SIST EN ISO 80601-2-74:2026

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2026)

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1           Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 2        Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 3        ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 4        A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
EXAMPLE 2           Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies.
EXAMPLE 3           Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies.
EXAMPLE 4           Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies.
EXAMPLE 5           Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply.
EXAMPLE 6           Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 5        ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME.
NOTE 6        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 7        Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789.
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber

Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für Atemgase (ISO 80601-2-74:2026)

Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'humidification respiratoire (ISO 80601-2-74:2026)

Le présent document s'applique à la sécurité de base et aux performances essentielles d'un humidificateur, ci-après également désigné par appareil EM, associé à ses accessoires, dont la combinaison est ci-après désignée par système EM.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés à un humidificateur, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles de l'humidificateur.
EXEMPLE 1           Tuyaux respiratoires chauffés (tuyaux respiratoires avec résistance chauffante) ou les appareils EM destinés à commander ces tuyaux respiratoires chauffés (commandes de tuyaux respiratoires chauffés).
NOTE 2        Les tuyaux respiratoires chauffés et leurs commandes sont des appareils EM et sont soumis aux exigences de l'IEC 60601‑1.
NOTE 3        L'ISO 5367 spécifie d'autres exigences de sécurité et de performance pour les tuyaux respiratoires.
Le présent document contient des exigences pour les différentes utilisations médicales de l'humidification, telles que la ventilation invasive, la ventilation non invasive, l'oxygénothérapie nasale à haut débit et le traitement de l'apnée obstructive du sommeil, ainsi que l'humidification pour les patients trachéotomisés.
NOTE 4        Un humidificateur peut être intégré dans un autre appareil. Dans ce cas, les exigences de l'autre appareil s'appliquent aussi à l'humidificateur.
EXEMPLE 2           Humidificateur chauffé intégré dans un ventilateur pulmonaire pour utilisation en soins intensifs où l'ISO 80601‑2-12 s’applique aussi.
EXEMPLE 3           Humidificateur chauffé intégré dans un ventilateur utilisé dans l'environnement des soins à domicile pour les patients dépendants où l'ISO 80601‑2‑72 s’applique aussi.
EXEMPLE 4           Humidificateur chauffé intégré dans du matériel de traitement respiratoire de l’apnée du sommeil où l’ISO 80601‑2‑70 s’applique aussi.
EXEMPLE 5           Humidificateur chauffé intégré dans l’équipement d’assistance ventilatoire où l’ISO 80601-2-79 ou l’ISO 80601-2-80 s’applique aussi.
EXEMPLE 6           Humidificateur chauffé intégré dans du matériel d'oxygénothérapie à haut débit où l’ISO 80601‑2‑90 s’applique aussi.
Le présent document contient également des exigences pour les ECH actifs (échangeurs de chaleur et d'humidité), appareils EM qui ajoutent activement de la chaleur et de l'humidité afin d'augmenter le niveau d'humidité du gaz administré au patient par l'ECH. Le présent document ne s'applique pas aux ECH passifs qui renvoient une partie de l'humidité et de la chaleur de l'air expiré par le patient aux voies respiratoires lors de l'inspiration, sans ajout de chaleur ou d'humidité.
NOTE 5        L’ISO 9360‑1 et l’ISO 9360‑2 spécifient les exigences de sécurité et de performances pour un ECH passif.
NOTE 6        Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1:2012+AMD

Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2026)

