EN ISO 24234-2015 en Dentistry - Dental amalgam《牙齿科 银汞合金(ISO 24234 2015)》.pdf

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1、BSI Standards PublicationBS EN ISO 24234:2015Dentistry Dental amalgamBS EN ISO 24234:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 24234:2015. It supersedes BS EN ISO 24234:2004+A1:2011 which is withdrawn.The UK participation in its preparation was en

2、trusted to TechnicalCommittee CH/106/1, Dental restorative and orthodontic 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 for its

3、correctapplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 79885 6ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Str

4、ategy Committee on 31 May 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24234 May 2015 ICS 11.060.10 Supersedes EN ISO 24234:2004English Version Dentistry - Dental amalgam (ISO 24234:2015) Mdecine bucco-dentair

5、e - 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 comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status

6、 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 versions (English, French, Germ

7、an). 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 Austria, Belgium, Bulgaria, Croatia

8、, 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, Sweden, Switzerland, Turkey and Unit

9、ed 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 CEN national Members. Ref. No. EN

10、ISO 24234:2015 EBS EN ISO 24234:2015EN ISO 24234:2015 (E) 3 Foreword This document (EN ISO 24234:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” incollaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall

11、be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by November 2015, and conflicting national standards shall be withdrawnat the latest by November 2015. Attention is drawn to the possibility that some of the elements of this docume

12、nt may be the subject of patentrights. 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 national standards organizations of the followingcountries are bou

13、nd to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

14、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. BS EN ISO 24234:2015ISO 24234:2015(E) ISO 2015 All rights reserved iiiContents PageForeword iv

15、Introduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Requirements 24.1 Chemical composition and purity of the dental amalgam alloy . 24.2 Foreign material and large particles in the dental amalgam alloy powder 34.3 Accuracy and variability of pre-proportioned masses . 34.4 P

16、roperties of the dental amalgam 44.5 Appearance of the mixed dental amalgam before setting . 45 Sampling 46 Test methods . 56.1 Chemical composition and purity of the dental amalgam alloy . 56.2 Foreign material and large particles in the dental amalgam alloy powder 56.3 Determination of the accurac

17、y and variability of pre-proportioned masses 56.4 Preparation of test-pieces to determine compliance with the requirements for creep, dimensional change during hardening, and compressive strength 76.5 Determination of creep . 126.6 Determination of dimensional change during hardening.126.7 Determina

18、tion of compressive strength 136.8 Appearance of the mixed dental amalgam before setting 147 Marking, labelling, and packaging 157.1 Packaging 157.2 Marking 157.3 Manufacturers instructions . 17Bibliography .19BS EN ISO 24234:2015ISO 24234:2015(E)ForewordISO (the International Organization for Stand

19、ardization) is a worldwide 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

20、to be represented on that 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.The procedures us

21、ed to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular 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

22、of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). 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. Details of any patent rights identifi

23、ed during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.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

24、the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO

25、/TC 106, Dentistry, Subcommittee SC 1, Filling and Restorative Materials.This second edition cancels and replaces the first edition (ISO 24234:2004), which has been technically revised. It also incorporates the amendment ISO 24234:2004/Amd, 1. The following changes have been made. The title of this

26、International Standard has been changed to reflect the content and requirements more accurately. The supply of dental mercury in units of greater mass (bulk dental mercury) is no longer within the scope of this International Standard. Through this restriction on the supply of dental mercury for a pr

27、oduct to comply with this International Standard (introduced by ISO/TC 106 SC1), a general concern about the environmental impact from the sale of mercury in bulk volumes (for all applications) is addressed. As a consequence of the removal of dental mercury supplied in bulk quantities from the scope

28、 of this International Standard, requirements for freedom from contamination (by water, oil and foreign bodies) and free pouring of dental mercury are no longer present in this International Standard. The values for the requirements on the dimensional change during hardening and the compressive stre

29、ngth 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) %. Furthermore, the “Minimum compressive strength at 1h” is increased from 80 to 100 MPa, and the “Minimum compressive strength at 24 h” is increased from 30

30、0 to 350 MPa. Provisions for packaging and marking have been revised. Markings required for mercury safety warnings and precautions have been revised. Normative annexes on procedures for corrosion testing have been removed from this International Standard and are now contained in a new International

31、 Technical Specification, ISO/TS 17988: Dentistry Corrosion test methods for dental amalgam.iv ISO 2015 All rights reservedBS EN ISO 24234:2015ISO 24234:2015(E)IntroductionDental amalgam alloy and dental mercury are the essential and only components of dental amalgam restorative material. This Inter

32、national Standard specifies the requirements and the test methods for dental amalgam alloy that is suitable for the preparation of dental amalgam, together with those for the set dental amalgam and the requirements for packaging and marking (including those for dental mercury), of which this Interna

33、tional Standard is the second edition.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this International Standard but it is recommended that, for the assessment of possible biological hazards, reference should be ma

34、de to ISO 10993 and ISO 7405.To enhance the safety of dentists and support staff, and minimize the consequence that might result from the 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 l

35、imited to a mass sufficient for one mix.Safety precautions relating to marking, labelling, and packaging have been strengthened in this revision.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

36、 is reported that restorations made with such alloys, as a group, have a better long term survival rate than those made with traditional 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 d

37、urable as those produced using some of the high copper products. (Factors other than the percentage of copper are important.) Also, it was 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 requir

38、ements for the properties that determine performance.Inclusion of a requirement for corrosion resistance was considered. However, it was agreed that the data available were insufficient to set a corrosion requirement in this edition of this International Standard. A requirement for the corrosion res

39、istance will be set and incorporated at the earliest possible date. It is recommended that, in assessing corrosion resistance of a dental 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 befo

40、re that in ISO 1559) a compression strength test was used to determine the resistance to fracture of dental amalgam. Such a test, with a compressive strength requirement, continues to be used in this edition. However, the Working Group recognizes that dental amalgam, is in effect, a brittle material

41、 and it is evaluating a suitable test procedure that produces tensile forces to initiate fracture in a way that replicates the clinical process. 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. Wh

42、en evaluation is completed, consideration will be given to adding a requirement for fracture resistance that utilizes this test. This will 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. ISO 2015 All

43、rights reserved vBS EN ISO 24234:2015BS EN ISO 24234:2015Dentistry Dental amalgam1 ScopeThis International Standard specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam, together with the requirements and test methods for that

44、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 powder in bulk, or a powder compressed to form a tablet, or a powder in a capsule (i.e. pre-capsulated).With respect to

45、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 dental mercury in one capsule or sachet shall be sufficient to produce a homogeneous plastic mix, appropriate for a s

46、mall 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. dental mercury in bulk). Dental mercury supplied in bulk volumes will not conform to this International Standard.This

47、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 intende

48、d 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 referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its applic

49、ation. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 286-2, Geometrical product specifications (GPS) ISO code system for tolerances on linear sizes Part 2: Tables of standard tolerance classes and limit deviations for holes and shaftsISO 1942, Dentistry VocabularyISO 3310-1, Test sieves Technical requirements and testing Part 1: Test sieves of metal wire clothISO 3864-2, Graphical symbols Safety colours and safety signs Part 2: