BS EN ISO 10651-6-2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Home-care ventilatory support devices《医用肺通气器 基本安全性和必要.pdf

1、BS EN ISO10651-6:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDLung ventilators formedical useParticular requirements for basicsafety and essential performance Part 6: Home-care ventilatory supportdevices (ISO 10651-6:2004)This British Standar

2、dwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2009. BSI 2009ISBN 978 0 580 65479 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10651-6:2009National forewordThis British Standard is the UK implementation of EN ISO10651-6:2009. It is i

3、dentical to ISO 10651-6:2004. It supersedes BS ENISO 10651-6:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can be obtained onreq

4、uest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10651-

5、6April 2009ICS 11.040.10 Supersedes EN ISO 10651-6:2004 English VersionLung ventilators for medical use - Particular requirements forbasic safety and essential performance - Part 6: Home-careventilatory support devices (ISO 10651-6:2004)Ventilateurs pulmonaires usage mdical - Exigencesparticulires p

6、our la scurit de base et les performancesessentielles - Partie 6: Dispositifs dassistance respiratoire domicile (ISO 10651-6:2004)Beatmungsgerte fr die medizinische Anwendung -Besondere Festlegungen fr die grundlegende Sicherheiteinschlielich der wesentlichen Leistungsmerkmale - Teil 6:Heimbeatmungs

7、gerte 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 this EuropeanStandard the status of a national standard without any alteration.

8、 Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationu

9、nder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece,

10、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre

11、: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10651-6:2009: EBS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 3 Foreword The text of ISO 10651-6:2004 has been prepared by Technical Committe

12、e ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been 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 sh

13、all be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest 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 docu

14、ment 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 10651-6:2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade

15、Association, and supports essential requirements of EC Directive. For relationship with EC 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 following countries are bound to

16、implement this European Standard: Austria, Belgium, 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, Switzer

17、land and the United Kingdom. Endorsement notice The text of ISO 10651-6:2004 has been approved by CEN as a EN ISO 10651-6:2009 without any modification. BS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements o

18、f EU Directive 93/42 EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard

19、is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of

20、conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes

21、All 1, 2, 3 4 (3.1) 4, 12.1 4 (3.4) 2 5.2 12.66.1 2, 13.16.1 7.5 (2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 e) 13.3 a) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 q) 13.3 k) 6.1 aa), 6.1 bb) 13.

22、2 6.1 cc) 13.3i) 6.1 dd) 13.3 i), 13.6 k) 6.1 ee) 13.3 e) 6.1 ff) 13.3 b), 13.3 f) 6.1 ff) 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 ff) 2) 13.2 6.1 ff) 3) 13.3 d), 13.5 6.1 ff) 4) 13.3 a) 6.1 ff) 5) 13.3 k) 6.1 ff) 6) 13.3 c) 6.1 ff) 8) 13.3 m

23、) 6.1 gg) 12.8.2, 13.2, 13.3 i) BS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes6.1 hh) 8.7 6.3 2, 10, 12.96.6 12.7.46.8 7.5 (3rdparagraph) This relevant Essential Requirement is not fully

24、addressed in this European Standard 6.8.2 2, 9.1, 13 6.8.2 d) 13.6 a), 13.6 h), 13.6 i) 6.8.2 d) 13.6 (h)(2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2 aa) 1) 13.4 6.8.2 aa) 2) 13.6 c) 6.8.2 aa) 4), 6.8.2 aa) 5), 6.8.2 aa) 6) 12.2, 13.6 d) 6

25、.8.2 aa) 7), 6.8.2 aa) 8) 12.2, 13.6 a) 6.8.2 aa) 9) 13.6 p) 6.8.2 aa) 10) 13.6 l) 6.8.2 aa) 11) 13.6 b) 6.8.2 aa) 12), 6.8.2 aa) 13), 6.8.2 aa) 14), 6.8.2 aa) 15), 6.8.2 aa) 16) 13.6 a) 6.8.2 aa) 15), 6.8.2 aa) 17) 13.6 d) 6.8.3 2, 3, 9.1, 13 6.101 10.27.101 9.1, 12.8.110 4, 5, 9.2 19.4 12.636 9.2,

26、 12.543.2 7.3, 9.344.3 7.644.7 8.144.8 7.1, 7.5 44.8 7.5 (1stparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 46 10.249.101 12.2 49.102 4, 9.2, 12.1 49.103 5, 9.2, 12.9 51.101 4, 9.2 51.102 6, 10.1 51.103 10.1, 12.4, 12.8.2 51.104 10.1. 12.4 51.105 12.4

27、, 12.8.2 52.5 2, 12.1 54.3 5, 9.2, 12.9 56.3 12.7.4 56.101 9.1, 12.8.1 57.3 2, 4, 12.1, 12.8.1 BS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes101 12.4, 12.8.2- 6a)This relevant Essential R

