ISO 80601-2-80:2024

International
Standard
ISO 80601-2-80
Second edition
Medical electrical equipment —
2024-08
Part 2-80:
Particular requirements for basic
safety and essential performance of
ventilatory support equipment for
ventilatory insufficiency
Appareils électromédicaux —
Partie 2-80: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'assistance
ventilatoire en cas d'insuffisance ventilatoire
Reference number
© ISO 2024
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Published in Switzerland
ii
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 . 24
201.5 General requirements for testing of ME equipment . 28
201.6 Classification of ME equipment and ME systems . 29
201.7 ME equipment identification, marking and documents . 29
201.8 Protection against electrical hazards from ME equipment . 37
201.9 Protection against mechanical hazards of ME equipment and ME systems . 37
201.10 Protection against unwanted and excessive radiation hazards . 39
201.11 Protection against excessive temperatures and other hazards . 39
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 43
201.13 Hazardous situations and fault conditions for ME equipment . 55
201.14 Programmable electrical medical systems (PEMS) . 56
201.15 Construction of ME equipment . 57
201.16 ME systems . 58
201.17 Electromagnetic compatibility of ME equipment and ME systems . 58
201.101 Gas connections . 59
201.102 Requirements for the VBS and accessories . 62
201.103 Spontaneous breathing during loss of power supply . 63
201.104 Indication of duration of operation . 64
201.105 Functional connection . 64
201.106 Display loops . 65
201.107 Ventilatory support equipment security . 65
202 Electromagnetic disturbances — Requirements and tests . 66
206 Usability . 67
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 69
211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment . 71
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 72
iii
Annex D (informative) Symbols on marking . 79
Annex AA (informative) Particular guidance and rationale . 81
Annex BB (informative) Data interface requirements . 102
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 109
Bibliography . 113
Terminology — Alphabetized index of defined terms . 116

iv
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 80601-2-80:2018), 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, IEC 60601-1-8:2006+AMD1:2012+AMD2:2020
and IEC 60601-1-11:2015+AMD1:2020;
— clarified maximum limited pressure requirements;
— clarified high airway pressure alarm condition requirements;
— added requirements for ventilatory support equipment system recovery; and
— harmonization with ISO 20417, where appropriate.
v
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.
vi
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 for 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).
Varying levels of ventilatory support is often used for patients who have stable ventilatory needs and in
some cases, changing needs as their disease worsens. This document addresses patients who typically
have severe enough respiratory function to prohibit certain activities that the patient might normally
pursue, and to interfere with daily living, occurring in association with measurements of respiratory
mechanics or gas exchange that are markedly abnormal. This is best characterised by lung functions
[36]
worse than
— FEV /FVC < 70 %, or
— FEV < 50 % predicted
where
FEV is the forced expiratory volume in 1 s, and
FVC is the forced vital capacity.
Examples of diseases that require ventilatory support are:
— moderate to severe Chronic Obstructive Pulmonary Disease (COPD);
[44]
— moderate Amyotrophic Lateral Sclerosis (ALS) ;
— severe bronchopulmonary dysplasia; and
— muscular dystrophy.
Ventilatory support equipment intended for this group of patients typically can require technical alarm
conditions in the event that essential performance is absent. The most fragile of these patients would
likely experience injury, but not serious injury or death, with the loss of this artificial ventilation. For
these patients, it is likely that ventilatory support is needed during waking hours while patients are
moving inside or outside the home in order to facilitate mobility and functional independence in the
activities of daily living.
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
— 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:

This is also known as the Tiffeneau-Pinelli index.
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.
vii
— “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.); 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 cons
...