EN ISO 15912-2016 en Dentistry - Refractory investment and die material《牙科 耐高温材料及模具材料(ISO 15912 2016)》.pdf

1、BSI Standards PublicationBS EN ISO 15912:2016Dentistry Refractoryinvestment and die materialBS EN ISO 15912:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO15912:2016. It supersedes BS EN ISO 15912:2006+A1:2011 which is withdrawn.The UK participation in

2、its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its

3、 correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83382 3ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Str

4、ategy Committee on 29 February 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15912 February 2016 ICS 11.060.10 Supersedes EN ISO 15912:2006English Version Dentistry - Refractory investment and die material (ISO

5、 15912:2016) Mdecine bucco-dentaire - Revtements et matriaux pour modles rfractaires (ISO 15912:2016) Zahnheilkunde - Hochtemperaturbestndige Einbettmassen und Stumpfmaterialien (ISO 15912:2016) This European Standard was approved by CEN on 24 October 2015. CEN members are bound to comply with the C

6、EN/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-CENELEC Management C

7、entre 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-CENELEC Management Centre has the same status as

8、the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Neth

9、erlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rig

10、hts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15912:2016 EBS EN ISO 15912:2016EN ISO 15912:2016 (E) 3 European foreword This document (EN ISO 15912:2016) has been prepared by Technical Committee ISO/TC 106“Dentistry” in collaboration wi

11、th Technical Committee CEN/TC 55 “Dentistry” the secretariat of whichis held by DIN. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by August 2016, and conflicting national standards shallbe withdraw

12、n at the latest by August 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 15912:2006. According to

13、 the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,France, Germany, Greece, H

14、ungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 15912:2016 has been approved by CEN as EN ISO 15912:2016 without any

15、modification. BS EN ISO 15912:2016ISO 15912:2016(E)Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 35 Requirements 35.1 General . 35.2 Material consistency and freedom from contamination . 35.3 Fluidity . 35.4 Initial setting time 45.5 Compressive strength .

16、45.6 Linear thermal dimensional change . 45.7 Adequacy of expansion of Type 1 and Type 2 materials . 46 Sampling, test conditions and mixing 46.1 Sampling . 46.2 Test conditions 46.3 Mixing . 56.3.1 Apparatus . 56.3.2 Procedure . 57 Test methods . 57.1 Material consistency and freedom from contamina

17、tion . 57.1.1 Test procedure . 57.1.2 Test report . 57.2 Fluidity . 57.2.1 Apparatus . 57.2.2 Number of test-pieces . 67.2.3 Test procedure . 67.2.4 Evaluation of results . 67.2.5 Test report . 67.3 Initial setting time 77.3.1 Apparatus . 77.3.2 Procedure . 97.3.3 Number of determinations 97.3.4 Eva

18、luation of results 107.3.5 Test report 107.4 Compressive strength 107.4.1 Apparatus 107.4.2 Number of test-pieces 107.4.3 Preparation of test-pieces . 117.4.4 Test procedure 117.4.5 Evaluation of results 127.4.6 Test report 127.5 Linear thermal dimensional change 127.5.1 Apparatus 127.5.2 Number of

19、test-pieces 137.5.3 Preparation of the test-piece 137.5.4 Test procedure for the measurement of linear thermal expansion of Types 1, 2 and 3 products 147.5.5 Test procedure for the measurement of linear thermal dimensional changes of a Type 4 product . 157.5.6 Evaluation of results 157.5.7 Test repo

20、rt 16 ISO 2016 All rights reserved iiiContents PageBS EN ISO 15912:2016ISO 15912:2016(E)7.6 Adequacy of expansion of Type 1 and Type 2 products .167.6.1 General. 167.6.2 Type 1 and Type 2 products intended for casting of dental metallic materials .177.6.3 Type 1 products intended for dental pressabl

21、e-ceramic products 187.6.4 Evaluation of results 207.6.5 Test report 208 Manufacturers instructions 208.1 General 208.2 Information for use 208.3 Physical properties . 218.4 Safety labelling and instructions for a product containing silica .229 Marking .229.1 General 229.2 Powder container 229.2.1 O

22、uter container 229.2.2 Individual packets 239.3 Liquid container 2310 Packaging 2310.1 Powder 2310.2 Liquid . 24Bibliography .25iv ISO 2016 All rights reservedBS EN ISO 15912:2016ISO 15912:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national s

23、tandards 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. International

24、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.The procedures used to develop this document and those intended for

25、its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different 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/

26、directives).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. Details of any patent rights identified during the development of the document will be in

27、 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 information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions rel

28、ated to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106 Dentistry, Subcommittee SC2, Prosthodontic Ma

