EN ISO 80601-2-84:2023
(Main)Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
General Information
- Abstract
This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
¾ intended to be operated by a healthcare professional operator;
¾ intended for use in the EMS environment; and
¾ intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
¾ user-powered resuscitators, which are given in ISO 10651‐4.
¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5.
¾ continuous positive airway pressure (CPAP) ME equipment.
¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
¾ high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
¾ oxygen therapy constant flow ME equipment.
¾ cuirass or “iron‐lung” ventilators.
- Status
- Published
- Publication Date
- 14-Nov-2023
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 15-Nov-2023
- Due Date
- 15-May-2024
- Completion Date
- 15-Nov-2023
Overview - EN ISO 80601-2-84:2023 (ISO 80601-2-84:2023)
EN ISO 80601-2-84:2023 sets particular requirements for the basic safety and essential performance of EMS ventilators (medical electrical equipment) intended for use in the emergency medical services environment. It applies to invasive and non‑invasive ventilators and their accessories that can affect ventilator safety or performance. The standard targets devices operated by healthcare professionals, including ventilators used for transport within healthcare facilities. It complements general medical electrical equipment requirements (IEC 60601 series) and focuses on EMS‑specific hazards, testing, marking, and documentation.
Key topics and technical requirements
- Scope and intended use: Defines EMS ventilators for varying levels of ventilatory support, operated by trained clinicians in pre‑hospital or transport settings.
- Essential performance & system recovery: Requirements to ensure ventilator functions reliably under expected EMS conditions and recovers appropriately after faults.
- Gas supply and connectors: Compatibility, overpressure protection, gas input characteristics, and requirements for gas connectors and hoses.
- Alarms and monitoring: Requirements for oxygen monitoring, airway pressure measurement, expired volume detection, high‑airway‑pressure protection and alarms to protect patients from hazardous outputs.
- Construction & robustness: Design provisions for rough handling, stability, grips, and mechanical protection typical of EMS and transport use.
- Accessories and interfaces: Requirements for accessories intended to connect to the breathing system where their characteristics affect safety or performance.
- Testing & verification: EMS‑specific test conditions, leakage and flow specifications, and test methods for essential performance.
- Infection control: Cleaning, disinfection and sterilization guidance for EMS workflows.
- PEMS & cybersecurity: Programmable system requirements, including cyber capability considerations for EMS ventilators.
- Labeling & documentation: Manufacturer information, operating instructions, start‑up procedures, warnings, units of measurement and accessory information for clinical use and maintenance.
Practical applications - who uses this standard
- Medical device manufacturers - design, risk management, testing and technical files for EMS ventilators.
- Test laboratories and conformity assessors - type testing and verification for regulatory compliance and CE marking in Europe.
- Procurement teams & clinical engineers - specifying robust ventilators for ambulances, air/ground transport and emergency departments.
- Regulators and standards bodies - benchmarking device safety and essential performance in pre‑hospital care.
- EMS clinicians and biomedical staff - understanding requirements that affect device operation, maintenance and training.
Related standards
- ISO 80601-2-12 (critical care ventilators), ISO 80601-2-72 (home ventilators), ISO 80601-2-13 (anaesthetic), ISO/TR 21954 (ventilator selection guidance), IEC 60601‑1 (general ME safety), plus standards for high‑frequency ventilation, respiratory high‑flow therapy and resuscitators referenced in the standard.
Keywords: EN ISO 80601-2-84:2023, EMS ventilator, emergency medical services environment, ventilator safety, essential performance, medical electrical equipment, ventilator testing, ventilator accessories, ISO 80601-2-84.
Relations
- Effective Date
- 18-Aug-2021
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Refers
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices - Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
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Frequently Asked Questions
EN ISO 80601-2-84:2023 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)". This standard covers: This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: ¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾ intended to be operated by a healthcare professional operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation. NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13. ¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80. ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70. ¾ user-powered resuscitators, which are given in ISO 10651‐4. ¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5. ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. ¾ high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87. NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. ¾ oxygen therapy constant flow ME equipment. ¾ cuirass or “iron‐lung” ventilators.
