Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)

ISO 80601-2-74 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). 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.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. 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.

Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für Atemgase (ISO 80601-2-74:2021)

IEC 60601-1:2005+AMD1:2012+AMD2:20201, Abschnitt 1 gilt mit der folgenden Ausnahme:
ANMERKUNG Die allgemeine Norm ist IEC 60601-1:2005+AMD1:2012+AMD2:2020.
[...]

Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'humidification respiratoire (ISO 80601-2-74:2021)

Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2021)

General Information

Status
Published
Public Enquiry End Date
19-Dec-2020
Publication Date
22-Aug-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
28-Jul-2021
Due Date
02-Oct-2021
Completion Date
23-Aug-2021

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SLOVENSKI STANDARD
SIST EN ISO 80601-2-74:2021
01-oktober-2021
Nadomešča:
SIST EN ISO 80601-2-74:2020
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (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)

Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für
Atemgase (ISO 80601-2-74:2021)

Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base

et les performances essentielles des équipements d'humidification respiratoire (ISO

80601-2-74:2021)
Ta slovenski standard je istoveten z: EN ISO 80601-2-74:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-74:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 80601-2-74:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 80601-2-74:2021
EN ISO 80601-2-74
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-74:2020
English Version
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment (ISO 80601-2-
74:2021)

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 von

d'humidification respiratoire (ISO 80601-2-74:2021) Anfeuchtersystemen für Atemgase (ISO 80601-2-

74:2021)
This European Standard was approved by CEN on 2 July 2021.

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, Turkey 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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-74:2021 E

worldwide for CEN national Members.
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SIST EN ISO 80601-2-74:2021
EN ISO 80601-2-74:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 80601-2-74:2021
EN ISO 80601-2-74:2021 (E)
European foreword

This document (EN ISO 80601-2-74:2021) 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 January 2022, and conflicting national standards shall

be withdrawn at the latest by January 2022.

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 80601-2-74:2020.

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 websites.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 80601-2-74:2021 has been approved by CEN as EN ISO 80601-2-74:2021 without any

modification.
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SIST EN ISO 80601-2-74:2021
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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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
---------------------- Page: 12 ----------------------
SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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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SIST EN ISO 80601-2-74:2021
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.
Claus
...

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-74:2020
01-december-2020
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO/DIS 80601-2-74:2020)

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and

essential performance of respiratory humidifying equipment (ISO/DIS 80601-2-74:2020)

Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen für
Atemgase (ISO/DIS 80601-2-74:2020)

Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base

et les performances essentielles des équipements d'humidification respiratoire (ISO/DIS

80601-2-74:2020)
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
oSIST prEN ISO 80601-2-74:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-74:2020
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oSIST prEN ISO 80601-2-74:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-74
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-10-26 2021-01-18
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
ICS: ISO ics
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
This draft is submitted to a parallel vote in ISO and in IEC.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-74:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 80601-2-74:2020
ISO 80601-2-74:2020(E)
ISO/DIS 80601-2-74:2020(E)
Contents Page

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

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

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

201.2 Normative references................................................................................................................. 4

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

201.4 General requirements ................................................................................................................ 9

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

201.10Protection against unwanted and excessive radiation hazards............................... 22

201.11Protection against excessive temperatures and other hazards............................... 22

201.12Accuracy of controls and instruments and protection against hazardous

outputs .......................................................................................................................................... 25

201.13Hazardous situations and fault conditions for ME Equipment .................................. 32

201.14Programmable electrical medical systems (PEMS) ...................................................... 33

201.15Construction of ME equipment.............................................................................................. 34

201.16ME systems ................................................................................................................................... 34

201.17Electromagnetic compatibility of ME equipment and ME systems ........................... 34

201.101 Breathing system connectors and ports................................................................... 34

201.102 Requirements for the breathing system and accessories................................... 37

201.103 Liquid container ................................................................................................................ 38

201.104 Functional connection ..................................................................................................... 38

202 Electromagnetic disturbances — Requirements and tests........................................ 39

206 Usability........................................................................................................................................ 40

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

electrical equipment and medical electrical systems.................................................. 41

211 Requirements for medical electrical equipment and medical electrical

systems used in the home healthcare environment..................................................... 41

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

ME equipment and ME systems.............................................................................................. 42

Annex D (informative) Symbols on marking .................................................................................... 47

Annex AA (informative) Particular guidance and rationale ...................................................... 49

COPYRIGHT PROTECTED DOCUMENT
Annex BB (normative) * Determination of the accuracy of the displayed measured
© ISO 2020

gas temperature......................................................................................................................... 68

