• BS 5724-3.12:1991

    Current The latest, up-to-date edition.

    Medical electrical equipment. Particular requirements for performance Method of declaring parameters for lung ventilators

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  29-11-1991

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Committees responsible
    Foreword
    Section 1. General
    1 Scope
    2 Definitions
    Section 2. Test and operating conditions
    3 Test conditions
    3.1 General
    3.2 Accuracy of measurement
    3.3 Test apparatus
    3.4 General test procedures, except for the pre-test
          running described in 5.2
    3.5 Reporting of test results in the ACCOMPANYING
          DOCUMENTS
    Section 3. Declaration and measurement of parameters
    4 Performance parameters
    5 Basic test procedures
    5.1 General
    5.2 Pre-test running
    5.3 Waveform performance test
    5.4 Expiratory resistance test (under CMV)
    5.5 Resistance test (under spontaneous ventilation
          conditions)
    5.6 Volume performance test
    5.7 I:E RATIO performance test
    5.8 INSPIRATORY TIME performance test
    5.9 Rebreathing test
    5.10 Actions-of-controls test
    5.11 MMV performance test
    5.12 Synchronization test
    5.13 Sequence of TRIGGERING sensitivity and delay tests
    5.14 TRIGGERING-FREQUENCY range test
    5.15 Over-maximum-FREQUENCY TRIGGERING waveform test
    5.16 TRIGGERING waveform recording
    6 LUNG VENTILATORS providing CMV
    6.1 General
    6.2 Waveform performance
    6.3 Expiratory resistance
    6.4 Volume performance
    6.5 I:E RATIO performance
    6.6 Rebreathing
    6.7 Additional tests for LUNG VENTILATORS with
          mechanisms for adjusting end-expiratory pressure
    6.8 Actions of controls
    6.9 Additional tests for LUNG VENTILATORS with
          mechanisms for triggered CMV
    7 LUNG VENTILATORS allowing spontaneous ventilation
          which is either unsupplemented or supplemented
          only by PRESSURE ASSISTANCE
    7.1 General
    7.2 Waveform performance
    7.3 Resistance
    7.4 Rebreathing
    7.5 Additional tests for LUNG VENTILATORS with means
          for the production of CPAP or CNAP
    7.6 Additional tests for LUNG VENTILATORS with
          adjustable mechanisms for assisting or hindering
          spontaneous ventilation
    8 LUNG VENTILATORS providing IMV
    8.1 General
    8.2 Tests with simulated spontaneous breaths only
    8.3 Tests with mandatory breaths only
    8.4 Tests with both mandatory and spontaneous breaths
    9 LUNG VENTILATORS providing MMV
    9.1 General
    9.2 Tests with simulated spontaneous breaths only
    9.3 Tests with mandatory breaths only
    9.4 Tests with both intermittent mandatory and
          spontaneous breaths or with pressure-assisted
          mandatory breaths
    Appendices
    A Respiratory data on normal children
    B Modes of operation
    C Bibliography
    Tables
    1 'High' and 'low' flows for resistance tests
    2 Required accuracies
    3 Values corresponding to unit distance in displays
          of waveform performance tests
    4 Static characteristics of the rebreathing test
          apparatus
    5 Settings of the LUNG VENTILATOR and the active
          part of the rebreathing test apparatus for the
          rebreathing tests
    6 Typical presentation of results of an actions-of-
          controls test
    7 Intervals corresponding to a given length of axis
          in plots of the spontaneous/mandatory interaction
          test
    8 Settings of the test apparatus for a sequence of
          TRIGGERING sensitivity and delay tests
    9 Conditions for individual TRIGGERING sensitivity
          and delay tests
    10 Typical presentation of results of a sequence of
          TRIGGERING sensitivity and delay tests
    11 Conditions for the waveform performance test for
          LUNG VENTILATORS providing CMV
    12 Conditions for volume performance test in CMV
    13 Conditions for I:E RATIO performance tests
    14 Settings of the LUNG VENTILATOR for a sequence of
          TRIGGERING sensitivity and delay tests in
          triggered CMV and in SIMV
    15 Settings of the LUNG VENTILATOR for the
          TRIGGERING-FREQUENCY range test in triggered CMV
    16 Typical presentation of results of a TRIGGERING-
          FREQUENCY range test in CMV
    17 Conditions for the waveform performance test for
          LUNG VENTILATORS allowing spontaneous ventilation
    18 Typical presentation of results of a TRIGGERING-
          FREQUENCY range test in PRESSURE ASSISTANCE
    19 Conditions for test 1 of waveform performance
          tests in IMV (DELIVERED VOLUME and INSPIRATORY
          TIME only) and MMV by IMV using only mandatory
          breaths
    20 Conditions for volume performance tests in IMV
    21 Conditions for INSPIRATORY TIME tests in IMV
    22 Conditions for waveform performance tests with
          interaction of spontaneous breathing and MMV
    23 Conditions for synchronization test recordings in
          SIMV
    24 Conditions for waveform performance tests with
          interaction of spontaneous breathing and MMV
    25 Conditions for MMV performance tests
    26 Conditions for synchronization test recordings in
          MMV by SIMV
    27 Respiratory data on normal children
    NUMEROUS FIGURES

    Abstract - (Show below) - (Hide below)

    Includes test methods to be used to measure parameters.

    Scope - (Show below) - (Hide below)

    This standard describes a method of declaring the performance parameters to be stated in documents accompanying a lung ventilator, together with test methods to be used to measure the parameters. It does not cover parameters resulting from recent developments such as jet and very high frequency ventilation and oscillation. Motive power units for lung ventilators together with resuscitators, respiratory therapy ventilators, external body ventilators, rocking apparatus and electrostimulators are outside the scope of this standard. The object of this standard is to permit the direct comparison of lung ventilators of different manufacture, and to standardize methods for the determination of compliance with the manufacturer\'s declared performance. NOTE The titles of the publications referred to in this standard are listed on the inside back cover.

    General Product Information - (Show below) - (Hide below)

    Committee CH/121/5
    Development Note Supersedes 89/53567 DC and BS 3806(1964) (08/2005) Reviewed and confirmed by BSI, March 2013. (03/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Evaluation and testing within a risk management process
    ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
    15/30278530 DC : 0 BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

    Standards Referencing This Book - (Show below) - (Hide below)

    BS 5724-1(1989) : 1989 AMD 6715 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY
    BS 5724-2.13(1990) : 1990 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ANAESTHETIC MACHINES
    BS 6015:1980 Glossary of terms used in anaesthesiology
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