ISO 10651-5-2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5 Gas-powered emergency resuscitat.pdf

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1、 Reference number ISO 10651-5:2006(E) ISO 2006INTERNATIONAL STANDARD ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators Ventilateurs pulmonaires usage mdical Exigences pa

2、rticulires pour la scurit de base et les performances essentielles Partie 5: Appareils de ranimation durgence aliments par gaz ISO 10651-5:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not

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5、mber bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or

6、mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web ww

7、w.iso.org Published in Switzerland ii ISO 2006 All rights reservedISO 10651-5:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 * Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 4 4.1 General. 4 4.2 Other test methods. 5 4.3 Acc

8、eptance criteria. 5 5 Constructional requirements. 6 5.1 General. 6 5.2 Connectors 7 6 Operational requirements 9 6.1 General. 9 6.2 Resistance to environmental influences10 6.3 Resistance to typical use. 10 6.4 Size and mass . 11 6.5 Gas supply. 11 7 Performance 12 7.1 Ventilatory requirements . 12

9、 7.2 * Ventilation performance . 14 8 Identification, marking and documents 17 8.1 General. 17 8.2 Marking 18 8.3 Information provided by the manufacturer for operation and maintenance 19 Annex A (informative) Rationale . 23 Annex B (normative) Test methods 28 Annex C (informative) Relationship betw

10、een this part of ISO 10651 and cardiopulmonary resuscitation guidelines. 40 Annex D (informative) Clauses of this part of ISO 10651 addressing the essential principles 41 Annex E (informative) Terminology Index of defined terms 43 Bibliography . 45 ISO 10651-5:2006(E) iv ISO 2006 All rights reserved

11、Foreword 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 body interested in a subject for which a t

12、echnical 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 Electrotechnical Commission (IEC) on all matters

13、 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 the technical committees are circulate

14、d 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

15、for identifying any or all such patent rights. ISO 10651-5 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. This first edition of ISO 10651-5, together with ISO 10651-4:2002, cancels and replaces ISO 838

16、2:1988, which has been technically revised. ISO 10651 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 3: Particular requi

17、rements for emergency and transport ventilators Part 4: Particular requirements for operator-powered resuscitators Part 5: Gas-powered emergency resuscitators Part 6: Home-care ventilatory support devices NOTE ISO 10651-1:1993, Lung ventilators for medical use Part 1: Requirements, was withdrawn in

18、2001 and has been revised as IEC 60601-2-12:2001, Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilators. ISO 10651-5:2006(E) ISO 2006 All rights reserved v Introduction For victims whose lives are at risk from respiratory failure

19、, in particular during cardiac arrest, resuscitation councils and associations teach that the best ultimate outcome will be achieved if there is a continuous chain of care starting with earliest possible bystander cardiopulmonary resuscitation and continuing until the victim can be put under profess

20、ional medical care. In order to improve the care possible at the early stages of this chain, authorities and organizations are training non-specialized personnel in key situations, such as where people congregate or where there are increased risks, so that they can be available to provide a higher l

21、evel of care with a minimum of delay. There is a growing realization that the effectiveness of such intervention can be greatly enhanced by the use of certain basic equipment, such as that which provides ventilation whilst avoiding mouth-to-mouth contact. Simple, gas-powered emergency resuscitators

22、can deliver controlled ventilation for this purpose and this document specifies the criteria they are required to satisfy. In this part of ISO 10651, the following symbols and notations are used: requirements, compliance with which can be tested, and definitions: roman type; notes, explanations, adv

23、ice, introductions, general statements and references: smaller roman type; test specifications: italic type; terms defined in ISO 4135:2001, IEC 60601-1:1988 or in this part of ISO 10651: bold type. Throughout this part of ISO 10651, text for which a rationale is provided in Annex A is indicated by

24、an asterisk (*). INTERNATIONAL STANDARD ISO 10651-5:2006(E) ISO 2006 All rights reserved 1 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators 1 * Scope This part of ISO 10651 specifies the basic safety and e

25、ssential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use. This part of ISO 10651 also specifies the requirem

26、ents for resuscitator sets (3.22). This part of ISO 10651 is not applicable to electrically-powered resuscitators. NOTE ISO 10651-3 covers emergency and transport ventilators. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated

27、references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 31 (all parts), Quantities and units ISO 32, Gas cylinders for medical use Marking for identification of content ISO 1000, SI units and recommenda

28、tions for the use of their multiples and of certain other units ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2:

29、Screw-threaded weight- bearing connectors ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed

30、 medical gases and vacuum ISO 10297, Gas cylinders Refillable gas cylinder valves Specification and type testing ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices ISO 10651-5:2006(E) 2 ISO 2006 All rights reserv

