SIST EN ISO 80601-2-79:2019

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)

Medicinska električna oprema - 2-79. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pomožne ventilacijske opreme pri okvari ventilatorja (ISO 80601-2-79:2018)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SLOVENSKI STANDARD
SIST EN ISO 80601-2-79:2019
01-november-2019
Medicinska električna oprema - 2-79. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pomožne ventilacijske opreme pri okvari ventilatorja (ISO 80601-
2-79:2018)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and
essential performance of ventilatory support equipment for ventilatory impairment (ISO
80601-2-79:2018)
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 80601-2-79:2018)
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 80601-2-79:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-79:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-79:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.

Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

EN ISO 80601-2-79
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2019
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Medical electrical equipment - Part 2-79: Particular
requirements for basic safety and essential performance of
ventilatory support equipment for ventilatory impairment
(ISO 80601-2-79:2018)
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 80601-2-79:2018) Patienten mit Atmungsbeeinträchtigungen (ISO 80601-
2-79:2018)
This European Standard was approved by CEN on 28 July 2019.

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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-79:2019 E
worldwide for CEN national Members.

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN ISO 80601-2-79:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN ISO 80601-2-79:2019 (E)
European foreword
The text of ISO 80601-2-79:2018 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO 80601-2-79:2019 by 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 2020, and conflicting national standards shall
be withdrawn at the latest by March 2020.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-79:2018 has been approved by CEN as EN ISO 80601-2-79:2019 without any
modification.


3

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
INTERNATIONAL ISO
STANDARD 80601-2-79
First edition
2018-07
Medical electrical equipment —
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 80601-2-79:2018(E)
©
ISO 2018

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-79:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-79:2018(E)
Contents
Foreword . iv
Introduction . vi
201.1 Scope, object and related standards . 1
201.2 Normative references . 4
201.3 Terms and definitions . 6
201.4 General requirements . 7
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 20
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 30
201.15 Construction of ME EQUIPMENT . 30
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
201.101 Gas connections . 31
201.102 Requirements for the VBS and ACCESSORIES . 33
201.103 * Training . 34
201.104 * Indication of duration of operation . 34
201.105 FUNCTIONAL CONNECTION . 35
201.106 Display loops . 35
201.107 Spontaneous breathing during loss of ventilation . 36
202 Electromagnetic disturbances — Requirements and tests . 36
206 Usability . 37
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 38
ME EQUIPMENT
Annex C (informative) Guide to marking and labelling requirements for
and ME SYSTEMS . 40
Annex D (informative) Symbols on marking . 46
Annex AA (informative) Particular guidance and rationale . 48
Annex BB (informative) Data interface requirements . 61
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 67
Annex DD (informative) Terminology — Alphabetized index of defined terms . 71
Bibliography . 75

© ISO 2018 – All rights reserved iii

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-79:2018(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. 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. 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.
ISO 80601-2-79 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.
[1]1
This first edition of ISO 80601-2-79, in combination with ISO 80601-2-80 , cancels and replaces
[2]
ISO 10651-6:2004 . This edition of ISO 80601-2-79 constitutes a major technical revision of
ISO 10651-6:2004 and includes an alignment with the third edition of IEC 60601-1, the fourth edition of
IEC 60601-1-2, the third edition of IEC 60601-1-6, the second edition of IEC 60601-1-8 and the second
edition of IEC 60601-1-11.
The most significant changes are the following modifications:
[2]
— splitting the scope of ISO 10651-6:2004 into two parts:
— one for VENTILATORY IMPAIRMENT, also known as RESPIRATORY IMPAIRMENT, (this document) and
— one for VENTILATORY INSUFFIENCY, also known as RESPIRATORY INSUFFICIENCY (ISO 80601-2-80);
— extending the scope to include the VENTILATORY SUPPORT EQUIPMENT and its ACCESSORIES, where the
characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the
VENTILATORY SUPPORT EQUIPMENT, and thus not the VENTILATORY SUPPORT EQUIPMENT itself;
— identification of ESSENTIAL PERFORMANCE for VENTILATORY SUPPORT EQUIPMENT and its ACCESSORIES;
and the following additions:
— tests for ventilation performance;

1
Numbers in square brackets refer to the Bibliography.
iv © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-79:2018(E)
— tests for mechanical strength (via IEC 60601-1-11);
— new symbols;
— requirements for VENTILATORY SUPPORT EQUIPMENT as a component of an ME SYSTEM;
— tests for ENCLOSURE integrity (water ingress via IEC 60601-1-11);
— tests for CLEANING and DISINFECTION PROCEDURES (via IEC 60601-1-11);
— consideration of contamination of the breathing gas delivered to the PATIENT from the GAS PATHWAYS.
© ISO 2018 – All rights reserved v

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-79:2018(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 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 complying with this document can be used
elsewhere (i.e. in healthcare facilities).
Ventilatory support is often needed 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
[3]
than :
2
— FEV /FVC < 70 %; or
1
— 50 % ≤ FEV < 80 % predicted
1
where
 FEV is the forced expiratory volume in 1 s, and
1
 FVC is the forced vital capacity.
Examples of diseases that require ventilation support are
— mild to moderate Chronic Obstructive Pulmonary Disease (COPD);
— 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 .
1
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.
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
This is also known as the Tiffeneau-Pinelli index.
vi © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-79:2018(E)
— Test specifications: 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;
3
— TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD , IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
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);
— “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.
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” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe permission (e.g. a permissible way to achieve compliance with a
requirement or test);
— “can” is used to describe a possibility or capability; and
— “must” is used express an external constraint.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.
The ISO and IEC 80601 family of documents are also parts of the IEC 60601 family of documents

3
The general standard is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
© ISO 2018 – All rights reserved vii

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
INTERNATIONAL STANDARD ISO 80601-2-79:2018(E)

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, Clause 1, applies, except as follows:
201.1.1 * Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT,
as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, 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; and
— 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).
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 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.
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.
© ISO 2018 – All rights reserved 1

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SIST EN ISO 80601-2-79:2019
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-79:2018(E)
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
[4]
ISO 80601-2-13 ;
— VENTILATORS or ACCESSORIES intended for the emergency medical services environment, which are
[5] [6]
4
given in ISO 80601-2-84 , the future replacement for ISO 10651-3 ;
— 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
[1]
given in ISO 80601-2-80 ;
[7]
— sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601-2-70 ;
— continuous positive airway pressure (CPAP) ME EQUIPMENT;
— high-frequency jet VENTILATORS (HFJVs);
[8]
— high-frequency oscillatory VENTILATORS (HFOVs) ;
— oxygen therapy constant flow ME EQUIPMENT;
— cuirass or “iron-lung” ventilation equipment.
This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the VENTILATORY SUPPORT EQUIPMENT and the
ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL
PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT.


4
Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.
2 © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-79:2019
Posebna objava SIS
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