1、September 2014 Translation by DIN-Sprachendienst.English price group 16No 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).
2、ICS 11.040.10!%:K“2235840www.din.deDDIN EN ISO 10079-3Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressuregas source (ISO 10079-3:2014);English version EN ISO 10079-3:2014,English translation of DIN EN ISO 10079-3:2014-09Medizinische Absauggerte Teil 3: Vaku
3、um- oder druckquellenbetriebene Absauggerte (ISO 10079-3:2014);Englische Fassung EN ISO 10079-3:2014,Englische bersetzung von DIN EN ISO 10079-3:2014-09Appareils daspiration mdicale Partie 3: Appareils daspiration aliments par une source de vide ou de pression(ISO 10079-3:2014);Version anglaise EN I
4、SO 10079-3:2014,Traduction anglaise de DIN EN ISO 10079-3:2014-09SupersedesDIN EN ISO 10079-3:2009-07www.beuth.deDocument comprises 40 pagesIn case of doubt, the German-language original shall be considered authoritative.08.14 DIN EN ISO 10079-3:2014-09 2 National foreword This document (EN ISO 1007
5、9-3:2014) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA). The responsible German body involved in its
6、preparation was the Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. Annex B “Rationale statement” includes remarks to some clauses and subclauses in the main body of this standard. The re
7、levant clauses and subclauses have been marked with an asterisk (*) after their number. DIN EN ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically powered suction equipment (under revision) Part 2: Manually powered suction equipment Part
8、 3: Suction equipment powered from a vacuum or positive pressure gas source The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3744 DIN EN ISO 3744 ISO 5356-1 DIN EN ISO 5356-1 ISO 5359 DIN EN ISO 5359 ISO 7000 DIN ISO 7000 ISO 7396-1 DIN
9、EN ISO 7396-1 ISO 8836 DIN EN ISO 8836 ISO 9170-1 DIN EN ISO 9170-1 ISO 10079-1 DIN EN ISO 10079-1 ISO 10079-2 DIN EN ISO 10079-2 ISO 10524-1 DIN EN ISO 10524-1 ISO 10651-4 DIN EN ISO 10651-4 ISO 14155 DIN EN ISO 14155 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 18082 DIN EN ISO 18
10、082 ISO 80369-1 DIN EN ISO 80369-1 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-6 DIN EN 60601-1-6 (VDE 0750-1-6) IEC 61672-1 DIN EN 61672-1 IEC 62366 DIN EN 62366 (VDE 0750-241) A comma is used as the decimal marker. DIN EN ISO 10079-3:2014-09 3 Amendments This standard differs from DIN EN I
11、SO 10079-3:2009-07 as follows: a) general requirements for the risk management, usability, clinical investigation and biophysical or modelling research have been supplemented; b) requirements for the cleaning, disinfection and sterilization of parts intended for re-use have been revised; c) a minimu
12、m length of the suction tubing of 1,3 m has been specified; d) requirements for suction equipment with interrupted suction have been supplemented; e) requirements for marking and information to be supplied by the manufacturer have been revised; f) test methods have been revised; g) Annex C (informat
13、ive) “Lumen size and its effect on flowrate” has been added; h) the standard has been editorially revised. Previous editions DIN EN ISO 10079-3: 1996-11, 2000-03, 2009-07 DIN EN ISO 10079-3:2014-09 4 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipme
14、nt Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-6 (VDE 0750-1-6), Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability DIN EN 61672-1, Electroacoustics Sound level meters Part 1
15、: Specifications DIN EN 62366 (VDE 0750-241), Medical devices Application of usability engineering to medical devices DIN EN ISO 3744, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a
16、reflecting plane DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5359, Low-pressure hose assemblies for use with medical gases DIN EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and va
17、cuum DIN EN ISO 8836, Suction catheters for use in the respiratory tract DIN EN ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum DIN EN ISO 10079-1, Medical suction equipment Part 1: Electrically powered suction equip
18、ment Safety requirements DIN EN ISO 10079-2, Medical suction equipment Part 2: Manually powered suction equipment DIN EN ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices DIN EN ISO 10651-4, Lung ventilators Par
19、t 4: Particular requirements for operator-powered resuscitators DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be
20、used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 18082, Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases DIN EN ISO 80369-1, Small bore connectors f
21、or liquids and gases in healthcare applications Part 1: General requirements DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-3 May 2014 ICS 11.040.10 Supersedes EN ISO 10079-3:2009 English Version Medical suction
22、equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) Appareils daspiration mdicale Partie 3: Appareils daspiration aliments par une source de vide ou de pression (ISO 10079-3:2014) Medizinische Absauggerte Teil 3: Vakuum- oder druckquellenbetri
