EN ISO 9917-2-2010 en Dentistry - Water-based cements - Part 2 Resin-modified cements《牙科 水基胶粘剂 第2部分 光敏胶粘剂》.pdf

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1、BS EN ISO9917-2:2010ICS 11.060.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Water-based cementsPart 2: Resin-modified cements (ISO9917-2:2010)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31

2、May2010. BSI 2010ISBN 978 0 580 59582 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 9917-2:2010National forewordThis British Standard is the UK implementation of EN ISO 9917-2:2010.It supersedes BS EN ISO 9917-2:2000 which is withdrawn.The UK participation in its preparation

3、was entrusted to TechnicalCommittee 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 fo

4、r its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9917-2 April 2010 ICS 11.060.10 Supersedes EN ISO 9917-2:1999English Version Dentistry - Water-based cements - Part 2: Resin-modified cem

5、ents (ISO 9917-2:2010) Mdecine bucco-dentaire - Ciments base deau - Partie 2: Ciments modifis par addition de rsine (ISO 9917-2:2010)Zahnheilkunde - Wasserhrtende Zemente - Teil 2: Kunststoffmodifizierte Zemente (ISO 9917-2:2010) This European Standard was approved by CEN on 15 March 2010. CEN membe

6、rs are bound 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 applicatio

7、n to the CEN 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 th

8、e same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

9、d, Portugal, Romania, 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 2010 CEN All rights of exploitation in any form and by an

10、y means reserved worldwide for CEN national Members. Ref. No. EN ISO 9917-2:2010: EBS EN ISO 9917-2:2010EN ISO 9917-2:2010 (E) 3 Foreword This document (EN ISO 9917-2:2010) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry”

11、 the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2010, and conflicting national standards shall be withdrawn at the latest by October 2010. Attenti

12、on is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9917-2:1999. According to the CEN/CENELEC Internal Regulation

13、s, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, N

14、etherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9917-2:2010 has been approved by CEN as a EN ISO 9917-2:2010 without any modification. BS EN ISO 9917-2:2010ISO 9917-2:2010(E) ISO 2010 All rights

15、reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification and applications2 4.1 Classification .2 4.2 Applications .2 5 Requirements.2 5.1 Materials .2 5.2 Working time3 5.3 Setting time Classes 1 and 3 materials only3 5.4 Film

16、thickness Luting cements only.3 5.5 Flexural strength .3 5.6 Radio-opacity.3 5.7 Shade and colour stability Restorative materials only.3 6 Sampling.3 7 Test conditions and preparation of test specimens 4 7.1 Test conditions 4 7.2 Method of mixing.4 7.3 Inspection requirements.4 8 Packaging, marking

17、and information to be supplied by the manufacturer.4 8.1 Packaging.4 8.2 Marking and instructions for use.4 Annex A (normative) Determination of working time and setting time.7 Annex B (normative) Determination of film thickness Luting materials only9 Annex C (normative) Determination of flexural st

18、rength11 Annex D (normative) Determination of radio-opacity .15 Annex E (normative) Determination of shade and colour stability Restorative and luting materials only 18 Bibliography19 BS EN ISO 9917-2:2010ISO 9917-2:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization

19、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 body interested in a subject for which a technical committee has been established has t

20、he 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Interna

21、tional Standards are drafted in accordance with the 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. Publicatio

22、n 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights

23、. ISO 9917-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This second edition cancels and replaces the first edition (ISO 9917-2:1998), which has been technically revised by the inclusion of resin-modified cements which set by both

24、chemically activated and light-activated polymerization. ISO 9917 consists of the following parts, under the general title Dentistry Water-based cements: Part 1: Powder/liquid acid-base cements Part 2: Resin-modified cements BS EN ISO 9917-2:2010ISO 9917-2:2010(E) ISO 2010 All rights reserved vIntro

25、duction This part of ISO 9917 has been prepared in order to present the requirements and test methods for cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The polymerization component of the reaction may be activated by mixing different components or

26、 through application of energy from an external source. As far as possible, test methods employed within this part of ISO 9917 have been harmonized with those used in ISO 4049 and ISO 9917-1. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in th

27、is part of ISO 9917, but it is recommended that reference be made to ISO 10993-1 and ISO 7405 when assessing possible biological or toxicological hazards. BS EN ISO 9917-2:2010BS EN ISO 9917-2:2010INTERNATIONAL STANDARD ISO 9917-2:2010(E) ISO 2010 All rights reserved 1Dentistry Water-based cements P

28、art 2: Resin-modified cements 1 Scope This part of ISO 9917 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a com

29、bination of an acid-base reaction and polymerization. EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this part of ISO 9917 will normall

30、y be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization. NOTE Attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917-1. Consideration should be giv

