EN ISO 4049-2009 en Dentistry - Polymer-based restorative materials《牙科学 聚合物基修复材料》.pdf

1、BS EN ISO4049:2009ICS 11.060.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Polymer-based restorativematerials (ISO4049:2009)This British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009. BSI 2

2、009ISBN 978 0 580 59576 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 4049:2009National forewordThis British Standard is the UK implementation of EN ISO 4049:2009. Itsupersedes BS EN ISO 4049:2000 which is withdrawn.The UK participation in its preparation was entrusted to Tec

3、hnicalCommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct applic

4、ation.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 4049 October 2009 ICS 11.060.10 Supersedes EN ISO 4049:2000English Version Dentistry - Polymer-based restorative materials (ISO 4049:2009) Art dentaire - Pro

5、duits 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 to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions

6、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 Management Centre or to any CEN member. This European Standard exists in three offi

7、cial 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 status as the official versions. CEN members are the national standards bodies of Austria

8、, 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 United Kingdom. EUROPEAN COMMITT

9、EE 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 worldwide for CEN national Members. Ref. No. EN ISO 4049:2009: EBS EN ISO 4049:2009EN IS

10、O 4049:2009 (E) 3 Foreword This document (EN ISO 4049:2009) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in 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 standard

11、, 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 an

12、d/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: Austr

13、ia, 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. Endorsemen

14、t notice The text of ISO 4049:2009 has been approved by CEN as a EN ISO 4049:2009 without any modification. BS EN ISO 4049:2009ISO 4049:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification .2 5 R

15、equirements.2 5.1 Biocompatibility.2 5.2 Physical and chemical properties .2 5.3 Shade, restorative materials 4 5.4 Colour stability after irradiation and water sorption .4 5.5 Radio-opacity.4 6 Sampling 5 7 Test methods .5 7.1 General reagent Water .5 7.2 Test conditions6 7.3 Inspection.6 7.4 Prepa

16、ration of test specimens .6 7.5 Measurement of film thickness of luting materials6 7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials.9 7.7 Working time, Class 1 and Class 3 luting materials 11 7.8 Setting time, Class 1 and Class 3 materials .11 7.9 Sensitivity t

17、o ambient light, Class 2 materials .13 7.10 Depth of cure, Class 2 materials14 7.11 Flexural strength .15 7.12 Water sorption and solubility.18 7.13 Shade and colour stability after irradiation and water sorption.21 7.14 Radio-opacity.22 8 Packaging, marking and instructions and information to be su

18、pplied by the manufacturer25 8.1 Packaging.25 8.2 Marking.25 8.3 Manufacturers instructions and information for the user27 Bibliography28 BS EN ISO 4049:2009ISO 4049:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of

19、national standards bodies (ISO member 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. Inte

20、rnational organizations, governmental 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 th

21、e rules given in the ISO/IEC Directives, Part 2. The main task of technical committees 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 b

22、y at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility 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 4049 was prepared by Technical Committee ISO

23、/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This fourth edition cancels and replaces the third edition (ISO 4049:2000) which has been reviewed and essentially reconfirmed. Several minor changes have been made to clarify content. Changes have been made to the test method

24、 for radio-opacity (see 7.14) in order to simplify this test. BS EN ISO 4049:2009ISO 4049:2009(E) ISO 2009 All rights reserved vIntroduction Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended th

25、at when assessing possible biological or toxicological hazards, reference should be made to ISO 10993-1 and ISO 7405. BS EN ISO 4049:2009BS EN ISO 4049:2009INTERNATIONAL STANDARD ISO 4049:2009(E) ISO 2009 All rights reserved 1Dentistry Polymer-based restorative materials 1 Scope This International S

26、tandard specifies requirements 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 fo

27、r luting. The polymer-based 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

28、that have an adhesive component 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 indispensab

29、le 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 1942, Dentistry Vocabulary ISO 3665, Photography Intra-oral dental radiographic film Specificat

30、ion ISO 3696, Water for 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 doc

31、ument, the terms and definitions 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 BS EN ISO 4

32、049:2009ISO 4049:2009(E) 2 ISO 2009 All rights reserved4 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 restor

33、ations involving occlusal surfaces; b) Type 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” materia

34、ls). Class 2: materials whose setting is effected 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

35、) Group 2: materials whose use requires the 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

36、 Class 2 luting materials will fall into Group 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 inf

37、ormation is available in ISO 7405 and ISO 10993-1. 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

38、 (5.2.7), depth of cure (5.2.8), shade (5.3) 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

39、 the maximum recommended proportion of tint 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 luti

40、ng materials shall not be tested unless the 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 BS EN

41、 ISO 4049:2009ISO 4049:2009(E) ISO 2009 All rights reserved 3“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 sha

42、de, this claim shall be tested. The requirements are summarised 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

43、no greater than 50 m. 5.2.3 Working time, Class 1 and Class 3 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

44、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. 5.2.5 Setting time, Class 1 materials The setting time for Class 1 restorative materials, excluding luting

45、materials, determined in accordance with 7.8, shall be not more 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

46、, shall be not more than 10 min. 5.2.7 Sensitivity to ambient 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 materi

47、als, excluding luting materials, shall be not less than 1 mm if 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 b

48、y the manufacturer as opaque materials, or not less than 1,5 mm 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 po

49、lymer-based restorative materials determined in accordance with 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 reaction, 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 suffic