BS ISO 20749-2017 Dentistry Pre-capsulated dental amalgam《牙科 预封装牙科用汞合金》.pdf

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1、BS ISO 20749:2017Dentistry Pre-capsulateddental amalgamBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 20749:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 20749:2017.The UK participation in its preparation was entr

2、usted to Technical Committee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its

3、 correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 91313 6 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy an

4、d Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 20749:2017 ISO 2017Dentistry Pre-capsulated dental amalgamMdecine bucco-dentaire Amalgame dentaire en capsules prdosesINTERNATIONAL STANDARDISO20749First edition2017-03Reference num

5、berISO 20749:2017(E)BS ISO 20749:2017ISO 20749:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electr

6、onic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier,

7、 Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 20749:2017ISO 20749:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Requirements 34.1 Package and capsule contamination 34.2 Chemical composition and purity

8、of the dental amalgam alloy . 34.3 Large particles in the dental amalgam alloy powder . 34.4 Loss of mass from the capsule during mixing 34.5 The yield of amalgam from the capsule . 34.6 Consistency of the dental amalgam from capsule to capsule . 44.7 Properties of the dental amalgam 44.7.1 Creep 44

9、.7.2 Dimensional changes during hardening 44.7.3 Compressive strength at 1 h 44.7.4 Compressive strength at 24 h . 44.8 Appearance of the mixed dental amalgam before setting . 44.9 Length tolerance for the capsule . 45 Sampling 56 Test methods . 56.1 Package and capsule contamination 56.1.1 Principl

10、e 56.1.2 Test sample . 56.1.3 Apparatus . 56.1.4 Procedure . 56.1.5 Expression of the results . 56.1.6 Report 56.2 Chemical composition and purity of the dental amalgam alloy . 56.2.1 Principle 56.2.2 Test sample . 66.2.3 Apparatus . 66.2.4 Procedure . 66.2.5 Expression of results 66.2.6 Report 66.3

11、 Large particles in the dental amalgam alloy powder . 66.3.1 Principle 66.3.2 Test sample . 76.3.3 Apparatus . 76.3.4 Test procedure . 76.3.5 Expression of the results . 76.3.6 Report 76.4 Loss of mass from the capsule during mixing 86.4.1 Principle 86.4.2 Test sample . 86.4.3 Apparatus . 86.4.4 Tes

12、t procedure . 86.4.5 Expression of the results . 96.4.6 Report 96.5 Yield of amalgam from the capsule . 96.5.1 Principle 96.5.2 Test sample . 9 ISO 2017 All rights reserved iiiContents PageBS ISO 20749:2017ISO 20749:2017(E)6.5.3 Apparatus . 96.5.4 Test procedure 106.5.5 Expression of the results 106

13、.5.6 Report . 106.6 Consistency of the dental amalgam from capsule to capsule 106.6.1 Principle . 106.6.2 Test sample 116.6.3 Apparatus 116.6.4 Test-piece production .126.6.5 Microhardness measurement 136.6.6 Expression of the results 136.6.7 Report . 146.7 Properties of the dental amalgam . 146.7.1

14、 Principle 146.7.2 Sample 146.7.3 Mould for the preparation of cylindrical test-pieces for determining creep, dimensional change during hardening and compressive strength .146.7.4 Preparation of cylindrical test-pieces to determine compliance with the requirements for creep, dimensional change durin

15、g hardening and compressive strength 186.7.5 Determination of creep .206.7.6 Determination of dimensional change during hardening .216.7.7 Determination of compressive strength .226.8 Appearance of the mixed dental amalgam before setting 236.8.1 Principle . 236.8.2 Apparatus 246.8.3 Test procedure 2

16、46.8.4 Expression of the results 246.8.5 Report . 256.9 Length tolerance for the capsule 256.9.1 Principle . 256.9.2 Test sample 256.9.3 Apparatus 256.9.4 Test procedure 256.9.5 Expression of the results 256.9.6 Report . 257 Marking, labelling and packaging .267.1 Packaging 267.2 Marking and labelli

17、ng 267.2.1 Information 267.2.2 Labelling of a package for dental mercury .267.2.3 Labelling of the outer surface of package or container used for shipping 277.3 Manufacturers instructions . 277.3.1 General instructions.277.3.2 Precautionary notes .27Bibliography .28iv ISO 2017 All rights reservedBS

18、ISO 20749:2017ISO 20749:2017(E)ForewordISO (the International Organization for Standardization) 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 interes

19、ted 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 part in the work. ISO collaborates closely with the International Electrotechnical C

20、ommission (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 particular the different approval criteria needed for the different types of ISO document

21、s 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 this document may be the subject of patent rights. ISO shall not be held responsibl

