EN ISO 4823-2015 en Dentistry - Elastomeric impression materials《牙科 弹性印模材料(ISO 4823 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 4823:2015Dentistry Elastomericimpression materials (ISO4823:2015)BS EN ISO 4823:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 4823:2015.It supersedes BS EN ISO 4823:2000+A1:2007 which is withdrawn.The UK participatio

2、n 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 include all the necessaryprovisions of a contract. Users are responsible fo

3、r its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 78979 3ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy an

4、d Strategy Committee on 31 August 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 4823 August 2015 ICS 11.060.10 Supersedes EN ISO 4823:2000English Version Dentistry - Elastomeric impression materials (ISO 4823:2015) Mdecine bucco-de

5、ntaire - 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 members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving t

6、his 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 in three official

7、 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 standards bodies of Aus

8、tria, 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, Swed

9、en, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CE

10、N national Members. Ref. No. EN ISO 4823:2015 EBS EN ISO 4823:2015EN ISO 4823:2015 (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 hel

11、d by 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. Attention is drawn to the possibility

12、 that 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 4823:2000. According to the CEN-CENELEC Internal Regulations, the national standards organi

13、zations 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, M

14、alta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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. BS EN ISO 4823:2015ISO 4823:2015(E)Foreword v1 Scop

15、e . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements for packaging, labelling, and information in manufacturers instructions . 25.1 Packaging requirements . 25.2 Labelling requirements . 35.2.1 Outer packages (containing one or more primary containers) . 35.2.2 Pr

16、imary containers within outer packaging 35.3 Requirements for information in manufacturers instructions 35.3.1 General 35.3.2 Identifying information 35.3.3 Specific instructions for use . 45.4 Requirements for characteristics and properties . 45.4.1 Component colours . 45.4.2 Mixing time (hand-spat

17、ulated or hand-kneaded mixes). 45.4.3 Consistency . 55.4.4 Working time. 55.4.5 Detail reproduction . 55.4.6 Linear dimensional change . 55.4.7 Compatibility with gypsum 55.4.8 Elastic recovery . 55.4.9 Strain-in-compression 56 Pre-test planning approaches . 66.1 Sampling . 66.2 Pre-test product exa

18、minations 66.2.1 Examinations for compliance with labelling requirements . 66.2.2 Examinations for effectiveness of the packaging . 66.2.3 Examinations for compliance with requirements for instructions for use . 66.3 Essential pre-test preparatory practices 76.3.1 Laboratory conditions . 76.3.2 Appa

19、ratus function verification steps . 76.3.3 Volume of materials to be mixed for each specimen 76.3.4 Order for conducting examinations and tests 76.3.5 Standardized approaches to proportioning, mixing, and handling of hand mixed materials to be tested 76.3.6 Timing for the specimen preparation and te

20、st procedures 76.3.7 Simulated oral time/temperature treatment of specimens formed in completely closed mould assemblies . 76.4 Pass/fail determinations 86.5 Expression of test results . 87 Test methods Specific . 87.1 Mixing-time 87.1.1 Apparatus . 87.1.2 Specimen preparation and test procedure (fi

21、ve specimens) . 87.1.3 Pass/fail determination and expression of results. 87.2 Consistency 87.2.1 Apparatus and materials . 87.2.2 Advance preparation steps 97.2.3 Specimen preparation and test procedure (3 specimens) 97.2.4 Pass/fail determination and expression of results10 ISO 2015 All rights res

22、erved iiiContents PageBS EN ISO 4823:2015ISO 4823:2015(E)7.3 Working-time 107.3.1 Apparatus and materials applicable to the Type 0 materials 107.3.2 Working time test for the Type 0 materials .107.3.3 Apparatus and materials applicable to the Types 1, 2, and 3 .127.3.4 Pretest apparatus function ver

23、ification and assembly 127.3.5 Pass/fail determination and expression of results137.4 Detail reproduction 137.4.1 Apparatus and materials 137.4.2 Specimen preparation (three specimens) 147.4.3 Test procedure 147.4.4 Pass/fail determination and expression of results147.5 Linear dimensional change . 1

