EN ISO 11143-2008 en Dentistry - Amalgam separators《牙科 汞合金分离器》.pdf

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1、BS EN ISO11143:2008ICS 11.060.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Amalgamseparators (ISO11143:2008)This British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30September 2008 BSI 2008ISBN 978 0 5

2、80 58161 8Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 11143:2008National forewordThis British Standard is the UK implementation of EN ISO 11143:2008.It is identical to . It supersedes BS EN ISO 11143:2000 which iswithdrawn.In the United Kingdom, Statutory Instrument and Legi

3、slation controlthe installation of all water fittings, hereafter referred to as the WaterSupply (Water Fittings) Regulations 1999. Therefore, it is a legalrequirement for all plumbing installations installed in England andWales after 1 July 1999 to comply with the requirements of the WaterSupply (Wa

4、ter Fittings) Regulations 1999. Similarly, all installationsinstalled in Scotland after 4 April 2000 will need to comply with theWater Byelaws 2000, now the Scottish Water Byelaws 2004. Similarlegislation covers Northern Ireland; particular attention should be givento Regulation/Byelaw 5.The UK part

5、icipation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users a

6、re responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11143July 2008ICS 11.060.20 Supersedes EN ISO 11143:1999 English VersionDentistry - Amalgam separators (ISO 11143:2008)Art

7、dentaire - Sparateurs damalgame (ISO 11143:2008) Zahnheilkunde - Amalgamabscheider (ISO 11143:2008)This European Standard was approved by CEN on 21 June 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the

8、status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German).

9、 A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic

10、, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALI

11、SATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11143:2008: EBS EN ISO 11143:2008EN ISO 11143:2008 (E) 3 Foreword This document (EN I

12、SO 11143:2008) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical 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

13、or by endorsement, at the latest by January 2009, and conflicting national standards shall be withdrawn at the latest by January 2009. Attention is drawn 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 responsibl

14、e for identifying any or all such patent rights. This document supersedes EN ISO 11143:1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Rep

15、ublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11143:2008 has

16、been approved by CEN as a EN ISO 11143:2008 without any modification. BS EN ISO 11143:2008ISO 11143:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Classification. 2 5 Requirements 3 5.1 Efficienc

17、y . 3 5.2 Warning system for collecting container . 3 5.3 Alarm system for collecting container . 3 5.4 Alarm system for malfunction of amalgam separator 3 5.5 Removal of removable filled collecting container. 3 5.6 Maximum fillable volume of the removable collecting container 4 5.7 Electrical safet

18、y. 4 6 Sampling 4 7 Test apparatus 4 7.1 Set-up of test apparatus. 4 7.2 Installation of amalgam separator 5 8 Test sample . 7 8.1 Preparation of test sample. 7 8.2 Particle fraction sizes. 7 8.3 Mass of dry test sample . 7 8.4 Particle fraction size distribution 7 8.5 Preparation of test slurry . 9

19、 8.5.1 Reagents 9 8.5.2 Apparatus 9 8.5.3 Procedure 9 9 Test method. 10 9.1 General. 10 9.2 Preconditioning. 10 9.3 Efficiency test 10 9.4 Number of tests. 13 9.5 Calculation of efficiency 13 9.6 Determination of efficiency 14 9.7 Test of warning system for removable collecting container 14 9.8 Test

20、 of alarm system for removable collecting container 14 9.9 Test of alarm system for malfunction of amalgam separator 14 9.10 Removal of filled collecting container 14 9.11 Maximum fillable volume of the removable collecting container 14 9.12 Electrical safety. 14 10 Test report . 15 11 Manufacturers

21、 instructions for installation, use, maintenance and service . 16 12 Marking 16 12.1 General. 16 12.2 Marking of amalgam separator 17 12.3 Marking of liquid inlet and outlet of the amalgam separator . 17 BS EN ISO 11143:2008ISO 11143:2008(E) iv ISO 2008 All rights reserved12.4 Marking of removable c

22、ollecting container 17 Annex A (informative) Preparation of amalgam test sample . 18 Annex B (informative) Procedure for grinding the hardened amalgam 21 Annex C (informative) Examination of particle fraction 3 using sedimentation with X-ray absorption 22 Annex D (informative) Particle fraction size

23、 distribution of amalgam in dental waste water. 24 Bibliography . 25 BS EN ISO 11143:2008ISO 11143:2008(E) ISO 2008 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing

24、 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 to be represented on that committee. International organizations, governmental and non-governmental, in liais

25、on with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of te

26、chnical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is dr

27、awn 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. ISO 11143 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. This secon

28、d edition cancels and replaces the first edition (ISO 11143:1999) which has been technically revised by means of the following changes: a) the description of the test method has been improved; b) testing at a minimum flow rate for certain types of separator is now required; c) updated labelling requ

