EN ISO 7488-2018 Dentistry - Mixing machines for dental amalgam.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Mixing machines for dental amalgamBS EN ISO 7488:2018National forewordThis British Standard is the UK implementation of EN ISO 7488:2018. It is identical to ISO 7488:2018. It supersedes BS EN ISO 7488:1996,

2、which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on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

3、provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 90204 8ICS 11.060.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was pub

4、lished under the authority of the Standards Policy and Strategy Committee on 30 June 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 7488:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 7488May 2018ICS 11.060.20 Supersedes EN ISO 7488:1995EURO

5、PEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 7488:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDenti

6、stry - Mixing machines for dental amalgam (ISO 7488:2018)Mdecine bucco-dentaire - Mlangeurs pour amalgame dentaire (ISO 7488:2018)Zahnheilkunde - Mischgerte fr zahnrztliches Amalgam (ISO 7488:2018)This European Standard was approved by CEN on 15 March 2018.CEN members are bound to comply with the CE

7、N/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-CENELEC Management Ce

8、ntre 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 same status as th

9、e 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, Luxembourg, Malta, Netherl

10、ands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 7488:2018 (E)European forewordThis document (EN ISO 7488:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Techni

11、cal 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, either by publication of an identical text or by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at

12、the latest by November 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 7488:1995.According to the CEN-CENELEC Int

13、ernal Regulations, the national 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,

14、Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 7488:2018 has been approved by CEN as EN ISO 7488:2018 without any modificatio

15、n.iiBS EN ISO 7488:2018ISO 7488:2018Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Safety . 24.1.1 Electrical . 24.1.2 Mechanical 24.2 Stability 24.3 Sound pressure . 34.4 Frequency 34.4.1 General 34.4.2 Variable-power machines 34.5 Amplitu

16、de 34.6 Mixing time. 34.6.1 Timing device . 34.6.2 Timing settings 34.7 Coherence time . 44.8 Long-term test . 45 Sampling 45.1 Mixing machine 45.2 Mixing-capsules 45.2.1 General 45.2.2 Mixing-capsule selection . 45.3 Test components . 56 Measurement and test methods . 56.1 Test conditions 56.1.1 Ge

17、neral 56.1.2 Reference charge mass, mref. 56.1.3 Minimum charge mass, mmin. 56.1.4 Maximum charge mass, mmax56.1.5 Maximum running duration, tmax56.1.6 Power supply conditions and apparatus . 56.1.7 Equipment setup 66.2 Visual inspection . 66.3 Sound pressure . 66.3.1 Apparatus and setup. 66.3.2 Pro

18、cedure . 76.3.3 Variable-power machines 76.4 Frequency tests . 76.4.1 Measurement of mixing-capsule oscillation frequency 76.5 Working length . 86.5.1 Principle 86.5.2 Apparatus . 86.5.3 Procedure . 86.6 Amplitude 86.6.1 Apparatus . 86.6.2 Procedure . 86.7 Mixing time. 96.7.1 Apparatus . 96.7.2 Proc

19、edure . 9 ISO 2018 All rights reserved iiiContents PageBS EN ISO 7488:2018ISO 7488:20186.8 Coherence time . 96.8.1 Apparatus and materials . 96.8.2 Procedure . 96.9 Long-term test 107 Instructions for use 117.1 General 117.2 Identification . 117.3 Safety 117.4 User maintenance 117.5 Other maintenanc

20、e . 117.6 Mixing-capsule requirements . 117.7 Mixing-capsule amplitude 117.8 Operational limitations . 117.8.1 Mixing machine limitations . 117.8.2 Mass and frequency 128 Packaging 129 Marking .129.1 On the mixing-machine . 129.2 On the packaging 12Bibliography .13iv ISO 2018 All rights reservedBS E

21、N ISO 7488:2018ISO 7488:2018ForewordISO (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 interested

22、 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 Comm

23、ission (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 documents s

24、hould 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 responsible for

25、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 for the con

26、venience 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 in the Te

27、chnical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.This second edition cancels and replaces the first edition (ISO 7488:1991), which has been technically rev

28、ised.The main changes compared to the previous edition are as follows: clarification of the scope; deletion of the classification (according to frequency); addition of the requirements for the maximum sound pressure level in 4.3; addition of measurement and test methods; ISO 2018 All rights reserved

29、 vBS EN ISO 7488:2018ISO 7488:2018IntroductionThe mixing performance requirement in this document is based on the concept of coherence time. This arises because it is not possible to define precisely just what constitutes a “clinically usable” mix, this being a subjective and vague value judgment. I