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

Annex CC (normative) * Determination of the humidification output .................................... 70

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

Annex DD (normative) * Specific enthalpy calculations.............................................................. 76

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
© ISO 2020 – All rights reserved iii
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)
Contents Page

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

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

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

201.2 Normative references ................................................................................................................. 4

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

201.4 General requirements ................................................................................................................ 9

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 ............................... 22

201.11 Protection against excessive temperatures and other hazards ............................... 22

201.12 Accuracy of controls and instruments and protection against hazardous

outputs .......................................................................................................................................... 25

201.13 Hazardous situations and fault conditions for ME Equipment .................................. 32

201.14 Programmable electrical medical systems (PEMS) ...................................................... 33

201.15 Construction of ME equipment .............................................................................................. 34

201.16 ME systems ................................................................................................................................... 34

201.17 Electromagnetic compatibility of ME equipment and ME systems ........................... 34

201.101 Breathing system connectors and ports ................................................................... 34

201.102 Requirements for the breathing system and accessories ................................... 37

201.103 Liquid container ................................................................................................................ 38

201.104 Functional connection ..................................................................................................... 38

202 Electromagnetic disturbances — Requirements and tests ........................................ 39

206 Usability ........................................................................................................................................ 40

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

electrical equipment and medical electrical systems .................................................. 41

211 Requirements for medical electrical equipment and medical electrical

systems used in the home healthcare environment ..................................................... 41

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

ME equipment and ME systems.............................................................................................. 42

Annex D (informative) Symbols on marking .................................................................................... 47

Annex AA (informative) Particular guidance and rationale ...................................................... 49

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

gas temperature ......................................................................................................................... 68

Annex CC (normative) * Determination of the humidification output .................................... 70

Annex DD (normative) * Specific enthalpy calculations .............................................................. 76

© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)

Annex EE (normative) Removable temperature sensors and mating ports ......................... 78

Annex FF (normative) * Reference temperature sensor ............................................................. 82

Annex GG (informative) Saturation vapour pressure................................................................... 85

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

guidances ..................................................................................................................................... 86

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

performance of medical devices in accordance with ISO 16142-1:2016 .............. 90

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

requirements .............................................................................................................................. 93

Annex KK (informative) Terminology — Alphabetized index of defined terms ................. 96

Bibliography ................................................................................................................................................. 101

iv © ISO 2020 – All rights reserved
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)
Foreword

ISO (the International Organization for Standardization) and IEC (the International

Electrotechnical Commission) form the specialized system for worldwide standardization.

National bodies that are members of ISO or IEC participate in the development of International

Standards through technical committees established by the respective organization to deal with

particular fields of technical activity. ISO and IEC technical committees collaborate in fields of

mutual interest. Other international organizations, governmental and non-governmental, in

liaison with ISO and IEC, also take part in the work.

The procedures used to develop this document and those intended for its further maintenance

are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria

needed for the different types of document should be noted. This document was drafted in

accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directives).

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

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

patent rights. Details of any patent rights identified during the development of the document

will be in the Introduction and/or on the ISO list of patent declarations received (see

www.iso.org/patents) or the IEC list of patent declarations received (see http://patents.iec.ch).

Any trade name used in this document is information given for the convenience of users and

does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see

www.iso.org/iso/foreword.html.

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 D, 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 first second of ISO 80601-2-74 cancels and replaces the first edition of ISO 80601-2-74.

The most significant changes are the following additions:
— harmonization with the ‘A2 project’ of the general standard;
— harmonization with ISO 20417; and
— addition of category 3 for high-flow equipment.
A list of all parts in the ISO 80601 series can be found on the ISO website.
© ISO 2020 – All rights reserved v
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)

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.
vi © ISO 2020 – All rights reserved
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(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 at the

patient-connection port 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 obstruction

[23] [35]
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;
© ISO 2020 – All rights reserved vii
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)
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.

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.
viii © ISO 2020 – All rights reserved
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)
1 Medical electrical equipment —
2 Part 2-74: Particular requirements for basic safety and
3 essential performance of respiratory humidifying equipment
4 201.1 Scope, object and related standards
5 IEC 60601-1:2005+AMD1:2012+AMD2:2020 , Clause 1 applies, except as follows.
6 NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
7 201.1.1 * Scope
8 Replacement:

9 This document applies to the basic safety and essential performance of a humidifier, also

10 hereafter referred to as ME equipment, in combination with its accessories, the combination also

11 hereafter referred to as ME system.

