DIN EN ISO 11143-2008 Dentistry - Amalgam separators (ISO 11143 2008) English version of DIN EN ISO 11143 2008-10《牙科 汞合金分离器》.pdf
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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
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