28、equirement is not addressed in this European Standard - 12.1a) This relevant Essential Requirement is not addressed in this European Standard. - 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard WARNING : Other requirements and other EU Directives may be applica

29、ble to the products falling within the scope of this standard. BS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 7 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 de

30、tails the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machin

31、ery directive and thus does not provide presumption of conformity for the machinery directive. Table ZA.2 Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s

32、) of this EN EHSR o 2006/42/EC Qualifying remarks/Notes- 1.1.4 This relevant EHSR is not addressed in this European Standard 6.1, 56 1.5.4 This relevant EHSR is not fully addressed in this European Standard - 1.6.1This relevant EHSR is not addressed in this European Standard - 1.6.2 This relevant EH

33、SR is not addressed in this European Standard - 1.6.3 This relevant EHSR is not addressed in this European Standard - 3.6.2 This relevant EHSR is not addressed in this European Standard BS EN ISO 10651-6:2009ISO 10651-6:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword vi Introduction v

34、ii 1 Scope 1 2 Normative references 1 3 Terms and definitions . 2 4 General requirements and general requirements for tests. 3 5 Classification . 3 6 Identification, marking and documents. 3 6.1 Marking on the outside of equipment or equipment parts 4 6.3 Marking of controls and instruments 5 6.6 Id

35、entification of medical gas cylinders and connections 5 6.101 Test method for legibility 7 7 Power input 8 7.101 Pneumatic power. 8 8 Basic safety categories. 8 9 Removable protective means. 8 10 Environmental conditions. 8 10.101 Pneumatic driving power supplies 9 11 Not used . 9 12 Not used . 9 13

36、 General 9 14 Requirements related to classification9 14.2 * Class II Equipment. 9 15 Limitation of voltage and/or energy. 9 16 Enclosures and protective covers . 9 17 Separation 9 18 Protective earthing, functional earthing and potential equalization 9 19 Continuous leakage currents and patient aux

37、iliary currents 10 19.4 * Tests 10 20 Dielectric strength . 10 21 Mechanical strength 10 22 Moving parts 10 23 Surfaces, corners and edges . 10 24 Stability in normal use 10 25 Expelled parts 10 BS EN ISO 10651-6:2009ISO 10651-6:2004(E) iv ISO 2004 All rights reserved26 Vibration and noise10 27 Pneu

38、matic and hydraulic power.10 28 Suspended masses .11 29 X-radiation 11 30 Alpha, beta, gamma, neutron radiation and other particle radiation11 31 Microwave radiation 11 32 Light radiation (including lasers) .11 33 Infra-red-radiation 11 34 Ultra-violet radiation 11 35 Acoustical energy (including ul

39、trasonics) 11 36 Electromagnetic compatibility11 37 Locations and basic requirements.11 38 Marking, accompanying documents12 39 Common requirements for category AP and category APG equipment12 40 Requirements and tests for category AP equipment, parts and components thereof.12 41 Requirements and te

40、sts for category APG equipment, parts and components thereof12 42 Excessive temperatures12 43 Fire prevention .12 43.2 Oxygen enriched atmospheres 12 43.101 Compatibility with pressurized oxygen .13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection a

41、nd compatibility 13 44.3 Spillage .13 44.7 Cleaning, sterilization and disinfection .13 44.8 Compatibility with substances used with the equipment13 45 Pressure vessels and parts subject to pressure13 46 Human errors14 47 Electrostatic charges.14 48 Biocompatibility .14 49 Interruption of the power

42、supply14 49.101 * Internal electrical power source.14 49.102 Spontaneous breathing during power failure .14 49.103 Accidental operation of the on/off-switch.15 50 Accuracy of operating data.15 51 Protection against hazardous output 15 51.101 Maximum ventilator breathing system pressure limitation.15

43、 51.102 Measurement of airway pressure.15 51.103 * High-inspiratory pressure alarm condition .15 51.104 Expiratory monitoring .15 51.105 Respiration rate alarm condition16 BS EN ISO 10651-6:2009ISO 10651-6:2004(E) ISO 2004 All rights reserved v52 Abnormal operation and fault conditions . 17 53 Envir

44、onmental tests 17 54 General 17 54.3 Protection against inadvertent adjustments. 17 55 Enclosures and covers . 17 56 Components and general assembly 17 56.3 Connections General 17 56.101 Reservoir bags and breathing tubes . 19 57 Mains parts, components and layout 19 57.3 * Power supply cords. 19 58

45、 Protective earthing Terminals and connections 19 59 Construction and layout . 20 101 Alarm systems . 20 102 Appendices of IEC 60601-1:1988 . 20 Annex AA (informative) Rationale. 21 Annex BB (informative) Reference to the Essential Principles . 25 Bibliography . 26 BS EN ISO 10651-6:2009ISO 10651-6:

46、2004(E) vi ISO 2004 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member bod

47、y interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrote

48、chnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by

49、 the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10651-6 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. This