DIN EN ISO 10651-6-2011 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6 Home-care ventilatory support devices (ISO 10.pdf

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1、June 2011 Translation by DIN-Sprachendienst.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 1

2、1.040.10!$r+e“1790866www.din.deDDIN EN ISO 10651-6Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)English translation of DIN EN ISO 10651-6:2011-06Beatmungsgerte fr die medizinische An

3、wendung Besondere Festlegungen fr die grundlegende Sicherheit einschlielich der wesentlichenLeistungsmerkmale Teil 6: Heimbeatmungsgerte zur Atemuntersttzung (ISO 10651-6:2004)Englische bersetzung von DIN EN ISO 10651-6:2011-06Ventilateurs pulmonaires usage mdical Exigences particulires pour la scur

4、it de base et les performances essentielles Partie 6: Dispositifs dassistance respiratoire domicile (ISO 10651-6:2004)Traduction anglaise de DIN EN ISO 10651-6:2011-06SupersedesDIN EN ISO 10651-6:2009-08www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be consi

5、dered authoritative.4205.11 DIN EN ISO 10651-6:2011-06 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 1 August 2009. DIN EN ISO 10651-6:2004-10 may be used in parallel until 21 March 2010. National foreword This standard has been prepared b

6、y Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the

7、 Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. DIN EN ISO 1065

8、1 consists of the following parts, under the general title Lung ventilators for medical use Particular requirements for basic safety and essential performance: Part 2: Home care ventilators for ventilator-dependent patients Part 4: Particular requirements for operator-powered resuscitators Part 6: H

9、ome care ventilatory support devices Particular requirements for the safety of critical care ventilators are dealt with in DIN EN 60601-2-12 (VDE 0750-2-12) will shortly be replaced by DIN EN 80601-2-12 (VDE 0750-1-12 and particular requirements for emergency and transport ventilators are covered by

10、 DIN EN 794-3. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 594-1 DIN EN 20594-1 ISO 4135 DIN EN ISO 4135 ISO 8359 DIN EN ISO 8359 ISO 14971 DIN EN ISO 14971 ISO 14937 DIN EN ISO 14937 ISO 18777 DIN EN ISO 18777 ISO 18779 DIN EN ISO

11、18779 IEC 60601-1 DIN EN 60601-1 (VDE 0750 Part 1) IEC 60601-1-1 DIN EN 60601-1-1 (VDE 0750 Part 1-1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750 Part 1-2) IEC 60601-1-4 DIN EN 60601-1-4 (VDE 0750 Part 1-4) DIN EN ISO 10651-6:2011-06 3 Amendments This standard differs from DIN EN ISO 10651-6:2004-10 as

12、 follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amendi

13、ng Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Compared with DIN EN ISO 10651-6:2009-08, the following c

14、orrection has been made to the German version only and therefore does not affect the English text: a) in Subclause 10.101, “200 ml/s” has been corrected to read “200 l/min”. Previous editions DIN EN 794-2: 1997-09 DIN EN ISO 10651-6: 2004-10, 2009-08 DIN EN ISO 10651-6:2011-06 4 National Annex NA (i

15、nformative) Bibliography DIN EN 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 Teil 1), Medical electrical equipment Part 1: General requirements for basic safety and essential performa

16、nce DIN EN 60601-1-1 (VDE 0750 Teil 1-1), Medical electrical equipment Part 1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems Amendment 1 DIN EN 60601-1-2 (VDE 0750 Teil 1-2), Medical electrical equipment Part 1-2: General requirements for bas

17、ic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests DIN EN 60601-1-4 (VDE 0750 Teil 1-4), Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems DIN EN ISO 4135, Ana

18、esthetic and respiratory equipment Vocabulary DIN EN ISO 8359, Oxygen concentrators for medical use Safety requirements DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 14937, Sterilization of health care products General criteria for characterization of

19、 a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 18777, Transportable liquid oxygen systems for medical use Particular requirements DIN EN ISO 18779, Medical devices for conserving oxygen and oxygen mixtures Particular

20、 requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10651-6 April 2009 ICS 11.040.10 Supersedes EN ISO 10651-6:2004 English Version Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices (IS

21、O 10651-6:2004) Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les performances essentielles Partie 6: Dispositifs dassistance respiratoire domicile (ISO 10651-6:2004) Beatmungsgerte fr die medizinische Anwendung Besondere Festlegungen fr die grundlegende Sich

22、erheit einschlielich der wesentlichen Leistungsmerkmale Teil 6: Heimbeatmungsgerte zur Atemuntersttzung (ISO 10651-6:2004) This European Standard was approved by CEN on 14 March 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

23、this European Standard 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 Management Centre or to any CEN member. This European Standard exists in three official versio

24、ns (English, 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium,

25、Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STAN

26、DARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10651-6:2009: EContents Page Foreword 5 Introdu

27、ction .6 1 Scope.8 2 Normative references.8 3 Terms and definitions 9 4 General requirements and general requirements for tests10 5 Classification 10 6 Identification, marking and documents .10 6.1 Marking on the outside of equipment or equipment parts 11 6.3 Marking of controls and instruments.12 6