Ta dokument se nanaša na osnovno varnost in bistveno zmogljivost vlažilnika, ki se v nadaljevanju imenuje tudi ME oprema, v kombinaciji z njegovimi dodatki, pri čemer se kombinacija v nadaljevanju imenuje tudi ME sistem.
Ta dokument se uporablja tudi za tiste dodatke, ki jih njihov proizvajalec namerava povezati z vlažilnikom, kjer lahko značilnosti teh dodatkov vplivajo na osnovno varnost ali bistveno zmogljivost vlažilnika.
PRIMER 1 Ogrevane dihalne cevi (ogrevane žične dihalne cevi) ali ME oprema, namenjena nadzoru teh ogrevanih dihalnih cevi (krmilniki ogrevanih dihalnih cevi).
OPOMBA 2 Ogrevane dihalne cevi in njihovi krmilniki so ME oprema in so predmet zahtev IEC 60601‑1.
OPOMBA 3 ISO 5367 določa druge zahteve glede varnosti in zmogljivosti za dihalne cevi.
Ta dokument vključuje zahteve za različne medicinske uporabe vlaženja, kot so invazivna ventilacija, neinvazivna ventilacija, nosna terapija z visokim pretokom in terapija za obstruktivno apnejo v spanju, kot tudi terapijo vlaženja za traheostomirane bolnike.
OPOMBA 4 Vlažilnik je lahko integriran v drugo opremo. V tem primeru se zahteve druge opreme uporabljajo tudi za vlažilnik.
PRIMER 2 Ogrevani vlažilnik, vgrajen v ventilator za intenzivno nego, kjer se uporablja tudi ISO 80601‑2-12.
PRIMER 3 Ogrevani vlažilnik, vgrajen v ventilator za domačo oskrbo odvisnih bolnikov, kjer se uporablja tudi ISO 80601‑2‑72.
PRIMER 4 Ogrevani vlažilnik, vgrajen v opremo za terapijo apneje v spanju, kjer se uporablja tudi ISO 80601‑2‑70.
PRIMER 5 Ogrevani vlažilnik, vgrajen v opremo za podporo ventilaciji, kjer se uporablja bodisi ISO 80601-2-79 ali ISO 80601-2-80.
PRIMER 6 Ogrevani vlažilnik, vgrajen v opremo za terapijo z visokim pretokom dihanja, kjer se uporablja tudi ISO 80601‑2‑90.
Ta dokument vključuje tudi zahteve za aktivni HME (izmenjevalnik toplote in vlage), ME opremo, ki aktivno dodaja toploto in vlago za povečanje ravni vlažnosti plina, ki ga HME dostavlja pacientu. Ta dokument se ne uporablja za pasivni HME, ki med vdihom vrača del izdihane vlage in toplote pacienta v dihalne poti brez dodajanja toplote ali vlage.
OPOMBA 5 ISO 9360‑1 in ISO 9360‑2 določata zahteve glede varnosti in zmogljivosti za pasivni HME.
OPOMBA 6 Če je člen ali podčlen posebej namenjen samo ME opremi ali samo ME sistemom, bo naslov in vsebina tega člena ali podčlena to navedla. Če to ni tako, se člen ali podčlen uporablja tako za ME opremo kot za ME sisteme, kot je ustrezno.
Nevarnosti, ki so lastne predvideni fiziološki funkciji ME opreme ali ME sistemov v okviru tega dokumenta, niso zajete s specifičnimi zahtevami v tem dokumentu, razen v IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 in 8.4.1.
OPOMBA 7 Dodatne informacije so na voljo v IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
Ta dokument ne določa zahtev za naprave za vlaženje s hladnim prehodom ali hladnim mehurčkanjem, za katere so zahteve podane v ISO 20789.
Ta dokument se ne uporablja za opremo, ki se običajno imenuje "sobni vlažilniki" ali vlažilnike, uporabljene v sistemih ogrevanja, prezračevanja in klimatizacije, ali vlažilnike, vgrajene v inkubatorje za dojenčke za vlaženje komore.

General Information

• Status: Published
• Public Enquiry End Date: 27-Feb-2025
• Publication Date: 13-May-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-May-2026
• Due Date: 09-Jul-2026
• Completion Date: 14-May-2026
• Ref Project: EN ISO 80601-2-74:2026 - Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2026)

Relations

• Replaces: SIST EN ISO 80601-2-74:2021 - Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)
• Effective Date: 01-Jun-2026
• Refers: SIST ISO 7000:2020 - Graphical symbols for use on equipment - Registered symbols
• Effective Date: 06-May-2026
• Referred By: SIST EN 13544-1:2007+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 29-Apr-2026
• Referred By: SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
• Effective Date: 29-Apr-2026
• Referred By: SIST EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 29-Apr-2026
• Referred By: SIST EN 13718-1:2008 - Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances
• Effective Date: 29-Apr-2026

Overview

kSIST FprEN ISO 80601-2-74:2025 is an international standard published by CEN that establishes particular requirements for the basic safety and essential performance of respiratory humidifying equipment. This standard applies to humidifiers-defined as medical electrical (ME) equipment-used for medical respiratory therapies, either as stand-alone devices or when integrated into larger medical systems along with relevant accessories. The scope also includes active heat and moisture exchangers (HMEs) that add heat or moisture to respiratory gases but excludes passive HMEs and non-patient-connected humidification devices.

