EN ISO 10637-2018 en Dentistry - Central suction source equipment.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Central suction source equipmentBS EN ISO 10637:2018National forewordThis British Standard is the UK implementation of EN ISO 10637:2018. It is identical to ISO 10637:2018. It supersedes BS EN ISO 10637:2000

2、, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on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 committee can be obtained on request to its secretary.This publication does not purport to include all the necessar

3、y provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 90886 6ICS 11.060.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was p

4、ublished under the authority of the Standards Policy and Strategy Committee on 30 June 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 10637:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10637June 2018ICS 11.060.20 Supersedes EN ISO 10637:20

5、00EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 10637:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national Membe

6、rsDentistry - Central suction source equipment (ISO 10637:2018)Mdecine bucco-dentaire - Systmes daspiration centrale (ISO 10637:2018)Zahnheilkunde - Zentrale Absauganlage (ISO 10637:2018)This European Standard was approved by CEN on 9 March 2018.CEN members are bound to comply with the CEN/CENELEC I

7、nternal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to

8、any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official

9、versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norwa

10、y, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 10637:2018 (E)European forewordThis document (EN ISO 10637:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Commi

11、ttee 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 or by endorsement, at the latest by December 2018, and conflicting national standards shall be withdrawn at the lates

12、t by December 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 10637:2000.According to the CEN-CENELEC Internal Re

13、gulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,

14、 Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 10637:2018 has been approved by CEN as EN ISO 10637:2018 without any modification.iiBS

15、 EN ISO 10637:2018ISO 10637:2018Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 34.1 Classification according to separation of solids and liquids from air flow . 34.2 Classification according to air flow rate 35 Requirements 45.1 Characterizati

16、on of central suction source equipment flow rate performance 45.2 Maximum suction pressure 45.3 Safety requirements . 45.4 Electromagnetic compatibility (EMC). 45.5 Other requirements as applicable 45.5.1 Amalgam separator . 45.5.2 Bacterial filter . 56 Sampling 57 Measurement and test methods . 57.

17、1 General . 57.1.1 General provisions for tests 57.1.2 Reference conditions (air flow rates) 57.1.3 Atmospheric conditions 57.1.4 Other conditions. 57.2 Performance tests . 67.2.1 Measurement of flow rate performance 67.2.2 Measurement of maximum suction pressure . 67.2.3 Measures to prevent excessi

18、ve static suction at the facility suction pipeline connection point 67.3 Bacterial filters 67.4 Visual inspection . 67.4.1 Visual inspection equipment . 67.4.2 Visual inspection of documentation . 68 Information supplied by the manufacturer . 78.1 General . 78.2 Instructions for use . 78.3 Technical

19、 description 79 Marking 89.1 Marking on outside of electrically operated central suction source equipment 89.2 Exhaust pipeline connection point 810 Packaging . 8Annex A (informative) Types of suction systems 10Annex B (informative) Dry-suction system source equipment diagram 12Annex C (informative)

20、 Semi-dry-suction system source equipment diagram .13Annex D (informative) Wet suction system source equipment diagram15Bibliography .17 ISO 2018 All rights reserved iiiContents PageBS EN ISO 10637:2018ISO 10637:2018ForewordISO (the International Organization for Standardization) is a worldwide fede

21、ration 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 established has the right to be represented on that commi

22、ttee. 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 standardization.The procedures used to develop this document and

23、 those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part

24、 2 (see www.iso.org/directives).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 such patent rights. Details of any patent rights identified during the development of the

25、 document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards

26、, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared

27、by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.This second edition cancels and replaces the first edition (ISO 10637:1999), which has been technically revised.The main changes compared to the previous edition are as follows: clarification of the scope; addition of

28、the classification according to the air flow rate (Type 1, Type 2 or Type 3); addition of measurement and test methods; addition of diagrams for different suction source equipment in the Annexes.iv ISO 2018 All rights reservedBS EN ISO 10637:2018ISO 10637:2018IntroductionDental suction systems evacu

29、ate solids, liquids, aerosols and gases from the oral cavity and immediate surrounding area for the purpose of improving operating effectiveness and efficiency during oral treatment procedures and limiting the contamination of the immediate environment. In central suction systems the equipment that

30、generates suction and performs other supporting functions is located in a central location outside of the dental treatment room to isolate this equipment from the immediate vicinity of patient treatment and often to provide suction to multiple treatment rooms.A central suction system consists of fou

