DIN EN ISO 4823-2015 Dentistry - Elastomeric impression materials (ISO 4823 2015) German version EN ISO 4823 2015《牙科 弹性印模材料(ISO 4823-2015) 德文版本EN ISO 4823-2015》.pdf

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1、December 2015 English price group 19No 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 11.060.10!%JwI“2398438www.din.d

2、eDIN EN ISO 4823Dentistry Elastomeric impression materials (ISO 4823:2015);English version EN ISO 4823:2015,English translation of DIN EN ISO 4823:2015-12Zahnheilkunde Elastomere Abformmaterialien (ISO 4823:2015);Englische Fassung EN ISO 4823:2015,Englische bersetzung von DIN EN ISO 4823:2015-12Mdec

3、ine bucco-dentaire Matriaux empreintes, base dlastomres (ISO 4823:2015);Version anglaise EN ISO 4823:2015,Traduction anglaise de DIN EN ISO 4823:2015-12SupersedesDIN EN ISO 4823:2007-10www.beuth.deDocument comprises 47 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language ori

4、ginal shall be considered authoritative.12.15 DIN EN ISO 4823:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 4823:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/T

5、C 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-0-22 AA Abformwerkstoffe. The DIN Standards corresponding to the International Standards referred to in C

6、lause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 6873 DIN EN ISO 6873 Amendments This standard differs from DIN EN ISO 4823:2007-10 as follows: a) the sequence of requirements has been modified to have the requirements for packaging and labelling listed before the requirements f

7、or characteristics and properties; b) the restriction that the working time shall be at least 30 seconds longer than the mixing time has been eliminated; this was considered necessary in view of the fact that several products have a shorter working time; c) the working time test procedures using the

8、 dead weight method (sink-in method) for Type O materials, which had been exempt from this requirement in the third edition, has been introduced (see 7.3.2); d) the current displacement rheometer procedure stated in ISO 4823:2000 will continue to be used for testing type 1, 2 and 3 materials without

9、 modification; e) concerning the order in which some clauses are presented: whereas in later years, most dental product standards have been structured to have the requirements and test methods clauses appear before the requirements for labelling and instructions for use clauses, this International S

10、tandard gives first ordering to the labelling and instructions for use requirements. This change was thought to be necessary because experience informs us that test operators will be better equipped to obtain success in testing if they first take into account the information available in the labelli

11、ng and in the instructions for use; f) Clause 6 has been added for the reasons explained in its first paragraph; g) Annex A has been created following the ISO Central Secretariat suggestion that all figures, grouped together instead of being presented individually on related pages of the text, are t

12、o be presented in a normative Annex and numbered according to existing rules. This is to make it easier for the figures to be located by users of the document; h) Annex B provides for standardized hand mixing methods to be used by test operators so that specimen preparation by mixing of the test spe

13、cimens will be more uniform and consistently fairer to the various products; i) Annex C identifies sources for the working-time test apparatus and the linear variable displacement transducer (LVTD). DIN EN ISO 4823:2015-12 3 Previous editions DIN 13913: 1982-02 DIN EN 24823: 1994-03 DIN EN ISO 4823:

14、 2001-08, 2007-10 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6873, Dentistry Gypsum products DIN EN ISO 4823:2015-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 4823 August 2015 ICS 11.060.10 Supersede

15、s EN ISO 4823:2000 English Version Dentistry - Elastomeric impression materials (ISO 4823:2015) Mdecine bucco-dentaire - Matriaux empreintes, base dlastomres (ISO 4823:2015) Zahnheilkunde - Elastomere Abformmaterialien (ISO 4823:2015) This European Standard was approved by CEN on 20 June 2015. CEN m

16、embers 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 applic

17、ation 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 made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Mana

18、gement 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, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvi

19、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T EUR O P EN D E NOR M A L I S ATI O N EUR O P I S C HES KOM I T E E F R NOR M UNG CEN-CENELEC Ma

20、nagement Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 4823:2015 E European foreword .41 Scope . 52 Normative references 53 Terms and definitions . 54 Classification 65 Requireme

21、nts for packaging, labelling, and information in manufacturers instructions . 65.1 Packaging requirements . 65.2 Labelling requirements . 75.2.1 Outer packages (containing one or more primary containers) . 75.2.2 Primary containers within outer packaging 75.3 Requirements for information in manufact

22、urers instructions 75.3.1 General 75.3.2 Identifying information 75.3.3 Specific instructions for use . 85.4 Requirements for characteristics and properties . 85.4.1 Component colours . 85.4.2 Mixing time (hand-spatulated or hand-kneaded mixes). 85.4.3 Consistency . 95.4.4 Working time. 95.4.5 Detai

23、l reproduction . 95.4.6 Linear dimensional change . 95.4.7 Compatibility with gypsum 95.4.8 Elastic recovery . 95.4.9 Strain-in-compression 96 Pre-test planning approaches 106.1 Sampling 106.2 Pre-test product examinations . 106.2.1 Examinations for compliance with labelling requirements 106.2.2 Exa

24、minations for effectiveness of the packaging 106.2.3 Examinations for compliance with requirements for instructions for use 106.3 Essential pre-test preparatory practices . 116.3.1 Laboratory conditions 116.3.2 Apparatus function verification steps 116.3.3 Volume of materials to be mixed for each sp

