DIN EN ISO 7494-2-2015 Dentistry - Dental units - Part 2 Air water suction and wastewater systems (ISO 7494-2 2015) German version EN ISO 7494-2 2015《牙科学 牙科治疗装置 第2部分 空气 水 吸水和污水系统 (.pdf

1、August 2015 Translation by DIN-Sprachendienst.English price group 15No part of this translation 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

2、 11.060.25!%D“2335661www.din.deDDIN EN ISO 7494-2Dentistry Dental units Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015);English version EN ISO 7494-2:2015,English translation of DIN EN ISO 7494-2:2015-08Zahnheilkunde Zahnrztliche Behandlungseinheiten Teil 2: Luft-, Wasser-, Absa

3、ugungs- und Abwassersysteme (ISO 7494-2:2015);Englische Fassung EN ISO 7494-2:2015,Englische bersetzung von DIN EN ISO 7494-2:2015-08Mdecine bucco-dentaire Units dentaires Partie 2: Systmes dalimentation en air et en eau, daspiration et dvacuation des eauxuses (ISO 7494-2:2015);Version anglaise EN I

4、SO 7494-2:2015,Traduction anglaise de DIN EN ISO 7494-2:2015-08SupersedesDIN EN ISO 7494-2:2003-10,DIN 13938:2008-08 andDIN EN ISO 11144:1996-11www.beuth.deDocument comprises 34 pagesIn case of doubt, the German-language original shall be considered authoritative.071155 DIN EN ISO 7494-2:2015-08 2 A

5、 comma is used as the decimal marker. National foreword This document (EN ISO 7494-2:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Working Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparatio

6、n was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committees NA 014-00-05 AA Zahnrztliche Ausrstung and NA 014-00-05-04 AK Wasser und Luft. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO

7、1942 ISO 7494-1 DIN EN ISO 7494-1 ISO 9168 DIN EN ISO 9168 ISO 10637 DIN EN ISO 10637 ISO 14971 DIN EN ISO 14971 IEC 61672-1 DIN EN 61672-1 IEC 62366 DIN EN 62366 Amendments This standard differs from DIN 13938:2008-08, DIN EN ISO 7494-2:2003-10 and DIN EN ISO 11144:1996-11 as follows: a) requiremen

8、ts formerly specified in DIN EN ISO 11144 have been incorporated in the scope; b) requirements formerly specified in DIN EN ISO 10637 have been partly incorporated in the scope; c) Annex B “Test sequences” has been added. Previous editions DIN 13938-1: 1983-02, 1986-08 DIN EN ISO 11144: 1996-11 DIN

9、EN ISO 7494-2: 2003-10 DIN 13938: 2008-08 DIN EN ISO 7494-2:2015-08 3 National Annex NA (informative) Bibliography DIN EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN ISO 1942, Dentist

10、ry Vocabulary DIN EN ISO 7494-1, Dentistry Dental units Part 1: General requirements and test methods DIN EN ISO 9168, Dentistry Hose connectors for air driven dental handpieces DIN EN ISO 10637, Dental equipment High- and medium-volume suction systems DIN EN ISO 14971, Medical devices Application o

11、f risk management to medical devices DIN EN ISO 7494-2:2015-08 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7494-2 April 2015 ICS 11.060.20 Supersedes EN ISO 11144:1996, EN ISO 7494-2:2003English Version Dentistry - Dental units - Part 2: Air, water, su

12、ction 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 Behandlungseinheiten -Teil 2: Luft-, Wasser-, Absaugungs- und Abwassersys

13、teme7494-2:2015) 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 status of a national standard without any alteration. Up-to-date lists and bi

14、bliographical 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, German). A version in any other language made by translation under the resp

15、onsibility 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Re

16、public 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NOR

17、MALISATION 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 ISO 7494-2:2015 E(ISO Foreword 4Introduction 51 Scope . 62 Normative re

18、ferences 63 Terms and definitions . 64 Classification 94.1 Classification of suction systems . 94.2 Classification of suction air volume flow rate 95 Requirements 95.1 Requirements for supply connections 95.2 Requirements for water and wastewater systems . 95.2.1 Incoming water 105.2.2 Materials use

19、d for construction of procedural water systems within the dental unit. 115.2.3 Backflow prevention device for dental units connected to the external drinking water supply 125.2.4 Cuspidors . 125.2.5 Water venturi . 125.2.6 Particle filter . 125.2.7 Bacterial filter 125.2.8 Bottled water system suppl

20、ying procedural water or solution 125.2.9 Retraction 125.2.10 Water disinfection systems 125.2.11 Water sampling connection point 135.2.12 Wastewater drain connection 135.3 Requirements for the air system 135.3.1 Incoming air (dental air) 135.3.2 Particle filters 135.3.3 Bacterial filters . 145.4 Re

