EN ISO 80601-2-90:2026
(Main)Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2026)
General Information
- Abstract
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
intended for use with patients who can breathe spontaneously; and
intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming.
Respiratory high-flow therapy equipment can be:
fully integrated ME equipment; or
a combination of separate items forming a ME system.
This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.
NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode.
NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.
EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.
NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.
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 the general standard, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in the general standard, 4.2.
This document does not specify the requirements for:
ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
ventilators or accessories intended for anaesthet
- Status
- Published
- Publication Date
- 21-Apr-2026
- 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
- 22-Apr-2026
- Completion Date
- 22-Apr-2026
Overview
EN ISO 80601-2-90:2026 sets out the particular requirements for the basic safety and essential performance of respiratory high-flow therapy equipment, as developed by CEN and ISO. This standard supports the safe and effective use of respiratory high-flow therapy equipment (ME equipment or ME system) combined with accessories for both clinical and certain home healthcare applications.
Respiratory high-flow therapy equipment delivers high-flow humidified gases to patients who can breathe spontaneously and can benefit from improved gas exchange or require humidification to enhance mucociliary clearance. This includes:
- Patients with reduced arterial blood oxygenation (Type 1 Respiratory Failure)
- Patients aiming for reduced work of breathing (Type 2 Respiratory Failure)
- Patients with a bypassed upper airway or those needing mucociliary clearance
The standard addresses equipment used predominantly in hospitals and acute care, with future standards expected to cover long-term home usage.
Key Topics
1. Scope of Application
- Applies to respiratory high-flow therapy equipment intended for use with spontaneously breathing patients.
- Covers both fully integrated ME equipment and ME systems assembled from multiple components.
- Encompasses accessories that may impact the equipment’s basic safety or essential performance, including humidifiers, breathing sets, nasal cannulas, tracheal and tracheostomy tubes, face masks, and alarm systems.
2. Safety and Performance Requirements
- Establishes baseline safety requirements such as:
- Protection against electrical, mechanical and radiation hazards
- Accurate control of gas flow rate and oxygen concentration
- Usability for operators in clinical environments
- Protection against hazardous outputs, unstable gas or oxygen supply, and equipment overheating
3. Risk Management
- Mandates identification and mitigation of risks such as contaminated air intake, unstable pressure/flow, insufficient oxygen delivery, and infection control.
- Special consideration for cleaning, disinfection, and sterilization procedures.
4. Information for Use
- Requires thorough marking, labelling, and documentation, including clear operating instructions and warnings for both professional and lay users.
- Demands consistent information on maintenance and technical specifications.
5. Systems and Accessories
- Defines requirements for interoperability, safe assembly, and performance when multiple devices and accessories are combined into a ME system.
Applications
Respiratory high-flow therapy equipment is used across diverse settings:
- Acute and Critical Care Units: To manage patients with acute respiratory failure, post-operative needs, or increased oxygen demand.
- Neonatal, Pediatric, and Adult Care: Particularly valuable for neonates and adults requiring non-invasive oxygenation support or humidified gas delivery.
- Home Healthcare: For selected patients needing transitional or short-term support, pending forthcoming standards for long-term therapy.
- Clinical Transport: Some equipment is designed to be transit-operable, ensuring continuity of care during patient transfers.
The standard is also relevant for any respiratory equipment featuring a high-flow therapy mode, including critical care and home ventilators, as well as anaesthetic workstations.
Related Standards
EN ISO 80601-2-90:2026 interfaces with a broad suite of respiratory equipment and medical electrical standards. Notably:
- ISO 80601-2-12: Critical care ventilators, especially those with high-flow therapy modes.
- ISO 80601-2-13: Anaesthetic workstations with high-flow capabilities.
- ISO 80601-2-72: Ventilators for the home healthcare environment.
- ISO 11195: Medical gas mixers.
- ISO 15002: Flowmeters.
- ISO 80601-2-87: High-frequency jet and oscillatory ventilators.
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
For a complete understanding of regulatory and market expectations, manufacturers, clinical end-users, and healthcare organizations should consider these related standards when implementing respiratory high-flow therapy equipment.
Keywords: respiratory high-flow therapy equipment, EN ISO 80601-2-90, medical electrical equipment, basic safety, essential performance, high-flow oxygen, humidified respiratory gases, CEN standard, medical devices, respiratory care, patient safety, acute care, ventilatory support.
