ISO 80601-2-80

Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, 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; — intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for transit-operable use; — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. 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 ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. 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[5]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[6][1], the future replacement for ISO 10651‑3[7]; — 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 impairment, which are given in ISO 80601‑2‑79[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[8]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[9]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a particular standard 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 2-80: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'assistance ventilatoire en cas d'insuffisance 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 les insuffisances ventilatoires, telles que définies en 201.3.204, 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; — destinés à être utilisés avec des patients souffrant d'une insuffisance ventilatoire ou d'un trouble ventilatoire, les plus fragiles de ces patients ayant des risques d'être blessés en cas de perte de cette ventilation artificielle; — destinés à être opérationnel en déplacement; — 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) modérée à grave, d'une sclérose latérale amyotrophique (SLA) modérée, d'une dysplasie bronchopulmonaire grave ou d'une dystrophie musculaire. 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 du ventilateur des équipements d'assistance ventilatoire en cas d'insuffisance ventilatoire, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles des équipements d'assistance ventilatoire en cas d'insuffisance 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[5]; — ventilateurs ou accessoires destinés à l'environnement des services médicaux d'urgence, qui sont données dans l'ISO 80601‑2‑84[6][1]), qui remplacera l'ISO 10651‑3[7]; 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 de trouble ventilatoire, qui sont données dans l'ISO 80601‑2‑79[1]; — appareils em de traitement de l'apnée du sommeil, qui sont données dans l'ISO 80601‑2‑70[8]; — appareils em délivrant une pression positive continue des voies aériennes (PPC); — jet-ventilateurs à haute fréquence (JVHF); — ventilateurs à oscillation haute fréquence (VOHF) [9] ; — appareils em délivrant un débit constant d'oxygénothérapie; — équipements de ventilation de type cuirasse ou «poumon d'acier». Le présent document est une norme particulière

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

• Consolidates: ISO 80601-2-87:2021 - Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
• Effective Date: 06-Jun-2022
• Revises: ISO 80601-2-80:2018 - Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS
80601-2-80
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-80:
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 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
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
This draft is submitted to a parallel vote in ISO and in IEC.
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
ISO/CEN PARALLEL PROCESSING
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 80601-2-80:2024(en) © ISO 2024

FINAL DRAFT
ISO/FDIS 80601-2-80:2024(en)
International
Standard
ISO/FDIS
80601-2-80
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-80:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
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
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
This draft is submitted to a parallel vote in ISO and in IEC.
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-
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
ISO/CEN PARALLEL PROCESSING
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 80601-2-80:2024(en) © ISO 2024

ii
ISO/FDIS 80601-2-80:2024(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 . 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
201.17 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
Annex D (informative) Symbols on marking . 79
iii
ISO/FDIS 80601-2-80:2024(en)
Annex AA (informative) Particular guidance and rationale . 81
AA.1 General guidance . 81
AA.2 Rationale for particular clauses and subclauses . 81
Annex BB (informative) Data interface requirements . 102
BB.1 Background and purpose . 102
BB.2 Data definition . 103
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 109
Bibliography . 113
Terminology — Alphabetized index of defined terms . 116

iv
ISO/FDIS 80601-2-80:2024(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 80601-2-80:2018), 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
ISO/FDIS 80601-2-80:2024(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.
vi
ISO/FDIS 80601-2-80:2024(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 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
...

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

ISO /FDIS 80601-2-80:2023(E2024(en)
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
[e-mail]
www.iso.org
ii © ISO 2023 – All rights reserved
ii
ISO /FDIS 80601-2-80:2023(E2024(en)
Contents
Introduction . ix
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 . 30
201.7 ME equipment identification, marking and documents . 30
201.8 Protection against electrical hazards from ME equipment . 37
201.9 Protection against mechanical hazards of ME equipment and ME systems . 38
201.10 Protection against unwanted and excessive radiation hazards . 40
201.11 Protection against excessive temperatures and other hazards . 40
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 44
201.13 Hazardous situations and fault conditions for ME equipment . 57
201.14 Programmable electrical medical systems (PEMS) . 58
201.15 Construction of ME equipment . 59
201.17 Electromagnetic compatibility of ME equipment and ME systems . 60
201.101 Gas connections . 61
201.102 Requirements for the VBS and accessories . 64
201.103 Spontaneous breathing during loss of power supply . 65
201.104 Indication of duration of operation . 66
201.105 Functional connection. 66
201.106 Display loops . 67
201.108 Ventilatory support equipment security . 68
202 Electromagnetic disturbances — Requirements and tests . 68
206 Usability . 69
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 71
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 73
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 74
Annex D (informative) Symbols on marking . 81
iii
ISO /FDIS 80601-2-80:2023(E2024(en)
Annex AA (informative) Particular guidance and rationale . 83
Annex BB (informative) Data interface requirements . 105
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances. 112
Annex DD (informative) Reference to the essential principles . Error! Bookmark not defined.
Foreword . vii
Introduction . ix
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 . 30
201.7 ME equipment identification, marking and documents . 30
201.8 Protection against electrical hazards from ME equipment . 37
201.9 Protection against mechanical hazards of ME equipment and ME systems . 38
201.10 Protection against unwanted and excessive radiation hazards . 40
201.11 Protection against excessive temperatures and other hazards . 40
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 44
201.13 Hazardous situations and fault conditions for ME equipment . 57
201.14 Programmable electrical medical systems (PEMS) . 58
201.15 Construction of ME equipment . 59
201.17 Electromagnetic compatibility of ME equipment and ME systems . 60
201.101 Gas connections . 61
201.102 Requirements for the VBS and accessories . 64
201.103 Spontaneous breathing during loss of power supply . 65
201.104 Indication of duration of operation . 66
201.105 Functional connection . 66
201.106 Display loops. 67
201.107 Ventilatory support equipment security . 68
202 Electromagnetic disturbances — Requirements and tests. 68
206 Usability . 69
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems. 71
211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment . 73
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 74
iv © ISO 2023 – All rights reserved
iv
ISO /FDIS 80601-2-80:2023(E2024(en)
Annex D (informative) Symbols on marking . 81
Annex AA (informative) Particular guidance and rationale . 83
AA.1 General guidance . 83
AA.2 Rationale for particular clauses and subclauses . 83
Annex BB (informative) Data interface requirements . 105
BB.1 Background and purpose. 105
BB.2 Data definition . 106
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 112
Bibliography . 116
Terminology — Alphabetized index of defined terms . 119

Figures
Figure 201.101 — Typical test setup for volume-control and pressure-control inflation-type
accuracy . 42

Tables
Table 201.101— Distributed essential performance requirements . 23
Table 201.102 — Test conditions for acoustic tests. 37
Table 201.103 — Examples of permissible combinations of temperature and
relative humidity . 38
Table 201.104 — Volume-control inflation-type type test settings . 43
Table 201.105 — Pressure-control inflation-type type test settings . 45
Table 201.C.101 — Marking on the outside of ventilatory support equipment, its parts or
accessories . 68
Table 201.C.102 — Accompanying documents, general . 69
Table 201.C.103 — Instructions for use. 70
Table 201.C.104 — Technical description .
...