29、terials.This second edition cancels and replaces the first edition (ISO 15912:2006), which has been technically revised. It also incorporates the Amendment ISO 15912-1:2006/Amd 1:2011.In this edition, dental pressable-ceramic investment materials are included in the Scope for the first time. These p

30、roducts are intended for the production of ceramic crowns and inlays and, as such, the same requirements as those for an investment product intended for the production of metallic crowns and inlays by casting are relevant (Type 1, according to the classification in this standard).The previous editio

31、n contained requirements and test methods that had been developed for discontinued composition specific standards. In recent years products have been introduced that have other chemistries (for the binder and the refractory phase), specifically to minimize chemical reaction between the mould and the

32、 molten casting metallic material. A number of technical changes have been made to enable all dental casting investment products, regardless of their composition, to seek compliance with this International Standard and maintains the agreed philosophy that this International Standard should be inclus

33、ive, application-driven and not be limited by composition considerations.Where appropriate, aspects of the test procedures have been changed to follow the manufacturers instructions for use. The requirement for thermal dimensional change now takes into account the cooling of some products (after bur

34、n-out) to a lower casting temperature. The specification for the dilatometer has been changed for it to be compatible with the heating and where relevant, the cooling after burn-out of the product to the casting temperature.The procedure for determining the initial setting time has been revised to h

35、armonize with that present in the latest edition of the standard for dental gypsum products, ISO 6873:2013.1Although substantially editorial, there are technical changes.Information for use now requires a statement of the type of refractory phase(s) that is (are) present. ISO 2016 All rights reserve

36、d vBS EN ISO 15912:2016ISO 15912:2016(E)Labelling requirements for products that contain silica have been revised to comply with the current United Nations Globally Harmonized System for Classification and Labelling of Chemicals (UN GHS)2and recommendations for silica as a hazardous material.Contain

37、ers of liquid must be marked to indicate the use to which the liquid is put.vi ISO 2016 All rights reservedBS EN ISO 15912:2016Dentistry Refractory investment and die material1 ScopeThis International Standard gives requirements and test methods for determining the compliance of dental casting inves

38、tment, dental brazing investment, dental pressable-ceramic investment and dental refractory die materials used in the dental laboratory, regardless of the composition of the refractory powder, the composition of the binder, or the particular application.This International Standard classifies such pr

39、oducts into types and classes, according to their intended use and the burn-out procedure recommended by the manufacturer.It also gives requirements for marking, labelling and manufacturers instructions.It specifies requirements for the essential physical and mechanical properties of the products an

40、d the test methods to be used for determining them.NOTE 1 Compliance with all of the requirements presented in Clause 5 may not be necessary for some products, and a requirement might not be applicable to a product with a particular binder chemistry or be intended for an application in which that re

41、quirement is irrelevant. When this is the case, a clear statement to this effect is given according to Clause 5.NOTE 2 A specific quantitative requirement for setting expansion is not included in this International Standard. If the setting expansion of gypsum-bonded investment is measured, then the

42、procedure given in ISO 68731can be considered a procedure not recommended, however, for investment materials with other binders.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referen

43、ces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 286-2, Geometrical product specifications (GPS) ISO code system for tolerances on linear sizes Part 2: Tables of standard tolerance classes and limit devi

44、ations for holes and shaftsISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specification and test methodsISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 6872, Dentistry Ceramic materialsISO 8601, Data elements and interchange forma

45、ts Information interchange Representation of dates and timesISO 15854, Dentistry Casting and baseplate waxesISO 22674, Dentistry Metallic materials for fixed and removable restorations and appliances3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942

46、 and the following apply.INTERNATIONAL STANDARD ISO 15912:2016(E) ISO 2016 All rights reserved 1BS EN ISO 15912:2016ISO 15912:2016(E)3.1dental casting investment materialpowdered particulate refractory and binder system that is mixed with a specified liquid to produce a pourable fluid that sets arou

47、nd a pattern to form the mould for casting a dental metallic prosthesisNote 1 to entry: In some products, the binder may be dispersed in the refractory powder and the product is supplied as a mixed powder. Alternatively, the chemistry of the binder may lead to it being present in a solution (to be u

48、sed with the powder that is supplied) with part or none of it being dispersed in the refractory powder, as received.Note 2 to entry: The specified liquid may be pure water, an aqueous binder solution, or an aqueous solution to enhance expansion.3.2dental refractory die materialpowdered particulate r

49、efractory and binder system that is mixed with a specified liquid to produce a fluid that sets (and is designed specifically) to form of a hard die, suitable for the production of a dental ceramic prosthesis using the sintering technique3.3dental brazing investment materialpowdered particulate refractory and binder system that is mixed with a specified liquid to produce a fluid that sets (and is designed specifically) to form a cast upon which metallic components are held, or are partly embedded, accurately in place wh