Relations
- Effective Date
- 07-Jun-2023
- Effective Date
- 06-May-2026
- Refers
IEC 62366-1:2015 - Medical devices — Part 1: Application of usability engineering to medical devices - Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
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Frequently Asked Questions
EN ISO 80601-2-90:2026 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2026)". This standard covers: This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories: intended for use with patients who can breathe spontaneously; and intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming. Respiratory high-flow therapy equipment can be: fully integrated ME equipment; or a combination of separate items forming a ME system. This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode. NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode. NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment. 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 the general standard, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; ventilators or accessories intended for anaesthet
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories: intended for use with patients who can breathe spontaneously; and intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming. Respiratory high-flow therapy equipment can be: fully integrated ME equipment; or a combination of separate items forming a ME system. This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode. NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode. NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment. 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 the general standard, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; ventilators or accessories intended for anaesthet
EN ISO 80601-2-90:2026 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 80601-2-90:2026 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-90:2021, ISO 5359:2014/Amd 1:2017, IEC 62366-1:2015, ISO 7010:2019, ISO 5367:2023, ISO 17664-2:2021, ISO 5359:2014, ISO 20417:2026, ISO 3744:2010, ISO 23328-1:2003, ISO 18190:2025, ISO 7396-1:2016, IEC 60601-1:2005, ISO 80601-2-61:2026, ISO 32:1977. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 80601-2-90:2026 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-junij-2026
Nadomešča:
SIST EN ISO 80601-2-90:2021
Medicinska električna oprema - 2-90. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za respiratorno terapijo z velikim pretokom (ISO 80601-2
-90:2026)
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and
essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2026)
Medizinische elektrische Geräte - Teil 2-90: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Geräten für die Beatmungstherapie mit
hohem Durchfluss (ISO 80601-2-90:2026)
Appareils électromédicaux - Partie 2-90: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements de thérapie respiratoire à haut débit
(ISO 80601-2-90:2026)
Ta slovenski standard je istoveten z: EN ISO 80601-2-90:2026
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-90
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-90:2021
English Version
Medical electrical equipment - Part 2-90: Particular
requirements for basic safety and essential performance of
respiratory high-flow therapy equipment (ISO 80601-2-
90:2026)
Appareils électromédicaux - Partie 2-90: Exigences Medizinische elektrische Geräte - Teil 2-90: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit und die wesentlichen
performances essentielles des équipements de Leistungsmerkmale von Geräten für die
thérapie respiratoire à haut débit (ISO 80601-2- Beatmungstherapie mit hohem Durchfluss (ISO 80601-
90:2026) 2-90:2026)
This European Standard was approved by CEN on 26 January 2026.
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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-90:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-90:2026) 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 October 2026, and conflicting national standards shall
be withdrawn at the latest by October 2026.
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 ISO 80601-2-90:2021.
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 80601-2-90:2026 has been approved by CEN as EN ISO 80601-2-90:2026 without any
modification.
International
Standard
ISO 80601-2-90
Second edition
Medical electrical equipment —
2026-04
Part 2-90:
Particular requirements for basic
safety and essential performance
of respiratory high-flow therapy
equipment
Appareils électromédicaux —
Partie 2-90: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements de thérapie
respiratoire à haut débit
Reference number
ISO 80601-2-90:2026(en) © ISO 2026
ISO 80601-2-90:2026(en)
© ISO 2026
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 80601-2-90:2026(en)
Contents
Foreword . v
Introduction . vii
201. 1 Scope, object and related standards . 1
201. 2 Normative references . 4
201. 3 Terms and definitions . 6
201. 4 General requirements . 21
201. 5 General requirements for testing of ME equipment . 24
201. 6 Classification of ME equipment and ME systems . 26
201. 7 ME equipment identification, marking and documents . 26
201. 8 Protection against electrical hazards from ME equipment . 33
201. 9 Protection against mechanical hazards of ME equipment and ME systems . 34
201. 10 Protection against unwanted and excessive radiation hazards . 35
201. 11 Protection against excessive temperatures and other hazards . 35
201. 12 Accuracy of controls and instruments and protection against hazardous outputs . 40
201. 13 Hazardous situations and fault conditions for ME equipment . 48
201. 14 Programmable electrical medical systems (PEMS) . 50
201. 15 Construction of ME equipment . 51
201. 16 ME systems. 52
201. 17 Electromagnetic compatibility of ME equipment and ME systems . 53
201.101 Gas connections . 53
201.102 Requirements for the breathing system and accessories . 56
201.103 Indication of duration of operation . 58
201.104 Functional connection . 58
201.105 Power supply cords . 59
201.106 Respiratory high-flow therapy equipment security . 59
202 Electromagnetic disturbances — Requirements and tests . 60
206 Usability . 60
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 62
211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment . 64
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 66
Annex D (informative) Symbols on marking . 74
Annex AA (informative) Particular guidance and rationale . 76
iii
ISO 80601-2-90:2026(en)
Annex BB (informative) Data interface requirements . 93
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 97
Annex DD (informative) Terminology — Alphabetized index of defined terms . 101
Bibliography . 106
iv
ISO 80601-2-90:2026(en)
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).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the use of
(a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent database
available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held responsible for
identifying any or all such patent rights.