Hospitals, home healthcare settings, and clinical environments depend on respiratory humidifiers for applications such as invasive or non-invasive ventilation, tracheostomy, nasal high-flow therapy, and obstructive sleep apnoea therapy. The standard is designed to ensure that these devices and their accessories are safe to use, function as intended, and meet rigorous performance criteria.

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Key Topics

kSIST FprEN ISO 80601-2-74:2025 covers a broad range of essential areas, including:

• Basic Safety and Essential Performance: Requirements to minimize risk of electrical, mechanical, thermal, and radiation hazards associated with medical humidifiers.
• System Integration: Guidelines for devices incorporated into ventilators or other respiratory support systems, ensuring they continue to meet safety standards when used as components.
• Accessory Compatibility: Clarifies requirements for accessories-such as heated breathing tubes and controllers-whose characteristics can influence device safety or performance.
• Alarms and Usability: Requirements and guidance for medical alarm systems, user interfaces, and usability for both professional and home healthcare environments.
• Testing and Classification: Procedures for ME equipment classification, marking, testing, and ensuring conformity with international safety regulations.
• Hygiene and Biocompatibility: Addresses cleaning, sterilization, and biocompatibility, helping manufacturers provide comprehensive accompanying information and labels.
• Performance Measurement: Outlines methods for measuring output parameters such as humidity, temperature, sound levels, and system recovery, with references to normative annexes.
• Exclusions: Explicitly does not cover cold pass-over humidifiers, nebulizers, room humidifiers, or those not directly connected to patients.

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Applications

Respiratory humidifying equipment designed according to kSIST FprEN ISO 80601-2-74:2025 is critical for:

• Intensive Care Units (ICU): Ensuring safe and effective humidification in invasive ventilation scenarios.
• Homecare Settings: Providing essential respiratory humidity for patients with chronic respiratory conditions via home ventilators.
• Operating Theatres & Anaesthesia: Assuring safe humidification during anaesthesia and post-operative care.
• Sleep Therapy Clinics: Supporting patients with obstructive sleep apnoea through integrated humidification in CPAP and bilevel devices.
• Tracheostomy Patients: Maintaining airway humidity to prevent mucosal drying and secretion thickening.
• High-flow Nasal Therapy: Enhancing patient comfort and compliance by delivering optimal humidity for therapies involving high-flow gases.

Compliance with this standard helps medical device manufacturers, clinical engineering teams, and healthcare providers select and integrate respiratory humidifiers with confidence, knowing that products meet up-to-date safety and performance criteria recognized internationally.

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Related Standards

When working with respiratory humidifying equipment, it’s essential to consider overlapping and supplementary standards, including:

• IEC 60601-1 - Medical electrical equipment: General requirements for basic safety and essential performance.
• ISO 5367 - Breathing sets and connectors for anaesthetic and respiratory equipment.
• ISO 20789 - Cold pass-over and bubble-through humidification devices.
• ISO 5367, ISO 5356-1 - Breathing tubes and connectors.
• ISO 9360-1/2 - Passive heat and moisture exchangers (not covered under 80601-2-74).
• ISO 80369-1/2 - Small-bore connectors for liquids and gases in healthcare.
• ISO 18562-1 - Biocompatibility of breathing gas pathways.
• ISO 27427, ISO 80601-2-94 - Nebulizers and inhalational therapy devices (for applications outside the scope of this standard).
• EN ISO 80601-2-12, EN ISO 80601-2-70, EN ISO 80601-2-72, EN ISO 80601-2-79, EN ISO 80601-2-80, EN ISO 80601-2-90 - Particular standards for ventilators and other respiratory therapy equipment incorporating humidifiers.