24、57.5.1 Apparatus and materials 157.5.2 Test block line-length measurement procedure 157.5.3 Specimen preparation (three specimens) 157.5.4 Test specimen measurement 167.6 Compatibility with gypsum . 167.6.1 Apparatus and materials 167.6.2 Specimen preparation 177.6.3 Test procedure 187.6.4 Pass/fail

25、 determination and expression of results187.7 Elastic recovery . 187.7.1 Apparatus and materials 187.7.2 Specimen preparation 187.7.3 Test procedure 197.7.4 Calculation of results .197.7.5 Pass/fail determination and expression of results197.8 Strain-in-compression . 207.8.1 Apparatus 207.8.2 Specim

26、en preparation 207.8.3 Test procedure 207.8.4 Calculation of results .207.8.5 Pass/fail determination and expression of results20Annex A (normative) Figures cited in this International Standard .21Annex B (normative) Standardized hand mixing methods 35Annex C (informative) Working-time test apparatu

27、s components Possible sources .38Bibliography .39iv ISO 2015 All rights reservedBS EN ISO 4823:2015ISO 4823:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standard

28、s 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 organizations, governmental and non-governmental, in liaison with ISO, also take

29、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 its further maintenance are described in the ISO/IEC Directives, Part 1. In parti

30、cular 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/directives).Attention is drawn to the possibility that some of the elements of th

31、is 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 the Introduction and/or on the ISO list of patent declarations received (see www

32、.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 related to conformity assessment, as well as information about ISOs adherence to the

33、 WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.This fourth edition cancels and replaces the third edition (ISO 4823:2

34、000), which has been technically revised with the following changes: modification of the sequence of requirements having the requirements for packaging and labelling listed before the requirements for characteristics and properties; the restriction that the working time shall be at least 30 s longer

35、 than the mixing time was eliminated; this was considered necessary in view of the fact that several products have shorter working time; working time test procedure using the dead weight method (Sink-in method) for Type 0 materials which had been exempt from this requirement in the third edition was

36、 introduced (see 7.3.2); the current displacement Rheometer procedure stated in ISO 4823:2000 will continue to be used for testing Type 1, 2, and 3 materials without modifications; concerning the order in which some clauses are presented, whereas in later years, most dental product standards have be

37、en structured to have the requirements and test methods clauses appear before the requirements for labelling and instructions for use clauses, this International Standard gives first ordering to the labelling and instructions for use requirements. This change was thought to be necessary because expe

38、rience 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 labelling and in the instructions for use; Clause 6 has been added for reasons explained in its first paragraph; concerning the Annexes Annex A

39、was created due to the ISO Central Secretariat suggestion that all figures, grouped together instead of being presented individually on related pages of the text, are to be presented in a normative Annex and numbered according to existing rules. This is to make it easier for the figures to be locate

40、d by users of the document; ISO 2015 All rights reserved vBS EN ISO 4823:2015ISO 4823:2015(E) Annex B provides for standardized hand mixing methods to be used by test operators so that specimen preparation mixing of the test specimens will be uniform and consistently fairer to the various products;

41、Annex C identifies sources for the working-time test apparatus and the linear variable displacement transducer (LVTD).vi ISO 2015 All rights reservedBS EN ISO 4823:2015Dentistry Elastomeric impression materials1 ScopeThis International Standard specifies the requirements and tests that the state-of-

42、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 materials.

43、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 edit

44、ion 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 the f

45、ollowing 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 deform

46、ationDEPRECATED: 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 mixingme

47、thod 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 or s

48、patulation3.5primary packagingcontainer designed to come into direct contact with the productSOURCE: ISO 21067:2007, 2.2.2, modified “packaging” replaced by “container” in the definition.INTERNATIONAL STANDARD ISO 4823:2015(E) ISO 2015 All rights reserved 1BS EN ISO 4823:2015ISO 4823:2015(E)3.6mixin

49、g timetime, measured from first contact between different 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 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 pri