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 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 80601-2-90:2021), which has been technically
revised.
The main changes are as follows:
— updated normative references;
— clarified system recovery requirements;
— added cybersecurity requirements; and
— added requirements for SpO monitoring equipment.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO and IEC websites.
v
ISO 80601-2-90:2026(en)
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.
vi
ISO 80601-2-90:2026(en)
Introduction
Respiratory high-flow therapy equipment has been used successfully for years with neonatal patients. In recent
years there is more information about treating adults with respiratory high-flow therapy equipment when it is
used as an intermediate therapy to improve oxygenation in adult critical care patients, respiratory care units
and for palliative care. High-flow therapy equipment is also used in the treatment of chronic respiratory disease
[29][42][43][46] 1
to reduce exacerbation, improve physiological outcomes and quality of life . The use of respiratory
high-flow therapy equipment continues to increase as it is easily set up and is well tolerated by patients.
Since the outbreak of COVID-19 in January of 2020, its spread has been rapid and fierce. In hospitals across
the world, all kinds of respiratory high-flow therapy equipment have been widely used. In general, there is a
trend to use more non-invasive respiratory therapy. More and more new manufacturers of respiratory high-
flow therapy equipment have rapidly emerged. Neither international nor national standards are available for
respiratory high-flow therapy equipment. With the spread of the epidemic globally, the demand for this
document is clear and very urgent.
The first respiratory high-flow therapy equipment was constructed by the connection of a humidifier,
air/oxygen mixer/blender, flowmeter, breathing tube and cannula. Based on the improvement in technical
integration in recent years, there are several technical routes for respiratory high-flow therapy equipment on
the market. Respiratory high-flow therapy equipment is not fully covered by the existing standards for
humidifiers, gas mixers for medical use, flowmeters or ventilators.
This document addresses the basic safety and essential performance requirements of respiratory high-flow
therapy equipment, including risks related to oxygen (e.g., fires, incorrect oxygen concentration, incorrect flow
delivery, etc.).
Specifically, the following risks and related requirements were considered in the development of this
document.
— Contaminated air entering the gas intake port of the respiratory high-flow therapy equipment.
— Instability of gas supply from a high-pressure inlet.
— Insufficient pressure from a high-pressure inlet, and subsequent effects on oxygen delivered to the patient.
— Insufficient oxygen being delivered to the patient, and related alarm condition.
— Usability by operators wearing personal protective equipment (such as gloves and blurred visors), when
setting up equipment, or viewing or changing settings.
— Instability of output delivered to patients, necessitating frequent operator adjustment.
— Processing of equipment, including the surface of the enclosure and internal gas pathways, particularly
after use on infectious patients.
— Infectious exhaled gas.
— Overheating of respiratory high-flow therapy equipment.
— Insufficient flow capability from a medical gas pipeline system, and subsequent effects on oxygen supply
to other patients in a care area.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in Clause 3 of the general standard, in this document or as noted: italic type;
Numbers in square brackets refer to the Bibliography.
vii
ISO 80601-2-90:2026(en)
— informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
text of tables is also in a smaller type.
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.
For the purposes of this document, the auxiliary verb:
— “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 express 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.
viii
International Standard ISO 80601-2-90:2025(en)
Medical electrical equipment —
Part 2-90:
Particular requirements for basic safety and essential
performance of respiratory high-flow therapy equipment
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in AA.2.1.
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment,
as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its
accessories:
— intended for use with patients who can breathe spontaneously; and
— intended for patients who would benefit from improved alveolar gas exchange; and who would benefit
from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway
is bypassed.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure,
where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home
healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for
acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy
in the home healthcare environment is expected to be forthcoming.
Respiratory high-flow therapy equipment can be:
— fully integrated ME equipment; or
— a combination of separate items forming a ME system.
This document also applies to other types of respiratory equipment when that equipment includes a
respiratory high-flow therapy mode.
NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.
ISO 80601-2-90:2026(en)
NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home
healthcare environment with a high-flow therapy mode.
NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the
respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic
safety or essential performance of the respiratory high-flow therapy equipment.
EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source,
distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal
airway.
NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory
high-flow therapy equipment.
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 the general standard,
7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in the general standard, 4.2.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which
are given in ISO 80601-2-12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;
— ventilators or accessories intended for the emergency medical services environment, which are given in
ISO 80601-2-84;
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment,
which are given in ISO 80601-2-72;
— ventilatory support equipment or accessories intended for patients with ventilatory impairment, which
are given in ISO 80601-2-79;
— ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which
are given in ISO 80601-2-80;
— sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
— continuous positive airway pressure (CPAP) ME equipment;
[31]
— high-frequency jet ventilators (HFJVs) , which are given in ISO 80601-2-87;
— gas mixers for medical use, which are given in ISO 11195;
— flowmeters, which are given in ISO 15002;
— high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87; and
— cuirass or “iron-lung” ventilation equipment.
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.
ISO 80601-2-90:2026(en)
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance requirements for
respiratory high-flow therapy equipment, as defined in 201.3.262, and its accessories.
NOTE 1 Accessories are included because the combination of the respiratory high-flow therapy equipment and the
accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential
performance of the respiratory high-flow therapy equipment.
NOTE 2 This document has been prepared to address the relevant International Medical Device Regulators Forum
(IMDRF) essential principles and labelling guidances as indicated in Annex CC.
NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of
[25]
European regulation (EU) 2017/745 .
201.1.3 Collateral standards
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard
and subclause 201.2 of this document.
IEC 60601-1-2:2014+AMD1:2020+AMD2:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 and IEC 60601-1-11:2015+AMD1:2020 apply as modified in
Clauses 202, 206, 208 and 211 respectively. IEC 60601-1-3 and IEC 60601-1-9 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 specifies basic safety and essential performance requirements,
and may modify, replace or delete requirements contained in the general standard, including the collateral
standards as appropriate for the particular ME equipment under consideration.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this particular document as the
general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to that 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, 211.10 in this document addresses the content of Clause 10 of the IEC 60601-1-11
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 the general standard or applicable collateral standard is
replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of the general standard or
applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is
amended as indicated by the text of this document.
ISO 80601-2-90:2026(en)
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, figures or tables which 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, 203 for IEC 60601-1-3, 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 particular document, the clause or subclause of
the general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this 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.
Clause 2 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
Replacement:
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
Addition:
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 5367:2023, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
The graphical symbol collections of ISO 7000, ISO 7001, ISO 7010 and IEC 60417 can be previewed and purchased on
the Online Browsing Platform (OBP), www.iso.org/obp
ISO 80601-2-90:2026(en)
ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical
gases and vacuum
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 18190:2025, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 20417:2026, Medical devices — Information to be supplied by the manufacturer
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 80369-2:2024, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for breathing systems and driving gases applications
ISO 80601-2-55:2018+AMD1:2023, Medical electrical equipment — Part 2-55: Particular requirements for the
basic safety and essential performance of respiratory gas monitors
ISO 80601-2-61:2026, Medical electrical equipment — Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment
ISO 80601-2-74:2026, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment
IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment Part 1-11: General requirements for basic
safety and essential performance Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical
devices
IEC 62570:2025, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security — Part 5-1:
Security — Activities in the product life cycle
The graphical symbol collections of ISO 7000, ISO 7001, ISO 7010 and IEC 60417 can be previewed and purchased on
the Online Browsing Platform (OBP), www.iso.org/obp
ISO 80601-2-90:2026(en)
IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+AMD1:2012+AMD2:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
NOTE An alphabetized index of defined terms is found Annex DD.
201.3.201
accompanying information
information supplied by the manufacturer with or marked on a medical device or accessory for the user or
responsible organization, particularly regarding safe use
Note 1 to entry: The accompanying information is regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description,
information shown on the packaging or graphical user interface (GUI), installation manual, quick reference guide, etc and
can address the installation, use, processing, maintenance and disposal of the medical device or accessory.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but can involve auditory,
visual, or tactile materials and multiple media types (e.g. CD-ROM, DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:2026, 3.2, modified — deleted note 4.]
201.3.202
acknowledged
state of an alarm system initiated by operator action, where the auditory alarm signal associated with a
currently active alarm condition is inactivated until the alarm condition no longer exists or until a
predetermined time interval has elapsed
Note 1 to entry: Acknowledged only affects alarm signals that are active at the time of the operator action.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.37]
201.3.203
airway device
device intended to provide a gas pathway to and from the patient’s airway
[SOURCE: ISO 4135:2022, 3.8.1.2]
201.3.204
airway pressure
p
aw
pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
connection port
Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the equipment.