21、quirements for dental unit suction systems . 145.4.1 Static vacuum pressure . 145.4.2 Head loss 145.4.3 Air separators 145.4.4 Cannula connectors and cannula 145.4.5 Operating hoses with cannula connectors .155.4.6 Solids filter .165.4.7 Noise level . 165.4.8 Dental unit suction source connection po

22、int .166 Sampling .167 Tests 167.1 Cuspidors 167.2 Water venturi 167.3 Systems directly connected to external drinking water supply .167.4 Bottled water system supplying procedural water or solution .167.5 Retraction . 177.6 Particle filters 177.7 Bacterial filters . 177.8 Water disinfection systems

23、 . 177.9 Tests for dental unit suction systems . 187.9.1 Static vacuum pressure test 187.9.2 Head loss test .187.9.3 Measurement of noise level . 19Contents Page2DIN EN ISO 7494-2:2015-08 EN ISO 7494-2:2015 (E)7.10 Water sampling connection point . 207.11 Incoming water and air quality . 207.12 Supp

24、ly connections 208 Manufacturers instructions for use 209 Technical description .21Annex A (informative) Schematic diagram of possible components and connections in a dental unit 23Annex B (informative) Test sequences 25Bibliography .303DIN EN ISO 7494-2:2015-08 EN ISO 7494-2:2015 (E) Foreword This

25、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 shall be given the status of a national standard, either by publication of an

26、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 document may be the subject of patent rights. CEN and/or CENELEC shall not be

27、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 the following countries are bound to implement this European Standard: Austria

28、, 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,

29、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. 4DIN EN ISO 7494-2:2015-08 EN ISO 7494-2:2015 (E)IntroductionThis part of ISO 7494 specifies requirements and test methods pertaining to

30、 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 acknowledges that requirements for microb

31、iological 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 microbiological requirements for air, water, an

32、d/or suction may follow.5DIN EN ISO 7494-2:2015-08 EN ISO 7494-2:2015 (E) 1 ScopeThis part of ISO 7494 specifies requirements and test methods concerninga) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,b) the ma

33、terials, 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 system.This part of ISO 7494 also specifies requirements for instructions for use and technical description.This par

34、t 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. Amalgam separators are not included in this International Standard.2 Normative referencesThe following documents, in wh

35、ole 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 latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 7494

36、-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 air driven dental handpiecesISO 10637:1999, Dental equipment High- and medium-volume suction systemsISO 14971, Medica

37、l devices Application of risk management to medical devicesIEC 61672-1, Electroacoustics Sound level meters Part 1: SpecificationsIEC 62366, Medical devices Application of usability engineering to medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions give

38、n in ISO 1942 and ISO 7494-1 and the following apply.3.1air separatorapparatus which separates liquids and solids from the suction air6DIN EN ISO 7494-2:2015-08 EN ISO 7494-2:2015 (E)3.2bacterial filterfilter designed to restrict the passage of bacteria and reduce bacteria in the procedural water or

39、 in the compressed air3.3backflowflow of water and/or another medium back into the external drinking water supply3.4backflow 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 c

40、onnected to an external drinking water supply system and is manually filled with incoming water or incoming solution3.6cannula 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

41、 for powering, controlling, and/or assisting various dental instruments and equipment, as well as for assisting practitioners 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 treatme

42、nt centrecombination of functional items for dental use which consist, for example, of dental unit, dental patient chair, and interconnected sub-units of dental equipment and instruments providing a functional environment for dental care3.9dental unit suction systempassive entity, including all the

43、components from the dental unit suction source connection point through the cannula connector, which can induce air flow when 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 u

44、nit suction source connection pointany port on the dental unit for connection to a supply of dental suction3.11filterapparatus which restricts targeted constituents from passing through it3.12incoming aircompressed air supplied to the dental unit3.13incoming air connection pointany port on the denta

45、l unit for connection to an external compressed air supply7DIN EN ISO 7494-2:2015-08 EN ISO 7494-2:2015 (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

46、 the procedural water or for other reasons, such as coolant for cutting burs or medicament for oral cavity3.15incoming 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

47、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, multifunc

48、tion handpieces (syringes) water, scaler coolant water, cup fill water.3.19retractionre-entry of water, air, and/or other medium into the dental unit or the dental instruments due to flow reversal, e.g. caused by momentary dynamic pressure variations during turning off the instruments3.20rinse waterwater for cleaning3.21spill-over levelhighest possible level of water or solution in a device above which the fluid will flow over the edge3.22suction systemactive entity of dental equ