oSIST prEN ISO 80601-2-79:2023

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO/DIS 80601-2-79:2023)

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[4];
— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84 [5] [1], the future replacement for ISO 10651‑3[6];
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
— ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80[1];
— sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[7];
— continuous positive airway pressure (CPAP) me equipment;
— high-frequency jet ventilators (HFJVs);
— high-frequency oscillatory ventilators (HFOVs)[8];
— oxygen therapy constant flow me equipment;
— cuirass or "iron-lung" ventilation equipment.
This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.
[1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Medizinische elektrische Geräte - Teil 2-79: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit Atmungsbeeinträchtigungen (ISO/DIS 80601-2-79:2023)

Appareils électromédicaux - Partie 2-79: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'assistance ventilatoire en cas de trouble ventilatoire (ISO/DIS 80601-2-79:2023)

Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements d'assistance ventilatoire, tels que définis en 201.3.205, pour le trouble ventilatoire, tels que définis en 201.3.202, ci-après également désignés par appareils em, en association avec leurs accessoires:
— destinés à être utilisés dans l'environnement des soins à domicile;
— destinés à être utilisés par un opérateur non spécialiste; et
— destinés à être utilisés avec des patients souffrant d'un trouble ventilatoire, les plus fragiles de ces patients ayant peu de risque d'être blessés en cas de perte de cette ventilation artificielle; et
— non destinés à être utilisés chez les patients dont le maintien immédiat des fonctions vitales dépend d'une ventilation artificielle.
EXEMPLE 1 Patients souffrant d'une bronchopneumopathie chronique obstructive (BPCO) légère à modérée.
NOTE 1 Dans l'environnement des soins à domicile, il est fréquent que le réseau d'alimentation ne soit pas fiable.
NOTE 2 Ces équipements d'assistance ventilatoire peuvent également être utilisés dans les établissements de santé professionnels, pour d'autres applications qu'en soins intensifs.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés au système respiratoire des équipements d'assistance ventilatoire en cas de trouble ventilatoire, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles des équipements d'assistance ventilatoire en cas de trouble ventilatoire.
EXEMPLE 2 Ensembles respiratoires, raccords, pièges à eau, valve expiratoire, humidificateur, filtre pour système respiratoire, source d'énergie électrique externe et système d'alarme réparti.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils em ou uniquement aux systèmes em, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Dans le cas contraire, l'article ou le paragraphe s'applique à la fois aux appareils em et aux systèmes em, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils em ou des systèmes em dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1:2012, 7.2.13 et 8.4.1.
NOTE 3 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012, 4.2.
Le présent document ne spécifie pas les exigences relatives aux:
— ventilateurs ou accessoires pour patients ventilo-dépendants prévus pour les applications en soins intensifs, qui sont données dans l'ISO 80601‑2‑12;
— ventilateurs ou accessoires prévus pour les applications en anesthésie, qui sont données dans l'ISO 80601‑2‑13[4];
— ventilateurs ou accessoires destinés à l'environnement des services médicaux d'urgence, qui sont données dans l'ISO 80601‑2‑84[5] [1]), qui remplacera l'ISO 10651‑3[6];
— ventilateurs ou accessoires pour patients ventilo-dépendants dans l'environnement des soins à domicile, qui sont données dans l'ISO 80601‑2‑72;
— équipements d'assistance ventilatoire ou accessoires prévus en cas d'insuffisance ventilatoire, qui sont données dans l'ISO 80601‑2‑80[1];
— appareils em de traitement de l'apnée du sommeil, qui sont données dans l'ISO 80601‑2‑70[7];
— appareils em délivrant une pression positive continue des voies aériennes (PPC);
— jet-ventilateurs à haute fréque

Medicinska električna oprema - 2-79. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pomožne ventilacijske opreme pri okvari ventilatorja (ISO/DIS 80601-2-79:2023)

