EN ISO 7494-2-2015 en Dentistry - Dental units - Part 2 Air water suction and wastewater systems《牙科学 牙科设备 第2部分 空气 水 抽吸和废水系统(ISO 7494-2 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 7494-2:2015Dentistry Dental unitsPart 2: Air, water, suction and wastewatersystems (ISO 7494-2:2015)BS EN ISO 7494-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO7494-2:2015. It supersedes BS EN ISO 11144:1997 and BS

2、 EN ISO7494-2:2003 which are withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include

3、all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 78985 4ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British S

4、tandard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2015.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7494-2 April 2015 ICS 11.060.20 Supersedes EN ISO 11144:1996, EN ISO 7494-2

5、:2003English Version Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) Mdecine bucco-dentaire - Units dentaires - Partie 2: Systmes dalimentation en air et en eau, daspiration et dvacuation des eaux uses (ISO 7494-2:2015) Zahnheilkunde - Zahnrztliche Beh

6、andlungseinheiten - Teil 2: Luft, Wasser, Absaugung und Abwassersystem (ISO 7494-2:2015) This European Standard was approved by CEN on 10 January 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the statu

7、s 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 any CEN member. This European Standard exists in three official versions (English, French, Ger

8、man). 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 versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croati

9、a, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and Uni

10、ted Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN

11、 ISO 7494-2:2015 EBS EN ISO 7494-2:2015EN ISO 7494-2:2015 (E) 3 Foreword This document (EN ISO 7494-2:2015) 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

12、shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2015, and conflicting national standards shall be withdrawn at the latest by October 2015. Attention is drawn to the possibility that some of the elements of this

13、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 7494-2:2003 and EN ISO 11144:1996. According to the CEN-CENELEC Internal Regulations, the national standards organizations of

14、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, Italy, Latvia, Lithuania, Luxembourg, Malta, Nethe

15、rlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 7494-2:2015 has been approved by CEN as EN ISO 7494-2:2015 without any modification. BS EN ISO 7494-2:2015ISO 7494-2:2015(E)Foreword vIntroduct

16、ion vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 44.1 Classification of suction systems . 44.2 Classification of suction air volume flow rate 45 Requirements 45.1 Requirements for supply connections 45.2 Requirements for water and wastewater systems . 45.2.1 Incom

17、ing water . 55.2.2 Materials used for construction of procedural water systems within the dental unit 65.2.3 Backflow prevention device for dental units connected to the external drinking water supply . 75.2.4 Cuspidors 75.2.5 Water venturi 75.2.6 Particle filter 75.2.7 Bacterial filter . 75.2.8 Bot

18、tled water system supplying procedural water or solution . 75.2.9 Retraction . 75.2.10 Water disinfection systems . 75.2.11 Water sampling connection point . 85.2.12 Wastewater drain connection. 85.3 Requirements for the air system . 85.3.1 Incoming air (dental air) . 85.3.2 Particle filters . 85.3.

19、3 Bacterial filters 95.4 Requirements for dental unit suction systems 95.4.1 Static vacuum pressure 95.4.2 Head loss . 95.4.3 Air separators . 95.4.4 Cannula connectors and cannula . 95.4.5 Operating hoses with cannula connectors .105.4.6 Solids filter .115.4.7 Noise level . 115.4.8 Dental unit suct

20、ion source connection point .116 Sampling .117 Tests 117.1 Cuspidors 117.2 Water venturi 117.3 Systems directly connected to external drinking water supply .117.4 Bottled water system supplying procedural water or solution .117.5 Retraction . 127.6 Particle filters 127.7 Bacterial filters . 127.8 Wa

21、ter disinfection systems . 127.9 Tests for dental unit suction systems . 137.9.1 Static vacuum pressure test 137.9.2 Head loss test .137.9.3 Measurement of noise level . 14 ISO 2015 All rights reserved iiiContents PageBS EN ISO 7494-2:2015ISO 7494-2:2015(E)7.10 Water sampling connection point . 157.

22、11 Incoming water and air quality . 157.12 Supply connections 158 Manufacturers instructions for use 159 Technical description .16Annex A (informative) Schematic diagram of possible components and connections in a dental unit 18Annex B (informative) Test sequences 20Bibliography .25iv ISO 2015 All r

23、ights reservedBS EN ISO 7494-2:2015ISO 7494-2:2015(E)ForewordISO (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 technical committees. Ea

24、ch 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 closely with the Internatio

25、nal Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and 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

26、 types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 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

27、 be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the 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 info

28、rmation given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see t

29、he following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.This edition of ISO 7494-2 cancels and replaces ISO 7494-2:2003 and ISO 11144, of which it constitutes a technical revision, while only repl