ISO 80601-2-90:2026(en)
[SOURCE: ISO 4135:2022, 3.1.4.41.1, modified — added letter symbol.]
201.3.205
alarm limit
threshold used by an alarm system to determine an alarm condition
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
201.3.206
alarm off
state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.4]
201.3.207
alarm paused
state of limited duration in which the alarm system or part of the alarm system does not generate alarm signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
201.3.208
alarm setting
alarm system configuration, including but not limited to:
– alarm limits;
– the characteristics of any alarm signal inactivation states; and
– the values of variables or parameters that determine the function of the alarm system
Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-determined.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.8]
201.3.209
artificial ventilation
intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external means
with the intention of augmenting, or totally controlling, the ventilation of a patient
EXAMPLE Means used to provide artificial ventilation are manual resuscitation; mouth-to-mouth resuscitation;
automatic ventilation; mechanical ventilation.
Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport; home-
care; anaesthesia; critical care; rehabilitation.
Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure; negative-
pressure; gas-powered; operator-powered; electrically-powered.
Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently lowering the
pressure in the lungs.
[SOURCE: ISO 19223:2019, 3.1.10]
201.3.210
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use of an
asset
ISO 80601-2-90:2026(en)
[SOURCE: IEC 81001-5-1:2021, 3.5]
201.3.211
audio off
state of indefinite duration in which the alarm system or part of the alarm system does not generate an auditory
alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.12]
201.3.212
audio paused
state of limited duration in which the alarm system or part of the alarm system does not generate an auditory
alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.13]
201.3.213
biocompatibility
ability of a medical device, accessory or material to perform with an appropriate host response in a specific
application
Note 1 to entry: A medical devices or accessory may produce some level of adverse effect, but that level may be
determined to be acceptable when considering the benefits provided.
[SOURCE: ISO 18562-1:2024, 3.6]
201.3.214
body temperature and pressure, saturated
BTPS
ambient atmospheric pressure, at a temperature of 37 °C, and a relative humidity of 100 %
[SOURCE: ISO 4135:2022, 3.1.1.7]
201.3.215
breathing system
pathways through which gas flows to or from the patient at respiratory pressures and continuously or
intermittently in fluid communication with the patient’s respiratory tract during any form of artificial
ventilation or respiratory therapy
[SOURCE: ISO 4135:2022, 3.6.1.1, modified — notes deleted.]
201.3.216
breathing system filter
BSF
device intended to reduce transmission of particulates, including microorganisms, in a breathing system
[SOURCE: ISO 4135:2022, 3.6.1.5]
201.3.217
breathing therapy mode
respiratory mode of a device that delivers a respirable gas at therapeutic breathing pressures to the patient's
airway with a primary intention other than to support a proportion of the patient's work of breathing
EXAMPLE 1 Sleep-apnoea therapy.
ISO 80601-2-90:2026(en)
EXAMPLE 2 CPAP.
EXAMPLE 3 High flow oxygen therapy.
EXAMPLE 4 Bi-level PAP.
[SOURCE: ISO 19223:2019, 3.11.22, modified — deleted note.]
201.3.218
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other debris) from
the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated process that prepares
the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2021, 3.1, modified — replaced “and/or” with “or”.]
201.3.219
connector
fitting to join two or more components
EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to maintain
gas specificity by the allocation of a set of different diameters to the mating connectors for each particular gas.
[SOURCE: ISO 4135:2022, 3.1.4.5]
201.3.220
continuous flow
gas flowing continuously through the breathing system, with a proportion intermittently passing to the
patient's lung whenever the airway pressure is raised by the ventilator or an operator action, or flow is
demanded by a patient's inspiratory effort
Note 1 to entry: Ventilator is taken to include respiratory high-flow therapy equipment.
[SOURCE: ISO 19223:2019, 3.7.8, modified — replaced “ventilator breathing system” with “breathing system”,
deleted notes and added note 1.]
201.3.221
cybersecurity
state where information and systems are protected from unauthorized activities, such as access, use,
disclosure, disruption, modification, or destruction to a degree that the related risks to violation of
confidentiality, integrity, and availability are maintained at an acceptable level throughout the life cycle
[SOURCE: IEC 81001-5-1:2021, 3.30, modified — deleted the term “security”.]
201.3.222
default alarm preset
alarm preset that can be activated by an alarm system without operator action
EXAMPLE Default alarm preset configured by the manufacturer or the responsible organization.
[SOURCE: IEC 60601-1-8:2006+AMD1:2020, 3.16, modified — replaced the note with the example.]
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