This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: ¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾ intended to be operated by a healthcare professional operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation. NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13. ¾ ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80. ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70. ¾ user-powered resuscitators, which are given in ISO 10651‐4. ¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5. ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. ¾ high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87. NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. ¾ oxygen therapy constant flow ME equipment. ¾ cuirass or “iron‐lung” ventilators.
EN ISO 80601-2-84:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 80601-2-84:2023 has the following relationships with other standards: It is inter standard links to EN 794-3:1998+A2:2009, IEC 62570:2014, ISO 18562-1:2017, ISO 10524-1:2018, IEC 62366-1:2015, ISO 19054:2005, ISO 23328-2:2002, ISO 7396-1:2016, ISO 80601-2-74:2021, ISO 10524-3:2019, ISO 7396-1:2016/Amd 1:2017, ISO 80601-2-55:2018, ISO 17664-2:2021, ISO 9360-1:2000, ISO 19054:2005/Amd 1:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 80601-2-84:2023 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 80601-2-84:2023 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN 794-3:2000+A2:2009
Medicinska električna oprema - 2-84. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev v okolju nujne medicinske pomoči (ISO 80601-2-
84:2023)
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and
essential performance of ventilators for the emergency medical services environment
(ISO 80601-2-84:2023)
Medizinische elektrische Geräte - Teil 2-84: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Notfall- und
Transportbeatmungsgeräten (ISO 80601-2-84:2023)
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 (ISO 80601-2-84:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-84:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 Prva pomoč First aid
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-84
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 794-3:1998+A2:2009
English Version
Medical electrical equipment - Part 2-84: Particular
requirements for the basic safety and essential
performance of ventilators for the emergency medical
services environment (ISO 80601-2-84:2023)
Appareils électromédicaux - Partie 2-84: Exigences Medizinische elektrische Geräte - Teil 2-84: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs utilisés wesentlichen Leistungsmerkmale von Notfall- und
dans l'environnement des services médicaux d'urgence Transportbeatmungsgeräten (ISO 80601-2-84:2023)
(ISO 80601-2-84:2023)
This European Standard was approved by CEN on 1 September 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-84:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-84:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 794-3:1998+A2:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-84:2023 has been approved by CEN as EN ISO 80601-2-84:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-84
Second edition
2023-11
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 80601-2-84:2023(E)
ISO 80601-2-84:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-84:2023(E)
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 . 5
201. 4 General requirements . 23
201. 4.3 Essential performance . 23
201. 4.3.101 Additional requirements for essential performance . 23
201. 4.3.102 System recovery . 23
201. 4.4 Additional requirements for expected service life . 24
201. 4.5 Alternative risk control measures or test methods for
ME equipment or ME system . 25
201. 4.6 ME equipment or ME system parts that contact the patient . 25
201. 4.11.101 Additional requirements for pressurized gas input . 25
201. 4.11.101.1 Overpressure requirement . 25
201. 4.11.101.2 Compatibility requirement for medical gas pipeline systems . 25
201. 4.11.101.3 Compatibility requirements for pressure regulators . 26
201. 5 General requirements for testing of ME equipment . 26
201. 5.101 Additional requirements for general requirements for testing
of ME equipment . 27
201. 5.101.1 EMS ventilator test conditions 27
201. 5.101.2 Gas flowrate and leakage specifications . 27
201. 5.101.3 EMS ventilator testing errors . 27
201. 6 Classification of ME equipment and ME systems . 27
201. 7 ME equipment identification, marking and documents . 28
201. 7.1.101 Information to be supplied by the manufacturer . 28