30、acing certain requirements specific to dental units given in ISO 10637. In addition, it consolidates and updates requirements formerly specified in ISO 10637:1999, Dental equipment High- and medium-volume suction systems, and ISO 11144:1995, Dental equipment Connections for supply and waste lines.IS

31、O 7494 consists of the following parts, under the general title Dentistry Dental units: Part 1: General requirements and test methods Part 2: Air, water, suction and wastewater systems ISO 2015 All rights reserved vBS EN ISO 7494-2:2015ISO 7494-2:2015(E)IntroductionThis part of ISO 7494 specifies re

32、quirements and test methods pertaining to components of the dental unit which convey air, water, suction, and wastewater. The requirements in this part of ISO 7494 focus on certain technical aspects regarded by the working group to be appropriate for international standardization. The working group

33、acknowledges that requirements for microbiological aspects of the fluids transported by dental units are also worthy of standardization and is working to develop requirements pertaining to the prevention, inhibition, and removal of dental unit waterline biofilm. Additional projects to develop microb

34、iological requirements for air, water, and/or suction may follow.vi ISO 2015 All rights reservedBS EN ISO 7494-2:2015Dentistry Dental units Part 2: Air, water, suction and wastewater systems1 ScopeThis part of ISO 7494 specifies requirements and test methods concerninga) the configuration of dental

35、unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,b) the materials, design, and construction of the compressed air and water system within the dental unit,c) the quality for incoming water and air, andd) the performance of dental unit suction

36、system.This part of ISO 7494 also specifies requirements for instructions for use and technical description.This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Ama

37、lgam separators are not included in this International Standard.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the

38、 latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 7494-1:2011, Dentistry Dental units Part 1: General requirements and test methodsISO 8573-1, Compressed air Part 1: Contaminants and purity classesISO 9168, Dentistry Hose connectors for a

39、ir driven dental handpiecesISO 10637:1999, Dental equipment High- and medium-volume suction systemsISO 14971, Medical devices Application of risk management to medical devicesIEC 61672-1, Electroacoustics Sound level meters Part 1: SpecificationsIEC 62366, Medical devices Application of usability en

40、gineering to medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and ISO 7494-1 and the following apply.3.1air separatorapparatus which separates liquids and solids from the suction airINTERNATIONAL STANDARD ISO 7494-2:2015(E) ISO 2015

41、 All rights reserved 1BS EN ISO 7494-2:2015ISO 7494-2:2015(E)3.2bacterial filterfilter designed to restrict the passage of bacteria and reduce bacteria in the procedural water or in the compressed air3.3backflowflow of water and/or another medium back into the external drinking water supply3.4backfl

42、ow prevention devicesafety device to prevent backflow3.5bottled water systemdental unit water system in which procedural water is supplied by an included reservoir which is not connected to an external drinking water supply system and is manually filled with incoming water or incoming solution3.6can

43、nula connectorcomponent at the end of the dental suction operating hose, which joins the cannula to the operating hose3.7dental aircompressed air supplied through the dental unit for powering, controlling, and/or assisting various dental instruments and equipment, as well as for assisting practition

44、ers with procedures in the oral cavity, but not for procedures requiring medical air or sterile air, such as endoscopy, oral surgery, analgesia, and life support3.8dental treatment centrecombination of functional items for dental use which consist, for example, of dental unit, dental patient chair,

45、and interconnected sub-units of dental equipment and instruments providing a functional environment for dental care3.9dental unit suction systempassive entity, including all the components from the dental unit suction source connection point through the cannula connector, which can induce air flow w

46、hen connected to a suction source to evacuate solids, liquids, aerosols and gases from the oral cavity and immediate surrounding area during oral treatment procedures3.10dental unit suction source connection pointany port on the dental unit for connection to a supply of dental suction3.11filterappar

47、atus which restricts targeted constituents from passing through it3.12incoming aircompressed air supplied to the dental unit3.13incoming air connection pointany port on the dental unit for connection to an external compressed air supply2 ISO 2015 All rights reservedBS EN ISO 7494-2:2015ISO 7494-2:20

48、15(E)3.14incoming solutionsolution of substances specified by the manufacturer, and introduced in combination with, or in place of, the incoming water in order to improve or maintain the quality of the procedural water or for other reasons, such as coolant for cutting burs or medicament for oral cav

49、ity3.15incoming waterwater supplied to the dental unit for procedural use or non-procedural use3.16incoming water connection pointany port on the dental unit for connection to an external drinking water supply3.17non-procedural waterwater supplied by the dental unit for purposes other than use in the oral cavityEXAMPLE Cuspidor bowl rinse water, water venturi supply water.3.18procedural waterwater supplied by the dental unit for use in the oral cavityEXAMPLE Handpiece coolant water, multifunction handpieces (syringes