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1、BRITISH STANDARD BS EN ISO 11143:2000 Incorporating corrigendum no. 1 Dental equipment Amalgam separators The European Standard EN ISO 11143:1999 has the status of a British Standard ICS 11.060.20 ? Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00
2、:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11143:2000 This British Standard was published under the authority of the Standards Committee and comes into effect on 15 April 2000 BSI 2007 ISBN 978 0 580 59728 2 National foreword This British Standard is the UK implementation of EN ISO 11143:1999, i
3、ncorporating corrigendum July 2002. It is identical with ISO 11143:1999, incorporating corrigendum June 2002. The start and finish of text introduced or altered by corrigendum is indicated in the text by tags . Text altered by ISO corrigendum June 2002 is indicated in the text by . The UK participat
4、ion in its preparation was entrusted to Technical Committee CH/60, Dental equipment. A list of organizations represented on this committee 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 i
5、ts correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments 17321 Corrigendum No. 1 28 September 2007See national foreword Licensed Copy: London South Bank University, London South Bank University
6、, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11143 December 1999 ICS 11.060.20 English version Dental equipment - Amalgam separators (ISO 11143:1999) Matriel dentaire - Sparateurs damalgame (ISO 11143:1999) Zahnrztliche Aus
7、rstung - Amalgamabscheider (ISO 11143:1999) This European Standard was approved by CEN on 15 November 1999. 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 standard without any alterat
8、ion. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the 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 translat
9、ion under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Ita
10、ly, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 1999 CENAll rights of exploitation in any form a
11、nd by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11143:1999 E Incorporating corrigendum July 2002 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Corrected 2000-02-23 Foreword The te
12、xt of the International Standard ISO 11143:1999 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
13、 publication of an identical text or by endorsement, at the latest by June 2000, and conflicting national standards shall be withdrawn at the latest by June 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement
14、 this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11143:1999 was ap
15、proved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 11143:1999 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy,
16、 (c) BSI Reference number ISO 11143:1999(E) INTERNATIONAL STANDARD ISO 11143 First edition 1999-12-01 Dental equipment Amalgam separators Matriel dentaire Sparateurs damalgame EN ISO 11143:1999 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2
17、007, Uncontrolled Copy, (c) BSI ii? EN ISO 11143:1999 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ?iii Contents?Page Foreword.iv Introduction.v 1?Scope 1 2?Normative references1 3?Terms and definitions .1 4
18、?Classification2 5?Requirements.3 6?Sampling.4 7?Test apparatus .4 8?Amalgam sample .7 9?Test procedure.9 10?Test report12 11?Instructions for installation, use, maintenance and service.13 12?Marking.14 Annex A (informative) Preparation of amalgam sample15 Annex B (informative) Procedure for grindin
19、g the amalgam18 Annex C (normative) Examination of fraction 3 particles using sedimentation with X-ray absorption.19 Annex D (informative) Particle size distribution of amalgam in dental waste water21 Bibliography22 EN ISO 11143:1999 Licensed Copy: London South Bank University, London South Bank Uni
20、versity, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv? Foreword ISO (the International 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
21、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 liaison with ISO, also take part in the work. ISO collaborates clo
22、sely 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 3. Draft International Standards adopted by the technical committees are circulated
23、 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 drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held
24、 responsible for identifying any or all such patent rights. International Standard ISO 11143 was prepared by Technical Committee ISO/TC 106,Dentistry, Subcommittee SC 6,Dental equipment. Annex C forms a normative part of this International Standard. Annexes A, B and D are for information only. EN IS
25、O 11143:1999 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ?v Introduction Amalgam separators are items of dental equipment designed to retain amalgam particles carried by the waste water from the dental trea
26、tment centre, so as to reduce the number 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, filtration, sedimentation or a combination of any of these methods. It is recognized that the te
27、st sample used to assess the efficiency 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 particl
28、e size distribution of amalgam particles in waste water from dental treatment centres (see annex D). EN ISO 11143:1999 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN ISO 11143:1999 Licensed Copy: London Sou
29、th Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDADR?ISO 34111:(9991)E ?1 Dental equipment Amalgam separators 1?Scope This International Standard specifies requirements for amalgam separators used in connection with d
30、ental 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 procedure for determining this efficiency. It also includes requirements for the safe functioning of the separat
31、or, marking, instructions for use, operation and maintenance. All tests described in this International Standard are type tests. 2?Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. Fo
32、r dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Fo
33、r undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1559:1995,Dental materials Alloys for dental amalgam. ISO 3585,Borosilicate glass 3.3 Properties. ISO 3696,Water for analy
34、tical laboratory use Specification and test methods. ISO 9687,Dental equipment Graphical symbols. ISO 10076:1991,Metallic powders Determination of particle size distribution by gravitational sedimentation in a liquid and attenuation measurement. IEC 60601-1:1988,Medical electrical equipment Part 1:
35、General requirements for safety. IEC 61010-1:1990,Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements. 3?Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 amalgam sep
36、arator 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 EN ISO 11143:1999 Licensed Copy: London South Bank Univers
37、ity, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2? NOTE?The amalgam separator may comprise any auxiliary units required for admission of water and the connecting lines inside the separator, but it does not include the supply and drainage pipes or tub
38、es. 3.2 collecting container that part of the amalgam separator for retention of separated amalgam waste for the purpose of disposal 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 pati
39、ent therapy 3.4 efficiency of amalgam separator mass percentage of the specified amalgam sample retained by the amalgam separator 3.5 maximum filling level level defined by the maximum collecting capacity of the collecting container of the amalgam separator at which the efficiency is unaffected 3.6
40、warning level level, below the maximum filling level, at which the collecting container should be emptied or replaced 3.7 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 i
41、f unattended 3.8 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 cl
42、assified 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 amalgam sep
43、arator is included in every dental treatment centre or built as a central amalgam separator for one or several dental treatment centres. EN ISO 11143:1999 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ?3 5?Re
44、quirements 5.1? Efficiency The efficiency of the amalgam separator shall be at least 95 % (mass fraction) when tested as specified in 9.3 to 9.6. 5.2? Warning system The amalgam separator shall include a warning system to indicate the degree of filling at which the collecting container should be emp
45、tied or replaced. The warning signal shall be activated at the warning level and before the maximum filling level is reached. Testing shall be carried out in accordance with 9.7. For type 2 amalgam separators, the warning system requirement can be met if the manufacturer clearly defines procedures b
46、y which the proper function of the amalgam separator is ensured, giving controllable maintenance and disposal 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 co
47、llecting container has reached the maximum filling level, as specified by the manufacturer, at which the device can perform to the specified efficiency. The alarm signal shall be activated at the maximum filling level. The alarm signal shall remain activated until the collecting container and/or fil
48、ter has been emptied or replaced. Testing shall be carried out in accordance with 9.8. For type 2 amalgam separators, the alarm system requirement 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 disposal procedures as in 11.2. Compliance shall be tested by visual inspection. 5.4? Alarm system for malfunction 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 d