201. 7.2.3 Consult accompanying documents . 28
201. 7.2.4.101 Additional requirements for accessories . 28
201. 7.2.18 External gas source . 28
201. 7.2.101 Additional requirements for marking on the outside of
ME equipment or ME equipment parts . 29
201. 7.4.2 Control devices . 30
201. 7.4.3 Units of measurement . 30
201. 7.4.101 Labelling of units of measurement . 30
201. 7.9.2.1 General . 30
201. 7.9.2.1.101 Additional general requirements . 30
201. 7.9.2.2.101 Additional requirements for warnings and safety notices . 30
201. 7.9.2.8.101 Additional requirements for start-up procedure . 31
201. 7.9.2.9.101 Additional requirements for operating instructions . 32
201. 7.9.2.12 Cleaning, disinfection, and sterilization . 33
201. 7.9.2.14.101 Additional requirements for accessories, supplementary
equipment, used material . 33
201. 7.9.3.1.101 Additional general requirements . 33
201. 7.9.3.101 Additional requirements for the technical description . 34
201. 8 Protection against electrical hazards from ME equipment . 34
201. 9 Protection against mechanical hazards of ME equipment and ME systems . 34
ISO 80601-2-84:2023(E)
201. 9.4.3.101 Additional requirements for instability from unwanted lateral
movement . 34
201. 9.4.4 Grips and other handling devices . 35
201. 9.6.2.1.101 Additional requirements for audible acoustic energy . 35
201. 10 Protection against unwanted and excessive radiation hazards. 36
201. 11 Protection against excessive temperatures and other hazards . 36
201. 11.1.2.2 Applied parts not intended to supply heat to a patient . 37
201. 11.6.6 Cleaning and disinfection of ME equipment or ME system . 37
201. 11.6.7 Sterilization of ME equipment or ME system . 38
201. 11.7 Biocompatibility of ME equipment and ME systems . 38
201. 12 Accuracy of controls and instruments and protection against
hazardous outputs . 38
201. 12.1.101 Volume-control inflation-type . 38
201. 12.1.102 Pressure-control inflation-type . 42
201. 12.1.103 Other inflation-types . 45
201. 12.1.104 Inspiratory volume monitoring equipment . 45
201. 12.4 Protection against hazardous output . 45
201. 12.4.101 Oxygen monitor . 45
201. 12.4.102 Measurement of airway pressure . 46
201. 12.4.103 Measurement of expired volume and low volume alarm conditions . 47
201. 12.4.104 Maximum limited pressure protection device . 48
201. 12.4.105 High airway pressure alarm condition and protection device . 48
201. 12.4.106 Expiratory end-tidal CO 2 monitoring equipment . 50
201. 12.4.107 Protection against inadvertent setting of high airway pressure . 50
201. 13 Hazardous situations and fault conditions for ME equipment . 50
201. 13.2.101 Additional specific single fault conditions . 50
201. 13.102 Failure of one gas supply to an EMS ventilator . 51
201. 13.103 Independence of ventilation control function and related risk
control measures . 51
201. 14 Programmable electrical medical systems (PEMS) . 52
201. 14.1 General . 52
201. 14.101 Cybersecurity capabilities of EMS ventilators . 52
201. 15 Construction of ME equipment . 53
201. 15.3.5.101 Additional requirements for rough handling . 53
201. 15.4.1 Construction of connectors . 53
201. 15.101 Mode of operation . 54
201. 15.102 Delivered oxygen concentration . 54
201. 15.103 Accessory self-check . 54
201. 16 ME systems . 54
201. 16.1.101 Additional general requirements for ME systems . 54
201. 16.2.101 Additional requirements for power supply . 55
201. 17 Electromagnetic compatibility of ME equipment and ME systems . 55
201. 101 Gas connections . 55
201. 101.1 Protection against reverse gas leakage . 55
201. 101.2 Connection to a high-pressure inlet . 56
201. 101.2.1 Low-pressure hose assembly . 56
201. 101.2.2 Filter . 56
201. 101.3 VBS connectors . 56
201. 101.3.1 General . 56
201. 101.3.2 Other named ports . 56
201. 101.3.2.1 Patient-connection port . 56
201. 101.3.2.2 Gas output port and gas return port . 57
201. 101.3.2.3 Flow-direction-sensitive components . 57
201. 101.3.2.4 Gas pathway connection port . 57
201. 101.3.2.5 Gas exhaust port . 58
iv © ISO 2023 – All rights reserved
ISO 80601-2-84:2023(E)
201. 101.3.2.6 Gas intake port. 58
201. 102 Requirements for the VBS and accessories . 58
201. 102.1 General . 58
201. 102.2 Labelling . 58
201. 102.3 Breathing sets . 59
201. 102.4 Water vapour management . 59
201. 102.4.1 Humidification system . 59
201. 102.4.2 Heat and moisture exchanger (HME) . 59
201. 102.5 Breathing system filters . 59
201. 102.6 Leakage from complete VBS . 59
201. 103 Spontaneous breathing during loss of ventilation . 60
201. 104 Indication of duration of operation . 60
201. 105 Functional connection . 60
