SIST EN ISO 80601-2-80:2019

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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SLOVENSKI STANDARD
SIST EN ISO 80601-2-80:2019
01-november-2019
Medicinska električna oprema - 2-80. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pomožne ventilacijske opreme pri nezadostnem prezračevanju
(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 (ISO
80601-2-80:2018)
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 80601-2-80:2018)
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 80601-2-80:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-80:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-80:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2019
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 80601-2-80
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2019
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Medical electrical equipment - Part 2-80: Particular
requirements for basic safety and essential performance of
ventilatory support equipment for ventilatory
insufficiency (ISO 80601-2-80:2018)
Appareils électromédicaux - Partie 2-80: Exigences Medizinische elektrische Geräte - Teil 2-80: 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 d'insuffisance Heimbeatmungsgeräten zur Atemunterstützung von
ventilatoire (ISO 80601-2-80:2018) Patienten mit Atmungsinsuffizienz (ISO 80601-2-
80:2018)
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 80601-2-80:2019 E
worldwide for CEN national Members.

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2019 (E)
European foreword
The text of ISO 80601-2-80:2018 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 80601-2-80:2019 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 80601-2-80:2018 has been approved by CEN as EN ISO 80601-2-80:2019 without any
modification.


3

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2019
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 80601-2-80
First edition
2018-07
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
Reference number
ISO 80601-2-80:2018(E)
©
ISO 2018

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(E)
Contents
Foreword . vi
Introduction . viii
201.1 Scope, object and related standards . 1
201.1.1 * Scope . 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 3
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 7
201.4.3 Essential performance . 7
201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE . 7
201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 7
201.4.11.101 * Additional requirements for pressurized gas input . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.5.101 * Additional requirements for the general requirements for testing of
ME EQUIPMENT . 9
201.5.101.1 Ventilatory support equipment test conditio ns . 9
201.5.101.2 * Gas flowrate and leakage specifications . 9
201.5.101.3 * VENTILATORY SUPPORT EQUIPMENT testing errors . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.6.101 * Additional requirements for 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 . 17
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.11.7 Biocompatiblity of ME EQUIPMENT and ME SYSTEMS . 20
201.11.8 Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT . 21
201.11.8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT ALARM CONDITION . 21
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 23
201.12.1 Accuracy of controls and instruments . 23
201.12.1.101 Volume-controlled breath type . 23
201.12.1.102 Pressure-controlled breath type . 26
201.12.1.103 Other breath types . 28
201.12.2.101 Usability of me equipment . 29
201.12.4 Protection against hazardous output . 29
201.12.4.101 * Measurement of AIRWAY PRESSURE . 29
201.12.4.102 Measurement of expired volume . 31
201.12.4.103 * Maximum limited pressure protection device . 31
201.12.4.104 Hypoventilation ALARM CONDITION . 31
201.12.4.105 * High leakage ALARM CONDITION . 31
201.12.4.106 * CO rebreathing . 32
2
201.12.101 * Protection against accidental adjustments . 32
© ISO 2018 – All rights reserved iii

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(E)
201.13 Hazardous situations and fault conditions for ME EQUIPMENT. 33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 34
201.15 Construction of ME EQUIPMENT . 34
201.15.101 Mode of operation . 34
201.15.102 Pre-use check . 34
201.16 ME SYSTEMS . 34
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
201.101 Gas connections . 35
201.101.1 VBS connectors . 35
201.101.1.1 General . 35
201.101.1.2 Other named ports . 35
201.102 Requirements for the VBS and ACCESSORIES . 36
201.102.1 * General . 36
201.102.2 Labelling . 37
201.102.3 Breathing sets . 37
201.102.4 * Humidification . 37
201.102.4.1 HUMIDIFIER . 37
201.102.4.2 HEAT AND MOISTURE EXCHANGER (HME) . 37
201.102.5 BREATHING SYSTEM FILTERS (BSF) . 37
201.103 * Spontaneous breathing during loss of power supply . 37
201.104 * Training . 38
201.105 * Indication of duration of operation . 38
201.106 Functional connection . 38
201.106.1 General . 38
201.106.2 * Connection to an electronic health record . 39
201.106.3 * Connection to a distributed alarm system . 39
201.106.4 Connection for remote control . 39
201.107 Display loops . 39
201.107.1 Pressure-volume loops . 39
201.107.2 Flow-volume loops . 39
201.108 Power supply cords . 40
201.109 Ventilatory support equipment security . 40
202 Electromagnetic disturbances — Requirements and tests. 40
206 Usability . 41
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems. 43
211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment . 44
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 45
Annex D (informative) Symbols on marking . 52
Annex AA (informative) Particular guidance and rationale . 54
Annex BB (informative) Data interface requirements . 69
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 76
iv © ISO 2018 – All rights reserved

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(E)
Annex DD (informative) Terminology — Alphabetized index of defined terms . 80
Bibliography . 84

© ISO 2018 – All rights reserved v

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(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 (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.
[1]1
This first edition of ISO 80601‐2‐80, in combination with ISO 80601‐2‐79 , cancels and replaces the
[2]
second edition of ISO 10651‐6:2004 . This edition of ISO 80601‐2‐80 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 (ISO 80601‐2‐79);
— one for ventilatory insufficiency, also known as respiratory insufficiency (this document);
— 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 only the VENTILATORY SUPPORT EQUIPMENT itself;

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

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(E)
— identification of ESSENTIAL PERFORMANCE for VENTILATORY SUPPORT EQUIPMENT and its ACCESSORIES;
and the following additions:
— tests for ventilation performance;
— tests for mechanical strength (via IEC 60601‐1‐11);
— requiring capable of TRANSIT‐OPERABLE use;
— 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 vii

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SIST EN ISO 80601-2-80:2019
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 80601-2-80:2018(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 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 complying 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 exchange that are markedly abnormal. This is best characterised by lung functions
[3]
worse than
2
— FEV/FVC < 70 %, or
1
— FEV < 50 % 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 severe Chronic Obstructive Pulmonary
[4]
Disease (COPD), Amyotrophic Lateral Sclerosis (ALS) , severe bronchopulmonary dysplasia and
muscular dystrophy. VENTILATORY SUPPORT EQUIPMENT intended for this group of PATIENTS typically ca
...