DIN EN ISO 24234-2015 Dentistry - Dental amalgam (ISO 24234 2015) German version EN ISO 24234 2015《牙科学 牙科汞合金(ISO 24234-2015) 德文版本EN ISO 24234-2015》.pdf

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1、August 2015 Translation 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

2、 11.060.10!%E2“2342915www.din.deDDIN EN ISO 24234Dentistry Dental amalgam (ISO 24234:2015);English version EN ISO 24234:2015,English translation of DIN EN ISO 24234:2015-08Zahnheilkunde Dentale Amalgame (ISO 24234:2015);Englische Fassung EN ISO 24234:2015,Englische bersetzung von DIN EN ISO 24234:20

3、15-08Mdecine bucco-dentaire Amalgame dentaire (ISO 24234:2015);Version anglaise EN ISO 24234:2015,Traduction anglaise de DIN EN ISO 24234:2015-08SupersedesDIN EN ISO 24234:2011-12www.beuth.deDocument comprises 27 pagesIn case of doubt, the German-language original shall be considered authoritative.0

4、8.15 DIN EN ISO 24234:2015-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 24234:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Ger

5、many). The responsible German body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committees NA 014-00-17 AA Metalle and NA 014-00-17-05 AK Metallische Fllungswerkstoffe. The DIN Standards corresponding to the International Standards refer

6、red to in this document are as follows: ISO 286-2 DIN EN ISO 286-2 ISO 1942 DIN EN ISO 1942 ISO 3310-1 DIN ISO 3310-1 ISO 3864-2 DIN ISO 3864-2 ISO 6344-1 DIN ISO 6344-1 ISO 7405 DIN EN ISO 7405 ISO 7488 DIN EN ISO 7488 ISO 10993-1 DIN EN ISO 10993-1 ISO 13565-2 DIN EN ISO 13565-2 ISO 13897 DIN EN I

7、SO 13897 ISO 15223-1 DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 24234:2011-12 as follows: a) the title of this International Standard has been changed to reflect the content and requirements more accurately; b) the supply of dental mercury in units of greater mass (bulk dent

8、al mercury) is no longer within the scope of this International Standard. Through this restriction on the supply of dental mercury for a product to comply with this International Standard (introduced by ISO/TC 106 SC 1), a general concern about the environmental impact from the sale of mercury in bu

9、lk volumes (for all applications) is addressed; c) as a consequence of the removal of dental mercury supplied in bulk quantities from the scope of this International Standard, requirements for freedom from contamination (by water, oil and foreign bodies) and free pouring of dental mercury are no lon

10、ger present in this International Standard; d) the values for the requirements on the dimensional change during hardening and the compressive strength at 1 h and 24 h have been revised. “Permitted dimensional change during hardening” is changed from (0,10 to +0,20) % to (0,10 to +0,15) %. Furthermor

11、e, the “Minimum compressive strength at 1 h” has been increased from 80 MPa to 100 MPa, and the “Minimum compressive strength at 24 h” has been increased from 300 MPa to 350 MPa. e) provisions for packaging and marking have been revised; DIN EN ISO 24234:2015-08 3 f) markings required for mercury sa

12、fety warnings and precautions have been revised; g) normative annexes on procedures for corrosion testing have been removed from this International Standard and are now contained in a new International Technical Specification, ISO/TS 17988, Dentistry Corrosion test methods for amalgam. Previous edit

13、ions DIN 13905: 1974-08, 1987-04 DIN EN 21560: 1991-09 DIN EN ISO 1559: 2001-12 DIN EN ISO 24234: 2005-01, 2011-12 National Annex NA (informative) Bibliography DIN EN ISO 286-2, Geometrical Product Specifications (GPS) ISO code system for tolerances on linear sizes Part 2: Tables of standard toleran

14、ce grades and limit deviations for holes and shafts DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry DIN EN ISO 7488, Dental amalgamators DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluatio

15、n and testing within a risk management system DIN EN ISO 13565-2, Geometrical Product Specifications (GPS) Surface texture: Profile method Surfaces having stratified functional properties Part 2: Height characterization using the linear material ratio curve DIN EN ISO 13897, Dentistry Amalgam capsul

16、es DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN ISO 3310-1, Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth DIN ISO 3864-2, Graphical symbols Safety

17、colours and safety signs Part 2: Design principles for product safety labels DIN ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test DIN EN ISO 24234:2015-08 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24234 May 2015 I

18、CS 11.060.10 Supersedes EN ISO 24234:2004English Version Dentistry - Dental amalgam (ISO 24234:2015) Mdecine bucco-dentaire - Amalgame dentaire(ISO 24234:2015) Zahnheilkunde - Dentale Amalgame (ISO 24234:2015) This European Standard was approved by CEN on 3 January 2015. CEN members are bound to com

19、ply 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 application to the CEN-CENELE

20、C 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 Management Centre has the s

21、ame 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, Latvia, Lithuania, Luxembour

22、g, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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 2

23、015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24234:2015 EContents PageForeword 3Introduction 41 Scope . 52 Normative references 53 Terms and definitions . 64 Requirements 64.1 Chemical composition and purity of the denta

