BS EN ISO 7488-1996 Dental amalgamators《牙科用混汞器》.pdf

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1、BRITISH STANDARD BS EN ISO 7488:1996 Dental amalgamators The European Standard EN ISO7488:1995 has the status of a BritishStandard ICS 11.060.20BSENISO7488:1996 This BritishStandard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityo

2、f the Standards Boardand comes into effect on 15June1996 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference CH/60 Draft for comment 88/54058 DC ISBN 0 580 25680 4 Committees responsible for this BritishStandard The preparation of this BritishStandard wa

3、s entrusted to Technical Committee CH/60, Dental equipment, upon which the following bodies were represented: Association of British Healthcare Industries British Dental Association British Dental Trade Association British Society for Restorative Dentistry Department of Health Institute of Physics W

4、ater Research Centre Amendments issued since publication Amd. No. Date CommentsBSENISO7488:1996 BSI 01-2000 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Introduction 3 1 Scope 3 2 Normative reference 3 3 Definitions 3 4 Classification 3 5 Requirements 3 6

5、 Sampling 4 7 Test methods 4 8 Instructions for use 5 9 Packaging 6 10 Marking 6 List of references Inside back coverBSENISO7488:1996 ii BSI 01-2000 National foreword This BritishStandard has been prepared by Technical Committee CH/60 and is the English language version of EN ISO7488:1995 Dental ama

6、lgamators, published by the European Committee for Standardization (CEN). It is identical with ISO7488:1991 published by the International Organization for Standardization (ISO). EN ISO7488 was produced as a result of international discussion in which the United Kingdom took an active part. A Britis

7、h Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-references Publication referred to Correspo

8、nding BritishStandard IEC 335-1:1976 BS 3456 Specification for safety of household and similar electrical appliances Part 101:1987 General requirements Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theENISO title page, pages2 to6, an inside back cover a

9、nd a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7488 October 1995 ICS 11.060.20 Descriptors: Dentistry, dent

10、al equipment, dental amalgamators, classification, specifications, tests, packaging, marking English version Dental amalgamators (ISO 7488:1991) Amalgamateurs dentaires (ISO 7488:1991) Zahnrztliche Amalgamatoren (ISO 7488:1991) This European Standard was approved by CEN on1995-10-04. CEN members are

11、 bound to comply 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 t

12、he Central Secretariat 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 Central Secretariat has the same sta

13、tus as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CEN European Committee for Standardization Com

14、it Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1995 All rights of reproduction and communication in any form and by any means reserved in all countries to CEN and its members. Ref.No.ENISO7488:1995EENISO7488:1995 BSI 01-2000 2 Fore

15、word The text of the International Standard from ISO/TC106, Dentistry, of the International Organization for Standardization (ISO) has been taken over as a European Standard by the Technical Committee CEN/TC55, Dentistry. This European Standard shall be given the status ofa national standard, either

16、 by publication of anidentical text or by endorsement, at the latest by April1996, and conflicting national standards shall be withdrawn at the latest by April1996. According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belg

17、ium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.ENISO7488:1995 BSI 01-2000 3 Introduction Electrically powered amalgamators are machines used primarily for mixing (trituration) of a

18、malgam alloys and mercury to produce dental amalgams but they may also be used for mixing other dental materials. In many amalgamators a removable capsule is used to contain the alloy and mercury. Although the capsule must be considered as part of the amalgamator when in use or under test, the requi

19、rements for capsules are not dealt with in this International Standard; they may be the subject of a separate Standard. Some amalgamators may incorporate a mechanism for dispensing the alloy or mercury or both. These devices may be subjected to the test in this International Standard except for the

20、dispensing stage. 1 Scope This International Standard specifies requirements, test methods to determine compliance with these requirements and details of marking of electrically powered mixing amalgamators suitable for mixing dental amalgam alloy and mercury for dental amalgams. It provides methods

21、of comparing uniformity of operation and performance of these amalgamators and is intended to ensure reproducibility of amalgamation. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the t

22、ime of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintai

23、n registers of currently valid International Standards. IEC 335-1:1976, Safety of household and similar electrical appliances Part1: General requirements. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 coherence state when all the alloy and the me

24、rcury are combined in a single unified mass NOTE 1Small cracks or a dry looking surface do not detract from coherence. 3.2 working length of capsule maximum internal dimension lying parallel to the direction of the greatest motion or, where uniform circular motion applies, the greatest internal dime

25、nsion parallel to a principal axis of the capsule in the plane of motion when the capsule is in its normal working or “activated” configuration 3.3 amplitude of capsule motion range of movement, in millimetres, of the midpoint of the capsule while running, measured in the direction of the working le

26、ngth 4 Classification Amalgamators are classified as follows: Type 1: Fixed frequency Type 2: Variable frequency 5 Requirements 5.1 Electrical safety Amalgamators shall comply as regards the electrical requirements and the testing with the relevant clauses of IEC335-1. NOTE 2Compliance with IEC335-1

27、 is required pending development and publication of IEC requirements for laboratory and related equipment. 5.2 Mechanical safety 5.2.1 The amalgamator shall have an enclosure that will contain a capsule, its contents, or a machine part that may become dislodged or broken during use. 5.2.2 Moving par

28、ts with which the user may normally be expected to come into contact shall be free from rough or sharp edges and corners. 5.2.3 In addition, the following requirements shall apply. a) During normal operation, insertion, or removal, the capsule shall not be damaged in such a way as to allow leakage o