31、edISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves ISO 11607, Packaging for terminally sterilized medical devices ISO 14971, Medical devices Application of risk management to medical devices and Amendment 1:2003 ISO 15223:2000, M

32、edical devices Symbols to be used with medical device labels, labelling and information to be supplied and Amendment 1:2002 and Amendment 2:2004 ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 23328-1

33、:2003, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects IEC 60529:2001, Degrees of protection provided by enclosures (IP

34、 code) IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety and Amendment 1:1991 and Amendment 2:1995 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4135:2001, IEC 60601-1:1988 and the following apply. For convenien

35、ce, the sources of all defined terms used in this document are given in Annex E. 3.1 accompanying documents documents accompanying resuscitator or resuscitator sets and containing all important information for the user, operator, installer or assembler of the resuscitator, particularly regarding saf

36、ety NOTE Adapted from IEC 60601-1:1988, definition 2.1.4. 3.2 automatic pressure-cycled resuscitator resuscitator in which the cycling from the inspiratory phase to the expiratory phase occurs after attaining a pressure determined by the control setting 3.3 automatic time-cycled resuscitator resusci

37、tator in which the cycling between the inspiratory phase and expiratory phase is controlled automatically at time intervals determined by the control setting 3.4 automatic volume-cycled resuscitator resuscitator in which the cycling from the inspiratory phase to the expiratory phase occurs after the

38、 delivery of a delivered volume determined by the control setting 3.5 cardiopulmonary resuscitation combination of rescue breathing and chest compressions delivered to victims thought to be in cardiac arrest AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Care ISO 10651-5:2006(E) ISO

39、2006 All rights reserved 33.6 clearly legible capable of being read by the operator or other relevant person with normal vision NOTE See also 8.2.1. 3.7 * delivered volume V delvolume of gas delivered through the patient connection port during an inspiratory phase 3.8 demand valve part of the resusc

40、itator that delivers a flow of gas related to a reduction of pressure generated by the patient at the patient connection port 3.9 first responder individual who has been trained to provide primary response to a respiratory emergency EXAMPLE 1 Fire fighter. EXAMPLE 2 Emergency medical technician. 3.1

41、0 gas-powered emergency resuscitator resuscitator portable equipment, powered by compressed gas, intended for immediate use to provide lung ventilation in the resuscitation of individuals who have sudden breathing difficulties 3.11 inadvertent positive end-expiratory pressure inadvertent PEEP uninte

42、nded positive pressure at the patient connection port at the end of the expiratory phase 3.12 intermediate hose hose that conducts gas between parts of the resuscitator 3.13 manually-cycled resuscitator resuscitator in which the inspiratory phase and expiratory phase are controlled by a repeated man

43、ual action of the operator NOTE A demand valve that can be overridden with a manual trigger is, for the purposes of this document, classified as a manually-cycled resuscitator incorporating a demand valve and not as a demand valve as they are commonly termed in some countries. 3.14 minute volume V v

44、olume of gas per minute entering or leaving the patients lungs 3.15 operator person handling the resuscitator NOTE Adapted from IEC 60601-1:1988, definition 2.12.17. ISO 10651-5:2006(E) 4 ISO 2006 All rights reserved3.16 patient-triggered resuscitator resuscitator in which the cycling from the expir

45、atory phase to the inspiratory phase is triggered by an inspiratory effort of the patient 3.17 patient-triggering mode of operation in which a reduction of pressure generated by the patient at the patient connection port initiates the set inspiratory phase 3.18 patient valve valve in the resuscitato

46、r breathing system that directs gas into the lungs during the inspiratory phase and from the lungs into the atmosphere during the expiratory phase 3.19 pressure-limiting device means for limiting the maximum pressure within the resuscitator breathing system 3.20 resuscitator breathing system breathi

47、ng system bounded by the low-pressure gas input port(s), the gas intake port(s) and the patient connection port, together with the fresh gas intake port and exhaust port(s), if these are provided 3.21 resuscitator dead space volume of previously exhaled gas within the resuscitator breathing system t

48、hat is delivered to the patient in the succeeding inspiratory phase 3.22 resuscitator set pack of all the necessary components that enable the resuscitator to be carried to the site of a resuscitation emergency and that enable the resuscitator to be made ready for immediate use 3.23 safety hazard po

49、tentially detrimental effect on the patient, other persons, animals, or the surroundings, arising directly from the resuscitator NOTE Adapted from IEC 60601-1:1988, definition 2.12.18. 3.24 single fault condition condition in which a single means for protection against a safety hazard in the resuscitator is defective or a single external abnormal condition is present NOTE Adapted from IEC 60601-1:1988, definition 2.10.11. 4 General requirements 4.1 General The r