1、October 2008DEUTSCHE NORM English price group 14No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.20!$Rz“1472787w
2、ww.din.deDDIN EN ISO 11143Dentistry Amalgam separators (ISO 11143:2008)English version of DIN EN ISO 11143:2008-10Zahnheilkunde Amalgamabscheider (ISO 11143:2008)Englische Fassung DIN EN ISO 11143:2008-10SupersedesDIN EN ISO 11143:2002-12www.beuth.deDocument comprises 32 pagesDIN EN ISO 11143:2008-1
3、0 2 National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards
4、 Committee), Technical Committee NA 014-00-05 AA Zahnrztliche Ausrstung, Working Group NA 014-00-05-03 AK Amalgamabscheider. The DIN Standards corresponding to the International Standards referred to in the EN are as follows: ISO 1942 E DIN EN ISO 1942 ISO 3585 DIN ISO 3585 ISO 3696:1987 DIN ISO 369
5、6:1991-06 ISO 9687 DIN EN ISO 9687 ISO 24234:2004 DIN EN ISO 24234:2005-01 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 61010-1 DIN EN 61010-1 (VDE 0411-1) Amendments This standard differs from DIN EN ISO 11143:2002-12 as follows: a) The description of the test method has been improved. b) Specific s
6、eparator types are now to be tested at minimum flow rate. c) Requirements for marking have been updated. Previous editions DIN EN ISO 11143: 2000-04, 2002-12 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic
7、safety and essential performance DIN EN 61010-1 (VDE 0411-1), Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements E DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 9687, Dental equipment Graphical symbols DIN ISO 3585, Borosilicate g
8、lass 3.3 Properties DIN EN ISO 24234:2005-01, Dentistry Mercury and alloys for dental amalgam (ISO 24234:2004) DIN ISO 3696:1991-06, Water for analytical laboratory use Specification and test methods EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11143July 2008ICS 11.060.20 Supersedes EN ISO
9、11143:1999 English VersionDentistry - Amalgam separators (ISO 11143:2008)Art 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 Reg
10、ulations which stipulate the conditions for giving this EuropeanStandard the 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 E
11、uropean Standard exists in three official versions (English, French, German). 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 na
12、tional standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, 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
13、United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES 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 11143:20
14、08: EContents Page 5.2 5.4 5.5 5.6 7.1 8.2 8.3 8.5 9.7 9.8 9.9 9.10 9.11 12.2 12.3 DIN EN ISO 11143:2008-10 EN ISO 11143:2008 (E) 21 Scope . 6 3 Terms and definitions. 6 Foreword. 4 Introduction 5 2 Normative references . 6 4 Classification. 7 5 Requirements 8 Warning system for collecting container
15、 . 8 Alarm system for malfunction of amalgam separator 8 5.1 Efficiency . 8 5.3 Alarm system for collecting container . 8 Removal of removable filled collecting container. 8 5.7 Electrical safety. 9 6 Sampling 9 Maximum fillable volume of the removable collecting container 9 Set-up of test apparatus
16、. 9 7 Test apparatus 9 7.2 Installation of amalgam separator 10 8 Test sample . 12 Particle fraction sizes. 12 8.4 Particle fraction size distribution 12 8.1 Preparation of test sample. 12 Mass of dry test sample . 12 Preparation of test slurry . 14 8.5.2 Apparatus 14 8.5.1 Reagents 14 8.5.3 Procedu
17、re 14 9 Test method. 15 9.3 Efficiency test 15 9.1 General. 15 9.2 Preconditioning. 15 9.4 Number of tests. 18 9.6 Determination of efficiency 19 9.5 Calculation of efficiency 18 9.12 Electrical safety. 19 Removal of filled collecting container 19 Test of alarm system for malfunction of amalgam sepa
18、rator 19 Test of warning system for removable collecting container 19 Maximum fillable volume of the removable collecting container 19 Test of alarm system for removable collecting container 19 10 Test report . 20 11 Manufacturers instructions for installation, use, maintenance and service . 21 12.1
19、 General. 21 Marking of liquid inlet and outlet of the amalgam separator . 22 12 Marking 21 Marking of amalgam separator 22 12.4 Annex C (informative) Examination of particle fraction 3 using sedimentation with X-ray DIN EN ISO 11143:2008-10 EN ISO 11143:2008 (E) 3Marking of removable collecting con
20、tainer 22 Annex A (informative) Preparation of amalgam test sample . 23 Annex B (informative) Procedure for grinding the hardened amalgam 26 absorption 27 Annex D (informative) Particle fraction size distribution of amalgam in dental waste water. 29 Bibliography . 30 DIN EN ISO 11143:2008-10 EN ISO