12 This document is also applicable to those accessories intended by their manufacturer to be

13 connected to a humidifier where the characteristics of those accessories can affect the basic safety

14 or essential performance of the humidifier.

15 EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to

16 control these heated breathing tubes (heated breathing tube controllers).

17 NOTE 1 Heated breathing tubes and their controllers are ME equipment and are subject to the

18 requirements of IEC 60601-1.

19 NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.

20 This document includes requirements for the different medical uses of humidification, such as

21 invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep

22 apnoea therapy, as well as humidification therapy for tracheostomy patients.

23 NOTE 3 A humidifier can be integrated into other equipment. When this is the case, the requirements of

24 the other equipment also apply to the humidifier.
[10]

25 EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601-2-12

26 also applies.

27 EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where

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

29 EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where

[11]
30 ISO 80601-2-70 also applies.

The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.
© ISO 2020 – All rights reserved 1
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)

31 EXAMPLE 5 Heated humidifier incorporated into respiratory high-flow therapy equipment where

[11]
32 ISO 80601-2-90 also applies.

33 This document also includes requirements for an active HME (heat and moisture exchanger),

34 ME equipment which actively adds heat and moisture to increase the humidity level of the gas

35 delivered from the HME to the patient. This document is not applicable to a passive HME, which

36 returns a portion of the expired moisture and heat of the patient to the respiratory tract during

37 inspiration without adding heat or moisture.
[4]

38 NOTE 4 ISO 9360-1 and ISO 9360-2 specify the safety and performance requirements for a passive

39 HME.

40 NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to

41 ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the

42 clause or subclause applies both to ME equipment and to ME systems, as relevant.

43 Hazards inherent in the intended physiological function of ME equipment or ME systems within

44 the scope of this document are not covered by specific requirements in this document except in

45 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.

46 NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

47 This document does not specify the requirements for cold pass-over or cold bubble-through

[6]
48 humidification devices, the requirements for which are given in ISO 20789 .

49 This document is not applicable to equipment commonly referred to as “room humidifiers” or

50 humidifiers used in heating, ventilation and air conditioning systems, or humidifiers

51 incorporated into infant incubators.

52 This document is not applicable to nebulizers used for the delivery of drugs to patients.

[7]

53 NOTE 7 ISO 27427 specifies the safety and performance requirements for nebulizers.

54 201.1.2 Object
55 Replacement:

56 The object of this document is to establish particular basic safety and essential performance

57 requirements for a humidifier, as defined in 201.3.209, and its accessories.

58 Accessories are included because the combination of the humidifier and the accessories needs to

59 be adequately safe. Accessories can have a significant impact on the basic safety or essential

60 performance of a humidifier.

61 NOTE 1 This document has been prepared to address the relevant essential principles and labelling

62 guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex HH.

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

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

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

66 requirements of European regulation (EU) 2017/745 as indicated in Annex JJ.
67 201.1.3 Collateral standards
68 Addition (add after existing text):
2 © ISO 2020 – All rights reserved
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oSIST prEN ISO 80601-2-74:2020
ISO/DIS 80601-2-74:2020(E)

69 This document refers to those applicable collateral standards that are listed in Clause 2 of the

70 general standard and in 201.2 of this document.
71 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,

72 IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 and IEC 60601-1-11:2015+AMD1:2020 apply as

73 modified in Clauses 202, 206, 208 and 211, respectively. IEC 60601-1-3:2008+AMD1:2013 does

74 not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

75 201.1.4 Particular standards
76 Replacement:

77 In the IEC 60601 series, particular standards define basic safety and essential performance

78 requirements, and may modify, replace or delete requirements contained in the general

79 standard and collateral standards as appropriate for the particular ME equipment under

80 consideration.

81 A requirement of a particular standard takes priority over the general standard.

82 For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the

83 general standard. Collateral standards are referred to by their document number.

84 The numbering of clauses and subclauses of this document corresponds to that of the general

85 standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of

86 the general standard) or applicable collateral standard with the prefix “20x”, where x is the final

87 digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the

88 content of Clause 4 of the IEC 60601-1-2 collateral standard, 208.6 in this document addresses

89 the content of Clause 6 of the IEC 60601-1-8 collateral standard, etc.). The changes to the text of

90 the general standard are specified by the use of the following words:

91 “Replacement” means that the clause or subclause of the general standard or applicable

92 collateral standard is replace
...

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