25、ecimen . 116.3.4 Order for conducting examinations and tests . 116.3.5 Standardized approaches to proportioning, mixing, and handling of hand mixed materials to be tested. 116.3.6 Timing for the specimen preparation and test procedures . 116.3.7 Simulated oral time/temperature treatment of specimens

26、 formed in completely closed mould assemblies 116.4 Pass/fail determinations . 126.5 Expression of test results 127 Test methods Specific 127.1 Mixing-time . 127.1.1 Apparatus 127.1.2 Specimen preparation and test procedure (five specimens) 127.1.3 Pass/fail determination and expression of results 1

27、27.2 Consistency . 127.2.1 Apparatus and materials 127.2.2 Advance preparation steps. 137.2.3 Specimen preparation and test procedure (3 specimens) . 137.2.4Pass/fail determination and expression of results14Contents PageDIN EN ISO 4823:2015-12 EN ISO 4823:2015 (E) 2 7.3 Working-time 147.3.1 Apparat

28、us and materials applicable to the Type 0 materials 147.3.2 Working time test for the Type 0 materials .147.3.3 Apparatus and materials applicable to the Types 1, 2, and 3 .167.3.4 Pretest apparatus function verification and assembly 167.3.5 Pass/fail determination and expression of results177.4 Det

29、ail reproduction 177.4.1 Apparatus and materials 177.4.2 Specimen preparation (three specimens) 187.4.3 Test procedure 187.4.4 Pass/fail determination and expression of results187.5 Linear dimensional change . 197.5.1 Apparatus and materials 197.5.2 Test block line-length measurement procedure 197.5

30、.3 Specimen preparation (three specimens) 197.5.4 Test specimen measurement 207.6 Compatibility with gypsum . 207.6.1 Apparatus and materials 207.6.2 Specimen preparation 217.6.3 Test procedure 227.6.4 Pass/fail determination and expression of results227.7 Elastic recovery . 227.7.1 Apparatus and ma

31、terials 227.7.2 Specimen preparation 227.7.3 Test procedure 237.7.4 Calculation of results .237.7.5 Pass/fail determination and expression of results237.8 Strain-in-compression . 247.8.1 Apparatus 247.8.2 Specimen preparation 247.8.3 Test procedure 247.8.4 Calculation of results .247.8.5 Pass/fail d

32、etermination and expression of results24Annex A (normative) Figures cited in this International Standard .25Annex B (normative) Standardized hand mixing methods 39Annex C (informative) Working-time test apparatus components Possible sources .42Bibliography .43DIN EN ISO 4823:2015-12 EN ISO 4823:2015

33、 (E) 3 European foreword This document (EN ISO 4823:2015) 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 standard,

34、 either by publication of an identical text or by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. C

35、EN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 4823:2000. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard:

36、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, Slovenia, Spain, S

37、weden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 4823:2015 has been approved by CEN as EN ISO 4823:2015 without any modification. DIN EN ISO 4823:2015-12 EN ISO 4823:2015 (E) 4 1 ScopeThis International Standard specifies the requirements and tests that the state

38、-of-the art body of knowledge suggests for helping determine whether the elastomeric impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes.NOTE This International Standard does not address possible biological hazards associated with the materia

39、ls. Therefore, interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of such hazards.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the

40、edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6873, Dentistry Gypsum products3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and t

41、he following apply.3.1consistencydegree of firmness with which particles of a material, prepared for use, cohere so as to allow the material to flow, or resist flow, as required to achieve the purpose for which it is intended3.2elastic recovery testDEPRECATED: compression setDEPRECATED: permanent de

42、formationDEPRECATED: recovery from deformationelastic impression materials method of determining whether the materials possess the elastic properties required to recover adequately after deformation occurring when the materials used for forming impressions are removed from the mouth3.3extrusion mixi

43、ngmethod by which two or more material components are extruded simultaneously from their separate primary containers through a special mixing tip from which the material components emerge as a homogeneous mixture3.4hand mixingmethod of mixing the components of a material by means of manual kneading

44、or spatulation3.5primary packagingcontainer designed to come into direct contact with the productSOURCE: ISO 21067:2007, 2.2.2, modified “packaging” replaced by “container” in the definition.DIN EN ISO 4823:2015-12 EN ISO 4823:2015 (E) 5 3.6mixing timetime, measured from first contact between differ

45、ent components of a material being mixed, required to achieve a homogeneous mixture when the components are mixed according to the manufacturers instructionsNote 1 to entry: The time of first contact between extrusion-mixed material components is defined as the time when the material components can

46、be seen entering into the mixing nozzle.3.7outer packagewrapping or carton, which may be required by law or a standard to bear specified labelling, used to cover one or more primary containers in preparation for retail marketing3.8strain-in-compression testelastic impression materials method of meas

47、uring the flexibility/stiffness property ranges of materials so as to determine whether the set materials, when formed as impressions, can be removed from the mouth without injury to impressed oral tissues and will have adequate stiffness in the more flexible portions of impressions to resist deform

48、ation when model-forming products are poured against them3.9working timeperiod of time beginning with the commencement of mixing and ending before the material being mixed has begun to exhibit elastic properties that will prevent the material from being manipulated as required to form an impression or a mould having the desired surface detail and dimensional characteristics4 ClassificationMaterials covered by this International Standard