Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

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 document is not applicable to nebulizers used for the delivery of a drug to patients.
NOTE 7 ISO 27427[7] specifies the safety and performance requirements for nebulizers.

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

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+AMD1:2012+AMD2:2020, 7.2.13 et 8.4.1.
NOTE 6 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
Le présent document ne spécifie pas les exigences pour les dispositifs d'humidification à froid par léchage («pass-over») ou à barbotage, dont les exigences sont données dans l'ISO 20789[6].
Le présent document ne s'applique pas aux appareils servant à humidifier des locaux et les humidificateurs utilisés pour le chauffage, la ventilation ou la climatisation ni aux humidificateurs utilisés dans les couveuses.
Le pr

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INTERNATIONAL ISO
STANDARD 80601-2-74
Second edition
2021-07
Medical electrical equipment —
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 80601-2-74:2021(E)
ISO 2021
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ISO 80601-2-74:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
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ISO 80601-2-74:2021(E)
Contents Page

Foreword ............................................................................................................................................................. v

Introduction ..................................................................................................................................................... vii

201.1 Scope, object and related standards...................................................................................... 1

201.2 Normative references ................................................................................................................. 3

201.3 Terms and definitions ................................................................................................................ 5

201.4 General requirements ................................................................................................................ 8

201.5 General requirements for testing of ME equipment ...................................................... 11

201.6 Classification of ME equipment and ME systems ............................................................. 12

201.7 ME equipment identification, marking and documents ............................................... 13

201.8 Protection against electrical hazards form ME equipment ........................................ 20

201.9 Protection against mechanical hazards of ME equipment and ME systems........... 20

201.10 Protection against unwanted and excessive radiation hazards ............................... 21

201.11 Protection against excessive temperatures and other hazards ............................... 21

201.12 Accuracy of controls and instruments and protection against hazardous outputs

.......................................................................................................................................................... 24

201.13 Hazardous situations and fault conditions for ME Equipment .................................. 30

201.14 Programmable electrical medical systems (PEMS) ........................................................ 31

201.15 Construction of ME equipment .............................................................................................. 32

201.16 ME systems ................................................................................................................................... 32

201.16.2 Accompanying documents of an ME system ...................................................................... 32

201.17 Electromagnetic compatibility of ME equipment and ME systems ........................... 32

201.101 Breathing system connectors and ports ............................................................................ 33

201.102 Requirements for the breathing system and accessories ............................................ 35

201.103 Liquid container ......................................................................................................................... 36

201.104 Functional connection .............................................................................................................. 36

202 Electromagnetic disturbances — Requirements and tests ........................................ 37

206 Usability ........................................................................................................................................ 38

208 General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems .................................................. 39

211 Requirements for medical electrical equipment and medical electrical systems

used in the home healthcare environment ...................................................................... 39

Annex C (informative) Guide to marking and labelling requirements for ME equipment

and ME systems ........................................................................................................................... 40

Annex D (informative) Symbols on marking .................................................................................... 45

Annex AA (informative) Particular guidance and rationale ...................................................... 47

Annex BB (normative) * Determination of the accuracy of the displayed measured gas

temperature ................................................................................................................................. 64

Annex CC (normative) * Determination of the humidification output .................................... 66

Annex DD (normative) * Specific enthalpy calculations .............................................................. 71

Annex EE (normative) Removable temperature sensors and mating ports ......................... 73

Annex FF (normative) * Reference temperature sensor ............................................................. 77

© ISO 2021 – All rights reserved iii
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ISO 80601-2-74:2021(E)

Annex GG (informative) Saturation vapour pressure ................................................................... 80

Annex HH (informative) Reference to the IMDRF essential principles and labelling

guidances ...................................................................................................................................... 81

Annex II (informative) Reference to the essential principles of safety and performance of

medical devices in accordance with ISO 16142-1:2016 ............................................... 85

Annex JJ (informative) Reference to the general safety and performance requirements

.......................................................................................................................................................... 88

Annex KK (informative) Terminology — Alphabetized index of defined terms ................. 91

Bibliography .................................................................................................................................................... 95

© ISO 2021 – All rights reserved
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ISO 80601-2-74:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national

standards bodies (ISO member bodies). The work of preparing International Standards is normally

carried out through ISO technical committees. Each member body interested in a subject for which a

technical committee has been established has the right to be represented on that committee.

International organizations, governmental and non-governmental, in liaison with ISO, also take part in

the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

matters of electrotechnical standardization.

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 ISO documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

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.

