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

Appareils électromédicaux — Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires — Amendement 1

General Information

• Status: Published
• Publication Date: 05-Dec-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Drafting Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Current Stage: 6060 - International Standard published
• Start Date: 06-Dec-2023
• Due Date: 07-Jul-2024
• Completion Date: 06-Dec-2023

Relations

• Consolidates: ISO 21628:2020 - Gardening machinery — Powered material-collecting systems — Safety
• Effective Date: 06-Jun-2022
• Amends: ISO 80601-2-55:2018 - Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
• Effective Date: 06-Jun-2022

Standards Content (Sample)

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
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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
...