201. 105.1 General . 60
201. 105.2 Connection to an electronic health record . 61
201. 105.3 Connection to a distributed alarm system . 61
201. 106 Display loops . 61
201. 106.1 Pressure-volume loops . 61
201. 106.2 Flow-volume loops . 61
201. 107 Timed ventilatory pause . 61
201. 107.1 Expiratory pause . 62
201. 107.2 Inspiratory pause . 62
202 Electromagnetic disturbances — Requirements and tests . 63
206 Usability . 64
206.101 Primary operating functions . 64
206.102 Training . 66
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 66
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment . 68
Annex C (informative) Guide to marking and labelling requirements for
ME equipment and ME systems . 71
201.C.1 Marking on the outside of ME equipment, ME systems or their parts . 71
201.C.2 Accompanying documents, general . 72
201.C.3 Accompanying documents, instructions for use . 72
201.C.4 Accompanying documents, technical description . 74
Annex D (informative) Symbols on marking . 76
Annex AA (informative) Particular guidance and rationale . 78
AA.1 General guidance . 78
AA.2 Rationale for particular clauses and subclauses . 78
Annex BB (informative) Data interfaces . 114
BB.1 Background and purpose . 114
BB.2 Data definition . 115
Annex CC (informative) Reference to the IMDRF essential principles and
labelling guidances . 122
Annex DD (informative) Reference to the essential principles . 126
Bibliography . 129
Terminology — Alphabetized index of defined terms . 133
ISO 80601-2-84:2023(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or
www.iec.ch/members_experts/refdocs).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
Details of any patent rights identified during the development of the document will be in the
Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents) or the
IEC list of patent declarations received (see https://patents.iec.ch).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62D,
Particular medical equipment, software, and systems, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80601-2-84:2020), which has been
technically revised. The main changes are as follows:
— alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020,
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, and
IEC 60601-1-12:2014+AMD1:2020;
— added requirements for a responsible organization log
— added requirements for the display legibility for operators wearing personal protective equipment;
— added requirements for display during calibration of gas monitors;
— clarified maximum limited pressure requirements;
— added requirements for ventilator system recovery;
— added requirements and definitions for cybersecurity; and
vi © ISO 2023 – All rights reserved
ISO 80601-2-84:2023(E)
— harmonization with ISO 20417, where appropriate.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO and IEC
websites.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html and www.iec.ch/national-
committees.
ISO 80601-2-84:2023(E)
Introduction
In referring to the structure of this document, the term
— “clause” means one of the five numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe a possibility or capability; and
— "must" is used to indicate an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
Requirements in this document have been decomposed so that each requirement is uniquely
delineated. This is done to support automated requirements tracking.
viii © ISO 2023 – All rights reserved
INTERNATIONAL STANDARD ISO 80601-2-84:2023(E)
Medical electrical equipment —
Part 2-84:
Particular requirements for the basic safety and essential
performance of ventilators for the emergency medical
services environment
201.1 Scope, object and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of an EMS ventilator in combination
with its accessories, hereafter also referred to as ME equipment:
intended for patients who need differing levels of support from artificial ventilation including
ventilator-dependent patients;
intended to be operated by a healthcare professional operator;
intended for use in the EMS environment; and
intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a
physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to
the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories
can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the
scope of this document are not covered by specific requirements in this document except in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
ventilators or accessories intended for ventilator-dependent patients in critical care applications,
which are given in ISO 80601-2-12.