Adhering to kSIST FprEN ISO 80601-2-74:2025 ensures medical humidification equipment satisfies rigorous modern requirements for safety, performance, and interoperability across diverse healthcare environments.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Nadomešča:
SIST EN ISO 80601-2-74:2021
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2026)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment (ISO 80601-2-74:2026)
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für
Atemgase (ISO 80601-2-74:2026)
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'humidification respiratoire (ISO
80601-2-74:2026)
Ta slovenski standard je istoveten z: EN ISO 80601-2-74:2026
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 80601-2-74
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-74:2021
English Version
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment (ISO 80601-2-
74:2026)
Appareils électromédicaux - Partie 2-74: Exigences Medizinische elektrische Geräte - Teil 2-74: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des équipements wesentlichen Leistungsmerkmale
d'humidification respiratoire (ISO 80601-2-74:2026) vonAnfeuchtersystemen für Atemgase (ISO 80601-2-
74:2026)
This European Standard was approved by CEN on 27 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 80601-2-74:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 80601-2-74:2026) 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 80601-2-74:2021.
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 80601-2-74:2026 has been approved by CEN as EN ISO 80601-2-74:2026 without any
modification.
International
Standard
ISO 80601-2-74
Third edition
Medical electrical equipment —
2026-04
Part 2-74:
Particular requirements for basic
safety and essential performance of
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d'humidification
respiratoire
Reference number
ISO 80601-2-74:2026(en) © ISO 2026

ISO 80601-2-74:2026(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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-74:2026(en)
Contents Page
Foreword . v
Introduction . vi
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 20
201.5 General requirements for testing of ME equipment . 23
201.6 Classification of ME equipment and ME systems . 25
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 . 33
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 . 38
201.13 Hazardous situations and fault conditions for ME Equipment . 43
201.14 Programmable electrical medical systems (PEMS) . 44
201.15 Construction of ME equipment . 45
201.16 ME systems . 45
201.16.2 Accompanying documents of an ME system . 45
201.17 Electromagnetic compatibility of ME equipment and ME systems . 46
201.101 Breathing system connectors and ports . 46
201.102 Requirements for the breathing system and accessories . 49
201.103 Liquid container. 49
201.104 Functional connection . 50
202 Electromagnetic disturbances — Requirements and tests . 50
206 Usability . 51
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 53
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 53
Annex C (informative)  Guide to marking and labelling requirements for
ME equipment and ME systems . 54
Annex D (informative)  Symbols on marking . 60
Annex AA (informative)  Particular guidance and rationale . 62
Annex BB (normative)  Determination of the accuracy of the displayed measured gas
temperature . 82
Annex CC (normative)  Determination of the humidification output . 84
Annex DD (normative)  Specific enthalpy calculations . 89
Annex EE (normative)  Removable temperature sensors and mating ports . 91
iii
ISO 80601-2-74:2026(en)
Annex FF (normative)  Reference temperature sensor . 94
Annex GG (informative)  Saturation vapour pressure . 97
Annex HH (informative)  Liquid fill port . 98
Annex II (informative)  Reference to the IMDRF essential principles and l abelling
guidances . 101
Annex JJ (informative)  Terminology — Alphabetized index of defined terms . 105
Bibliography . 110
iv
ISO 80601-2-74:2026(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.
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constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
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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 third edition cancels and replaces the second edition (ISO 80601-2-74:2021), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— updated normative references;
— added requirements for the fill connector; and
— clarified system recovery requirements.
A list of all parts in the ISO 80601 and 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.
v
ISO 80601-2-74:2026(en)
Introduction
This document specifies requirements for respiratory humidifying equipment intended for use on patients in
home healthcare environment and in professional healthcare environment. Humidifiers are used to raise the
water content of gases delivered to patients. Gases available for medical use do not contain sufficient moisture
and can damage or irritate the respiratory tract or desiccate secretions of patients whose upper airways have
been bypassed. Inadequate humidity in the inspired gas can cause drying of the upper airway, or desiccation
of tracheo-bronchial secretions in the tracheal or tracheostomy tube, which can cause narrowing or even
[27] [37]
obstruction of the airway . Heat is employed to increase the water output of the humidifier.
In addition, many humidifiers utilize heated breathing tubes in order to increase operating efficiency and
reduce water loss (condensate) as well as heat loss in the breathing tube. Some ventilator and anaesthesia
breathing tubes in common use cannot withstand the heat generated by humidifiers and breathing tube heating
mechanisms.
Many humidifier manufacturers use off-the-shelf electrical connectors for their electrically heated breathing
tubes. However, since different manufacturers have used the same electrical connector for different power
outputs, electrically heated breathing tubes can be physically, but not electrically, interchangeable. Use of
improper electrically heated breathing tubes has caused overheating, circuit melting, patient and operator
burns and fires. It was not found practical to specify the interface requirements for electrical connectors to
ensure compatibility between humidifiers and breathing tubes produced by different manufacturers.
Since the safe use of a humidifier depends on the interaction of the humidifier with its many accessories, this
document sets total system performance requirements up to the patient-connection port. These requirements
are applicable to accessories such as breathing tubes (both heated and non-heated), temperature sensors and
equipment intended to control the environment within these breathing tubes.
Humidification can also be used by respiratory support ME equipment to increase patient comfort and
compliance with the therapy. Examples are obstructive sleep apnoea and nasal high-flow therapy equipment.
The humidification output requirements of such ME equipment is less demanding as the patient’s upper airway
is not bypassed.
Humidifiers are commonly used with air and air-oxygen mixtures and any humidifier should be able to operate
with these gases. Care should be taken if using other gas mixes such as helium-oxygen mixtures, as the
different physical and thermal properties of these gases may disturb the operation of the humidifier.
In this document, the following print types are used:
— requirements and definitions: roman type;
— test specifications and terms defined in Clause 3 of the general standard, in this document or as noted: italic
type;
— 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 document are by number only.
vi
ISO 80601-2-74:2026(en)
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 to 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.
vii
International Standard ISO 80601-2-74:2026(en)

