oSIST prEN ISO 80601-2-80:2023
(Main)Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO/DIS 80601-2-80:2023)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO/DIS 80601-2-80:2023)
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.
Medizinische elektrische Geräte - Teil 2-80: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit Atmungsinsuffizienz (ISO/DIS 80601-2-80:2023)
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 (ISO/DIS 80601-2-80:2023)
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
Medicinska električna oprema - 2-80. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pomožne ventilacijske opreme pri nezadostnem prezračevanju (ISO/DIS 80601-2-80:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-80:2023
01-julij-2023
Medicinska električna oprema - 2-80. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pomožne ventilacijske opreme pri nezadostnem prezračevanju
(ISO/DIS 80601-2-80:2023)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and
essential performance of ventilatory support equipment for ventilatory insufficiency
(ISO/DIS 80601-2-80:2023)
Medizinische elektrische Geräte - Teil 2-80: Besondere Festlegungen für die
grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von
Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit Atmungsinsuffizienz
(ISO/DIS 80601-2-80:2023)
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 (ISO/DIS 80601-2-80:2023)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-80
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-80:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-80:2023
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oSIST prEN ISO 80601-2-80:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-80
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-05-11 2023-08-03
Medical electrical 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
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
This draft is submitted to a parallel vote in ISO and in IEC.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-80:2023(E)
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 2023
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-80
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
Medical electrical 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
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
This draft is submitted to a parallel vote in ISO and in IEC.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
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© ISO 2023
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THEREFORE SUBJECT TO CHANGE AND MAY
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NOT BE REFERRED TO AS AN INTERNATIONAL
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IN ADDITION TO THEIR EVALUATION AS
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NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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ii
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
Contents
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 . 27
201.6 Classification of ME equipment and ME systems. 28
201.7 ME equipment identification, marking and documents. 28
201.8 Protection against electrical hazards from ME equipment . 35
201.9 Protection against mechanical hazards of ME equipment and ME systems . 35
201.10 Protection against unwanted and excessive radiation hazards . 37
201.11 Protection against excessive temperatures and other hazards . 37
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 41
201.13 Hazardous situations and fault conditions for ME equipment . 52
201.14 Programmable electrical medical systems (PEMS) . 53
201.15 Construction of ME equipment . 54
201.17 Electromagnetic compatibility of ME equipment and ME systems . 55
201.101 Gas connections . 55
201.102 Requirements for the VBS and accessories . 58
201.103 Spontaneous breathing during loss of power supply . 60
201.104 Indication of duration of operation . 60
201.105 Functional connection . 60
201.106 Display loops . 61
201.108 Ventilatory support equipment security . 62
202 Electromagnetic disturbances — Requirements and tests . 62
206 Usability . 63
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 65
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 67
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 68
Annex D (informative) Symbols on marking . 75
Annex AA (informative) Particular guidance and rationale . 77
Annex BB (informative) Data interface requirements . 96
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 103
Annex DD (informative) Reference to the essential principles . 107
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 . 73
Table 201.D.1.101 — Additional symbols on marking . 75
Table BB.101 — Parameters and units of measurement . 97
Table BB.102 — Equipment Identification . 97
Table BB.103 — Usage monitoring . 98
Table BB.104 — Equipment settings . 98
Table BB.105 — Ventilation monitoring . 100
Table BB.106 — Ventilatory support equipment alarm limits . 100
Table BB.107 — Event information . 101
Table BB.108 — Service monitoring . 102
Table CC.1 — Correspondence between this document and the IMDRF essential principles . 103
Table CC.2 — Correspondence between this document and the IMDRF labelling principles . 106
Table DD.1 — Correspondence between this document and the essential principles . 107
iv © ISO 2023 – All rights reserved
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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 ISO
documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights
identified during the development of the document will be in the Introduction and/or on the ISO list of patent
declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not constitute
an endorsement.
For an explanation on 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 the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting to
the national bodies of both ISO and IEC.
This second edition cancels and replaces the first edition (ISO 80601-2-80:2018), which has been technically
revised.
The most significant changes are the following modifications:
— 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;
— reformatted according to most recent Central Secretariat editing rules;
— 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.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
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.
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
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 are needed 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
[36]
exchange that are markedly abnormal. This is best characterised by lung functions worse than
1
— FEV /FVC < 70 %, or
1
— FEV < 50 % predicted
1
where
FEV1 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
[44]
Disease (COPD), 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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
— requirements and definitions: roman type;
2
— test specifications and terms defined in Clause 3 of the general standard , in this document or as noted: italic
type;
— 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, etc.);
— “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.
1
This is also known as the Tiffeneau-Pinelli index.
2
The general standard is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance.
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
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.
The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2. For the
purposes of this document, the auxiliary verb:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe 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.
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oSIST prEN ISO 80601-2-80:2023
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
Medical electrical equipment
Part 2-80:
Particular requirements for basic safety and essential
performance of ventilatory support equipment for ventilatory
insufficiency
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 insufficiency, as defined in 201.3.301, 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 insufficiency or failure, the most fragile of which would
likely experience injury with the loss of this artificial ventilation;
— intended for transit-operable use; and
— 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.
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
ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
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 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 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 impairment, which are given in
ISO 80601-2-79;
— sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
— high-frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87;
[20]
— high-frequency oscillatory ventilators (HFOVs) ;
— respiratory high flow equipment, which are given in ISO 80601-2-90;
NOTE 6 ISO 80601-2-80 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 insufficiency, as defined in 201.3.302, and its accessories.
2 © ISO 2023 – All rights reserved
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oSIST prEN ISO 80601-2-80:2023
ISO/DIS 80601-2-80:2023(E)
ISO 80601-2-80:2023(E)
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 Forum
[31] [32]
(IMDRF) essential principles and labelling guidances as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance 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 requirements of
[33]
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,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 and IEC 60601-1-11:2015+AMD1:2020 apply as modified in
Clauses 202, 206, 208 and 211 respectively. IEC 60601-1-3:2008, 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 define basic safety and essential performance requirements, and
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
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