BS ISO 10651-5-2008 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Gas-powered emergency resuscitators《医用肺呼吸器 基本安全和基本性能的特殊要.pdf

1、BRITISH STANDARDBS ISO 10651-5:2006Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitatorsICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40

2、g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS ISO 10651-5:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 May 2008 BSI 2008ISBN 978 0 580 53750 9National forewordThis British Standard is

3、the UK implementation of ISO 10651-5:2006. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations represented on this committe

4、e can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments/corrigenda issued since

5、 publicationDate CommentsReference numberISO 10651-5:2006(E)INTERNATIONAL STANDARD ISO10651-5First edition2006-02-01Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators Ventilateurs pulmonaires usage mdical Ex

6、igences particulires pour la scurit de base et les performances essentielles Partie 5: Appareils de ranimation durgence aliments par gaz BS ISO 10651-5:2006ii iiiContents Page Foreword iv Introduction v 1 * Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 4 4.1 G

7、eneral. 4 4.2 Other test methods. 5 4.3 Acceptance 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 Perfo

8、rmance 12 7.1 Ventilatory requirements . 12 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

9、 28 Annex C (informative) Relationship between 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 BS ISO 1

10、0651-5:2006iv 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

11、 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 Commission (IEC)

12、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 technical committees

13、 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 hel

14、d 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, cancels and re

15、places 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 Part 3: Pa

16、rticular 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: Requirements, was

17、 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. BS ISO 10651-5:2006vIntroduction For victims whose lives are at risk from respiratory failure, in particular d

18、uring 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 professional medical car

19、e. 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 level of care with

20、 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 can deliver contr

21、olled 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, advice, introduction

22、s, 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 an asterisk (*).

23、BS ISO 10651-5:2006blank1Lung 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 essential performance requirements for gas-powered emergency resusc

24、itators (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 requirements for resuscitator sets (3.22). This part of ISO 10651 is not a

25、pplicable 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 references, only the edition cited applies. For undated references

26、, 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 recommendations for the use of their multiples and of certain other units IS

27、O 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: Screw-threaded weight-bearing connectors ISO 5359, Low-pressure ho

28、se 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 medical gases and vacuum ISO 10297, Gas cylinders Refillable gas c

29、ylinder 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 BS ISO 10651-5:20062 ISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integr

30、ated 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, Medical devices Symbols to be used with medical device labels, labelling and information to be su

31、pplied 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 23328-1:2003, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to

32、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 code) IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety an

33、d 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 all defined terms used in this document are given in Annex E. 3.1 accompanyin

34、g 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 from IEC 60601-1:1988, definition 2.1.4. 3.2 automatic pressure-cycled resuscit

35、ator 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 cycling between the inspiratory phase and expiratory phase is controlled auto

36、matically 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 delivered volume determined by the control setting 3.5 cardiopulmonary resuscitat

37、ion combination of rescue breathing and chest compressions delivered to victims thought to be in cardiac arrest AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Care BS ISO 10651-5:200633.6 clearly legible capable of being read by the operator or other relevant person with normal visio

38、n 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 flow of gas related to a reduction of pressure generated by the patient at the patient connection port 3

39、.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 resuscitator resuscitator portable equipment, powered by compressed gas, intended for immediate use to

40、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 the patient connection port at the end of the expiratory phase 3.12 intermediate hose hose that condu

41、cts 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 manual action of the operator NOTE A demand valve that can be overridden with a manual trigger is, for the purposes of this docume

42、nt, 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 entering or leaving the patients lungs 3.15 operator person handling the resuscitator NOTE Adapted from

43、IEC 60601-1:1988, definition 2.12.17. BS ISO 10651-5:20064 3.16 patient-triggered resuscitator resuscitator in which the cycling from the expiratory 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 p

44、ressure generated by the patient at the patient connection port initiates the set inspiratory phase 3.18 patient valve valve in the resuscitator 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 press

45、ure-limiting device means for limiting the maximum pressure within the resuscitator breathing system 3.20 resuscitator breathing system breathing 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

46、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 phase 3.22 resuscitator set pack of all the necessary components that enable the resuscitator t

47、o 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 potentially detrimental effect on the patient, other persons, animals, or the surroundings, arising directly from the resuscitator NOTE Adapted from IEC 60601-

48、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 Gene

49、ral The resuscitator shall, when transported, stored, installed, operated in normal use, and maintained according to the accompanying documents, cause no safety hazard that could reasonably be foreseen and that is not connected with its intended application, in normal condition and in single fault condition. A risk management process complying with ISO 14971 shall be performed. BS ISO 10651-5:20065In applying ISO 14971: a) the term “medical device” shall assume the same meaning as resuscitator; b)