Medical electrical equipment —
Part 2-74:
Particular requirements for basic safety and essential
performance of respiratory humidifying 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 a humidifier, also hereafter referred to
as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a
humidifier where the characteristics of those accessories can affect the basic safety or essential performance of
the humidifier.
EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated
breathing tubes (heated breathing tube controllers).
NOTE 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of
IEC 60601-1.
NOTE 3 ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive
ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well
as humidification therapy for tracheostomy patients.
NOTE 4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other
equipment also apply to the humidifier.
EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601-2-12 also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72
also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70 also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or
ISO 80601-2-80 also apply.
ISO 80601-2-74:2026(en)
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601-2-90 also
applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment
which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the
patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture
and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 5 ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for a passive HME.
NOTE 6 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 7 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for cold pass-over or cold bubble-through humidification
devices, the requirements for which are given in ISO 20789.
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers
used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to
humidify the chamber air (i.e., are not directly connected to the patient).
This document is not applicable to nebulizers used for the delivery of a drug to patients.
NOTE 8 ISO 27427 specifies the safety and performance requirements for nebulizers.
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance requirements for
a humidifier, as defined in 201.3.240, and its accessories.
Accessories are included because the combination of the humidifier and the accessories needs to be adequately
safe. Accessories can have a significant impact on the basic safety or essential performance of a humidifier.
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 II.
NOTE 2 This document has been prepared to address the relevant general safety and performance requirements of
[19]
European regulation (EU) 2017/745 .
201.1.3 Collateral standards
Addition (add after existing text):
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.
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 60601-1-11:2015+AMD1:2020 apply as modified in
Clauses 202, 206, 208 and 211, respectively. IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 and IEC 60601-
1-9:2007+AMD1:2013+AMD2:2020 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
ISO 80601-2-74:2026(en)
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards define basic safety and essential performance requirements, and
may modify, replace or delete requirements contained in the general standard and 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 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 “20x”, where x is the final digit(s) 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, 208.6 in this document addresses the content of Clause 6 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 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.
Clauses, subclauses, figures or tables which 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, 211 for IEC 60601-1-11,
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 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.
Addition:
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 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 80601-2-74:2026(en)
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
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 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 18562-1:2024, 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 80369-1:2025, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-2:2024, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for respiratory applications
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62304:2006+AMD1:2015, Medical device software — Software life cycle processes
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
IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
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
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 80601-2-74:2026(en)
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1-8:2006+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 in Annex JJ.
201.3.201
absolute humidity
mass of water vapour present in a unit volume of gas
Note 1 to entry: In respiratory applications absolute humidity is commonly represented in units of milligrams per litre or
grams per cubic metre, with volume expressed at BTPS condition.
Note 2 to entry: See also relative humidity.
[SOURCE: ISO 4135:2022, 3.1.1.1]
