SIST EN ISO 80601-2-55:2018/A1:2024
(Amendment)Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires - Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires - Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)
Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov - Dopolnilo A1 (ISO 80601-2-55:2018/Amd 1:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti monitorjev dihalnih plinov - Dopolnilo A1 (ISO 80601-2-
55:2018/Amd 1:2023)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and
essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-
55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des moniteurs de gaz respiratoires -
Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des moniteurs de gaz respiratoires -
Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-55:2018/A1:2023
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.
EN ISO 80601-2-
EUROPEAN STANDARD
55:2018/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2023
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-55: Particular
requirements for the basic safety and essential
performance of respiratory gas monitors - Amendment 1
(ISO 80601-2-55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences Medizinische elektrische Geräte - Teil 2 55: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des moniteurs de gaz wesentlichen Leistungsmerkmale von
respiratoires - Amendement 1 (ISO 80601-2- Überwachungsgeräten für Atemgase - Änderung 1 (ISO
55:2018/Amd 1:2023) 80601-2-55:2018/Amd 1:2023)
This amendment A1 modifies the European Standard EN ISO 80601-2-55:2018; it was approved by CEN on 6 June 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-55:2018/A1:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-55:2018/A1:2023) has been prepared by Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 80601-2-55:2018 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by June
2024, and conflicting national standards shall be withdrawn at the latest by June 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-55:2018/Amd 1:2023 has been approved by CEN as EN ISO 80601-2-
55:2018/A1:2023 without any modification.
INTERNATIONAL ISO
STANDARD 80601-2-55
Second edition
2018-02
AMENDMENT 1
2023-12
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic
safety and essential performance of
respiratory gas monitors
AMENDMENT 1
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des moniteurs de gaz respiratoires
AMENDEMENT 1
Reference number
ISO 80601-2-55:2018/Amd.1:2023(E)
ISO 80601-2-55:2018/Amd.1:2023(E)
© ISO 2023
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-55:2018/Amd.1:2023(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical
activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
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 document 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 or
www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of
any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC
had not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines, in collaboration with
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical
equipment, and with the European Committee for Standardization (CEN) Technical Committee CEN/TC
215, Respiratory and anaesthetic equipment, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO/IEC 80601 series can be found on the ISO and IEC websites.
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 and
www.iec.ch/national-committees.
iii
ISO 80601-2-55:2018/Amd.1:2023(E)
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
AMENDMENT 1
201.1
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.1.1
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.1.2
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.1.3
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.1.4
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.2
Replace the following references:
IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020,
IEC 60601-1-2:2014 with IEC 60601-1-2:2014+Amd 1:2020,
IEC 60601-1-6:2010+Amd 1:2013 with IEC 60601-1-6:2010+Amd 1:2013+Amd 2:2020,
IEC 60601-1-8:2006+Amd 1:2012 with IEC 60601-1-8:2006+Amd 1:2012+Amd 2:2020, and
IEC 60601-1-12:2014 with IEC 60601-1-12:2014+Amd 1:2020
201.3
Replace the introductory sentence with the following sentence:
For the purpose of this document, the terms and definitions given in IEC 60601-1:2005+Amd 1:2012+Amd
2:2020, IEC 60601-1-2, IEC 60601-1-6:2010+Amd 1:2013+Amd 2:2020, IEC 60601-1-8:2006+Amd
1:2012+Amd 2:2020, IEC 60601-1-11, IEC 60601-1-12 and ISO 80601-2-13:2011+Amd 1:2015 and the
following apply.
ISO 80601-2-55:2018/Amd.1:2023(E)
201.4
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.4.3
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.5
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.6
Replace IEC 60601-1:2005 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.2.3
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.4.3
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2.2
Replace IEC 60601-1:2005 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2.2.101
Replace the first paragraph with:
The instructions for use of a diverting rgm that is equipped with a gas exhaust connection shall include
a warning regarding the risk of patient cross-infection if the sampled gas is returned to the breathing
system, unless the manufacturer can demonstrate that the risk of patient cross-infection is reduced
to an acceptable level in the returned gas. Additional requirements are found in 201.105.2.
Note the means of risk control can be part of a host device.
Change the check compliance sentence to:
Check conformance by inspection of the manufacturer’s instructions for use or risk management
file.
201.7.9.2.5
Replace IEC 60601-1:2005 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2.8
Replace IEC 60601-1:2005 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
ISO 80601-2-55:2018/Amd.1:2023(E)
201.7.9.2.9
Replace IEC 60601-1:2005 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2.9.101
Replace the first sentence with the following:
The instructions for use shall include the following, if applicable:
201.7.9.2.13
Replace IEC 60601-1:2005 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2.14
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.2.15
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.7.9.3
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.8
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.9
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.10
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.11
Replace IEC 60601-1:2005+Amd 1:2012 with IEC 60601-1:2005+Amd 1:2012+Amd 2:2020
201.11.6.6
Replace IEC 60601-1:2005
...
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