EN ISO 6873-2013 en Dentistry - Gypsum products《牙科 石膏制品》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 6873:2013Dentistry Gypsum products(ISO 6873:2013)BS EN ISO 6873:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 6873:2013

2、.It supersedes BS EN ISO 6873:2000 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic materials.A list of organizations represented on this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 in

3、clude all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 74586 7ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This Bri

4、tish Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6873 April 2013 ICS 11.060.10 Supersedes EN ISO 6873:2000English Version Dentis

5、try - Gypsum products (ISO 6873:2013) Mdecine bucco-dentaire - Produits base de gypse (ISO 6873:2013) Zahnheilkunde - Gipse (ISO 6873:2013) This European Standard was approved by CEN on 21 March 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condi

6、tions 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 Centre or to any CEN member. This European Standard exists

7、 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 the official versions. CEN members are the national stand

8、ards 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, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slo

9、venia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide

10、for CEN national Members. Ref. No. EN ISO 6873:2013: EBS EN ISO 6873:2013EN ISO 6873:2013 (E) 3 Foreword This document (EN ISO 6873:2013) 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 b

11、y 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 2013, and conflicting national standards shall be withdrawn at the latest by October 2013. Attention is drawn to the possibility that

12、 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 6873:2000. According to the CEN-CENELEC Internal Regulations, the national standards organizatio

13、ns of the following 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

14、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 6873:2013 has been approved by CEN as EN ISO 6873:2013 without any modification. BS EN ISO 6873:2013ISO 6873:2013(E) ISO 2013 All rights

15、reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 15 Requirements 25.1 Quality 25.2 Fluidity at pouring time (Type 1 materials only) 25.3 Setting time 25.4 Linear setting expansion 25.5 Fracture (Type 1 materials only) 25

16、.6 Compressive strength . 25.7 Reproduction of detail 26 Testing Generalities . 36.1 Sampling . 36.2 Test conditions 36.3 Mixing method 37 Test methods . 37.1 Visual inspection . 37.2 Fluidity at pouring time for Type 1 materials 37.3 Setting time 47.4 Linear setting expansion 77.5 Fracture 127.6 Co

17、mpressive strength 127.7 Reproduction of detail . 138 Packaging, marking and information to be supplied by the manufacturer .188.1 Packaging 188.2 Labelling 188.3 Instructions for use 19BS EN ISO 6873:2013ISO 6873:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide

18、 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 the right to be represented on that

19、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.International Standards are drafted in acco

20、rdance 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. Publication as an International Standard requir

21、es 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.Specific qualitative and quantitative

22、 requirements for freedom from biological hazard are not included in this International Standard but it is recommended that, in assessing possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.ISO 6873 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee

23、 SC 2, Prosthodontic materials.This third edition cancels and replaces the second edition (ISO 6873:1998) of which Clause 4 and subclauses 5.4 and 8.2 have been technically revised. An alternative design for the extensometer used to measure setting expansion is included.iv ISO 2013 All rights reserv

24、edBS EN ISO 6873:2013ISO 6873:2013(E)IntroductionThis revision was necessary because gypsum products have been marketed since the last edition of ISO 6873 was published, which have properties (required for newly introduced dental technology) for which the requirements set in that edition were not ap

25、propriate. In this edition the classification has been altered to take this into account and in so doing, requirements have been set appropriately. In addition there was concern that Type 4 dental stone used for CAD/CAM models should not produce significant setting expansion at times beyond the 2 h

26、period at which setting expansion was measured and a requirement had been set. In this edition the setting expansion for Type 4 dental stone is measured at 24 h as well. ISO 2013 All rights reserved vBS EN ISO 6873:2013BS EN ISO 6873:2013Dentistry Gypsum products1 ScopeThis International Standard gi

27、ves a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions, moulds, casts, dies or model bases, and mounting models. It specifies the test methods to be employed to determine compliance with these requirements. It also includes r

28、equirements for the labelling of packaging and for adequate instructions to accompany each package.This International Standard does not apply to dental bone graft substitutes composed of calcium sulfate hemihydrate (or gypsum).2 Normative referencesThe following referenced documents are indispensabl

29、e 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 1302, Geometrical Product Specifications (GPS) Indication of surface texture in technical product

30、 documentationISO 1942, Dentistry VocabularyISO 3696:1987, Water for analytical laboratory use Specification and test methodsISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 15223-1, Medical devices Symbols to be used with medical device la

31、bels, labelling and information to be supplied Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1gypsum productdental product composed essentially of a hemihydrate of calcium sulfate and any ne

32、cessary modifiersNote 1 to entry: Colouring matter and flavouring, if present, are regarded as necessary modifiers.4 ClassificationThe five types of gypsum product used in dentistry are classified in accordance with this International Standard as follows:a) Type 1: Dental plaster for impressions;b)

33、Type 2: Dental plaster for mounting (Class 1) and for models (Class 2);c) Type 3: Dental stone for models;d) Type 4: Dental stone (high strength, low expansion) for dies, model bases and CAD/CAM dies;INTERNATIONAL STANDARD ISO 6873:2013(E) ISO 2013 All rights reserved 1BS EN ISO 6873:2013ISO 6873:20