30、t is to be noted that the readily identifiable stage in the mixing process designated coherence is an intermediate stage and is an indication that satisfactory mixing is occurring. A “clinically usable” amalgam mix or other material mix cannot be obtained unless coherence is first achieved. A “clini

31、cally usable” mix generally requires mixing further to that required for coherence.The scope is intended in due course to include machines for mixing material other than dental amalgam, such as cements. However, the relevant information is not yet to be available, and all mixing related references i

32、n this document are in respect of dental amalgam. The scope will be extended to include capsulated cements as soon as suitable data become available and consequential additions will be included in the requirements and test methods.vi ISO 2018 All rights reservedBS EN ISO 7488:2018Dentistry - Mixing

33、machines for dental amalgam1 ScopeThis document specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam.This document specifies the test methods used to determine conformity with these requirements.This

34、 document refers to those machines that mix by an oscillating action and which are sold by the manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing any other type of product.This document does not specify requirements for removable mixing-capsules, as are

35、 used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For da

36、ted references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyIEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC

37、61671-1:2013, Electroacoustics Sound level meters Part 1: Specifications3 Terms and definitionsFor the 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: I

38、EC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1coherencecondition of the powder and liquid having been combined into a single massNote 1 to entry: Small cracks or a dry-looking surface do not detract from coherence.3.2coh

39、erence timetime taken for mixing all powder and liquid to achieve coherenceNote 1 to entry: The mix produced for the purposes of this definition is not necessarily mixed to the degree necessary for clinical use.INTERNATIONAL STANDARD ISO 7488:2018 ISO 2018 All rights reserved 1BS EN ISO 7488:2018ISO

40、 7488:20183.3length to amplitude ratioratio of mixing-capsule working length (3.5) to mixing-capsule amplitude (3.4) of its motionNote 1 to entry: Length to amplitude ratio is the principal (non-monotonic) determinant of the efficiency of the mixing process.3.4mixing-capsule amplituderange of moveme

41、nt of the midpoint of the mixing capsule while running measured in the direction of the mixing-capsule working length (3.5)3.5mixing-capsule working lengthmaximum internal dimension of the mixing capsule lying parallel to the direction of the oscillatory motion3.6mixing machine for dental amalgamele

42、ctrically-powered devices for mixing by an oscillating action dental amalgam alloy and dental mercury in capsules to produce dental amalgam3.7power ratingcube of oscillation frequency, expressed in hertz, multiplied by the square of the mixing-capsule amplitude (3.4), expressed in metresNote 1 to en

43、try: Power rating is proportional to the maximum power available for the mixing process, but is not in itself a measure or determinant of efficiency or efficacy.Note 2 to entry: See Formula (1). Power rating is expressed in mW/g.4 Requirements4.1 Safety4.1.1 ElectricalThe mixing machine for dental a

44、malgam shall be in accordance with the relevant clauses of IEC 60601-1.4.1.2 MechanicalThe mixing machine for dental amalgam shall have an enclosure that will contain a mixing-capsule, its contents or a machine part that may become dislodged or broken during use.Movable components with which the use

45、r may normally be expected to come into contact shall be free from rough or sharp edges and corners.Test in accordance with 6.2.4.2 StabilityThe mixing machine for dental amalgam shall not visibly move across the glass surface while running for the maximum running duration, tmax(6.1.5), using the ma

46、ximum charge mass, mmax(6.1.4) at any frequency setting.Test in accordance with 6.1 and 6.2.2 ISO 2018 All rights reservedBS EN ISO 7488:2018ISO 7488:20184.3 Sound pressureThe acoustic power output of the mixing machine for dental amalgam shall not exceed 70 dB(A).Test in accordance with 6.3.4.4 Fre

47、quency4.4.1 GeneralThe frequency of operation of the mixing machine shall not vary by more than 0,5 Hz at any frequency setting during any run of duration tmax(6.1.5) for that setting when subjected individually to each of the following:a) supply voltage variation of 5 % of the rated voltage, or if

48、a supply voltage range is given, variation of the voltage over the stated range, using the reference charge mass, mref(6.1.2);b) variation of the charge mass, using the minimum and maximum charge, mmin(6.1.3) and mmax(6.1.4);c) three immediately successive mixing operations, using the reference char

49、ge mass, mref(6.1.2);d) variation of the ambient temperature over the range 18 C to 28 C, using the reference charge mass, mref(6.1.2).Test in accordance with 6.4.1.4.4.2 Variable-power machinesAt any frequency or power setting, variable-power machines shall operate within 5 % of the indicated frequency, if given, with a reproducibility of 0,5 Hz, and shall also conform to the requirements of 4.4.1 at each setting.Test in accordance with 6.4.1.3.4.5 AmplitudeThe mixing-capsule amplitude shall remain stable to 1 mm while the machine is r