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

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1、ANSI/AAMI/ISO 10651-5:2006Lung ventilators for medical useParticular requirements for basic safety and essential performancePart 5: Gas-powered emergency resuscitators American National StandardThis document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an A

2、AMI standard. The original formatting has been maintained, so there are some variations from the typical AAMI style. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancem

3、ent of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaini

4、ng to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Viol

5、ators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. P

6、hone: 703-525-4890; Fax: 703-525-1067. Printed in the United States of America ISBN 157020540X ASTM InternationalINTERNATIONALSTANDARDANSI/ISO10651-5First edition2006-02-01Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergenc

7、y resuscitators Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les performances essentielles Partie 5: Appareils de ranimation durgence aliments par gaz ANSI/ISO 10651-5:2006(E) MOD in ANSI/ISO 10651-5 means that ASTM International has approved the standard as

8、 an American National Standard with deviations. The U.S. deviations are appended to the end of ANSI/ISO 10651-5.ASTM InternationalThese materials are subject to copyright claims of ASTM International. Not for resale without the prior written permission of ASTM International. No part of this publicat

9、ion may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASTM International. ii ASTM International ANSI/ISO 10651-5:2006(E) ASTM International iiiContents PageForeword .ivIntroductionv1 * Scope12 Normative references .13 Terms and definitio

10、ns.24 General requirements.44.1 General 44.2 Other test methods .54.3 Acceptance criteria.55 Constructional requirements .65.1 General 65.2 Connectors76 Operational requirements 96.1 General 96.2 Resistance to environmental influences.106.3 Resistance to typical use .106.4 Size and mass .116.5 Gas s

11、upply.117 Performance127.1 Ventilatory requirements127.2 * Ventilation performance148 Identification, marking and documents.178.1 General 178.2 Marking188.3 Information provided by the manufacturer for operation and maintenance 19Annex A (informative) Rationale .23Annex B (normative) Test methods 28

12、Annex C (informative) Relationship between this part of ISO 10651 and cardiopulmonary resuscitation guidelines .40Annex D (informative) Clauses of this part of ISO 10651 addressing the essential principles 41Annex E (informative) Terminology Index of defined terms.43Bibliography.45ANSI/ISO 10651-5:2

13、006(E) ivASTM InternationalForeword 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

14、 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 Electrotechnical Comm

15、ission (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 the technic

16、al 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 sha

17、ll not be held responsible 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, can

18、cels and replaces ISO 8382:1988, 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

19、 Part 3: Particular requirements 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: Requir

20、ements, was withdrawn in 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.ANSI/ISO 10651-5:2006(E) ASTM International vIntroductionFor victims whose lives are at risk from re

21、spiratory failure, 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

22、put under professional 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 p

23、rovide a higher level 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 emergen

24、cy resuscitators 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,

25、explanations, advice, 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

26、is indicated by an asterisk (*).INTERNATIONAL STANDARD ANSI/ISO 10651-5:2006(E)ASTM International 1Lung 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 safe

27、ty and essential 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 r

28、equirements 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

29、dated 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 unitsISO 32, Gas cylinders for medical use Marking for identification of contentISO 1000, SI units and recomm

30、endations for the use of their multiples and of certain other unitsISO 4135:2001, Anaesthetic and respiratory equipment VocabularyISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2:

31、 Screw-threaded weight-bearing connectorsISO 5359, Low-pressure hose assemblies for use with medical gasesISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilatorsISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed me

32、dical gases and vacuumISO 10297, Gas cylinders Refillable gas cylinder valves Specification and type testingISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devicesANSI/ISO 10651-5:2006(E) 2ASTM InternationalISO 10524-

33、3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valvesISO 11607, Packaging for terminally sterilized medical devicesISO 14971, Medical devices Application of risk management to medical devices and Amendment 1:2003 ISO 15223:2000, Medical devices

34、 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 devicesISO 23328-1:2003, Breathin

35、g system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performanceISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspectsIEC 60529:2001, Degrees of protection provided by enclosures (IP code)IEC 60601-1

36、: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 convenience, the sources of

37、 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 safety NOTE Adapted f

38、rom 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 resuscitator in which the

39、 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 delivery of a del

40、ivered 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 CareANSI/ISO 10651-5:2006(E) ASTM International

41、 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 Vdelvolume of gas delivered through the patient connection port during an inspiratory phase 3.8 demand valve part of the resuscitator that delivers a fl

42、ow of gas related to a reduction of pressure generated by the patientat the patient connection port3.9 first responder individual who has been trained to provide primary response to a respiratory emergency EXAMPLE 1 Fire fighter. EXAMPLE 2 Emergency medical technician. 3.10 gas-powered emergency res

43、uscitator 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 unintended positive pressure at t

44、he patient connection port at the end of the expiratory phase3.12 intermediate hose hose that conducts gas between parts of the resuscitator3.13 manually-cycled resuscitator resuscitator in which the inspiratory phase and expiratory phase are controlled by a repeated manual action of the operatorNOT

45、E 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 Vvolume of gas per minute enterin

46、g or leaving the patients lungs 3.15 operator person handling the resuscitatorNOTE Adapted from IEC 60601-1:1988, definition 2.12.17. ANSI/ISO 10651-5:2006(E) 4ASTM International3.16 patient-triggered resuscitator resuscitator in which the cycling from the expiratory phase to the inspiratory phase i

47、s triggered by an inspiratory effort of the patient3.17 patient-triggering mode of operation in which a reduction of pressure generated by the patient at the patient connection port initiates the set inspiratory phase3.18 patient valve valve in the resuscitator breathing system that directs gas into

48、 the lungs during the inspiratory phase and from the lungs into the atmosphere during the expiratory phase3.19 pressure-limiting device means for limiting the maximum pressure within the resuscitator breathing system3.20 resuscitator breathing system breathing system bounded by the low-pressure gas

49、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 that is delivered to the patient in the succeeding inspiratory phase3.22 resuscitator set pack of all the necessary components that enable the