SIST EN ISO 80601-2-74:2020

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)

Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2017)

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)

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SLOVENSKI STANDARD
01-april-2020
Nadomešča:
SIST EN ISO 8185:2009
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2017)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen (ISO
80601-2-74:2017)
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'humidification respiratoire (ISO
80601-2-74:2017)
Ta slovenski standard je istoveten z: EN ISO 80601-2-74:2020
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 80601-2-74
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment (ISO 80601-2-
74:2017)
Appareils électromédicaux - Partie 2-74: Exigences Medizinische elektrische Geräte - Teil 2-74: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des équipements wesentlichen Leistungsmerkmale von
d'humidification respiratoire (ISO 80601-2-74:2017) Anfeuchtersystemen (ISO 80601-2-74:2017)
This European Standard was approved by CEN on 11 November 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-74:2020 E
worldwide for CEN national Members.

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 80601-2-74:2020 (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 80601-2-74:2020 (E)
European foreword
The text of ISO 80601-2-74:2017 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 80601-2-74:2020 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 August 2020, and conflicting national standards shall
be withdrawn at the latest by August 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.
This document supersedes EN ISO 8185:2009.
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 80601-2-74:2017 has been approved by CEN as EN ISO 80601-2-74:2020 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.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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 80601-2-74
First edition
2017-05
Medical electrical equipment —
Part 2-74:
Particular requirements for basic
safety and essential performance of
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d’humidification
respiratoire
Reference number
ISO 80601-2-74:2017(E)
©
ISO 2017
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 80601-2-74:2017(E)
© ISO 2017, Published in Switzerland
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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – 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.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-74:2017(E)
Contents Page
Foreword . v
Introduction . vii
201.1   Scope, object and related standards . 1
201.2   Normative references . 3
201.3   Terms and definitions . 5
201.4   General requirements . 7
201.5   General requirements for testing of ME EQUIPMENT . 10
201.6   Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7   ME EQUIPMENT identification, marking and documents . 11
201.8   Protection against electrical HAZARDS form ME EQUIPMENT . 19
201.9   Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 19
201.10   Protection against unwanted and excessive radiation HAZARDS . 21
201.11   Protection against excessive temperatures and other HAZARDS . 21
201.12   Accuracy of controls and instruments and protection against
hazardous outputs . 24
201.13   HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 27
201.14   Programmable electrical medical systems (pems) . 28
201.15   Construction of ME EQUIPMENT . 28
201.16   ME SYSTEMS . 29
201.17   Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
201.101   BREATHING SYSTEM connectors and ports . 29
201.102   Requirements for the BREATHING SYSTEM and ACCESSORIES . 32
201.103   LIQUID CONTAINER . 33
201.104   FUNCTIONAL CONNECTION . 34
202   Electromagnetic disturbances — Requirements and tests . 34
206   Usability . 35
208   General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 36
211   Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 36
Annex C (informative)  Guide to marking and labelling requirements for
ME EQUIPMENT and ME SYSTEMS . 38
Annex D (informative)  Symbols on Marking . 44
Annex AA (informative)  Particular guidance and rationale . 45
Annex BB (normative)  * Determination of the accuracy of the displayed MEASURED
GAS TEMPERATURE . 61
Annex CC (normative)  * Determination of the HUMIDIFICATION OUTPUT . 63
Annex DD (normative)  * Specific enthalpy calculations . 67
© ISO 2017 – All rights reserved iii

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 80601-2-74:2017(E)
Annex EE (normative)  Removable temperature sensors and mating ports . 69
Annex FF (normative)  * Standard temperature sensor . 73
Annex GG (informative)  Saturation vapour pressure . 76
Annex HH (informative)  Reference to the essential principles of safety and
[7]
performance of medical devices in accordance with ISO 16142-1:2016 . 77
Annex II (informative)  Terminology — Alphabetized index of defined terms . 81
Bibliography . 85

iv © ISO/IEC 2016 – 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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