23、ebene Absauggerte (ISO 10079-3:2014) This European Standard was approved by CEN on 15 February 2014. 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
24、-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, German). A version in any other language made by trans
25、lation 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finlan
26、d, 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION
27、 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10079-3:2014 E Contents PageForeword 41 Scope
28、. 52 Normative references 53 Terms and definitions . 64 General requirements . 84.1 Risk management . 84.2 Usability 94.3 Clinical investigation 94.4 Biophysical or modelling research . 105 Cleaning, disinfection and sterilization . 106 Design requirements . 106.1 Collection container. 106.2 Connect
29、ions 116.3 Suction tubing . 116.4 Vacuum level indicators . 116.5 Supply connections 127 Operational requirements 127.1 Ease of operation . 127.2 Dismantling and reassembly 127.3 Mechanical shock . 127.4 Stability . 137.5 Protective devices 137.6 Noise . 137.7 Air leakage . 148 Physical requirements
30、 for field and transport use suction equipment .148.1 (*)Dimensions . 148.2 Mass . 149 Performance requirements for vacuum level and flowrate .159.1 High vacuum/high flowrate equipment . 159.2 Medium vacuum equipment. 159.3 Low vacuum/low flowrate equipment 159.4 Low vacuum/high flowrate equipment 1
31、59.5 Thoracic drainage equipment for adults .159.6 Intermittent vacuum equipment 169.7 Vacuum regulators with fixed setting 169.8 Vacuum regulators with variable setting 169.9 Equipment intended for pharyngeal suction .1610 (*)Resistance to environment of suction equipment for field and/or transport
32、 use .1610.1 Operating conditions 1610.2 Storage 1611 Marking .1611.1 Use of symbols 1611.2 Equipment 1711.3 Equipment or carrying case 1812 Information to be supplied by the manufacturer 18DIN EN ISO 10079-3:2014-09 EN ISO 10079-3:2014 (E) 2Annex D (informative) Schematic of suction equipment 33Bib
33、liography .36Annex A (normative) Test methods 20Annex B (informative) Rationale statement 31Annex C (informative) Lumen size and its effect on flowrate 32DIN EN ISO 10079-3:2014-09 EN ISO 10079-3:2014 (E) 3ZAnnex A (informative) Relationship between this European Standard and the Essential Requireme
34、nts of EU Directive 93/42/EEC Page34Foreword This document (EN ISO 10079-3:2014) has been prepared by Technical Committee ISO/TC 121 Anaesthetic and respiratory equipment in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by
35、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 November 2014, and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the possibility that some
36、 of the elements of 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 10079-3:2009. This document has been prepared under a mandate given to CEN by the European Commission
37、 and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the foll
38、owing 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, Netherlands,
39、Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10079-3:2014 has been approved by CEN as EN ISO 10079-3:2014 without any modification. “”DIN EN ISO 10079-3:2014-09 EN ISO 10079-3:2014 (E) 41 ScopeThi
40、s part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrate
41、s the three parts of ISO 10079 by providing a schematic for typical systems.The equipment can be stand-alone or part of an integrated system.Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079.This part of ISO 10079 does not ap
42、ply to the following:a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;b) end-piece such as suction catheters, Yankauer sucker and suction tips;c) syringes;d) dental suction equipment;e) anaesthetic gas scavenging systems;f)
43、laboratory suction;g) autotransfusion systems;h) closed systems for wound drainage;i) mucus extractors, including neonatal mucus extractors;j) ventouse (obstetric) equipment;k) breast pumps;l) liposuction;m) uterine aspiration;n) plume evacuation systems.2 Normative referencesThe following documents
44、, 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 latest edition of the referenced document (including any amendments) applies.DIN EN ISO 10079-3:2014-09 EN I
45、SO 10079-3:2014 (E) 5ISO 3744, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting planeISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and s
46、ocketsISO 5359, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gasesISO 70001), Graphical symbols for use on equipment Registered symbolsISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14971, Medical devices
47、 Application of risk management to medical devicesISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applicationsIEC 60601-1:
48、2005+A1:2012, Medical electrical equipment Part 1: General requirements for safetyIEC 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performanceCollateral standard: UsabilityIEC 61672-1, Electroacoustics Sound level meters Part 1: SpecificationsIEC 62366, Medical devices Application of usability engineering to medical devicesEN 1041, Information supplied by the manufacturer of me
