ISO 80601-2-79:2024

International
Standard
ISO 80601-2-79
Second edition
Medical electrical equipment —
2024-08
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
Reference number
© ISO 2024
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Published in Switzerland
ii
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 . 26
201.8 Protection against electrical hazards from ME equipment. 33
201.9 Protection against mechanical hazards of ME equipment and ME systems . 33
201.10 Protection against unwanted and excessive radiation hazards . 35
201.11 Protection against excessive temperatures and other hazards . 35
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 38
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
201.16 ME systems . 52
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
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 95
Bibliography . 100
Terminology — Alphabetized index of defined terms . 103
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, Respiratory devices and related equipment used for patient care, 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.
iv
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
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 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 .
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
— 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); and
— “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.
For the purposes of this document, the auxiliary verb:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates 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 docume
...