24、l amalgam alloy .64.2 Foreign material and large particles in the dental amalgam alloy powder 74.3 Accuracy and variability of pre-proportioned masses . 74.4 Properties of the dental amalgam 84.5 Appearance of the mixed dental amalgam before setting .85 Sampling 86 Test methods . 96.1 Chemical compo

25、sition and purity of the dental amalgam alloy . 96.2 Foreign material and large particles in the dental amalgam alloy powder 96.3 Determination of the accuracy and variability of pre-proportioned masses 96.4 Preparation of test-pieces to determine compliance with the requirements for creep, dimensio

26、nal change during hardening, and compressive strength . 116.5 Determination of creep . 166.6 Determination of dimensional change during hardening.166.7 Determination of compressive strength 176.8 Appearance of the mixed dental amalgam before setting 187 Marking, labelling, and packaging 197.1 Packag

27、ing 197.2 Marking 197.3 Manufacturers instructions . 21Bibliography .23DIN EN ISO 24234:2015-08 EN ISO 24234:2015 (E) 2 Foreword This document (EN ISO 24234:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secre

28、tariat of which is held 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 November 2015, and conflicting national standards shall be withdrawn at the latest by November 2015. Attention is dr

29、awn to the possibility 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 24234:2004. According to the CEN-CENELEC Internal Regulations, the na

30、tional standards organizations 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, L

31、ithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 24234:2015 has been approved by CEN as EN ISO 24234:2015 without any modification. DIN EN ISO 24234:2015-08 E

32、N ISO 24234:2015 (E) 3 IntroductionDental amalgam alloy and dental mercury are the essential and only components of dental amalgam restorative material. This International Standard specifies the requirements and the test methods for dental amalgam alloy that is suitable for the preparation of dental

33、 amalgam, together with those for the set dental amalgam and the requirements for packaging and marking (including those for dental mercury), of which this International Standard is the second edition.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biol

34、ogical hazard are not included in this International Standard but it is recommended that, for the assessment of possible biological hazards, reference should be made to ISO 10993 and ISO 7405.To enhance the safety of dentists and support staff, and minimize the consequence that might result from the

35、 accidental damage to containers during shipping, the scope is limited solely to dental mercury that is supplied pre-capsulated or in pre-dosed sachets. Both are limited to a mass sufficient for one mix.Safety precautions relating to marking, labelling, and packaging have been strengthened in this r

36、evision.Restricting the scope to dental amalgam alloys with copper contents above 12 % by mass (i.e. “high copper” dental amalgam alloy) was considered, because it is reported that restorations made with such alloys, as a group, have a better long term survival rate than those made with traditional

37、alloys (i.e. “low copper” dental amalgam alloy). This was rejected since there are a few products with a low copper content that produce restorations that are as durable as those produced using some of the high copper products. (Factors other than the percentage of copper are important.) Also, it wa

38、s felt that excluding products from compliance should not be done by a change to the composition requirement; it should be on the basis of a revision to the requirements for the properties that determine performance.Inclusion of a requirement for corrosion resistance was considered. However, it was

39、agreed that the data available were insufficient to set a corrosion requirement in this edition of this International Standard. A requirement for the corrosion resistance will be set and incorporated at the earliest possible date. It is recommended that, in assessing corrosion resistance of a dental

40、 amalgam product (relative to other dental amalgam products) reference should be made to ISO/TS 17988.In the first edition of this International Standard (and before that in ISO 1559) a compression strength test was used to determine the resistance to fracture of dental amalgam. Such a test, with a

41、compressive strength requirement, continues to be used in this edition. However, the Working Group recognizes that dental amalgam, is in effect, a brittle material and it is evaluating a suitable test procedure that produces tensile forces to initiate fracture in a way that replicates the clinical p

42、rocess. At this time, the work has not reached the point at which this test (with a requirement) can be included in this revision of the International Standard. When evaluation is completed, consideration will be given to adding a requirement for fracture resistance that utilizes this test. This wil

43、l be in the form of a Technical Amendment.Requirements and test methods for the capsules used for pre-capsulated products are contained in ISO 13897.DIN EN ISO 24234:2015-08 EN ISO 24234:2015 (E) 4 1 ScopeThis International Standard specifies the requirements and test methods for dental amalgam allo

44、ys that are suitable for the preparation of dental amalgam, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking (including those for dental mercury).It is applicable to dental amalgam alloys supplied in the form of a free-flowing pow

45、der in bulk, or a powder compressed to form a tablet, or a powder in a capsule (i.e. pre-capsulated).With respect to dental mercury, the scope is limited solely to dental mercury which is supplied pre-capsulated or in pre-dosed sachets. Both are limited to a mass sufficient for one mix. The mass of

46、dental mercury in one capsule or sachet shall be sufficient to produce a homogeneous plastic mix, appropriate for a small or medium sized restoration in a single tooth. This International Standard is not applicable to mercury supplied in masses greater than this in a single primary container (i.e. d

47、ental mercury in bulk). Dental mercury supplied in bulk volumes will not conform to this International Standard.This International Standard does not exclude the supply of dental amalgam alloy or dental mercury separately.This International Standard is not applicable to metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.NOTE Dental mercury is at least 99,99 % pure, and as such, it is a metallic element of high commercial purity, and not an alloy2 Normative