ISO 80601-2-84:2023(E)
ventilators or accessories intended for ventilator-dependent patients in the home healthcare
environment, which are given in ISO 80601-2-72.
ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
ventilators or accessories intended for ventilatory support equipment (intended only to augment
the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and
ISO 80601-2-80.
obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70.
user-powered resuscitators, which are given in ISO 10651-4.
gas-powered emergency resuscitators, which are given in ISO 10651-5.
continuous positive airway pressure (CPAP) ME equipment.
high-frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
[44]
high-frequency oscillatory ventilators (HFOVs) , which are given in ISO 80601-2-87.
NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-
modes.
respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for
spontaneously breathing patients.
oxygen therapy constant flow ME equipment.
cuirass or “iron-lung” ventilators.
201.1.2 Object
Replacement:
The object of this particular document is to establish basic safety and essential performance
requirements for an EMS ventilator, as defined in 201.3.228, and its accessories.
Accessories are included because the combination of the EMS ventilator and the accessories needs to
have acceptable risk. Accessories can have a significant impact on the basic safety or essential
performance of an EMS ventilator.
[38] [39]
NOTE 1 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex DD.
NOTE 3 This document has been prepared to address the relevant general safety and performance requirements
[40]
of European regulation (EU) 2017/745 .
201.1.3 Collateral standards
Amendment (add at the end of the subclause):
2 © ISO 2023 – All rights reserved
ISO 80601-2-84:2023(E)
This document refers to those applicable collateral standards that are listed in Clause 2 of the general
standard and in 201.2 of this document.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2016+AMD1:2012+AMD2:2020 and IEC 60601-1-12:2014+AMD1:2020 apply as
modified in Clauses 202, 206, 208 and 212 respectively.
IEC 60601-1-3, IEC 60601-1-9, and IEC 60601-1-11 do not apply.
All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
the general standard, including the collateral standards, as appropriate for the particular ME equipment
under consideration, and may add other basic safety or essential performance requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005+AMD1:2012+AMD2:2020
or the collateral standards.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular document corresponds to those of the
general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits
of the collateral standard document number (e.g. 202.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard
are specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020 or
the applicable collateral standard is replaced completely by the text of this particular document.
“Addition” means that the text of this document is additional to the requirements of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the
applicable collateral standard is amended as indicated by the text of this document.
Subclauses, figures or tables that are additional to those of the general standard are numbered starting
from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1
through 3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard (e.g. 202 for IEC 60601-1-2, 208 for IEC 60601-
1-8, etc.).
The term “this document” is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
not relevant, applies without modification; where it is intended that any part of
ISO 80601-2-84:2023(E)
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
relevant, is not to be applied, a statement to that effect is given in this particular document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5359:2014+AMD1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for
use with medical gases
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml
ISO 10524-1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
ISO 10524-3:2019, Pressure regulators for use with medical gases — Part 3: Pressure regulators
integrated with cylinder valves (VIPRS)
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2023, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 19054:2005+AMD1:2016, Rail systems for supporting medical equipment
ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
4 © ISO 2023 – All rights reserved
ISO 80601-2-84:2023(E)
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use: — Part 1: Salt test
method to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use: — Part 2: Non-filtration
aspects
ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors
ISO 80601-2-74:2021, Medical electrical equipment — Part 2-74: Particular requirements for the basic
safety and essential performance of respiratory humidifying equipment
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-12:2014+AMD1:2020, Medical Electrical Equipment — Part 1-12: General requirements for
basic safety and essential performance — Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the emergency medical services environment
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical
devices
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC Guide 115:2021, Application of uncertainty of measurement to conformance assessment activiti
...