General Information

• Status: Not Published
• Public Enquiry End Date: 18-Jul-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 19-May-2023
• Due Date: 06-Oct-2023
• Ref Project: prEN ISO 80601-2-79 - Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO/DIS 80601-2-79:2023)

Relations

• Revises: SIST EN ISO 80601-2-79:2019 - Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
• Effective Date: 28-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-79:2023
01-julij-2023
Medicinska električna oprema - 2-79. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pomožne ventilacijske opreme pri okvari ventilatorja (ISO/DIS
80601-2-79:2023)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and
essential performance of ventilatory support equipment for ventilatory impairment
(ISO/DIS 80601-2-79:2023)
Medizinische elektrische Geräte - Teil 2-79: Besondere Festlegungen für die
grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von
Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit
Atmungsbeeinträchtigungen (ISO/DIS 80601-2-79:2023)
Appareils électromédicaux - Partie 2-79: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'assistance ventilatoire en cas de
trouble ventilatoire (ISO/DIS 80601-2-79:2023)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-79
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-79:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-79:2023

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oSIST prEN ISO 80601-2-79:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-79
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-05-11 2023-08-03
Medical electrical equipment —
Part 2-79:
Particular requirements for basic safety and essential
performance of ventilatory support equipment for
ventilatory impairment
Appareils électromédicaux —
Partie 2-79: Exigences particulières pour la sécurité de base et les performances essentielles des
équipements d'assistance ventilatoire en cas de trouble ventilatoire
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 80601-2-79:2023(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 2023

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oSIST prEN ISO 80601-2-79:2023
ISO/DIS 80601-2-79:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-79
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:

Medical electrical equipment —
Part 2-79:
Particular requirements for basic safety and essential
performance of ventilatory support equipment for
ventilatory impairment
Appareils électromédicaux —
Partie 2-79: Exigences particulières pour la sécurité de base et les performances essentielles des
équipements d'assistance ventilatoire en cas de trouble ventilatoire
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 80601-2-79:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 80601-2-79:2023

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oSIST prEN ISO 80601-2-79:2023
ISO/DIS 80601-2-79:2023(E)
ISO 80601-2-79:2023(E)
Contents
Foreword iv
Introduction . v
201.1 Scope, object and related standards . 1
201.2 Normative references . 4
201.3 Terms and definitions . 5
201.4 General requirements . 23
201.5 General requirements for testing of ME equipment . 25
201.6 Classification of ME equipment and ME systems. 26
201.7 ME equipment identification, marking and documents . 26
201.8 Protection against electrical hazards from ME equipment . 33
201.9 Protection against mechanical hazards of ME equipment and ME systems . 33
Figure 201.101 — Standard resistance . 35
201.10 Protection against unwanted and excessive radiation hazards . 35
201.11 Protection against excessive temperatures and other hazards . 35
Table 201.101 — Examples of permissible combinations of temperature and relative humidity . 36
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 38
Table 201.103 — Pressure-control inflation-type type test settings . 43
201.13 Hazardous situations and fault conditions for ME equipment . 49
201.14 Programmable electrical medical systems (PEMS) . 50
201.15 Construction of ME equipment . 51
201.17 Electromagnetic compatibility of ME equipment and ME systems . 52
201.101 Gas connections . 52
201.102 Requirements for the VBS and accessories . 55
201.103 Spontaneous breathing during loss of power supply . 57
201.104 Indication of duration of operation . 57
201.105 Functional connection . 57
201.106 Display loops . 58
201.107 Oxygen inlet port . 59
202 Electromagnetic disturbances — Requirements and tests . 59
206 Usability . 60
206.101 Training . 61
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment . 62
Annex C (informative) Guide to marking and labelling requirements for ME equipment
and ME systems . 63
Annex D (informative) Symbols on marking . 69
Annex AA (informative) Particular guidance and rationale . 71
Annex BB (informative) Data interface requirements . 89
ii © ISO 2023 – All rights reserved

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oSIST prEN ISO 80601-2-79:2023


ISO/DIS 80601-2-79:2023(E)


ISO 80601-2-79:2023(E)


