SIST EN ISO 80601-2-74:2021
(Main)Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (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)
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)
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un humidificateur, ci-après également désigné par appareil EM, associé à ses accessoires, dont la combinaison est ci-après désignée par système EM.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés à un humidificateur, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles de l'humidificateur.
EXEMPLE 1 Tuyaux respiratoires chauffés (tuyaux respiratoires avec résistance chauffante) ou les appareils EM destinés à commander ces tuyaux respiratoires chauffés (commandes de tuyaux respiratoires chauffés).
NOTE 1 Les tuyaux respiratoires chauffés et leurs commandes sont des appareils EM et sont soumis aux exigences de l'IEC 60601‑1.
NOTE 2 L'ISO 5367 spécifie d'autres exigences de sécurité et de performance pour les tuyaux respiratoires.
Le présent document contient des exigences pour les différentes utilisations médicales de l'humidification, telles que la ventilation invasive, la ventilation non invasive, l'oxygénothérapie nasale à haut débit et le traitement de l'apnée obstructive du sommeil, ainsi que l'humidification pour les patients trachéotomisés.
NOTE 3 Un humidificateur peut être intégré dans un autre appareil. Dans ce cas, les exigences de l'autre appareil s'appliquent aussi à l'humidificateur.
EXEMPLE 2 Humidificateur chauffé intégré dans un ventilateur pulmonaire pour utilisation en soins intensifs où l'ISO 80601‑2-12[10] s'applique aussi.
EXEMPLE 3 Humidificateur chauffé intégré dans un ventilateur utilisé dans l'environnement des soins à domicile pour les patients dépendants où l'ISO 80601‑2-72[12] s'applique aussi.
EXEMPLE 4 Humidificateur chauffé intégré dans du matériel de traitement respiratoire de l'apnée du sommeil où l'ISO 80601‑2‑70[11] s'applique aussi.
EXEMPLE 5 Humidificateur chauffé intégré dans l’équipement d’assistance ventilatoire où l’ISO 80601-2-79[13] ou l’ISO 80601-2-80[14] s’applique aussi.
EXEMPLE 6 Humidificateur chauffé intégré dans du matériel d'oxygénothérapie à haut débit où l'ISO 80601‑2‑90[15] s'applique aussi.
Le présent document contient également des exigences pour les ECH actifs (échangeurs de chaleur et d'humidité), appareils EM qui ajoutent activement de la chaleur et de l'humidité afin d'augmenter le niveau d'humidité du gaz administré au patient par l'ECH. Le présent document ne s'applique pas aux ECH passifs qui renvoient une partie de l'humidité et de la chaleur de l'air expiré par le patient aux voies respiratoires lors de l'inspiration, sans ajout de chaleur ou d'humidité.
NOTE 4 L’ISO 9360‑1 et l’ISO 9360‑2[4] spécifient les exigences de sécurité et de performances pour un ECH passif.
NOTE 5 Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Dans le cas contraire, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2021)
General Information
Relations
Standards Content (Sample)
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.
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SIST EN ISO 80601-2-74:2021
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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
2
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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.
3
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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
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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
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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;
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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
vi
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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).
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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.
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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.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 80601-2-74:2020
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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
1
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.
1
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
2
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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