ISO 80601-2-12:2020

Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators

ISO 80601-2-12:2020

Name:ISO 80601-2-12:2020   Standard name:Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators
Standard number:ISO 80601-2-12:2020   language:English language
Release Date:24-Feb-2020   technical committee:SC 62D - Particular medical equipment, software, and systems
Drafting committee:JWG 1 - TC 62/SC 62D/JWG 1   ICS number:01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION

INTERNATIONAL ISO
STANDARD 80601-2-12
Second edition
2020-02
Medical electrical equipment —
Part 2-12:
Particular requirements for basic
safety and essential performance of
critical care ventilators
Appareils électromédicaux —
Partie 2-12: Exigences particulières relatives à la sécurité de base
et aux performances essentielles des ventilateurs pulmonaires pour
utilisation en soins intensifs
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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Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents
201. 1 Scope, object and related standards . 1
201. 1.1 * Scope . 1
201. 1.2 Object . 2
201. 1.3 Collateral standards . 3
201. 1.4 Particular standards . 3
201. 2 Normative references . 4
201. 3 Terms and definitions . 7
201. 4 General requirements . 9
201. 4.3 Essential performance . 9
201. 4.3.101 * Additional requirements for essential performance . 9
201. 4.4 Additional requirements for expected service life . 9
201. 4.6 * ME equipment or ME system parts that contact the patient . 10
201. 4.11.101 * Additional requirements for pressurized gas input . 10
201. 4.11.101.1 Overpressure requirement . 10
201. 4.11.101.2 Compatibility requirement . 10
201. 5 General requirements for testing of ME equipment. 11
201. 5.101 Additional requirements for general requirements for testing
of ME equipment . 11
201. 5.101.1 Ventilator test conditions . 11
201. 5.101.2 * Gas flowrate and leakage specifications . 11
201. 5.101.3 * Ventilator testing errors . 11
201. 6 Classification of ME equipment and ME systems . 12
201. 7 ME equipment identification, marking and documents . 12
201. 7.2.3 * Consult accompanying documents . 12
201. 7.2.4.101 Additional requirements for accessories . 12
201. 7.2.13.101 Additional requirements for physiological effects . 12
201. 7.2.17.101 Additional requirements for protective packaging . 12
201. 7.2.18 External gas source . 13
201. 7.2.101 * Additional requirements for marking on the outside of
ME equipment or ME equipment parts . 13
201. 7.4.3 * Units of measurement . 14
201. 7.9.1 Additional general requirements . 14
201. 7.9.2.1.101 Additional general requirements . 14
201. 7.9.2.2.101 * Additional requirements for warnings and safety notices . 15
201. 7.9.2.8.101 * Additional requirements for start-up procedure . 16
201. 7.9.2.9.101 * Additional requirements for operating instructions . 16
201. 7.9.2.12 Cleaning, disinfection, and sterilization . 17
201. 7.9.2.14.101 * Additional requirements for accessories, supplementary
equipment, used material . 17
201. 7.9.2.16.101 * Additional requirements for reference to the technical
description . 18
201. 7.9.3.1.101 * Additional general requirements . 18
201. 7.9.3.101 Additional requirements for the technical description . 18
201. 8 Protection against electrical hazards from ME equipment . 19
201. 9 Protection against mechanical hazards of ME equipment and ME systems 19
201. 9.6.2.1.101 * Additional requirements for audible acoustic energy . 19
201. 9.101 * Additional requirements for suction procedures . 20
201. 10 Protection against unwanted and excessive radiation hazards . 23
201. 11 Protection against excessive temperatures and other hazards . 23
201. 11.1.2.2 * Applied parts not intended to supply heat to a patient . 23
201. 11.6.5.101 * Additional requirements for ingress of water or particulate
matter into ME equipment or ME system . 23
201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system . 24
201. 11.6.7 Sterilization of ME equipment or ME system . 24
201. 11.7 Biocompatibility of ME equipment and ME systems . 24
201. 11.8.101 * Additional requirements for interruption of the power
supply/supply mains to ME equipment . 25
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201. 12.1 * Accuracy of controls and instruments . 27
201. 12.1.101 * Volume-control inflation-type . 27
201. 12.1.102 * Pressure-control inflation-type . 31
201. 12.1.103 Other inflation-types . 34
201. 12.1.104 * Inspiratory volume monitoring . 35
201. 12.1.105 * Response of the ventilator to an increase in set O
concentration . 35
201. 12.4 Protection against hazardous output . 37
201. 12.4.101 Oxygen monitor . 37
201. 12.4.102 * Measurement of airway pressure . 38
201. 12.4.103 * Measurement of expired volume and low volume alarm
conditions . 39
201. 12.4.103.1 Ventilators intended to provide a tidal volume >50 ml . 39
201. 12.4.103.2 Ventilators intended to provide a tidal volume ≤50 ml . 40
201. 12.4.104 * Expiratory end-tidal CO monitoring equipment . 41
201. 12.4.105 * Maximum limited pressure protection device . 42
201. 12.4.106 * High airway pressure alarm condition and protection device 42
201. 12.4.107 PEEP alarm conditions . 43
201. 12.4.108 * Obstruction alarm condition . 44
201. 12.4.109 * Disconnection alarm condition . 45
201. 12.4.110 Protection against inadvertent setting of high airway pressure .
.................................................................................................................... 45
201. 12.101 * Protection against accidental or unintentional adjustments 45
201. 13 Hazardous situations and fault conditions for ME equipment . 46
iv © ISO 2020 – All rights reserved

