BS EN ISO 9917-2-2017 Dentistry Water-based cements Resin-modified cements《牙科 水基黏固粉 树脂改良黏固粉》.pdf

1、Dentistry - Water-based cementsPart 2: Resin-modified cements (ISO 9917-2:2017)BS EN ISO 9917-2:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 9917-2:2017. It is identical to ISO 9917-2:20

2、17. It supersedes BS EN ISO 9917-2:2010, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publi

3、cation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 92103 2ICS 11.060.10Compliance with a British Standard cannot confer immunity

4、 from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 9917-2:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN I

5、SO 9917-2September 2017ICS 11.060.10 Supersedes EN ISO 9917-2:2010EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 9917-2:2017: EAll rights of exploitation in an

6、y form and by any means reserved worldwide for CEN national MembersDentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2017)Mdecine bucco-dentaire - Ciments base deau - Partie 2: Ciments modifis par addition de rsine (ISO 9917-2:2017)Zahnheilkunde - Wasserhrtende Zemente - T

7、eil 2: Kunststoffmodifizierte Zemente (ISO 9917-2:2017)This European Standard was approved by CEN on 1 July 2017.CEN members 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 al

8、teration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language ma

9、de by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Eston

10、ia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO

11、 9917-2:2017 (E)European forewordThis document (EN ISO 9917-2:2017) 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 s

12、tandard, either by publication of an identical text or by endorsement, at the latest by March 2018 and conflicting national standards shall be withdrawn at the latest by March 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. C

13、EN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 9917-2:2010.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgiu

14、m, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,

15、Switzerland, Turkey and the United Kingdom.2BS EN ISO 9917-2:2017ISO 9917-2:2017(E)Foreword ivIntroduction v1 Scope .12 Normative references 13 Terms and definitions .14 Classification and applications 24.1 Classification . 24.2 Applications . 25 Requirements 35.1 Materials .35.2 Working time 35.3 S

16、etting time Class 1 and Class 3 materials only 35.4 Film thickness Luting materials only (see 4.2 ) .35.5 Flexural strength .35.6 Radio-opacity .35.7 Shade and colour stability Restorative materials only 36 Sampling 37 Test conditions and preparation of test specimens .47.1 Test conditions 47.2 Meth

17、od of mixing 47.3 Inspection 48 Packaging, marking and information to be supplied by the manufacturer 48.1 Packaging . 48.2 Marking and instructions for use 5Annex A (normative) Determination of working time and setting time .8Annex B (normative) Determination of film thickness Luting materials only

18、 .10Annex C (normative) Determination of flexural strength .12Annex D (normative) Determination of radio-opacity .17Annex E (normative) Determination of shade and colour stability Restorative (except for tooth core build-up) and luting materials only .19Bibliography .21 ISO 2017 All rights reserved

19、iiiContents PageBS EN ISO 9917-2:2017ISO 9917-2:2017(E)ForewordISO (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.

20、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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Internat

21、ional Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the differe

22、nt types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall n

23、ot be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is in

24、formation given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization

25、 (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document 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 (IS

26、O 9917-2:2010), which has been technically revised. The main changes compared to the previous edition are as follows: the adoption of ISO 13116 as the measuring procedure of the test method for radio-opacity; the inclusion of tooth core build-up as a restoration in the scope; the adoption of other m

27、inor technical revisions in the test methods.A list of all parts of the ISO 9917 series can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 9917-2:2017ISO 9917-2:2017(E)IntroductionThis document has been prepared in order to present the requirements and test methods for cements

28、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 through application of energy from an external source. As far as possible, test methods employed within this docu

29、ment have been harmonized with those used in ISO 4049 and ISO 9917-1.No specific qualitative and quantitative requirements for ensuring the absence of biological hazard are included in this document, but it is recommended that reference be made to ISO 10993-1 and ISO 7405 when assessing possible bio

30、logical or toxicological hazards. ISO 2017 All rights reserved vBS EN ISO 9917-2:2017This page deliberately left blankDentistry - Water-based cements Part 2: Resin-modified cements (ISO 9917-2:2017)1 ScopeThis document specifies requirements and test methods for water-based dental cements in which s

