DIN EN ISO 80601-2-72-2016 Medical electrical equipment - Part 2-72 Particular requirements for basic safety and essential performance of home healthcare environment ventilators fo.pdf

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1、April 2016 English price group 32No 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!%Q5“2469718www.din.deDIN

2、 EN ISO 80601-2-72Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015);English version EN ISO 80601-2-72:2015,English translation of DIN EN ISO 806

3、01-2-72:2016-04Medizinische elektrische Gerte Teil 2-72: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Heimbeatmungsgerten fr vom Gert abhngige Patienten (ISO 80601-2-72:2015);Englische Fassung EN ISO 80601-2-72:2015,Englische bersetzung von DIN EN ISO

4、 80601-2-72:2016-04Appareils lectromdicaux Partie 2-72: Exigences particulires pour la scurit de base et les performances essentielles des ventilateurs utiliss dans lenvironnement des soins domicile pour les patients ventilo-dpendants (ISO 80601-2-72:2015);Version anglaise EN ISO 80601-2-72:2015,Tra

5、duction anglaise de DIN EN ISO 80601-2-72:2016-04SupersedesDIN EN ISO 10651-2:2011-06See start of applicationwww.beuth.deDocument comprises 105 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 80601-2-72:2016-04

6、 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2016-04-01. For DIN EN ISO 10651-2:2:2011-06 there is a transition period ending on 2018-09-30. National foreword This document (EN ISO 80601-2-72:2015) has been prepared by Technical Committe

7、e 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 preparation was DIN-Normenausschuss Rettungsdiens

8、t und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 594-1 DIN EN 20594-1 ISO 3744 DIN EN ISO 3744 ISO 4135 D

9、IN EN ISO 4135 ISO 4871 DIN EN ISO 4871 ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 5359 DIN EN ISO 5359 ISO 5367 DIN EN ISO 5367 ISO 7000 DIN ISO 7000 ISO 7101 DIN EN ISO 7010 ISO 7396-1 DIN EN ISO 7396-1 ISO 8185 DIN EN ISO 8185 ISO 8836 DIN EN ISO 8836 ISO 9360-1 DIN EN ISO 9360

10、-1 ISO 9360-2 DIN EN ISO 9360-2 ISO 10524-1 DIN EN ISO 10524-1 ISO 10651-4 DIN EN ISO 10651-4 ISO 10651- DIN EN ISO 10651-6 ISO 14159 DIN EN ISO 14159 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 17664 DIN EN ISO 17664 ISO 23328-1 DIN EN ISO 23328-1 ISO 23

11、328-2 DIN EN ISO 23328-2 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750-1-2) IEC 60601-1-3 DIN EN 60601-1-3 (VDE 0750-1-3) IEC 60601-1-6 DIN EN 60601-1-6 (VDE 0750-1-6) IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750-1-8) IEC 60601-1-11 DIN EN 60601-1-11 (VDE 0750-1-11) IE

12、C 60601-2-2 DIN EN 60601-2-2 (VDE 0750-2-2) IEC 60721-3-7 DIN EN 60721-3-7 IEC 61672-1 DIN EN 61672-1 DIN EN ISO 80601-2-72:2016-04 3 IEC 62304 DIN EN 62304 (VDE 0750-101) IEC 62366 DIN EN 62366 (VDE 0750-241) ISO 80369-1 DIN EN ISO 80369-1 ISO 80369-2 DIN EN ISO 80369-2 ISO 80601-2-12 DIN EN ISO 80

13、601-2-12 (VDE 0750-2-12) ISO 80601-2-55 DIN EN ISO 80601-2-55 (VDE 0750-2-55) Amendments This standard differs from DIN EN ISO 10651-2:2011-06 as follows: a) the standard has been aligned with DIN EN 60601-1:2007-07 and DIN EN 60601-1-11; b) the scope has been extended to include the ventilator and

14、its accessories, where the characteristics of those accessories can affect the basic safety and essential performance of the ventilator; c) the essential performance of a ventilator and its accessories has been identified; d) the requirements for the alarm condition of the obstruction of the expirat

15、ory limb (continuing airway pressure) have been modified; e) tests for ventilation performance, mechanical strength, enclosure integrity as well as for cleaning and disinfection procedures have been included; f) requirements for a ventilator as a component of a medical electrical system have been sp

16、ecified; g) details regarding contamination of the breathing gas delivered to the patient from the gas pathways have been included; h) requirements for marking and information to be supplied by the manufacturer have been revised; i) requirements for functional connections to support the remote conne

17、ction, including informative details regarding a data interface have been specified; j) the standard has been editorially revised. Previous editions DIN EN 794-2: 1997-09 DIN EN ISO 10651-2: 2004-10, 2009-08, 2011-06 DIN EN ISO 80601-2-72:2016-04 4 National Annex NA (informative) Bibliography DIN EN

18、 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-2 (VDE 0750-1-2),

19、 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances Requirements and tests DIN EN 60601-1-3 (VDE 0750-1-3), Medical electrical equipment Part 1-3: General requirements for basic safety and essential