29、f mercury. b) The capsule shall be securely and firmly retained during operation of the amalgamator at the highest power recommended by the manufacturer seeclause8 e). c) The position of the capsule shall be definite and reproducible. Testing shall be carried out in accordance with7.2.ENISO7488:1995

30、 4 BSI 01-2000 5.3 Capsule oscillation frequency 5.3.1 General The operating frequency of the amalgamator shall not vary by more than2Hz at any frequency setting during any run of not less than15 s or the maximum duration recommended by the manufacturer for that setting when subjected individually t

31、o each of the following: a) variation of the supply voltage by 5% of the rated voltage, or if a supply voltage range is given, variation of the voltage throughout the stated range; b) variation of the mass of the capsule and contained alloy and mercury within the range recommended by the manufacture

32、r; c) three immediately successive mixing operations for the maximum duration recommended by the manufacturer. Testing shall be carried out in accordance with7.3. 5.3.2 Variable frequency amalgamators At any frequency or power setting, variable amalgamators shall operate within 1mm while the machine

33、 is running for the maximum duration recommended by the manufacturer. Testing shall be carried out in accordance with7.3. 5.4 Amplitude of capsule motion The amplitude shall remain stable to 1mm while the machine is running for the maximum duration recommended by the manufacturer. Testing shall be c

34、arried out in accordance with7.4. 5.5 Timing control 5.5.1 Timing device Machines shall be provided with a timing device to allow selection and control of the duration of mixing. 5.5.2 Timing settings The timing device may provide continuously variable settings or settings in steps. The intervals pr

35、oduced shall be accurate to5% of the nominal value of the setting or 0,5s whichever is the larger: the intervals shall also be reproducible within 2% of the actual value of the setting or 0,2 s whichever is the larger. These provisions shall further apply when the machine is subjected individually t

36、o supply voltage variation of5% at the rated voltage, or if a supply voltage range is given, variation of the voltage over the stated range. Testing shall be carried out in accordance with7.5. 5.6 Coherence The amalgamator shall operate in a manner that will cause the amalgam to display coherence in

37、 any and all capsules and alloys, recommended for use by the manufacturer, in less time than the manufacturer recommends for trituration. Testing shall be carried out in accordance with7.2. 5.7 Stability While running for the maximum duration recommended by the manufacturer at any frequency setting,

38、 the machine shall not move more than5mm across the glass surface. Testing shall be carried out in accordance with7.2. 6 Sampling The test office shall procure its test sample devices including amalgamator, capsule and alloys for testing independently. Product names, descriptions and batch numbers s

39、hall be recorded. 7 Test methods 7.1 Test conditions 7.1.1 General Put the amalgamator on a tray to prevent spillage of mercury and test it at(23 2) C. The amalgamator shall have in position a capsule recommended by the manufacturer. The capsule shall contain(600 2,5)mg of any fine grain amalgam all

40、oy powder. No pestle shall be used. The amalgamator shall be placed on a rigidly supported, smooth, flat, horizontal glass surface, using any of the bases or supports recommended by the manufacturer. 7.1.2 Power supply The power supply shall be stabilized to1% of the rated voltage of the machine. If

41、 a supply voltage range is given, then control shall be 1% of the midpoint of the stated range, or 1% of nominal test voltage as appropriate. A record of supply frequency and voltage shall be maintained. If a supply frequency variation more than 0,1Hz or a voltage more than the limit cause the machi

42、ne under test to fail, the results shall be discarded and the test rerun. 7.2 Visual inspection Visually inspect to determine compliance with the specifications of this International Standard. 7.3 Capsule oscillation frequency 7.3.1 Apparatus A suitable “non-contact” means of determining oscillation

43、 frequency is needed.ENISO7488:1995 BSI 01-2000 5 7.3.2 Procedure Do not operate the machine for at least2h before the oscillation frequency tests are conducted according to5.3. 7.3.2.1 Fixed frequency amalgamators Determine the operating frequency of the triturator of the amalgamator under the cond

44、itions outlined in7.1. Exclude the first1s of running for measurement purposes in all tests. The test shall be carried out three times. The average of three determinations shall establish the frequency. 7.3.2.2 Variable frequency machines Determine the trituration frequency of the amalgamator under

45、the conditions outlined in7.1. Test only three points in the range, the two extremes and one setting close to the midpoint of thetrituration frequency range. Make a total of fivedeterminations at each point in alternately ascending and descending sequences, viz.:1,2,3,3,2. and such as to approach th

46、e set point from alternating directions where the device permits. In the case of continuously variable controls, interpret the extremes of the range as the extreme points which are calibrated or bear index marks. Do not employ the limits of travel of the control unless they are so calibrated. Take t

47、he mean of the five determinations rounded to the nearest0,1Hz as indicating the actual value at each setting. Determine the accuracy by the difference between the actual and nominal values of the setting. Determine compliance with the reproducibility requirement by comparison of each recorded value

48、 with the limits stated(5.3.2) referred to the actual value of the setting rounded to the nearest0,1Hz. 7.4 Amplitude of capsule motion 7.4.1 Apparatus The following apparatus is needed: a) lamp providing strong continuous illumination, e.g.tungsten filament lamp; b) measuring device to determine th

49、e distance between the end points of the capsule motion, e.g.vernier caliper gauge, cathetometer, or calibrated photographic system. 7.4.2 Procedure Mark the approximate midpoint of the capsule in its normal working configuration, viewed in a direction perpendicular to the measured working length. Mount the capsule containing(600 2,5)mg of alloy powder so that the mark is at the mean radius of movement or otherwise such as to obtain a measurement of amplitude as given in3.3. Start the machine and, under strong illumination7.4.1 b), determine the dis