201. 13.2.101 * Additional specific single fault conditions . 46
201. 13.2.102 * Failure of one gas supply to a ventilator . 46
201. 13.2.103 * Independence of ventilation control function and related risk
control measures . 47
201. 13.2.104 * Failure of functional connection to a ventilator control or
monitoring means . 47
201. 14 Programmable electrical medical systems (PEMS) . 47
201. 14.101 Software life cycle . 48
201. 15 Construction of ME equipment . 48
201. 15.3.5.101 Additional requirements for rough handling . 48
201. 15.3.5.101.1 * Shock and vibration (robustness) . 48
201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during
operation . 49
201. 15.4.1 Construction of connectors . 51
201. 15.101 Mode of operation . 51
201. 15.102 Delivered oxygen concentration . 51
201. 15.103 Accessory self-check . 51
201. 16 ME systems . 52
201. 16.1.101 Additional general requirements for ME systems . 52
201. 16.2.101 * Additional general requirements for accompanying documents
of an ME system . 52
201. 17 Electromagnetic compatibility of ME equipment and ME systems. 52
201. 101 Gas connections . 52
201. 101.1 * Protection against reverse gas leakage . 52
201. 101.2 Connection to a high-pressure input port . 53
201. 101.2.1 Connector . 53
201. 101.2.2 * Filter . 53
201. 101.3 VBS connectors . 53
201. 101.3.1 * General . 53
201. 101.3.2 Other named ports . 53
201. 101.3.2.1 Patient-connection port . 53
201. 101.3.2.2 Gas output port and gas return port . 54
201. 101.3.2.3 Emergency intake port . 54
201. 101.3.2.4 Flow-direction-sensitive components. 54
201. 101.3.2.5 * Accessory port . 54
201. 101.3.2.6 Gas exhaust port . 55
201. 101.3.2.7 Temperature sensor port . 55
201. 102 Requirements for the VBS and accessories . 55
201. 102.1 * General . 55
201. 102.2 Labelling . 55
201. 102.3 Breathing tubes . 55
201. 102.4 * Water vapour management . 56
201. 102.4.1 Humidification system . 56
201. 102.4.2 Heat and moisture exchanger (HME) .
...

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