Table BB.101 — Parameters and units of measurement . 90

Table BB.103 — Usage monitoring . 91

Table BB.104 — Equipment settings . 91

Table BB.105 — Ventilation monitoring . 93
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 95

Annex DD (informative) Reference to the essential principles . 99

Bibliography . 103
Terminology — Alphabetized index of defined terms. 106
© ISO 2023 – All rights reserved iii

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oSIST prEN ISO 80601-2-79:2023

ISO/DIS 80601-2-79:2023(E)

ISO 80601-2-79:2023(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. 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. 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.
ISO 80601-2-79 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee
IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft
was circulated for voting to the national bodies of both ISO and IEC.
This second edition cancels and replaces the first edition (ISO 80601-2-79:2018), which has been
technically revised.
The most significant changes are the following modifications:
— alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020;
— reformatted according to most recent Central Secretariat editing rules;
— clarified maximum limited pressure requirements;
— clarified high airway pressure alarm condition requirements; and
— harmonization with ISO 20417, where appropriate.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
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.
iv © ISO 2023 – All rights reserved

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oSIST prEN ISO 80601-2-79:2023


ISO/DIS 80601-2-79:2023(E)


ISO 80601-2-79:2023(E)


Introduction


This document specifies requirements for ventilatory support equipment that is intended for use in the
home healthcare environment for patients who are not dependent on ventilation for their life support.

Ventilatory support equipment is frequently used in locations where supply mains is not reliable.
Ventilatory support equipment is often supervis ed by non-healthcare personnel (lay operators) with
varying levels of training. Ventilatory support equipment conforming with this document can be used

elsewhere (i.e. in healthcare facilities).

Ventilatory support is often needed for patients who have stable ventilatory needs. This document
addresses patients who have significant respiratory dysfunction resulting in an abnormality of a sufficient
[35]
degree to be noticeable by the patient. This is best characterized by lung functions not worse than :
1
— FEV /FVC < 70 %; or
1
— 50 % ≤ FEV < 80 % predicted
1
where
FEV is the forced expiratory volume in 1 s, and
1
FVC is the forced vital capacity.
Examples of diseases that require ventilation support are
— mild to moderate Chronic Obstructive Pulmonary Disease (COPD);
— neuromuscular/ amyotrophic lateral sclerosis (ALS);
— obese patients Obese Hypoventilation Syndrome (OHS);
— Cheyne–Stokes respiration (CSR/CSA).
CSR/CSA is an abnormal pattern of breathing characterized by progressively deeper and sometimes
faster breathing, followed by a gradual decrease that results in a temporary stop in breathing called an
apnoea. The pattern repeats, with each cycle usually taking 30 s to 2 min.
Cardiac patients with CSR/CSA might be breathless without having significant reduction in FEV .
1
Reducing the work of breathing can help normalize their breathing.
This ventilatory support equipment is intended for patients who are spontaneously breathing and do not
require ventilation for life support or intermittent periods of ventilation to maintain vital signs.
Ventilatory support equipment intended for this group of patients typically does not require physiological
alarm conditions as no essential performance exists. These patients can gain adequate relief from fatigue
related to the work of breathing by using ventilatory support equipment during the night and while taking
breaks during the day. This can enable a patient with ventilatory impairment to continue to move about
and participate in the activities of daily living. Non-transit-operable ventilatory support equipment that
provides ventilatory support at the bedside and beside a chair or other resting place should be adequate
in this application.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
— Requirements and definitions: roman type;
1
This is also known as the Tiffeneau-Pinelli index.
© ISO 2023 – All rights reserved v

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oSIST prEN ISO 80601-2-79:2023

ISO/DIS 80601-2-79:2023(E)

ISO 80601-2-79:2023(E)

2
— 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);

— “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 particular 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.