22、e 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 .iso .org/ patents).Any trade name used in this document is information given fo

23、r the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles

24、in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. ISO 2017 All rights reserved vBS ISO 20749:2017ISO 20749:2017(E)IntroductionThis is the first

25、edition of this document. Its scope is limited solely to dental amalgam alloy and dental mercury that are supplied pre-capsulated in masses that are sufficient to produce a mass of dental amalgam that is considered to be suitable for a single small or medium size restoration in a single tooth.Dental

26、 amalgam alloy and dental mercury are the essential and only components of dental amalgam restorative material. This document 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 amalga

27、m, those for the capsules themselves and the requirements for packaging and marking.This document has been developed in response to the UNEP Minamata Convention on Mercury. The objective of the Minamata Convention is to reduce anthropogenic mercury pollution by restricting the use of mercury, produc

28、ts containing mercury and materials that release mercury during use. In this convention, dental amalgam is classified as a “mercury-added product”, for which parties to the agreement are to adopt two or more measures from a list of nine. One of these is “restricting the use of dental amalgam to its

29、encapsulated form”. In some countries, the term encapsulated has been interpreted as the pre-capsulated form alone. Given the increased vigilance on the use of dental amalgam products since 2013, when the Minamata Agreement was signed, this document will enable countries that do not allow the use of

30、 products other than those that are pre-capsulated to adopt an ISO standard on dental amalgam. Not all of the membership of the UN has signed the Minamata Convention and in non-signatory countries, dental amalgam products outside the scope of this document, but within the scope of ISO 24234, will co

31、ntinue to be marketed. Thus, both standards are required to provide full global coverage for compliance.Although this document is based on ISO 24234, there have been significant technical changes. Also, the requirements for the capsule that were in ISO 13897 have been transferred to this document, t

32、reating a product that falls within the scope as an entity. This document differs technically from ISO 24234 in the following respects: The scope of this document is restricted to pre-capsulated products alone. A requirement for packaging and capsule to be free from contamination is present. The req

33、uirement concerning foreign matter in the dental amalgam alloy powder has been removed. A requirement for loss of mass from the capsule during mixing has been added. A requirement for the yield of dental amalgam from a capsule replaces the requirement for the masses of dental mercury and dental amal

34、gam powder present before mixing. A requirement for the consistency in the ratio of dental mercury to dental amalgam alloy powder in capsules has been changed radically. Determination of the effect of variation in this ratio upon properties replaces weighing the dental mercury and the dental amalgam

35、 alloy powder. Requirements for the capsule have been introduced and revised technically.A decision was taken not to alter requirements upon which capsulation has no bearing, these being: the requirements on chemical composition and purity of the dental amalgam alloy; the requirements for the proper

36、ties of dental amalgam; the requirement for the appearance of dental amalgam before setting.As with ISO 24234, the inclusion of a requirement for corrosion resistance was considered. However, it was agreed that the data available were insufficient to set a corrosion resistance requirement in this ed

37、ition of this document. 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 amalgam product (relative to other dental amalgam products), reference can be made to ISO/TS 17988.vi IS

38、O 2017 All rights reservedBS ISO 20749:2017Dentistry Pre-capsulated dental amalgam1 ScopeThis document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creat

39、ion of a single dental restoration.This document specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging a

40、nd marking.This document is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.This document is not applicable to other metallic materials in which an alloy pow

41、der reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment o

42、f possible biological hazards, reference can be made to ISO 10993-1 and ISO 7405.The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free

43、-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requ

44、irements of this document. 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

45、of standard tolerance classes and limit deviations for holes and shaftsISO 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: Design principles for product safety labelsISO 6344-1, Coated

46、 abrasives Grain size analysis Part 1: Grain size distribution testISO 7488, Dental amalgamatorsISO 13565-2, Geometrical Product Specifications (GPS) Surface texture: Profile method; Surfaces having stratified functional properties Part 2: Height characterization using the linear material ratio curv

47、eISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsGlobally Harmonized System of Classification and Labelling of Chemicals (GHS). United Nations, New York and Geneva, 5th Revised Edition, 2013, ISBN 978-92

48、-1-117067-2INTERNATIONAL STANDARD ISO 20749:2017(E) ISO 2017 All rights reserved 1BS ISO 20749:2017ISO 20749:2017(E)UN Recommendations on the Transport of Dangerous Goods, Model Regulations. United Nations, New York and Geneva, 18th Edition, 2013, ISBN 978-92-1-193146-63 Terms and definitionsFor the

49、 purposes of this document, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp3.1dental amalgam alloyalloy in fine particles, composed mainly of silver, tin and copper, which, when mixed with dental mercury (3.2), produces a dental amalgam3.2dental mercurymercu