29、irement has been introduced. BS EN ISO 11143:2008ISO 11143:2008(E) vi ISO 2008 All rights reservedIntroduction Amalgam separators are items of dental equipment designed to retain amalgam particles carried by the waste water from the dental treatment centre, so as to reduce the number of amalgam part

30、icles and therefore the mass of amalgam entering the sewage system. Separation of the amalgam particles may be effected by the use of a centrifuge, sedimentation, filtration, or a combination of any of these methods. It is recognised that the test sample used to assess the efficiency of an amalgam s

31、eparator should have a particle size distribution which reflects the actual situation in dental treatment centres. The test sample used in this International Standard is based on investigations that have been carried out to determine the particle size distribution of amalgam particles in waste water

32、 from dental treatment centres (see Annex D). The principle of the test is that the effluent water from the amalgam separator is collected in a vessel. The collected effluent water, containing amalgam particles not retained by the amalgam separator, is filtered through a series of preweighed filters

33、. The filters, with the amalgam particles collected on them, are dried to a constant weight in a desiccator at room temperature and the total mass of collected particles is measured to determine the collection efficiency. BS EN ISO 11143:2008INTERNATIONAL STANDARD ISO 11143:2008(E) ISO 2008 All righ

34、ts reserved 1Dentistry Amalgam separators 1 Scope This International Standard specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retenti

35、on of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, and for instructions for use, operation and maintenance. All tests described in this International Standard a

36、re type tests. 2 Normative references The following referenced documents are indispensable for the application 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 1942, D

37、entistry Vocabulary ISO 3585, Borosilicate glass 3.3 Properties ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 9687, Dental equipment Graphical symbols ISO 24234:2004, Dentistry Mercury and alloys for dental amalgam IEC 60601-1:2005, Medical electrical equipmen

38、t Part 1: General requirements for basic safety and essential performance IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given

39、 in ISO 1942 and ISO 24234 and the following apply. 3.1 amalgam separator item of dental equipment designed to remove amalgam particles from the waste water from the dental treatment centre, so as to reduce the number of amalgam particles and therefore the mass (amount) of amalgam entering the sewag

40、e system BS EN ISO 11143:2008ISO 11143:2008(E) 2 ISO 2008 All rights reserved3.2 collecting container integrated part of the amalgam separator for retention of separated amalgam waste for the purpose of recovery 3.3 dental treatment centre combination of units consisting, as a minimum, of the dental

41、 unit and the dental chair combination, which enable the dentist to perform patient therapy 3.4 efficiency of amalgam separator mass percentage of the specified test sample retained by the amalgam separator 3.5 maximum fillable volume level or volume defined by the maximum waste solids/sludge collec

42、ting capacity of the removable collecting container of the amalgam separator at which the efficiency is unaffected NOTE For the purposes of conducting these tests the maximum fillable volume is 95 % of the maximum solids/sludge collecting capacity of the removable collecting container. 3.6 volume of

43、 an amalgam separator system capacity of the collecting container and those cavities that are integral to the collecting container and/or to the operation of the collecting container, including, but is not limited to, air-water separator tanks or cavities that support or incorporate an outlet port f

44、or treated effluent, a flow restrictor, or water venturi 3.7 warning level level, below the maximum fillable volume, at which the collecting container should be emptied or replaced 3.8 warning signal auditory or visual sign, signal and/or other kind of indicator, or a combination thereof, indicating

45、 an adverse condition likely to cause reduction of efficiency if unattended 3.9 alarm signal auditory or visual sign, signal and/or other kind of indicator, or a combination thereof, indicating an adverse condition affecting the efficiency of the amalgam separator 4 Classification For the purposes o

46、f this International Standard, amalgam separator systems are classified according to the method of separation into the following types: Type 1: centrifugal system Type 2: sedimentation system Type 3: filter system Type 4: any combination of Types 1, 2 and 3. This classification is applicable to all

47、amalgam separators, irrespective of whether the amalgam separator is included in every dental treatment centre or built as a central amalgam separator for one or several dental treatment centres. BS EN ISO 11143:2008ISO 11143:2008(E) ISO 2008 All rights reserved 35 Requirements 5.1 Efficiency The ef

48、ficiency of the amalgam separator shall be at least 95 % (mass fraction). The determination of the efficiency shall be carried out under empty and full conditions for all types of amalgam separators. Test in accordance with 9.1 to 9.6. 5.2 Warning system for collecting container The amalgam separato

49、r shall include a warning system to indicate the degree of filling at which the collecting container should be emptied or replaced. The warning signal shall be activated at the warning level and before the maximum fillable volume is reached. Test in accordance with 9.7. For Type 2 amalgam separators, the requirement for the warning system can be met if the manufacturer clearly defines procedures by which the proper function of the amalgam separator is ensured, giving controllable maintenance and recovery procedures as in 11.