DIN EN ISO 10079-1-2016 Medical suction equipment - Part 1 Electrically powered suction equipment (ISO 10079-1 2015) German version EN ISO 10079-1 2015《医用抽吸设备 第1部分 电动抽吸设备(ISO 10079.pdf

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1、May 2016 English price group 17No 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 11.040.10!%SL“2484199www.din.deDIN E

2、N ISO 10079-1Medical suction equipment Part 1: Electrically powered suction equipment (ISO 10079-1:2015);English version EN ISO 10079-1:2015,English translation of DIN EN ISO 10079-1:2016-05Medizinische Absauggerte Teil 1: Elektrisch betriebene Absauggerte (ISO 10079-1:2015);Englische Fassung EN ISO

3、 10079-1:2015,Englische bersetzung von DIN EN ISO 10079-1:2016-05Appareils daspiration mdicale Partie 1: Appareils lectriques daspiration (ISO 10079-1:2015);Version anglaise EN ISO 10079-1:2015,Traduction anglaise de DIN EN ISO 10079-1:2016-05SupersedesDIN EN ISO 10079-1:2009-07See start of applicat

4、ionwww.beuth.deDocument comprises 42 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 10079-1:2016-05 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 20

5、16-05-01. For DIN EN ISO 10079-1:2009-07 there is a transition period ending on 2018-11-30. National foreword This document (EN ISO 10079-1:2015) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom) in collaboration with Techn

6、ical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA). The responsible German body involved in its preparation was DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01 AA Ansthes

7、ie und Beatmung. An amendment to ISO 10079-1 containing modifications to the requirements for the resistance to environment of suction equipment for field and/or transport use is currently being prepared by the responsible Subcommittee of ISO/TC 121, SC 8 “Suction devices for hospital and emergency

8、care use”. In the present edition, a resistance of such equipment to ambient temperatures of -18 C and + 50 C is specified (see Subclause 10.1). The intended amendment will include further temperature requirements to be specified by the equipment manufacturer (see also 11.3, item k). DIN EN ISO 1007

9、9 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically powered suction equipment Part 2: Manually powered suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source The DIN Standards corresponding to the Inter

10、national Standards referred to in this document are as follows: ISO 3744 DIN EN ISO 3744 ISO 5356-1 DIN EN ISO 5356-1 ISO 7000 DIN ISO 7000 ISO 8836 DIN EN ISO 8836 ISO 10079-2 DIN EN ISO 10079-2 ISO 10079-3 DIN EN ISO 10079-3 ISO 10651-4 DIN EN ISO 10651-4 ISO 14155 DIN EN ISO 14155 ISO 14971 DIN E

11、N ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 80369 (all parts) DIN EN ISO 80369 (all parts) IEC 60529 DIN EN 60529 (VDE 0470-1) IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-6 DIN EN 60601-1-6 (VDE 0750-1-6) IEC 60601-1-11 DIN EN 60601-1-11 (VDE 0750-1-11) IEC 60601-1-12 DIN EN 60601-1-12 (V

12、DE 0750-1-12) IEC 61672-1 DIN EN 61672-1 IEC 62366 DIN EN 62366 (VDE 0750-241) DIN EN ISO 10079-1:2016-05 3 Amendments This standard differs from DIN EN ISO 10079-1:2009-07 as follows: a) the requirements have been completely redefined and restructured and are thus no longer based on the structure o

13、f IEC 60601-1; b) general requirements for the risk management, usability, clinical investigation and biophysical or modelling research have been supplemented; c) requirements for the cleaning, disinfection and sterilization of parts intended for re-use have been revised; d) design requirements have

14、 been revised; e) performance requirements and test methods have been revised; f) requirements for marking and information to be supplied by the manufacturer have been revised; g) the standard has been editorially revised. Previous editions DIN EN ISO 10079-1: 1996-11, 2000-03, 2009-07 DIN EN ISO 10

15、079-1:2016-05 4 National Annex NA (informative) Bibliography DIN EN 60529 (VDE 0470-1), Degrees of protection provided by enclosures (IP code) DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-6 (VDE 0750-

16、1-6), Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability DIN EN 60601-1-11 (VDE 0750-1-11), Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard:

17、Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment DIN EN 60601-1-12 (VDE 0750-1-12), Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance Collateral standard: Requirements for medica

18、l electrical equipment and medical electrical systems intended for use in the emergency medical services environment DIN EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications DIN EN 62366 (VDE 0750-241), Medical devices Application of usability engineering to medical devices DIN EN

19、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 reflecting plane DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN IS

20、O 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 8836, Suction catheters for use in the respiratory tract DIN EN ISO 10079-2, Medical suction equipment Part 2: Manually powered suction equipment DIN EN ISO 10079-3, Medical suction equipment Part 3: Suction equipment power

