SIST EN ISO 80601-2-79:2024

SLOVENSKI STANDARD
01-november-2024
Nadomešča:
SIST EN ISO 80601-2-79:2019
Medicinska električna oprema - 2-79. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pomožne ventilacijske opreme pri okvari ventilatorja (ISO 80601-
2-79:2024)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and
essential performance of ventilatory support equipment for ventilatory impairment (ISO
80601-2-79:2024)
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 80601-2-79:2024)
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 80601-2-79:2024)
Ta slovenski standard je istoveten z: EN ISO 80601-2-79:2024
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 80601-2-79
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-79:2019
English Version
Medical electrical equipment - Part 2-79: Particular
requirements for basic safety and essential performance of
ventilatory support equipment for ventilatory impairment
(ISO 80601-2-79:2024)
Appareils électromédicaux - Partie 2-79: Exigences Medizinische elektrische Geräte - Teil 2-79: Besondere
particulières pour la sécurité de base et les Festlegungen für die grundlegende Sicherheit und die
performances essentielles des équipements wesentlichen Leistungsmerkmale von
d'assistance ventilatoire en cas de trouble ventilatoire Heimbeatmungsgeräten zur Atemunterstützung von
(ISO 80601-2-79:2024) Patienten mit Atmungsbeeinträchtigungen (ISO 80601-
2-79:2024)
This European Standard was approved by CEN on 5 August 2024.

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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-79:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 80601-2-79:2024) 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 March 2025, and conflicting national standards shall
be withdrawn at the latest by March 2025.
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 80601-2-79:2019.
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 website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-79:2024 has been approved by CEN as EN ISO 80601-2-79:2024 without any
modification.
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 80601-2-79:2024(en) © ISO 2024

ISO 80601-2-79:2024(en)
© ISO 2024
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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-79:2024(en)
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
ISO 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, 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
ISO 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.
v
ISO 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 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
ISO 80601-2-79:2024(en)
— 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 document.
Requirements in this document have been decomposed so that each requirement is uniquely
delineated. This is done to support automated requirements tracking.

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
International Standard ISO 80601-2-79:2024(en)

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 201.3.302, for ventilatory impairment, as defined in 201.3.300, 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 80601-2-79:2024(en)
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 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 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 6 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, for ventilatory impairment, as defined in 201.3.300,
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.
ISO 80601-2-79:2024(en)
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.
NOTE 3 This document has been prepared to address the relevant general safety and performance
[39]
requirements 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.
ISO 80601-2-79:2024(en)
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.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2, applies, except as follows:
Replacement:
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
Addition:
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5367:2023, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396-1:2016/Amd 1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 80601-2-79:2024(en)
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
ISO 80369-1:— , Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80601-2-74:2021, Medical electrical equipment — Part 2-74: Particular requirements for basic safety
and essential performance of respiratory humidifying equipment
IEC 60601-1:2005+AMD1:2012+AMD2:2020 , Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical
devices
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+AMD1:2012+AMD2:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
201.3.201
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]