31、r basic elements:1) dental treatment room suction components (e.g. dental unit suction system);2) facility suction pipeline;3) central suction source equipment;4) exhaust pipeline.The central suction source equipment consists of all the components from the facility suction pipeline connection point

32、(i.e. discharge end of the facility suction pipeline) to the exhaust pipeline connection point (i.e. inlet to the exhaust pipeline). In addition to the equipment that generates air flow, centrally located amalgam separators and air water separators (if present) are also component parts of the centra

33、l suction source equipment. ISO 2018 All rights reserved vBS EN ISO 10637:2018This page deliberately left blankDentistry - Central suction source equipment1 ScopeThis document specifies requirements and test methods for stationary, electrically powered central suction source equipment, including cen

34、trally located amalgam separators and air water separators.It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central suction source equipment as part of the complete dental suction system.This document

35、 specifies requirements for central suction source equipment used to provide vacuum pressure and flow at the facility pipeline connection point.This document does not apply to portable suction source equipment, air/water venturi suction source equipment, or to suction source equipment located in the

36、 treatment room. It also does not apply to suction source equipment used for life support or for scavenging halogenated anaesthetic gases.This document does not include requirements for facility and exhaust piping systems or treatment room equipment.2 Normative referencesThe following documents are

37、referred to in the text in such a way that some or all of their content constitutes requirements 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 Vocabu

38、laryISO 5167-1, Measurement of fluid flow by means of pressure differential devices inserted in circular cross-section conduits running full Part 1: General principles and requirementsISO 7010:2011, Graphical symbols Safety colours and safety signs Registered safety signsISO 7494-2, Dentistry Dental

39、 units Part 2: Air, water, suction and wastewater systemsISO 9687, Dentistry Graphical symbols for dental equipmentISO 11143, Dentistry Amalgam separatorsISO 29463-1:2017, High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and markin

40、gIEC 60335-1, Household and similar electrical appliances Safety Part 1: General requirementsIEC 61000-6-2, Electromagnetic compatibility (EMC) Part 6-2: Generic standards Immunity standard for industrial environmentsIEC 61000-6-3, Electromagnetic compatibility (EMC) Part 6-3: Generic standards Emis

41、sion standard for residential, commercial and light-industrial environments3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 7494-2 and the following apply.INTERNATIONAL STANDARD ISO 10637:2018 ISO 2018 All rights reserved 1BS EN ISO 10637:201

42、8ISO 10637:2018ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org ISO Online browsing platform: available at https:/www.iso.org/obp3.1air separatorapparatus which separates liquids and solids

43、from the suction system air flow (3.11)3.2cannula connectorcomponent at the inlet end of the dental suction operating hose, which joins the cannula to the operating hose3.3central suction source equipmentassembly of components located between the facility suction pipeline (3.8) connection point and

44、the exhaust pipeline connection point (3.7) which, when activated creates reduced air pressure capable of inducing an air flow at the facility suction pipeline connection point (3.9)Note 1 to entry: Centrally located amalgam separators and air water separators are both component parts of the central

45、 suction source equipment.3.4central suction systemassembly of equipment, including dental treatment room suction equipment, facility suction pipeline (3.8), central suction source equipment (3.3) and exhaust pipeline (3.6) which can induce an air flow to evacuate solids, liquids, aerosols and gases

46、 from the oral cavity and immediate surrounding area during oral treatment procedures3.5dental unit suction systemdental suction system components that are part of the dental unitNote 1 to entry: When a dental unit suction system is an element of a central suction system (3.4), it extends from the a

47、tmospheric inlet to the dental unit suction source connection point i.e. the connection to the facility suction pipeline (3.8).3.6exhaust pipelinegrouping of pipes and fittings used to carry the air and other gases with entrained substances discharged by the central suction source equipment (3.3)3.7

48、exhaust pipeline connection pointport on the central suction source equipment (3.3) for connection to the exhaust pipeline (3.6)3.8facility suction pipelinegrouping of pipes and fittings that connect the dental unit suction system to the central suction source equipment (3.3)3.9facility suction pipe

49、line connection pointlocation within the central suction source equipment (3.3) where connection is made to the facility suction pipeline (3.8)2 ISO 2018 All rights reservedBS EN ISO 10637:2018ISO 10637:20183.10suction machinecentral suction source equipment (3.3) component that produces pressure lower than atmosphericEXAMPLE Pump, side channel blower.3.11suction system air flowmovement of air along a pipeline induced by a pressure difference4 Classification4.1 Classification according to separation of solids and liquids fr