ISO 80601-2-55:2018/Amd 1:2023
(Amendment)Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1
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
- 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
- Effective Date
- 06-Jun-2022
- Effective Date
- 06-Jun-2022
Overview
ISO 80601-2-55:2018/Amd 1:2023 is the latest amendment to the international standard that sets particular requirements for the basic safety and essential performance of respiratory gas monitors. Published by the International Organization for Standardization (ISO) in December 2023, this amendment updates critical references and technical requirements, reinforcing the safety, accuracy, and reliability of medical electrical equipment used in respiratory gas monitoring.
This standard is essential for manufacturers, healthcare providers, and regulators involved in the design, production, testing, and certification of respiratory gas monitors. It integrates updated requirements harmonized with current IEC standards, ensuring these monitors meet stringent international safety and performance benchmarks.
Key Topics
Updated Reference Standards
The amendment replaces previous editions of IEC 60601 series documents with their latest amendments, including IEC 60601-1:2005+Amd 1:2012+Amd 2:2020, IEC 60601-1-2:2014+Amd 1:2020, and others. This ensures modern risk management, electrical safety, and performance criteria are met.Measurement Accuracy Requirements
For each respiratory gas monitored by the device, accuracy must meet specified levels over at least 6 hours of use with defined gas mixtures. Drift in measurement accuracy must be disclosed, enhancing transparency and reliability.Risk Management Enhancements
The amendment strengthens risk control measures for potential hazards such as patient cross-infection from gas sample exhaust systems, demanding warnings and effective infection control mechanisms in the instructions for use.Detailed Terminology and Definitions
Updates align with revised definitions from IEC 60601 series, covering terms like alarm conditions, essential performance, risk, and usability to unify understanding across manufacturers and users.Instructions for Use (IFU) Requirements
Clear guidance on calibration, automatic zeroing, alarm functions, and safety warnings must be included in the device documentation, supporting proper clinical use and maintenance.Calibration and Response Time Testing
Refined protocols for testing gas sensor response times and stability, including specific gas mixtures for halogenated agents, ensure device performance under realistic clinical conditions.
Applications
ISO 80601-2-55:2018/Amd 1:2023 is applicable to the following areas:
Respiratory Gas Monitoring Devices
Used in operating rooms, intensive care units, and critical care settings to monitor gases such as oxygen, carbon dioxide, nitrous oxide, and volatile anesthetic agents during anesthesia or respiratory therapy.Medical Device Manufacturing
Guides manufacturers in updating product design to comply with modern safety and performance requirements, facilitating global market acceptance.Healthcare Risk Management
Helps clinical engineers and biomedical safety officers ensure respiratory gas monitors meet the latest standards for electrical safety and reduce risks related to gas sampling and patient exposure.Regulatory Compliance and Certification
Supports conformity assessment processes aligned with international regulations, enabling effective device approval and market access across jurisdictions.
Related Standards
ISO 80601-2-55:2018/Amd 1:2023 complements and references multiple IEC and ISO documents, including but not limited to:
- IEC 60601-1:2005+Amd 1:2012+Amd 2:2020: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2:2014+Amd 1:2020: Requirements for electromagnetic compatibility in medical devices.
- IEC 60601-1-6:2010+Amd 1:2013+Amd 2:2020: Usability engineering standards.
- IEC 60601-1-8:2006+Amd 1:2012+Amd 2:2020: Requirements for medical device alarm systems.
- IEC 60601-1-11:2015+Amd 1:2020: Standards for home healthcare device safety.
- IEC 60601-1-12:2014+Amd 1:2020: Requirements for medical electrical systems.
- ISO 80601-2-13:2011+Amd 1:2015: Safety and performance of anaesthetic machines.
These interlinked standards create a comprehensive safety and performance framework for respiratory gas monitors within the broader context of medical electrical equipment.
Keywords: ISO 80601-2-55 amendment, respiratory gas monitors standard, medical electrical equipment safety, respiratory gas monitor accuracy, IEC 60601 updates, risk management medical devices, respiratory gas analysis, medical device compliance, respiratory gas monitor calibration, infection control respiratory monitors.
Frequently Asked Questions
ISO 80601-2-55:2018/Amd 1:2023 is a standard published by the International Organization for Standardization (ISO). Its full title is "Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1". This standard covers: Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1
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 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 80601-2-55:2018/Amd 1:2023 has the following relationships with other standards: It is inter standard links to ISO 21628:2020, ISO 80601-2-55:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 80601-2-55:2018/Amd 1:2023 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...