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INTERNATIONAL ISO
STANDARD 80601-2-84
First edition
2020-07
Medical electrical equipment —
Part 2-84:
Particular requirements for the basic
safety and essential performance of
ventilators for the emergency medical
services environment
Appareils électromédicaux —
Partie 2-84: Exigences particulières relatives à la sécurité de base
et aux performances essentielles des ventilateurs utilisés dans
l'environnement des services médicaux d'urgence
Reference number
©
ISO 2020
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2020 – All rights reserved
Contents
Foreword . vi
Introduction . viii
201.1 Scope, object and related standards . 1
201.1.1 * Scope. 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 3
201.2 Normative references . 4
201.3 Terms and definitions . 6
201.4 General requirements . 6
201.4.3 Essential performance . 6
201.4.3.101 * Additional requirements for essential performance . 6
201.4.4 Additional requirements for expected service life . 7
201.4.6 * ME equipment or ME system parts that contact the patient . 7
201.4.11.101 * Additional requirements for pressurized gas input . 7
201.4.11.101.1 Overpressure requirement . 7
201.4.11.101.2 Compatibility requirement for medical gas pipeline systems . 8
201.4.11.101.3 Compatibility requirements for pressure regulators . 8
201.5 General requirements for testing of ME equipment . 9
201.5.101 * Additional requirements for general requirements for testing
of ME equipment . 9
201.5.101.1 EMS ventilator test conditions . 9
201.5.101.2 * Gas flowrate and leakage specifications . 9
201.5.101.3 * EMS ventilator testing errors . 9
201.6 Classification of ME equipment and ME systems . 9
201.7 ME equipment identification, marking and documents . 9
201.7.2.3 * Consult accompanying documents . 9
201.7.2.4.101 Additional requirements for accessories . 10
201.7.2.13.101 Additional requirements for physiological effects . 10
201.7.2.17.101 Additional requirements for protective packaging . 10
201.7.2.18 External gas source . 10
201.7.2.101 * Additional requirements for marking on the outside of
ME equipment or ME equipment parts . 11
201.7.4.2 * Control devices . 12
201.7.4.3 * Units of measurement . 12
201.7.4.101 Labelling of units of measurement . 12
201.7.9.1 Additional general requirements . 12
201.7.9.2.1.101 Additional general requirements . 12
201.7.9.2.2.101 * Additional requirements for warnings and safety notices. 13
201.7.9.2.8.101 * Additional requirements for start-up procedure . 13
201.7.9.2.9.101 * Additional requirements for operating instructions . 14
201.7.9.2.12 Cleaning, disinfection, and sterilization . 15
201.7.9.2.14.101 * Additional requirements for accessories, supplementary
equipment, used material……. . 15
201.7.9.3.1.101 * Additional general requirements . 15
201.7.9.3.101 Additional requirements for the technical description . 16
201.8 Protection against electrical hazards from ME equipment . 16
201.9 Protection against mechanical hazards of ME equipment and ME systems . 16
201.9.4.3.101 * Additional requirements for instability from unwanted
lateral movement………………. . 16
201.9.4.4 Grips and other handling devices . 17
201.9.6.2.1.101 Additional requirements for audible acoustic energy . 17
201.10 Protection against unwanted and excessive radiation hazards . 18
201.11 Protection against excessive temperatures and other hazards . 18
201.11.1.2.2 * Applied parts not intended to supply heat to a patient . 18
201.11.6.6 * Cleaning and disinfection of ME equipment or ME system . 19
201.11.6.7 Sterilization of ME equipment or ME system . 20
201.11.7 Biocompatibility of ME equipment and ME systems . 20
201.12 Accuracy of controls and instruments and protection against
hazardous outputs . 21
201.12.1.101 * Volume-control inflation-type . 21
201.12.1.102 * Pressure-controlled inflation-type . 24
201.12.1.103 Other inflation-types…………… . 27
201.12.1.104 Inspiratory volume monitoring equipment . 28
201.12.4 Protection against hazardous output . 28
201.12.4.101 Oxygen monitor………………… . 28
201.12.4.102 * Measurement of airway pressure . 29
201.12.4.103 * Measurement of expired volume and low volume alarm
conditions…………………………… . 30
201.12.4.104 * Maximum limited pressure protection device . 31
201.12.4.105 * High airway pressure alarm condition and protection device . 31
201.12.4.106 * Expiratory end-tidal CO monitoring equipment . 33
201.12.4.107 Protection against inadvertent setting of high airway pressure . 33
201.13 Hazardous situations and fault conditions for ME equipment . 33
201.13.2.101 * Additional specific single fault conditions . 33
201.13.102 Failure of one gas supply to an EMS ventilator . 34
201.13.103 * Independence of ventilation control function and related risk
control measures . 34
201.14 Programmable electrical medical systems (PEMS) . 35
201.14.101 Software life cycle . 35
201.15 Construction of ME equipment . 35
201.15.3.5.101 * Additional requirements for rough handling . 35
201.15.4.1 Construction of connectors . 36
201.15.101 Mode of operation . 36
201.15.102 * Delivered oxygen concentration . 36
201.15.103 Accessory self-check . 36
201.16 ME systems . 36
201.16.1.101 Additional general requirements for ME systems . 36
201.16.3.101 Additional requirements for power supply . 37
201.17 Electromagnetic compatibility of ME equipment and ME systems. 37
201.101 Gas connections . 37
201.101.1 * Protection against reverse gas leakage . 37
201.101.2 Connection to a high-pressure input port . 37
201.101.2.1 Connector…………………………. . 37
201.101.2.2 * Filter………………………………. . 37
201.101.3 VBS connectors . 38
201.101.3.1 * General…………………… . 38
iv © ISO 2020 – All rights reserved
201.101.3.2 Other named ports………… . 38
201.101.3.2.1 Patient-connection port . 38
201.101.3.2.2 Gas output port and gas return port . 38
201.101.3.2.3 Flow-direction-sensitive components . 38
201.101.3.2.4 * Accessory port……………. . 39
201.101.3.2.5 Gas exhaust por…………………. . 39
201.102 Requirements for the VBS and accessories . 39
201.102.1 * General . 39
201.102.2 Labelling . 39
201.102.3 Breathing tubes . 40
201.102.4 * Water vapour management . 40
201.102.4.1 * Humidification system . 40
201.102.4.2 Heat and moisture exchanger (HME) . 40
201.102.5 Breathing system filters . 40
201.102.6 * Leakage from complete VBS . 40
201.103 Spontaneous breathing during loss of power supply. 41
201.104 * Indication of duration of operation . 41
201.105 Functional connection . 41
201.105.1 General . 41
201.105.2 * Connection to an electronic health record . 42
201.105.3 * Connection to a distributed alarm system . 42
201.106 Display loops . 42
201.106.1 Pressure-volume loops . 42
201.106.2 Flow-volume loops . 42
201.107 Timed ventilatory pause . 43
201.107.1 Expiratory pause . 43
201.107.2 Inspiratory pause . 43
202 Electromagnetic dist
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