31、etting is achieved by a combination of an acid-base reaction and polymerization. The materials are intended for luting, base or lining, restoration and tooth core build up purposes.EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass

32、 with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this document will normally 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 The attention of manufacturers and test

33、 laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917-1 so that they can consider which is the most appropriate for evaluating any individual product.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of thei

34、r content constitutes requirements 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 VocabularyISO 3696, Water for analytical laboratory use Specificatio

35、n and test methodsISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 7491, Dental materials Determination of colour stabilityISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 13116:2014, Dentistry Test m

36、ethod for determining radio-opacity of materials3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platf

37、orm: available at http:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/ 3.1mixing timeportion of the working time required in order to obtain a satisfactory mix of the componentsNote 1 to entry: Materials that fall within the scope of this document include materials that r

38、equire mixing and single component materials that do not require mixing.INTERNATIONAL STANDARD ISO 9917-2:2017(E) ISO 2017 All rights reserved 1BS EN ISO 9917-2:2017ISO 9917-2:2017(E)SOURCE: ISO 9917-1:2007, 3.1, modified “that part of” has been replaced with “portion of” in the definition, and note

39、 1 to entry has been added.3.2working timeperiod of time, measured from the start of mixing (if required), during which it is possible to manipulate the material without an adverse effect on its propertiesSOURCE: ISO 9917-1:2007, 3.2 modified3.3setting timeperiod of time, from the start of mixing, u

40、ntil the completion of setting, as defined by the ability of the material to support an indenter under a known load, when the material needs to be mixed to set3.4outer packpackaging used for single dose container(s)/capsule(s)3.5outermost packagingpackaging used to combine material and additional it

41、ems, including instructions for use and any proportioning or mixing devices that are supplied with the material4 Classification and applications4.1 ClassificationFor the purposes of this document, materials consist of water-based components which set by acid-base reaction and polymer-based component

42、(s) are classified on the basis of their setting characteristics of polymer-based component(s) as follows: Class 1: materials setting of polymer-based components is activated following mixing of the components of the material; Class 2: materials setting of polymer-based component(s) is activated by

43、irradiation of light to the mixed material; Class 3: materials setting of polymer-based components is activated following mixing of the components and which can also be activated by irradiation of light to the mixed material.4.2 ApplicationsFor the purposes of this document, the clinical application

44、 of these materials is signified as follows:a) luting;b) base or lining;c) restoration, including for tooth core build-up.2 ISO 2017 All rights reservedBS EN ISO 9917-2:2017ISO 9917-2:2017(E)5 Requirements5.1 MaterialsDuring the course of testing, there shall be no visible signs of extraneous matter

45、 in any component. Separately supplied liquid shall be free of any gelation.NOTE Gelation is the transition of a material from a fluid consistency to a state in which the material has developed viscous or elastic properties. See ISO 14356:2003, 3.9.5.2 Working timeWhen tested in accordance with Anne

46、x 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 22).5.3 Setting time Class 1 and Class 3 materials onlyWhen tested in accordance with Annex A, the setting time of Class 1 and Class 3 mat

47、erials 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 23).5.4 Film thickness Luting materials only (see 4.2 ) The film thickness of luting materials when determined in accordance with Annex B, shall be no more th

48、an 5 m above any value claimed by the manufacturer (i.e. the first requirement) and in any event shall comply with the requirements given in Table 1 (i.e. the second requirement).5.5 Flexural strengthWhen tested in accordance with Annex C, the flexural strength shall comply with the requirements giv

49、en in Table 1.5.6 Radio-opacityIf the manufacturer claims that the material is radio-opaque (see Table 2, item 14), the radio-opacity, determined in accordance with Annex D and ISO 13116:2014, 7.3 or 7.4, shall be equal to or greater than that of the same thickness of aluminium. If greater radio-opacity is stated by the manufacturer, it shall not be less than the value stated by the manufacturer (see Table 2, item 15).5.7 Shade and colour stability Restorative materials onlyWhen tested in accordance with An