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

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.

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

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 fréquence (JVHF); — ventilateurs à oscillation haute fréquence (VOHF)[8] ; — appareils em délivrant un débit constant d'oxygénothérapie; — équipements de ventilation de type cuirasse ou «poumon d'acier». Le présent document fait partie des séries de documents de l'IEC 60601 et IEC/ISO 80601. [1]) En cours d?élaboration. État au moment de la parution: ISO/DIS 80601-2-84:2017.

General Information

• Status: Not Published
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
• Drafting Committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
• Current Stage: 6000 - International Standard under publication
• Completion Date: 05-Jul-2024

Relations

• Revises: ISO 80601-2-79:2018 - Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS
80601-2-79
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-79:
Voting begins on:
2024-05-09
Particular requirements for basic
safety and essential performance of
Voting terminates on:
2024-07-04
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
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 80601-2-79:2024(en) © ISO 2024

FINAL DRAFT
ISO/FDIS 80601-2-79:2024(en)
International
Standard
ISO/FDIS
80601-2-79
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-79:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
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
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
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 SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 80601-2-79:2024(en) © ISO 2024

ii
ISO/FDIS 80601-2-79:2024(en)
Contents
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 . 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 humidity36
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 38
Table 201.103 — Test settings for pressure-control inflation-type type . 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 . 56
201.103 Spontaneous breathing during loss of power supply . 57
201.104 Indication of duration of operation . 57
201.105 Functional connection . 58
201.106 Display loops . 58
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
Table BB.101 — Parameters and units of measurement . 90
iii
ISO/FDIS 80601-2-79:2024(en)
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
Bibliography . 100
Terminology — Alphabetized index of defined terms . 103
iv
ISO/FDIS 80601-2-79:2024(en)
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 or
www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of
any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC
had not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.
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. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee
IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular medical equipment,
software, and systems, 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 80601-2-79:2018), which has been
technically revised.
The main changes are as follows:
— 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;
— 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 and IEC
websites.
v
ISO/FDIS 80601-2-79:2024(en)
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 and www.iec.ch/national-
committees.
vi
ISO/FDIS 80601-2-79:2024(en)
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 supervised 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 used for patients who have stable ventilatory needs. This document
addresses patients who have significant respiratory dysfunction resulting in an abnormality of a
sufficient degree to be noticeable by the patient. This is best characterized by lung functions not worse
[35]
than :
— FEV /FVC < 70 %; or
— 50 % ≤ FEV < 80 % predicted
where
FEV is the forced expiratory volume in 1 s, and
FVC is the forced vital capacity.
Examples of diseases that require ventilation support are:
— mild to moderate Chronic Obstructive Pulmonary Disease (COPD);
— mild to moderate 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 te
...

ISO/TC 121/SC3/
ISO/TC 121/SC 3/
2024-04-0302
Secretariat: ANSI
Medical Electrical Equipmentelectrical 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

FDIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is
subject to change without notice and may not be referred to as an International Standard.
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.

All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland.
ii © ISO 2024 – All rights reserved

Contents
Foreword  . iv
Introduction . vi
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 . 27
201.8 Protection against electrical hazards from ME equipment . 33
201.9 Protection against mechanical hazards of ME equipment and ME systems . 34
Figure 201.101 — Standard resistance . 36
201.10 Protection against unwanted and excessive radiation hazards . 36
201.11 Protection against excessive temperatures and other hazards. 36
Table 201.101 — Examples of permissible combinations of temperature and relative humidity36
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 39
Table 201.103 — Test settings for pressure-control inflation-type type . 44
201.13 Hazardous situations and fault conditions for ME equipment . 50
201.14 Programmable electrical medical systems (PEMS) . 51
201.15 Construction of ME equipment . 52
201.17 Electromagnetic compatibility of ME equipment and ME systems . 53
201.101 Gas connections . 53
201.102 Requirements for the VBS and accessories . 57
201.103 Spontaneous breathing during loss of power supply . 58
201.104 Indication of duration of operation . 59
201.105 Functional connection . 59
201.106 Display loops . 60
202 Electromagnetic disturbances — Requirements and tests. 60
206 Usability . 61
206.101 Training . 63
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment . 63
Annex C (informative) Guide to marking and labelling requirements for ME equipment
and ME systems . 64
Annex D (informative) Symbols on marking . 70
Annex AA (informative) Particular guidance and rationale . 72
Annex BB (informative) Data interface requirements . 90
Table BB.101 — Parameters and units of measurement . 91
ii © ISO 2024 – All rights reserved

ISO/FDIS 80601-2-79:2024(en)
Table BB.103 — Usage monitoring . 92
Table BB.104 — Equipment settings . 92
Table BB.105 — Ventilation monitoring . 94
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 96
Bibliography . 101
Terminology — Alphabetized index of defined terms . 105

iii
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 or
www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of
any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC
had not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.
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. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee
IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular medical equipment,
software, and systems, 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 80601-2-79:2018), which has been
technically revised.
The main changes are as follows:
— 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.
iv © ISO 2024 – All rights reserved

ISO/FDIS 80601-2-79:2024(en)
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 and www.iec.ch/national-
committees.
v
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 supervised 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 used for patients who have stable ventilatory needs. This document
addresses patients who have significant respiratory dysfunction resulting in an abnormality of a
sufficient degree to be noticeable by the patient. This is best characterized by lung functions not worse
[35]
than :
— FEV /FVC < 70 %; or
— 50 % ≤ FEV < 80 % predicted
where
FEV1 is the forced expiratory volume in 1 s, and
FVC is the forced vital capacity.
Examples of diseases that require ventilation support are:
— mild to moderate Chronic Obstructive Pulmonary Disease (COPD);
— mild to moderate 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 FEV1.
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.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in Clause 3 of the general standard , in this document or as noted: italic type; and

This is also known as the Tiffeneau-Pinelli index.
vi © ISO 2024 – All rights reserved

ISO/FDIS 80601
...