21、ed from a vacuum or positive pressure gas source DIN EN ISO 10651-4, Lung ventilators Part 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

22、 of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 80369 (all parts), Small bore connectors for liquids and gases in healthcare applications EUROPEA

23、N STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-1 November 2015 ICS 11.040.10 Supersedes EN ISO 10079-1:2009English Version Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) Appareils daspiration mdicale - Partie 1: Appareils lectriques daspiration

24、 (ISO 10079-1:2015) Medizinische Absauggerte - Teil 1: Elektrisch betriebene Absauggerte (ISO 10079-1:2015) This European Standard was approved by CEN on 13 May 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Sta

25、ndard 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 any CEN member. This European Standard exists in three official versions (Engli

26、sh, 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 versions. CEN members are the national standards bodies of Austria, Belgium, B

27、ulgaria, 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, Switzerland,

28、 Turkey andUnited 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 Member

29、s. Ref. No. EN ISO 10079-1:2015 EEuropean foreword .41 Scope . 92 Normative references 93 Terms and definitions 104 General requirements 124.1 Risk management 124.2 Usability . 134.3 Clinical investigation . 134.4 Biophysical or modelling research . 134.5 Test methods 135 Cleaning, disinfection and

30、sterilization . 136 Design requirements . 146.1 Collection container. 146.1.1 General. 146.1.2 Container capacity . 146.1.3 Container strength 146.2 Connections 146.2.1 Tubing connectors for collection containers 146.2.2 Inlet port 156.2.3 Exhaust port 156.3 Suction tubing . 156.4 Vacuum level indic

31、ators . 156.5 Spillage on electrical suction equipment 167 Operational requirements 167.1 Ease of operation . 167.2 Dismantling and reassembly 167.3 Mechanical shock . 167.4 Stability . 167.5 Protective devices 177.5.1 Contamination protection . 177.5.2 Overfill protection devices . 177.5.3 Pressure

32、 protection 177.6 Noise . 177.6.1 Low vacuum/low flowrate equipment 177.6.2 Suction equipment other than that specified in 7.6.1 . 177.7 Air leakage . 187.7.1 Collection containers for general use .187.7.2 Collection containers for thoracic drainage 188 Physical requirements for suction equipment fo

33、r field use .188.1 (*) Dimensions . 188.2 Mass . 189 Performance requirements for vacuum level and flowrate .189.1 High vacuum/high flowrate equipment . 189.2 Medium vacuum equipment. 199.3 Low vacuum/low flowrate equipment 19Contents PageAnnex ZA (informative) Relationship between this European Sta

34、ndard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered 5 Foreword 8.DIN EN ISO 10079-1:2016-05 EN ISO 10079-1:2015 (E)2 9.10 Battery powered transportable suction equipment 209.11 Interruption of the power supply 2010 (*) Resistance to environment of suction equipme

35、nt for field and/or transport use .2010.1 Operating conditions 2010.2 Storage 2011 Information to be supplied by the manufacturer (labelling and instructions for use) .2111.1 Information supplied by the manufacturer shall comply with EN 1041. 2111.3 Labelling of equipment . 2111.4 Instructions for u

36、se 22Annex A (normative) Test methods 24Annex B (informative) Rationale statement 35Annex C (informative) Lumen size and its effect on flowrate 36Annex D (informative) Schematic of suction equipment 37Bibliography .389.4 Low vacuum/high flowrate equipment 199.5 Thoracic drainage equipment for adults

37、 . 199.6 Intermittent vacuum equipment 199.7 Vacuum regulators with fixed setting 199.8 Vacuum regulators with variable setting 209.9 Equipment intended for pharyngeal suction .20DIN EN ISO 10079-1:2016-05 EN ISO 10079-1:2015 (E)3 European foreword This document (EN ISO 10079-1:2015) has been prepar

38、ed 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 BSI. This European Standard shall be given the status of a national standard, either by public

39、ation of an identical text or by endorsement, at the latest by May 2016, and conflicting national standards shall be withdrawn at the latest by November 2018. 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 shal

40、l not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10079-1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(

41、s). For relationship with EU Directive(s), 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 following countries are bound to implement this European Standard: Austria, Belgium, Bulgari

42、a, 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, Switzerland, Turke

43、y and the United Kingdom. Endorsement notice The text of ISO 10079-1:2015 has been approved by CEN as EN ISO 10079-1:2015 without any modification. DIN EN ISO 10079-1:2016-05 EN ISO 10079-1:2015 (E)4 Annex ZA (informative) Relationship between this European Standard and the essential requirements of

44、 Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council D

45、irective 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard,

46、 a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC

47、 as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in co

48、mpliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 Third indent only 4.4 7.2 5; 7.5