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, Electrical equipment in medical practice, Subcommittee SC 62D,

Electromedical equipment, 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 80601-2-74:2017), which has been

technically revised.
The main changes compared to the previous edition are as follows:
— harmonization with the ‘A2 project’ of the general standard;
— harmonization with ISO 20417;
— addition of category 3 for respiratory high-flow therapy equipment;

— modification of requirements for humidification output of category 2 humidifiers;

— addition of requirements for maximum temperature in normal use;
— addition of requirements for static and dynamic temperature stability;
© ISO 2021 – All rights reserved v
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ISO 80601-2-74:2021(E)
— addition of requirements for low humidification output alarm condition;
— modification of audible acoustic energy test procedure;
— modification of thermal requirements for applied parts;
— modification of measured gas temperature test procedure;
— enlarged the ØW dimension of the temperature sensor port; and
— modification of humidification output test procedure.

A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO and IEC

websites.

Any feedback or questions on this document should be directed to the user’s national standards body.

A complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2021 – All rights reserved
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ISO 80601-2-74:2021(E)
Introduction

This document specifies requirements for respiratory humidifying equipment intended for use on

patients in home healthcare environment and in healthcare facilities. 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,

[25] [38]

which can cause narrowing or even 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. Ventilator and anaesthesia

breathing tubes in common use might not 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).
© ISO 2021 – All rights reserved vii
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ISO 80601-2-74:2021(E)

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.

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” means that conformance with a requirement or a test is mandatory for conformance with

this document;

— “should” means that conformance with a requirement or a test is recommended but is not

mandatory for conformance with this document;

— “may” is used to describe permission (e.g. a permissible way to achieve conformance with a

requirement or test);
— "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.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex AA.
© ISO 2021 – All rights reserved
viii
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INTERNATIONAL STANDARD ISO 80601-2-74:2021(E)
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:

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.
[10]

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

[12]
ISO 80601-2-72 also applies.
[11]

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-

[13] [14]
79 or ISO 80601-2-80 also apply.

EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where

[15]
ISO 80601-2-90 also applies.
© ISO 2021 – All rights reserved 1
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ISO 80601-2-74:2021(E)

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.
[4]

NOTE 4 ISO 9360-1 and ISO 9360-2 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

[6]
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.

This document is not applicable to nebulizers used for the delivery of a drug to patients.

[7]

NOTE 7 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 201.3.214, 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 HH.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance

of ISO 16142-1:2016 as indicated in Annex II.

NOTE 3 This document has been prepared to address the relevant general safety and performance

requirements of European regulation (EU) 2017/745 as indicated in Annex JJ.
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 does not

apply. All other published collateral standards in the IEC 60601-1 series apply as published.

2 © ISO 2021 – All rights reserved
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ISO 80601-2-74:2021(E)
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.
Replacement:
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 2021 – All rights reserved 3
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ISO 80601-2-74:2021(E)

ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and

sockets

ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors

ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed

medical gases and vacuum

ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml

ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having

minimum tidal volumes of 250 ml

ISO 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 16142-1:2016, Medical devices -- Recognized essential principles of safety and performance of medical

devices — Part 1: General essential principles and additional specific essential principles for all non-IVD

medical devices and guidance on the selection of standards

ISO 17664:2017, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —

Part 1: Evaluation and testing within a risk management process

ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics

ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer

ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration

aspects

ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1:

General requirements

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General

requirements for basic safety and essential performance

IEC 60601-2-19:2020, Medical electrical equipment — Part 2-19: Particular requirements for the basic

safety and essential performance of infant incubators

IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to

medical devices

IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the

magnetic resonance environment
4 © ISO 2021 – All rights reserved
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ISO 80601-2-74:2021(E)
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 7396-1:2016,

ISO 9360-1:2000, ISO 17664:2017, ISO 18562-1:2017, ISO 19223:2019, ISO 23328-2:2002,

IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020,

IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-11:2015, IEC 62366-1:2015 and the

following apply.

ISO and IEC maintain terminological 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 KK.
201.3.201
absolute humidity
mass of water vapour present in a unit volume of moist gas

Note 1 to entry: In respiratory applications absolute humidity is commonly represented in units of milligrams per

litre or grams per cubic metre.
Note 2 to entry: See also relative humidity.
[1]
[SOURCE: ISO 4135:— , 3.1.1.1]
201.3.202
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
[1]
[SOURCE: ISO 4135:— , 3.7.2.3, modified —replaced 'device' with 'humidifier'.]
201.3.203
aerosol
suspension of liquid or solid particles in a gas
[1]
, 3.1.1.3]
[SOURCE: ISO 4135:—
201.3.204
airway device
device intended to provide a gas pathway to and from the patie
...

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