prEN ISO 80601-2-74
(Main)Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO/DIS 80601-2-74:2024)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO/DIS 80601-2-74:2024)
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 1 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 2 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 3 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[10] also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2-72[12] also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70[11] also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply.
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90[15] 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 4 ISO 9360‑1 and ISO 9360‑2[4] specify safety and performance requirements for a passive HME.
NOTE 5 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 6 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[6].
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.
This
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für Atemgase (ISO/DIS 80601-2-74:2024)
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'humidification respiratoire (ISO/DIS 80601-2-74:2024)
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 1 Les tuyaux respiratoires chauffés et leurs commandes sont des appareils EM et sont soumis aux exigences de l'IEC 60601‑1.
NOTE 2 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 3 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[10] 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[12] 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[11] s'applique aussi.
EXEMPLE 5 Humidificateur chauffé intégré dans l’équipement d’assistance ventilatoire où l’ISO 80601-2-79[13] ou l’ISO 80601-2-80[14] s’applique aussi.
EXEMPLE 6 Humidificateur chauffé intégré dans du matériel d'oxygénothérapie à haut débit où l'ISO 80601‑2‑90[15] 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 4 L’ISO 9360‑1 et l’ISO 9360‑2[4] spécifient les exigences de sécurité et de performances pour un ECH passif.
NOTE 5 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. Dans le cas contraire, 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
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO/DIS 80601-2-74:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2025
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO/DIS 80601-2-74:2024)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment (ISO/DIS 80601-2-74:2024)
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für
Atemgase (ISO/DIS 80601-2-74:2024)
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'humidification respiratoire (ISO/DIS
80601-2-74:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-74
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.
DRAFT
International
Standard
ISO/DIS 80601-2-74
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-74:
Voting begins on:
Particular requirements for basic 2024-12-06
safety and essential performance of
Voting terminates on:
2025-02-28
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d'humidification
respiratoire
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
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This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
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This draft is submitted to a parallel vote in ISO and in IEC.
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Reference number
ISO/DIS 80601-2-74:2024(en)
ISO/DIS 80601-2-74:2024(en)
DRAFT
International
Standard
ISO/DIS 80601-2-74
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-74:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d'humidification
respiratoire
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARD UNTIL
© ISO 2024 PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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This document is circulated as received from the committee secretariat.
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TECHNOLOGICAL, COMMERCIAL AND
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PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 80601-2-74:2024(en)
ii
ISO/DIS 80601-2-74:2024(en)
1 Contents Page
2 Foreword . v
3 Introduction . vi
4 201.1 Scope, object and related standards . 1
5 201.2 Normative references . 3
6 201.3 Terms and definitions . 4
7 201.4 General requirements . 19
8 201.5 General requirements for testing of ME equipment . 22
9 201.6 Classification of ME equipment and ME systems . 24
10 201.7 ME equipment identification, marking and documents . 25
11 201.8 Protection against electrical hazards form ME equipment . 32
12 201.9 Protection against mechanical hazards of ME equipment and ME systems . 32
13 201.10 Protection against unwanted and excessive radiation hazards . 33
14 201.11 Protection against excessive temperatures and other hazards . 33
15 201.12 Accuracy of controls and instruments and protection against
16 hazardous outputs . 36
17 201.13 Hazardous situations and fault conditions for ME Equipment . 41
18 201.14 Programmable electrical medical systems (PEMS) . 42
19 201.15 Construction of ME equipment . 43
20 201.16 ME systems . 43
21 201. 16.2 Accompanying documents of an ME system . 43
22 201.17 Electromagnetic compatibility of ME equipment and ME systems . 44
23 201.101 Breathing system connectors and ports . 44
24 201.102 Requirements for the breathing system and accessories . 46
25 201.103 Liquid container . 47
26 201.104 Functional connection. 48
27 202 Electromagnetic disturbances — Requirements and tests . 48
28 206 Usability . 49
29 208 General requirements, tests and guidance for alarm systems in
30 medical electrical equipment and medical electrical systems . 50
31 211 Requirements for medical electrical equipment and medical electrical
32 systems used in the home healthcare environment . 51
33 Annex C (informative) Guide to marking and labelling requirements for
34 ME equipment and ME systems . 52
35 Annex D (informative) Symbols on marking. 57
36 Annex AA (informative) Particular guidance and rationale . 59
37 Annex BB (normative) Determination of the accuracy of the displayed measured gas
38 temperature . 78
39 Annex CC (normative) Determination of the humidification output . 80
40 Annex DD (normative) Specific enthalpy calculations . 85
41 Annex EE (normative) Removable temperature sensors and mating ports . 87
42 Annex FF (normative) Reference temperature sensor. 90
ISO/DIS 80601-2-74:2024(en)
43 FF.1 Test preparation . 90
44 Annex GG (informative) Saturation vapour pressure . 93
45 Annex HH (informative) Liquid fill port . 94
46 Annex II (informative) Reference to the IMDRF essential principles and
47 labelling guidances . 97
48 Annex JJ (informative) Terminology — Alphabetized index of defined terms . 101
49 Bibliography . 106
iv © ISO 2024 – All rights reserved
ISO/DIS 80601-2-74:2024(en)
51 Foreword
52 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
53 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
54 technical committees. Each member body interested in a subject for which a technical committee has been
55 established has the right to be represented on that committee. International organizations, governmental and
56 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
57 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
58 The procedures used to develop this document and those intended for its further maintenance are described in
59 the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO
60 documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC
61 Directives, Part 2 (see www.iso.org/directives).
62 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
63 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights
64 identified during the development of the document will be in the Introduction and/or on the ISO list of patent
65 declarations received (see www.iso.org/patents).
66 Any trade name used in this document is information given for the convenience of users and does not constitute
67 an endorsement.
68 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
69 related to conformity assessment, as well as information about ISO's adherence to the World Trade
70 Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
71 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
72 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and Technical
73 Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62D, Particular medical
74 equipment, software, and systems, in collaboration with the European Committee for Standardization (CEN)
75 Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement
76 on technical cooperation between ISO and CEN (Vienna Agreement).
77 This third edition cancels and replaces the second edition (ISO 80601-2-74:2021), which has been technically
78 revised.
79 The main changes compared to the previous edition are as follows:
80 — updated normative references;
81 — added requirements for the fill connector; and
82 — clarified system recovery requirements.
83 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO and IEC websites.
84 Any feedback or questions on this document should be directed to the user’s national standards body. A
85 complete listing of these bodies can be found at www.iso.org/members.html.
ISO/DIS 80601-2-74:2024(en)
86 Introduction
87 This document specifies requirements for respiratory humidifying equipment intended for use on patients in
88 home healthcare environment and in professional healthcare environment. Humidifiers are used to raise the
89 water content of gases delivered to patients. Gases available for medical use do not contain sufficient moisture
90 and can damage or irritate the respiratory tract or desiccate secretions of patients whose upper airways have
91 been bypassed. Inadequate humidity in the inspired gas can cause drying of the upper airway, or desiccation of
92 tracheo-
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