, Class 3 materials The setting time for Class 3 materials, determined in accordance with 7.8, shall be not more than 10 min. 5.2.7 Sensitivity to ambient
44、light, Class 2 materials When tested in accordance with 7.9, the material shall remain physically homogeneous. 5.2.8 Depth of cure, Class 2 materials When determined in accordance with 7.10, the depth of cure of Class 2 restorative materials, excluding luting materials, shall be not less than 1 mm i
45、f they are labelled by the manufacturer as opaque, or not less than 1,5 mm for other restorative materials. The depth of cure of luting materials when determined in accordance with 7.10 shall be not less than 0,5 mm if they are labelled by the manufacturer as opaque materials, or not less than 1,5 m
46、m for other materials. In any event, the values for all materials, with the exception of opaque luting materials, shall be no more than 0,5 mm below the value stated by the manufacturer. 5.2.9 Flexural strength The flexural strength of polymer-based restorative materials determined in accordance wit
47、h 7.11 shall be equal to or greater than the limits specified in Table 1. 1) Vitais a trade name of Vita Zahnfabrik, H Rauter GmbH in this event, the mould shall be at least 2 mm longer than twice the claimed depth of cure. NOTE A mould release agent which does not interfere with the setting reactio
48、n, for example a 3 % solution of polyvinyl ether wax in hexane, can be used to facilitate removal of the specimen. 7.10.1.2 Two glass slides/plates, each of sufficient area to cover one side of the mould. NOTE Standard glass microscope slides can be used. 7.10.1.3 White filter paper. 7.10.1.4 Film,
49、transparent to the activating radiation, (50 30) m thick, e.g. polyester. 7.10.1.5 External energy source, as recommended by the manufacturer for use with the test material see 8.3 e). 7.10.1.6 Micrometer, accurate to 0,01 mm. 7.10.1.7 Plastics spatula. DIN EN ISO 4049:2010-03 18 EN ISO 4049:2009 (E) 7.10.2 Procedure Place the mould (7.10.1.1) on a strip of the transparent film (7.10.1.4) on a glass microscope slide (7.10.1.2). Fill the mould with the test material, prepared in accordance with the manufacturers inst
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