31、en as to which is the most appropriate International Standard by which to evaluate any individual product. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, t

32、he latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 3665:1996, Photography Intra-oral dental radiographic film Specification ISO 3696, Water for analytical laboratory use Specification and test methods ISO 7491, Dental materials Determi

33、nation 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 definitions given in ISO 1942 and the following apply. 3.1 mixing time that part of the workin

34、g time required in order to obtain a satisfactory mix of the components NOTE Materials that fall within the scope of this part of ISO 9917 include materials that require mixing and single component materials that do not require mixing. BS EN ISO 9917-2:2010ISO 9917-2:2010(E) 2 ISO 2010 All rights re

35、served3.2 working time period of time, measured from start of mixing (if required), during which it is possible to manipulate the material without an adverse effect on its properties NOTE Working time is determined in the absence of activating radiation, if required for activation for Class 3 materi

36、als (see Clause 4). 3.3 setting time period of time, from start of mix, until the completion of set, as defined by the ability of the material to support an indenter under a known load 3.4 outer pack form of packaging used to combine a number of single dose containers or capsules 3.5 outermost packa

37、ging form of packaging used to combine material and additional items, including instructions for use and any proportioning or mixing devices that are supplied with the material 4 Classification and applications 4.1 Classification For the purposes of this part of ISO 9917, materials are classified on

38、 the basis of their setting characteristics as follows. Class 1: materials in which the setting reaction of the polymerizable component is activated chemically following mixing of components. Class 2: materials in which the setting reaction of the polymerizable component is light-activated. Class 3:

39、 materials in which the setting reaction of the polymerizable component is activated chemically following mixing of components and may also be light-activated. 4.2 Applications For the purposes of this part of ISO 9917, the clinical application of these materials is signified as follows: a) luting;

40、b) base or lining; c) restoration. 5 Requirements 5.1 Materials During the course of testing, there shall be no visible signs of extraneous matter in any component and separately supplied liquid shall be free of any gelation. BS EN ISO 9917-2:2010ISO 9917-2:2010(E) ISO 2010 All rights reserved 35.2

41、Working time When tested in accordance with Annex A, the working time shall comply with the requirements given in Table 1 and shall be at least as long as the value given by the manufacturer (see Table 2, item 24). 5.3 Setting time Classes 1 and 3 materials only When tested in accordance with Annex

42、A, the setting time of Classes 1 and 3 materials shall comply with the requirements given in Table 1 and shall be no longer than the value given by the manufacturer (see Table 2, item 25). 5.4 Film thickness Luting cements only (see 4.2) When tested in accordance with Annex B, the film thickness of

43、luting materials shall comply with the requirements given in Table 1. 5.5 Flexural strength When tested in accordance with Annex C, the flexural strength shall comply with the requirements given in Table 1. 5.6 Radio-opacity If the manufacturer claims that the material is radio-opaque (see Table 2,

44、item 16), the radio-opacity, determined in accordance with Annex D, shall be equal to or greater than that of the same thickness of aluminium. If greater radio-opacity is claimed, it shall not be less than 0,5 mm below the value claimed by the manufacturer (see Table 2, item 17). 5.7 Shade and colou

45、r stability Restorative materials only When tested in accordance with Annex E, the set material shall closely match that of the shade guide specified by the manufacturer. When tested in accordance with Annex E and ISO 7491, there shall be no more than a slight change in colour after 7 d. Table 1 Req

46、uirements for dental cements Film thickness m Working time min Setting timeamin Flexural strength MPa Application Max. Min. Max. Min.Luting 25 1,5 8 10 Base or lining 1,5 6 10 Restoration 1,5 6 25 a Class 1 and 3 materials only. Class 3 materials tested without activation by light. 6 Sampling A samp

47、le drawn from one batch shall provide sufficient material to complete all the prescribed tests plus an allowance for any repeat tests, should they become necessary. The test sample shall consist of packages prepared for retail sale. BS EN ISO 9917-2:2010ISO 9917-2:2010(E) 4 ISO 2010 All rights reser

48、ved7 Test conditions and preparation of test specimens 7.1 Test conditions Prepare and test all specimens at an ambient temperature of (23 2) C. Control the relative humidity to ensure that it remains at (50 20) % at all times. If the material was refrigerated for storage, allow it to reach (23 2) C

49、. Test equipment should be maintained at the condition specified in individual tests. For Classes 2 and 3 materials, activating radiation shall be excluded during the determination of working time. Water used in all tests specified in this part of ISO 9917 shall be prepared in accordance with ISO 3696, grade 2. For Classes 2 and 3 materials, reference shall be made according to the manufacturers instructions (see Table 2, item 26), which state the external energy source to be used. Care