The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2. For the
purposes of this document, the auxiliary verb:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” is used to describe a possibility or capability; and
— “must” is used to express an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
Requirements in this document have been decomposed so that each requirement is uniquely delineated.
This is done to support automated requirements tracking.
2
The general standard is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
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oSIST prEN ISO 80601-2-79:2023


ISO/DIS 80601-2-79:2023(E)


ISO 80601-2-79:2023(E)




Medical electrical equipment


Part 2-79:
Particular requirements for the basic safety and essential

performance of ventilatory support equipment for ventilatory

impairment
201.1 Scope, object and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1, applies, except as follows:
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as
defined in 201.3.301, for ventilatory impairment, as defined in 201.3.299, hereafter also referred to as ME
equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is
often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
— intended for use by a lay operator;
— intended for use with patients who have ventilatory impairment, the most fragile of these patients,
would not likely experience injury with the loss of this artificial ventilation; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it
uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to
the breathing system of ventilatory support equipment for ventilatory impairment, where the
characteristics of those accessories can affect the basic safety or essential performance of the ventilatory
support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external
electrical power source, distributed alarm system.
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.
© ISO 2023 – All rights reserved 1

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oSIST prEN ISO 80601-2-79:2023

ISO/DIS 80601-2-79:2023(E)

ISO 80601-2-79:2023(E)

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, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.

This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications,

which are given in ISO 80601-2-12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;

— ventilators or accessories intended for the emergency medical services environment, which are given
in ISO 80601-2-84;

— ventilators or accessories intended for ventilator-dependent patients in the home healthcare
environment, which are given in ISO 80601-2-72;

— ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in
ISO 80601-2-80;
— sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
[33]
— high-frequency jet ventilators (HFJVs) , which are given in ISO 80601-2-87;
[22]
— high-frequency oscillatory ventilators (HFOVs) ;
— respiratory high flow equipment, which are given in ISO 80601-2-90;
NOTE 5 ISO 80601-2-79 ventilatory support equipment can incorporate high-flow therapy operational mode,
but such a mode is only for spontaneously breathing patients.
— user-powered resuscitators, which are given in ISO 10651-4;
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— oxygen therapy constant flow ME equipment; and
— cuirass or “iron-lung” ventilation equipment.
201.1.2 Object
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 is replaced by:
The object of this document is to establish particular basic safety and essential performance requirements
for ventilatory support equipment, as defined in 201.3.301, and its accessories.
Accessories are included because the combination of the ventilatory support equipment and the accessories
need to be adequately safe. Accessories can have a significant impact on the basic safety or essential
performance of the ventilatory support equipment.
NOTE 1 This document has been prepared to address the relevant International Medical Device Regulators
[37] [38]
Forum (IMDRF) essential principles and labelling guidances as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance
[10]
of ISO 16142-1:2016 as indicated in Annex DD.
2 © ISO 2023 – All rights reserved

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oSIST prEN ISO 80601-2-79:2023


ISO/DIS 80601-2-79:2023(E)


ISO 80601-2-79:2023(E)


NOTE 3 This document has been prepared to address the relevant general safety and performance requirements
[39]

of European regulation (EU) 2017/745 .

201.1.3 Collateral standards

IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:

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

standard and Clause 201.2 of this document.

IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, and
IEC 60601-1-11:2015+AMD1:2020 apply as modified in Clauses 202, 206 and 211 respectively.
IEC 60601-1-3 IEC 60601-1-9 and IEC 60601-1-12 do not apply. All other published collateral standards
in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.4 is replaced by:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
the general standard, including the 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 particular 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 “2xx”, where xx is the final digits 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, 211.10 in this document addresses the content of Clause 10 of the
IEC 60601-1-11 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.
Subclauses, figures or tables that are additional to those of the general standard are numbered starting
from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201. Additional
annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting
from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for
IEC 60601-1-3, etc.
The term “this document” is used to make reference to the IEC 60601-1:2005+AMD1:2012+AMD2:2020,
any applicable collateral standards and this document taken together.
Where there is no corresponding clause or subclause in this particular document, the clause or subclause
of the general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular
document.
© ISO 2023 – All rights reserved 3

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