DIN EN ISO 6873-2013 Dentistry - Gypsum products (ISO 6873 2013) German version EN ISO 6873 2013《牙科 石膏制品(ISO 6873-2013) 德文版本EN ISO 6873-2013》.pdf

1、July 2013Translation by DIN-Sprachendienst.English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11

2、.060.10!%English version EN ISO 6873:2013,English translation of DIN EN ISO 6873:2013-07Zahnheilkunde Gipse (ISO 6873:2013);Englische Fassung EN ISO 6873:2013,Englische bersetzung von DIN EN ISO 6873:2013-07Mdecine bucco-dentaire Produits base de gypse (ISO 6873:2013);Version anglaise EN ISO 6873:20

3、13,Traduction anglaise de DIN EN ISO 6873:2013-07SupersedesDIN EN ISO 6873:2000-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 25 pages06.13 DIN EN ISO 6873:2013-07 2 A comma is used as the decimal marker. National foreword This docu

4、ment (EN ISO 6873:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Working Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), W

5、orking Committee NA 014-00-09 AA Gipse, Wachse, Einbettmassen. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1302 DIN EN ISO 1302 ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 8601 DIN ISO 8601 ISO 15223-1 DIN EN ISO 15223-1 Amen

6、dments This standard differs from DIN EN ISO 6873:2000-07 as follows: a) type 2 gypsum products are divided up into dental plaster for mounting (Class 1) and for models (Class 2); b) further applications have been included for type 4 dental stones: dies, model bases and CAD/CAM dies; c) in Subclause

7、 5.4, a new test relating to the setting expansion after 24 h has been included (for type 4 materials only); d) Subclause 8.2 “Labelling” has been modified. Previous editions DIN 13911: 1976-04, 1984-01 DIN EN 26873: 1992-01 DIN EN ISO 6873: 2000-07 National Annex NA (informative) Bibliography DIN E

8、N ISO 1302, Geometrical Product Specifications (GPS) Indication of surface texture in technical product documentation DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requ

9、irements DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6873 April 2013 ICS 11.060.10 Supersedes EN

10、 ISO 6873:2000English Version Dentistry - Gypsum products (ISO 6873:2013) Mdecine bucco-dentaire - Produits base de gypse 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

11、 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 Centre or to any CEN member. This Euro

12、pean 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 the official versions. CEN members ar

13、e 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, Netherlands, Norway, Poland, Portugal, Ro

14、mania, Slovakia, Slovenia, 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

15、 reserved worldwide for CEN national Members. Ref. No. EN ISO 6873:2013: E(ISO 6873:2013) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 5 4 Classification 5 5 Requirements . 6 5.1 Quality . 6 5.2 Fluidity at pouring time (Type 1 materials o

16、nly) . 6 5.3 Setting time . 6 5.4 Linear setting expansion . 6 5.5 Fracture (Type 1 materials only) . 6 5.6 Compressive strength . 6 5.7 Reproduction of detail . 6 6 Testing Generalitie 7 6.1 Sampling . 7 6.2 Test conditions . 7 6.3 Mixing method 7 7 Test methods 7 7.1 Visual inspection 7 7.2 Fluidi

17、ty at pouring time for Type 1 materials 7 7.3 Setting time . 8 7.4 Linear setting expansion . 11 7.5 Fracture . 16 7.6 Compressive strength . 16 7.7 Reproduction of detail . 17 8 Packaging, marking and information to be supplied by the manufacturer 22 8.1 Packaging . 22 8.2 Labelling 22 8.3 Instruct

18、ions for use 23 2DIN EN ISO 6873:2013-07 EN ISO 6873:2013 (E) This document (EN ISO 6873:2013) has been prepared by Technical Committee ISO/TC 106 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

19、 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 some of the elements of this document may be the subje

20、ct 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 organizations of the following countries are bound to implement th

21、is 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, Netherlands, Norway, Poland, Portugal, Romania, Slovak

22、ia, 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. Foreword“Dentistry” 3DIN EN ISO 6873:2013-07 EN ISO 6873:2013 (E) IntroductionThis revision was necessary becau

23、se 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 appropriate. In this edition the classification has been altered to take this into a

24、ccount 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 period at which setting expansion was measured and a requirement had been set. In

25、this edition the setting expansion for Type 4 dental stone is measured at 24 h as well.4DIN EN ISO 6873:2013-07 EN ISO 6873:2013 (E) 1 ScopeThis International Standard gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions,

26、 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 requirements for the labelling of packaging and for adequate instructions to accompany each package.This International Standard doe

27、s not apply to dental bone graft substitutes composed of calcium sulfate hemihydrate (or gypsum).2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest e

28、dition of the referenced document (including any amendments) applies.ISO 1302, Geometrical Product Specifications (GPS) Indication of surface texture in technical product documentationISO 1942, Dentistry VocabularyISO 3696:1987, Water for analytical laboratory use Specification and test methodsISO 8

29、601, Data elements and interchange formats Information interchange Representation of dates and timesISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements3 Terms and definitionsFor the purposes of this documen

30、t, 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 necessary modifiersNote 1 to entry: Colouring matter and flavouring, if present, are regarded as necessary modifiers.4 Classificatio

31、nThe 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) 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

32、(high strength, low expansion) for dies, model bases and CAD/CAM dies;5DIN EN ISO 6873:2013-07 EN ISO 6873:2013 (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 Re

33、quirements5.1 QualityWhen tested according to 7.1, the powder shall be uniform and free from foreign matter and 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 a

34、t a pouring time of 1,25 min, the fluidity of type 1 materials shall be equal to or greater than 70 mm.5.3 Setting 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

35、 value claimed by the manufacturer in 8.2.1 h) or 8.2.2 h), whichever is appropriate for the packaging in which 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 expansionW

36、hen tested according to 7.4, the linear setting expansion shall be within the range listed in Table 1.Table 1 Linear 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

37、- - 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 -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 o

38、riginal unbroken specimen.5.6 Compressive strengthWhen tested according to 7.6, the compressive strength shall 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

39、 7.7, groove a in Figure 6 shall be reproduced.6DIN EN ISO 6873:2013-07 EN ISO 6873:2013 (E) 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

40、packaging in which the product is supplied. Do not use powder from previously opened, broken 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 an

41、d testing are clean, dry and free from particles of gypsum. Before testing begins, hold material 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

42、 the methods (hand or mechanical) specified by the manufacturer in the instructions (see 8.3), 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.

43、1, 5.5 and 5.7 (unless as stated otherwise, as in 7.7 ).Determine compliance with the requirements 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 corro

44、sion-resistant, non-absorbent material, having a length of (50,0 0,1) mm and an inside diameter 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 a

45、nd minor diameters of the slumped mix to the nearest millimetre.7.2.2 ProcedureRest the glass 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) dispen

46、sed to an accuracy of 0,1 ml to a mixing bowl and mix as described in 6.3.Completely fill the 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 a

47、llow the mix to slump or spread over the plate. One minute after the mould is lifted, measure 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.7DIN EN ISO 6873:2013-07 EN ISO 6873:2013 (E) 7.2.3

48、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 three

49、more tests. If all three of these average values meet the requirement given in 5.2, the product meets the requirement for fluidity. Otherwise it fails.7.3 Setting time7.3.1 Apparatus7.3.1.1 Needle penetrometer, an example of which is shown in Figure 1, meeting the following requirements:a) Penetrometer needle (1), 50 mm long, of circular cross-section, with a diameter of (1,00 0,05) mm and a squared end.b) Rod (2), of approximate dimensions 270