28、.6 Identification of medical gas cylinders and connections 12 6.101 Test method for legibility.14 7 Power input.15 7.101 Pneumatic power15 8 Basic safety categories .15 9 Removable protective means15 10 Environmental conditions .15 10.101 Pneumatic driving power supplies.16 11 Not used 16 12 Not use

29、d 16 13 General 16 14 Requirements related to classification 16 14.2 * Class II Equipment .16 15 Limitation of voltage and/or energy .16 16 Enclosures and protective covers16 17 Separation.16 18 Protective earthing, functional earthing and potential equalization.16 19 Continuous leakage currents and

30、 patient auxiliary currents 17 19.4 * Tests 17 20 Dielectric strength17 21 Mechanical strength.17 22 Moving parts .17 23 Surfaces, corners and edges 17 24 Stability in normal use .17 25 Expelled parts.17 DIN EN ISO 10651-6:2011-06 EN ISO 10651-6:2009 (E) 2 26 Vibration and noise17 27 Pneumatic and h

31、ydraulic power.17 28 Suspended masses18 29 X-radiation 18 30 Alpha, beta, gamma, neutron radiation and other particle radiation18 31 Microwave radiation.18 32 Light radiation (including lasers) .18 33 Infra-red-radiation 18 34 Ultra-violet radiation 18 35 Acoustical energy (including ultrasonics) 18

32、 36 Electromagnetic compatibility18 37 Locations and basic requirements.18 38 Marking, accompanying documents19 39 Common requirements for category AP and category APG equipment 19 40 Requirements and tests for category AP equipment, parts and components thereof.19 41 Requirements and tests for cate

33、gory APG equipment, parts and components thereof 19 42 Excessive temperatures19 43 Fire prevention .19 43.2 Oxygen enriched atmospheres 19 43.101 Compatibility with pressurized oxygen .20 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatib

34、ility 20 44.3 Spillage .20 44.7 Cleaning, sterilization and disinfection .20 44.8 Compatibility with substances used with the equipment20 45 Pressure vessels and parts subject to pressure 20 46 Human errors21 47 Electrostatic charges.21 48 Biocompatibility .21 49 Interruption of the power supply21 4

35、9.101 * Internal electrical power source .21 49.102 Spontaneous breathing during power failure .21 49.103 Accidental operation of the on/off-switch .22 50 Accuracy of operating data.22 51 Protection against hazardous output 22 51.101 Maximum ventilator breathing system pressure limitation.22 51.102

36、Measurement of airway pressure .22 51.103 * High-inspiratory pressure alarm condition .22 51.104 Expiratory monitoring22 51.105 Respiration rate alarm condition23 DIN EN ISO 10651-6:2011-06 EN ISO 10651-6:2009 (E) 3 52 Abnormal operation and fault conditions24 53 Environmental tests .24 54 General 2

37、4 54.3 Protection against inadvertent adjustments .24 55 Enclosures and covers 24 56 Components and general assembly.24 56.3 Connections General.24 56.101 Reservoir bags and breathing tubes26 57 Mains parts, components and layout.26 57.3 * Power supply cords .26 58 Protective earthing Terminals and

38、connections 26 59 Construction and layout 27 101 Alarm systems27 102 Appendices of IEC 60601-1:1988 27 Annex AA (informative) Rationale .28 Annex BB (informative) Reference to the Essential Principles 32 Bibliography 33 Annex ZA (informative) Relationship between this European Standard and the Essen

39、tial Requirements of EU Directive 93/42 EEC 35 DIN EN ISO 10651-6:2011-06 EN ISO 10651-6:2009 (E) 4 Foreword The text of ISO 10651-6:2004 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has be

40、en taken over as EN ISO 10651-6:2009 by 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 publication of an identical text or by endorsement, at the latest

41、 by October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. 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 held responsible for identifying any or all such

42、patent rights. This document supersedes EN ISO 10651-6:2004. 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 EC Directive. For relationship with EC Directive, see informative Annex

43、 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, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Ge

44、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10651-6:2004 has been approved by CEN as a EN ISO 10651-6:2

45、009 without any modification. DIN EN ISO 10651-6:2011-06 EN ISO 10651-6:2009 (E) 5 Introduction This part of ISO 10651 specifies requirements for ventilatory support devices mainly for home-care use but which could be used elsewhere (in healthcare facilities or other locations) for patients not depe

46、ndent on ventilatory support, i.e. where the ventilator is not considered to be life-supporting equipment. These ventilators are frequently used in locations where driving power is not reliable. These ventilators often are supervised by non-healthcare personnel with varying levels of training. This

47、part of ISO 10651 is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic standard for the safety of all medical electrical equipment used by or under the supervision of qualified

48、 personnel in the general medical and patient environment; it also contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or

49、hazards and apply to all applicable equipment, such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collateral Standard and Particular Standards can be found in IEC 60601-1:1988, 1.5 and A.2, respectively. To facilitate the use of this part of ISO 10651, the fol