20、 performance Collateral standard: Radiation protection in diagnostic X-ray equipment 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 60601-1-8 (VDE 0750-1-8), Medical electri

21、cal equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems DIN EN 60601-1-11 (VDE 0750-1-11), Medical electrical equipment Part

22、1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment DIN EN 60601-2-2 (VDE 0750-2-2), Medical electrical equipment Part 2-2: Particular requireme

23、nts for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories DIN EN 60721-3-7, Classification of environmental conditions Part 3: Classification of groups of environmental parameters and their severities Section 7: Portable and non-s

24、tationary use DIN EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications DIN EN 62304 (VDE 0750-101), Medical device software Software life cycle processes DIN EN 62366 (VDE 0750-241), Medical devices Application of usability engineering to medical devices DIN EN ISO 3744, Acoustics

25、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 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 4871, Acoustics Declaration and verification of noi

26、se emission values of machinery and equipment DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 80601-2-72:2016-04 5 DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connec

27、tors DIN EN ISO 5359, Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases DIN EN ISO 5367, Anaesthetic and respiratory equipment Breathing sets and connectors DIN EN ISO 7010, Graphical symbols Safety colours and safety signs Registered safety signs DIN EN I

28、SO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems DIN EN ISO 8836, Suction catheters for use in the respiratory tract D

29、IN EN ISO 9360-1, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml DIN EN ISO 9360-2, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying

30、respired gases in humans Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml 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 Pa

31、rt 4: Particular requirements for operator-powered resuscitators DIN EN ISO 10651-6, Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices DIN EN ISO 14159, Safety of machinery Hygiene requirements for the de

32、sign of machinery DIN EN ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 14971, Medical devices Application of risk manageme

33、nt 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 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of reste

34、rilizable medical devices DIN EN ISO 23328-1, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance DIN EN ISO 23328-2, Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects DIN EN ISO 80369-1, Sma

35、ll bore connectors for liquids and gases in healthcare applications Part 1: General requirements DIN EN ISO 80601-2-72:2016-04 6 DIN EN ISO 80369-2, Small bore connectors for liquids and gases in healthcare applications Part 2: Connectors for breathing systems and driving gases applications DIN EN I

36、SO 80601-2-12 (VDE 0750-2-12), Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators DIN EN ISO 80601-2-55 (VDE 0750-2-55), Medical electrical equipment Part 2-55: Particular requirements for basic safety and essential

37、 performance of respiratory gas monitors DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-72 September 2015 ICS 11.040.10 Supersedes EN ISO 10651-2:2009English Version Medical electrical equipment - Part 2-72: Pa

38、rticular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) Appareils lectromdicaux - Partie 2-72: Exigences particulires pour la scurit de base et les performances essentielles des ventilateurs u

39、tiliss dans lenvironnement des soins domicile pour les patients ventilo-dpendants (ISO 80601-2-72:2015) Medizinische elektrische Gerte - Teil 2-72: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Heimbeatmungsgerten fr vom Gert abhngige Patienten (ISO 80

40、601-2-72:2015) This European Standard was approved by CEN on 7 May 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 bibliogra

41、phical 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 responsibil

42、ity 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 Republic

43、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 NORMALISAT

44、ION 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 80601-2-72:2015 EContents Page European foreword 6 Introduction 9 201.1 Sc

45、ope, object and related standards . 10 201.1.1 *Scope . 10 201.1.2 Object 11 201.1.3 Collateral standards . 11 201.1.4 Particular standards 11 201.2 Normative references 12 201.3 Terms and definitions . 14 201.4 General requirements . 16 201.4.3 ESSENTIAL PERFORMANCE . 16 201.4.3.101 *Additional req

46、uirements for ESSENTIAL PERFORMANCE 17 201.4.6 *ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT 17 201.4.10.2 *SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS. 17 201.4.11.101 *Additional requirements for pressurized gas input . 18 201.4.11.101.1 Overpressure requirement . 18 201.4.11.101.2 Co

47、mpatibility requirement 18 201.5 General requirements for testing of ME EQUIPMENT 19 201.5.101 *Additional requirements for general requirements for testing of ME EQUIPMENT 19 201.5.101.1 VENTILATOR test conditions . 19 201.5.101.2 *Gas flowrate and leakage specifications 19 201.5.101.3 *VENTILATOR

48、testing errors 19 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 19 201.7 ME EQUIPMENT identification, marking and documents . 19 201.7.2.3 *Consult ACCOMPANYING DOCUMENTS . 19 201.7.2.4.101 Additional requirements for ACCESSORIES 20 201.7.2.13.101 Additional requirements for physiological effe

49、cts . 20 201.7.2.17.101 Additional requirements for protective packaging 20 201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 20 201.7.4.2 Control devices . 21 201.7.4.3 *Units of measurement . 21 201.7.9.1 Additional general requirements 21 201.7.9.2.1.101 Additional general requirements 21 201.7.9.2.1.10