34、13(E)e) Type 5: Dental stone (high strength, high expansion) for dies when this degree of expansion is necessary for shrinkage compensation of some materials used in dental restoration.5 Requirements5.1 QualityWhen tested according to 7.1, the powder shall be uniform and free from foreign matter and

35、 lumps. When mixed according to the manufacturers instructions the product shall produce a homogeneous mix.5.2 Fluidity at pouring time (Type 1 materials only)When tested according to 7.2 at a pouring time of 1,25 min, the fluidity of type 1 materials shall be equal to or greater than 70 mm.5.3 Sett

36、ing timeWhen tested according to 7.3, the setting time of type 1 materials shall be in the range of 2,5 min to 5,0 min and the setting time of all material types shall be within 20 % of the value claimed by the manufacturer in 8.2.1 h) or 8.2.2 h), whichever is appropriate for the packaging in which

37、 the product is supplied. If the manufacturer claims a range of setting time, then the midpoint of this range is taken as the value claimed by the manufacturer.5.4 Linear setting expansionWhen tested according to 7.4, the linear setting expansion shall be within the range listed in Table 1.Table 1 L

38、inear setting expansion and compressive strengthType Linear setting expansion %Compressive strength MPa2 h 24 h 1 hmin. max. min. max. min. max.1 0,00 0,15 - - 4,0 8,02 (Class 1) 0,00 0,05 - - 9,0 -2 (Class 2) 0,06 0,30 - - 9,0 -3 0,00 0,20 - - 20,0 -4 0,00 0,15 0,00 0,18 35,0 -5 0,16 0,30 - - 35,0

39、-5.5 Fracture (Type 1 materials only)When tested according to 7.5, Type 1 impression plaster shall break with a clean fracture and be readily reassembled to form the shape and size of the original unbroken specimen.5.6 Compressive strengthWhen tested according to 7.6, the compressive strength shall

40、meet the requirement(s) of Table 1.5.7 Reproduction of detailTypes 1 and 2: When tested according to 7.7, groove c in Figure 6 shall be reproduced.Types 3, 4 and 5: When tested according to 7.7, groove a in Figure 6 shall be reproduced.2 ISO 2013 All rights reservedBS EN ISO 6873:2013ISO 6873:2013(E

41、)6 Testing Generalities6.1 SamplingSelect the material for testing from one lot that has been produced for retail and that is not beyond its expiry date 8.2.1 b) or 8.2.2 b), whichever is appropriate for the packaging in which the product is supplied. Do not use powder from previously opened, broken

42、 or damaged containers.6.2 Test conditionsCarry out all mixing and testing of the dental gypsum product at (23 2) C and (50 10) % relative humidity. Ensure that all apparatus and instruments used in mixing and testing are clean, dry and free from particles of gypsum. Before testing begins, hold mate

43、rial and test apparatus at the test temperature for a period of time that is sufficient to equilibrate with this temperature.NOTE A minimum storage period of 15 h is recommended.6.3 Mixing methodMix by one of the methods (hand or mechanical) specified by the manufacturer in the instructions (see 8.3

44、), using water, which meets the requirements of ISO 3696, Grade 3.7 Test methods7.1 Visual inspectionCarry out visual inspection without magnification to determine compliance with the requirements given in 5.1, 5.5 and 5.7 (unless as stated otherwise, as in 7.7 ).Determine compliance with the requir

45、ements given in Clause 8 for packaging, marking and information supplied by the manufacturer.7.2 Fluidity at pouring time for Type 1 materials7.2.1 Apparatus7.2.1.1 Cylindrical mould, constructed from a corrosion-resistant, non-absorbent material, having a length of (50,0 0,1) mm and an inside diame

46、ter of (35,0 0,1) mm. Clean and dry.7.2.1.2 Glass plate, flat and smooth, with sides of length at least 100 mm. Clean and dry.7.2.1.3 Means of measuring lengths from 35 mm to 100 mm, for measuring the major and minor diameters of the slumped mix to the nearest millimetre.7.2.2 ProcedureRest the glas

47、s plate on a surface that is free of vibration. Place the mould upright on the centre of the plate.Add (100,0 0,1) g of the sample to the manufacturers recommended quantity of water (ISO 3696, Grade 3) dispensed to an accuracy of 0,1 ml to a mixing bowl and mix as described in 6.3.Completely fill th

48、e mould and level off the mixed material so that it is flush with the top of the mould. At 1,25 min after the start of mixing, lift the mould vertically from the plate at a rate of approximately 10 mm/s and allow the mix to slump or spread over the plate. One minute after the mould is lifted, measur

49、e the major and minor axes of the slumped material to the nearest millimetre. Record the average of these two diameters as the fluidity at the pouring time. ISO 2013 All rights reserved 3BS EN ISO 6873:2013ISO 6873:2013(E)7.2.3 EvaluationCarry out the test twice. If both average values meet the requirement given in 5.2, then the product meets the requirement for fluidity. If neither meets this requirement, then the product fails. If one average value meets the requirement given in 5.2, and the other fails, carry out thre