Under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2024.
There exists a consolidated edition 3.2(2020) including IEC 60601-1:2005, its Amendment 1:2012 and its Amendment 2:2020.
ISO 80601-2-79:2024(en)
201.3.202
acknowledged
state of an alarm system initiated by operator action, where the auditory alarm signal associated with a
currently active alarm condition is inactivated until the alarm condition no longer exists or until a
predetermined time interval has elapsed
Note 1 to entry: Acknowledged only affects alarm signals that are active at the time of the operator action.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.37]
201.3.203
airway pressure
P
aw
pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
connection port
Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the
equipment.
[SOURCE: ISO 4135:2022, 3.1.4.41.1]
201.3.204
alarm condition delay
time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or
in the equipment, for technical alarm conditions, to when the alarm system determines that an alarm
condition exists
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.2]
201.3.205
alarm limit
threshold used by an alarm system to determine an alarm condition
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
201.3.206
alarm off
state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm
signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.4]
201.3.207
alarm paused
state of limited duration in which the alarm system or part of the alarm system does not generate alarm
signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
201.3.208
alarm setting
alarm system configuration, including but not limited to:
– alarm limits;
– the characteristics of any alarm signal inactivation states; and
– the values of variables or parameters that determine the function of the alarm system
Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-
determined.
ISO 80601-2-79:2024(en)
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.8]
201.3.209
alarm signal generation delay
time from the onset of an alarm condition to the generation of its alarm signal(s)
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.10]
201.3.210
artificial ventilation
intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external
means with the intention of augmenting, or totally controlling, the ventilation of a patient
EXAMPLE Means used to provide artificial ventilation are manual resuscitation; mouth-to-mouth resuscitation;
automatic ventilation; mechanical ventilation.
Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport;
home-care; anaesthesia; critical care; rehabilitation.
Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure;
negative-pressure; gas-powered; operator-powered; electrically-powered.
Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently
lowering the pressure in the lungs.
[SOURCE: ISO 19223:2019, 3.1.10]
201.3.211
assured inflation-type rate
number of assured inflation-type initiations in a specified period of time, expressed as breaths per
minute
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity.
[SOURCE: ISO 19223:2019, 3.5.2.1, modified — deleted note 2.]
201.3.212
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use
of an asset
[SOURCE: IEC 81001-5-1:2021, 3.5]
201.3.213
audio off
state of indefinite duration in which the alarm system or part of the alarm system does not generate an
auditory alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.12]
201.3.214
audio paused
state of limited duration in which the alarm system or part of the alarm system does not generate an
auditory alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.13]
ISO 80601-2-79:2024(en)
201.3.215
BAP
quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure
[SOURCE: ISO 19223:2019, 3.10.2, modified — deleted notes.]
201.3.216
biocompatibility
ability of a medical device, accessory or material to perform with an appropriate host response in a
specific application
Note 1 to entry: A medical device or accessory may produce some level of adverse effect, but that level may be
determined to be acceptable when considering the benefits provided by the medical device or accessory.
[SOURCE: ISO 18562-1:2024, 3.6]
201.3.217
body temperature and pressure saturated
BTPS
ambient atmospheric pressure, at a temperature of 37 °C, and a relative humidity of 100 %
[SOURCE: ISO 4135:2022, 3.1.1.7]
201.3.218
breathing system
pathways through which gas flows to or from the patient at respiratory pressures and continuously or
intermittently in fluid communication with the patient’s respiratory tract during any form of artificial
ventilation or respiratory therapy
[SOURCE: ISO 4135:2022, 3.6.1.1, modified — deleted notes.]
201.3.219
breathing system filter
BSF
device intended to reduce transmission of particulates, including microorganisms, in breathing systems
[SOURCE: ISO 23328-2:2002, 3.1]
201.3.220
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other
debris) from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated
process that prepares the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2021, 3.1, modified — replaced 'and/or' with 'or'.]
201.3.221
connector
fitting to join two or more components
EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to
maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each
particular gas.
[SOURCE: ISO 4135:2022, 3.1.4.5]
ISO 80601-2-79:2024(en)
201.3.222
CPAP
continuous positive airway pressure
ventilation-mode or sleep-apnoea breathing-therapy mode in which the patient breathes continuously
at a set airway-pressure level, above ambient pressure
Note 1 to entry: CPAP is intended to maintain the airway pressure at its set value apart from the inevitable minor
deviations that are necessary for it to perform its function. Although there are currently no tests for acceptable
levels for such deviations, they are expected to neither add to nor subtract from the patient's perceived work of
breathing to a greater extent than could be experienced during natural breathing.
Note 2 to entry: This definition excludes the use of the term to describe ventilation-modes where spontaneous
inspirations are supported by intermittently elevated pressures other than with the intention to compensate for
any actual or perceived imposed work of breathing.
Note 3 to entry: Because, as used for this ventilation-mode, the concept of a CPAP level coincides with that of a
baseline airway pressure the setting could be designated as for either concept but as the intention of the operator
selecting this ventilation-mode will be to achieve a specific CPAP level, this becomes an acceptable admitted term
to designate the set quantity.
Note 4 to entry: Although at the periphery of the spectrum of what constitutes a ventilation-mode, CPAP is
included in this document because it is commonly made available on typical critical care ventilators for use as part
of a continuum of a patient's treatment without the necessity to change to another device.
Note 5 to entry: It is possible for a ventilation-mode resembling CPAP to be realized on a ventilator by the use of
CSV (continuous spontaneous ventilation) with the pres
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