201.3.202
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.]
201.3.203
active HME
humidifier where water, water vapour or heat is actively added to the HME to increase the humidity level of
the gas delivered from the HME to the patient
[SOURCE: ISO 4135:2022, 3.7.2.3, modified —replaced 'device' with 'humidifier'.]
201.3.204
aerosol
suspension of liquid or solid particles in a gas
[SOURCE: ISO 4135:2022, 3.1.1.3]
201.3.205
airway device
device intended to provide a gas pathway to and from the patient’s airway
ISO 80601-2-74:2026(en)
[SOURCE: ISO 4135:2022, 3.8.1.2]
201.3.206
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.
[SOURCE: ISO 4135:2022, 3.1.4.41.1, — modified, added letter symbol.]
201.3.207
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]
201.3.208
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]
201.3.209
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]
201.3.210
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]
ISO 80601-2-74:2026(en)
201.3.211
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use of an
asset
[SOURCE: IEC 81001-5-1:2021, 3.5]
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
BAP
quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure
[SOURCE: ISO 19223:2019, 3.10.2, modified — deleted admitted terms and notes.]
201.3.214
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 device or accessory may produce some level of adverse effect, but that level may be
determined to be acceptable when considering the benefit provided.
[SOURCE: ISO 18562-1:2024, 3.6]
201.3.215
body temperature and pressure, saturated
BTPS
ambient atmospheric pressure, at a temperature of 37 °C, and at a relative humidity of 100 %
[SOURCE: ISO 4135:2022, 3.1.1.7]
201.3.216
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 —deleted the notes to entry.]
201.3.217
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]
ISO 80601-2-74:2026(en)
201.3.218
breathing tube
non-rigid tube used to convey gases or vapours within the operator-detachable section of a breathing system
[SOURCE: ISO 4135:2022, 3.1.4.4, modified —replaced “user” with “operator” deleted note.]
201.3.219
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'.]
201.3.220
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]
201.3.221
CPAP
continuous positive airway pressure
ventilation-mode or sleep-apnoea breathing-therapy mode in which the patient breathes continuously at a set
airway-pressure level, above ambient pressure
[SOURCE: ISO 19223:2019, 3.11.15, modified — deleted notes.]
201.3.222
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”.]
201.3.223
delivered gas temperature
temperature of the gas, or aerosol, or both, being delivered to a patient, referenced to the patient-connection
port
[SOURCE: ISO 4135:2022, 3.1.1.13]
201.3.224
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being appropriate
for a defined purpose
[SOURCE: ISO 17664-1:2021, 3.3]
ISO 80601-2-74:2026(en)
201.3.225
distributed alarm system
DAS
alarm system that involves more than one item of equipment of a ME system intended for delivery of alarm
conditions with technical confirmation
Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.
Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm condition.
Note 3 to entry: Technical confirmation means that each element of a distributed alarm system confirms or guarantees
the successful delivery of the alarm condition to the next element or appropriate technical alarm conditions are created.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.17, modified — deleted “For the purposes of this
document, “ and “ as described in 6.11.2.2.1”.]
201.3.226
emergency medical services environment
EMS environment
actual conditions and settings, in which operators interact with the ME equipment or ME system, in and around
the scene of an emergency outside of a professional healthcare facility where a patient can be given medical
care, basic or advanced life support as well as during professional transport to a professional healthcare
facility or between professional healthcare facilities
EXAMPLE 1 Responding to and providing life support at the scene of an emergency to a patient reported as experiencing
injury or illness in a pre-hospital setting, and transporting the patient, while continuing such life support care, to an
appropriate professional healthcare facility for further care.
EXAMPLE 2 Providing monitoring, treatment or diagnosis during transport between professional healthcare facilities.
Note 1 to entry: The EMS environment is not considered to be part of the professional healthcare environment.
Note 2 to entry: Use of equipment intended for the EMS environment and temporarily used in the home healthcare
environment by emergency medical personnel is considered use in the EMS environment.
Note 3 to entry: The operators of equipment intended for the EMS environment are presumed to be healthcare professional
operators.
Note 4 to entry: Emergency medical services are known by various names in different countries and regions.
Note 5 to entry: Transport includes road, rotary and fixed-wing ambulances.
[SOURCE: IEC 60601-1-12:2014+AMD1:2020, 3.1, modified —replaced “professional medical personnel or
personnel with relevant specialized training” with “healthcare professional operators”, replaced original note
...