21、11143:2008 (E) 4Foreword This document (EN ISO 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,
22、 either by publication of an identical text 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
23、 and/or CENELEC shall not be held responsible 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: A
24、ustria, Belgium, Bulgaria, Cyprus, Czech Republic, 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. Endors
25、ement notice The text of ISO 11143:2008 has been approved by CEN as a EN ISO 11143:2008 without any modification. Introduction 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
26、 of amalgam particles 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
27、 of an amalgam separator 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 particle
28、s in waste water 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 pr
29、eweighed filters. 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. DIN EN ISO 11143:2008-10 EN ISO 11143:2008 (E) 51 Scope This I
30、nternational 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 retention of amalgam based on a laboratory test and the test pr
31、ocedure 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 are type tests. 2 Normative references The following refe
32、renced 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, Dentistry Vocabulary ISO 3585, Borosilicate glass 3.3 Pro
33、perties 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 equipment Part 1: General requirements for basic safety and esse
34、ntial 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 in ISO 1942 and ISO 24234 and the following apply. 3.1
35、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 sewage system DIN EN ISO 11143:2008-10 EN ISO 11143:2008 (E)
36、63.2 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 unit and the dental chair combination, which enable the dentist to perform
37、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 collecting capacity of the removable collecting container of the amalgam separator
38、 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 an amalgam separator system capacity of the collecting container and those
39、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 for treated effluent, a flow restrictor, or water venturi 3.7 warning level l
40、evel, 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 an adverse condition likely to cause reduction of efficiency if unattended
41、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 of this International Standard, amalgam separator systems are classified acco
42、rding 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 amalgam separators, irrespective of whether the amalgam separator is include
43、d in every dental treatment centre or built as a central amalgam separator for one or several dental treatment centres. DIN EN ISO 11143:2008-10 EN ISO 11143:2008 (E) 75 Requirements 5.1 Efficiency The efficiency of the amalgam separator shall be at least 95 % (mass fraction). The determination of t
44、he 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 separator shall include a warning system to indicate the degree of filling at which the collecting conta
45、iner 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 procedur
46、es by which the proper function of the amalgam separator is ensured, giving controllable maintenance and recovery procedures as in 11.2. Compliance shall be tested by visual inspection. 5.3 Alarm system for collecting container The amalgam separator shall include an alarm system to indicate that the
47、 collecting container has reached the maximum filling level, as specified by the manufacturer, at which the amalgam separator can perform to the specified efficiency. The alarm signal shall be activated at the maximum fillable volume. The alarm signal shall remain activated until the collecting cont
48、ainer and/or filter has been emptied or replaced. Test in accordance with 9.8. For Type 2 amalgam separators, the requirement for the alarm system can be met if the manufacturer clearly defines procedures by which the proper function of the amalgam separator is ensured, giving controllable maintenan
49、ce and recovery procedures as in 11.2. Compliance shall be tested by visual inspection. 5.4 Alarm system for malfunction of amalgam separator Malfunction of amalgam separators of Types 1 and 4, but only if Type 4 includes centrifugal systems, shall be indicated by activation of an alarm system. It shall not be possible to inactivate signals during use until the malfunction is corrected. Test in accordance with 9.9. 5.5 Removal of removable filled collecting container The removable filled collecting container shall be capable of bein
