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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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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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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EN ISO 80601-2-79:2019 (E)
Contents Page
European foreword . 3

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.
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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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
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)
© 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

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

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 interest
...