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1、BS EN ISO 11143:2008 ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Dentistry Amalgam separators (ISO 11143:2008) Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI This British Stand
2、ard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2008 BSI 2008 ISBN 978 0 580 58161 8 Amendments/corrigenda issued since publication DateComments BS EN ISO 11143:2008 National foreword This British Standard is the UK implementation of EN ISO 11143:
3、2008. It is identical to . It supersedes BS EN ISO 11143:2000 which is withdrawn. In the United Kingdom, Statutory Instrument and Legislation control the installation of all water fittings, hereafter referred to as the Water Supply (Water Fittings) Regulations 1999. Therefore, it is a legal requirem
4、ent for all plumbing installations installed in England and Wales after 1 July 1999 to comply with the requirements of the Water Supply (Water Fittings) Regulations 1999. Similarly, all installations installed in Scotland after 4 April 2000 will need to comply with the Water Byelaws 2000, now the Sc
5、ottish Water Byelaws 2004. Similar legislation covers Northern Ireland; particular attention should be given to Regulation/Byelaw 5. 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 co
6、mmittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed Copy: London Sou
7、th Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11143 July 2008 ICS 11.060.20Supersedes EN ISO 11143:1999 English Version Dentistry - Amalgam separators (ISO 11143:2008) Art dentaire - Sparateurs damalga
8、me (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 European Standard the status of a national standa
9、rd without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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). A version in any other l
10、anguage made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Fi
11、nland, 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES
12、 KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11143:2008: E Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52,
13、Uncontrolled Copy, (c) BSI BS EN ISO 11143:2008 EN ISO 11143:2008 (E) 3 Foreword 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 St
14、andard shall be given the status of a national standard, 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 o
15、f this document may be the subject of patent rights. CEN 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 co
16、untries are bound to implement this European Standard: 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, S
17、pain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11143:2008 has been approved by CEN as a EN ISO 11143:2008 without any modification. Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2
18、008 ISO 11143:2008(E) ISO 2008 All rights reserved iii Contents 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 Efficiency. 3 5.2 Warning system for collecting container. 3 5.3 Alarm system for collecting con
19、tainer . 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 safety. 4 6 Sampling 4 7 Test apparatus 4 7.1 Set-up of test apparatus. 4 7.2 Installation of
20、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 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
21、 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 of alarm system for removable collecting container 14 9.9 Test of alarm system for malfunc
22、tion 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 instructions for installation, use, maintenance and service . 16 12 Marking 16 12.1 Genera
23、l. 16 12.2 Marking of amalgam separator 17 12.3 Marking of liquid inlet and outlet of the amalgam separator . 17 Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2008 ISO 11143:2008(E) iv ISO 2008 All rights reserved 12.
24、4 Marking of removable collecting container17 Annex A (informative) Preparation of amalgam test sample .18 Annex B (informative) Procedure for grinding the hardened amalgam21 Annex C (informative) Examination of particle fraction 3 using sedimentation with X-ray absorption22 Annex D (informative) Pa
25、rticle fraction size distribution of amalgam in dental waste water.24 Bibliography .25 Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2008 ISO 11143:2008(E) ISO 2008 All rights reserved v Foreword ISO (the Internationa
26、l 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 in a subject for which a technical committee has been es
27、tablished 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 Commission (IEC) on all matters of electrotechnical standardi
28、zation. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for vot
29、ing. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 identifying any or all suc
30、h patent rights. ISO 11143 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. This second 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
31、method has been improved; b) testing at a minimum flow rate for certain types of separator is now required; c) updated labelling requirement has been introduced. Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2008 ISO
32、11143:2008(E) vi ISO 2008 All rights reserved 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 of amalgam particles and therefore the mass of amalgam entering the
33、 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 separator should have a particle size distribution wh
34、ich 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 from dental treatment centres (see Annex D). The pr
35、inciple 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. The filters, with the amalgam particles collected
36、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. Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2
37、008 INTERNATIONAL STANDARD ISO 11143:2008(E) ISO 2008 All rights reserved 1 Dentistry 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 effici
38、ency of the amalgam separators in terms of the level of retention 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 ma
39、intenance. All tests described in this International Standard are 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 refe
40、renced document (including any amendments) applies. ISO 1942, Dentistry 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 f
41、or dental amalgam IEC 60601-1:2005, Medical electrical equipment 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
42、 the purposes of this document, the terms and definitions given 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 particle
43、s and therefore the mass (amount) of amalgam entering the sewage system Licensed Copy: London South Bank University, South Bank University, 16/11/2008 11:52, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2008 ISO 11143:2008(E) 2 ISO 2008 All rights reserved 3.2 collecting container integrated part of t
44、he 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 patient therapy 3.4 efficiency of amalgam sepa
45、rator 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 at which the efficiency is unaffected NOTE Fo
46、r 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 cavities that are integral to the collecting c
47、ontainer 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 level, below the maximum fillable volume, at wh
48、ich 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 3.9 alarm signal auditory or visual sign, sign
49、al 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 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 amalgam separators, irrespective of whether the amalg
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