EN ISO 80601-2-61:2026
(Main)Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2026)
General Information
- Abstract
This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.
This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
This document is not applicable to pulse oximeter equipment intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function.
This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use.
This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
- Status
- Published
- Publication Date
- 21-Apr-2026
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 22-Apr-2026
- Completion Date
- 22-Apr-2026
Overview
EN ISO 80601-2-61:2026, developed by CEN, specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for human use. This international standard applies to all parts necessary for the normal operation of pulse oximeters, including monitors, probes, and probe cable extenders. It governs both new and remanufactured devices, ensuring that safety and performance are maintained regardless of equipment origin.
Pulse oximeter equipment plays a critical role in professional healthcare institutions, home healthcare settings, and emergency medical services. The standard ensures consistent safety and performance, addressing the broad range of environments and user needs in which these medical devices are deployed.
Key Topics
- Basic Safety and Essential Performance: The standard sets detailed criteria for the protection of patients and users from electrical, mechanical, thermal, and radiation hazards associated with pulse oximeter equipment.
- Scope of Application: Applies to pulse oximeter monitors, probes, and cable extenders, whether new or remanufactured. Excludes devices used for laboratory research, fetal applications, or those requiring blood samples.
- Intended Use: Covers devices used for non-invasive estimation of arterial oxygen haemoglobin saturation (SpO₂) and pulse rate in various healthcare settings.
- Clinical Performance Verification: Emphasizes clinical evaluation and verification for all component parts, with increased disclosure and reporting requirements.
- Diverse Use Environments: Includes requirements for use under extreme or uncontrolled conditions, such as ambulances or air transport, addressing unique stresses not encountered in hospital environments.
- Alignment with Other Standards: Harmonizes with IEC 60601-1, IEC 60601-1-11 (home healthcare), IEC 60601-1-12 (emergency medical services), and ISO 20417 (medical device information).
Applications
Pulse oximetry is vital across various clinical and non-clinical scenarios, including:
- Hospitals and Clinics: Continuous monitoring of oxygen saturation and pulse rate for preoperative, intraoperative, and postoperative care.
- Home Healthcare: Supports the management of chronic respiratory and cardiac conditions by enabling patient self-monitoring and remote care.
- Emergency Medical Services: Provides rapid assessment in ambulances or during air transport, even in challenging environmental conditions.
- Disease Compensation & Alleviation: Assists in the compensation or alleviation of disease, injury, or disability where monitoring oxygen status is critical.
- Universal Applicability: Ensures compatibility and safety whether products are new, refurbished, or used as part of comprehensive medical electrical systems.
Related Standards
EN ISO 80601-2-61:2026 is part of a family of international standards for medical electrical equipment:
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic compatibility.
- IEC 60601-1-8: Alarm systems in medical electrical equipment.
- IEC 60601-1-11: Requirements for use in the home healthcare environment.
- IEC 60601-1-12: Requirements for use in emergency medical services environments.
- ISO 20417: Information to be supplied by the medical device manufacturer.
- ISO 15223-1: Medical device symbols and labeling.
Manufacturers, healthcare professionals, and regulatory authorities rely on EN ISO 80601-2-61:2026 to validate the safety and performance of pulse oximeter equipment, support conformity assessment, and promote international harmonization. This standard is essential for anyone involved in the development, selection, deployment, or maintenance of pulse oximetry devices in healthcare.
Relations
- Effective Date
- 16-Feb-2022
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Refers
IEC 60825-1:2014 - Safety of laser products - Part 1: Equipment classification and requirements - Effective Date
- 06-May-2026
- Effective Date
- 06-May-2026
- Effective Date
- 29-Apr-2026
- Effective Date
- 29-Apr-2026
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Frequently Asked Questions
EN ISO 80601-2-61:2026 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2026)". This standard covers: This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products). The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability. This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. This document is not applicable to pulse oximeter equipment intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products). The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability. This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. This document is not applicable to pulse oximeter equipment intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
EN ISO 80601-2-61:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 80601-2-61:2026 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-61:2019, IEC 60068-2-31:2008, IEC 60068-2-64:2008, ISO 15223-1:2021/Amd 1:2025, ISO 20417:2026, IEC 60068-2-27:2008, ISO 14155:2026, IEC 60601-1-11:2015, IEC 60825-2:2021, IEC 60601-1-12:2014/Amd 1:2020, IEC 60601-1:2005, IEC 60825-1:2014, ISO 15223-1:2021, EN 13718-1:2008, EN 1789:2007+A1:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 80601-2-61:2026 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)
SLOVENSKI STANDARD
01-junij-2026
Nadomešča:
SIST EN ISO 80601-2-61:2019
Medicinska električna oprema - 2-61. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pulznega oksimetra (ISO 80601-2-61:2026)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment (ISO 80601-2-61:2026)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO
80601-2-61:2026)
Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base
et les performances essentielles pour les oxymètres de pouls (ISO 80601-2-61:2026)
Ta slovenski standard je istoveten z: EN ISO 80601-2-61:2026
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-61
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 11.040.55 Supersedes EN ISO 80601-2-61:2019
English Version
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse oximeter equipment (ISO 80601-2-61:2026)
Appareils électromédicaux - Partie 2-61: Exigences Medizinische elektrische Geräte - Teil 2-61: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles pour les oxymètres de pouls wesentlichen Leistungsmerkmale von
(ISO 80601-2-61:2026) Pulsoximetriegeräten (ISO 80601-2-61:2026)
This European Standard was approved by CEN on 17 March 2026.
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, 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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-61:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-61:2026) 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 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 October 2026, and conflicting national standards shall
be withdrawn at the latest by October 2026.
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 80601-2-61:2019.
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 80601-2-61:2026 has been approved by CEN as EN ISO 80601-2-61:2026 without any
modification.
International
Standard
ISO 80601-2-61
Third edition
Medical electrical equipment —
2026-04
Part 2-61:
Particular requirements for basic
safety and essential performance of
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
Reference number
ISO 80601-2-61:2026(en) © ISO 2026
ISO 80601-2-61:2026(en)
© ISO 2026
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 80601-2-61:2026(en)
Contents Page
Foreword . v
Introduction . vii
201.1 Scope, object, and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 3
201.4 General requirements . 17
201.5 General requirements for testing of ME equipment . 19
201.6 Classification of ME equipment and ME systems . 19
201.7 ME equipment identification, marking and documents . 19
201.8 Protection against electrical hazards from ME equipment . 24
201.9 Protection against mechanical hazards of ME equipment and ME systems . 24
201.10 Protection against unwanted and excessive radiation hazards . 24
201.11 Protection against excessive temperatures and other hazards . 24
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 26
201.13 Hazardous situations and fault conditions for ME equipment . 41
201.14 Programmable electrical medical systems (PEMS) . 42
201.15 Construction of ME equipment . 43
201.16 ME systems . 44
201.17 Electromagnetic compatibility of ME equipment and ME systems . 44
201.101 Pulse oximeter probes and probe cable extenders . 44
201.102 Saturation pulse information signal . 45
201.103 Functional connection . 45
202 Electromagnetic disturbances – Requirements and tests . 46
206 Usability . 47
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 48
211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment . 48
212 Requirements for medical electrical equipment and medical electrical systems used in
the emergency medical services environment . 49
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 50
Annex D (informative) Symbols on marking . 54
Annex AA (informative) Particular guidance and rationale . 55
Annex BB (informative) Skin temperature at the pulse oximeter probe . 76
iii
ISO 80601-2-61:2026(en)
Annex CC (informative) Determination of accuracy, pigmentation differential bias, sample size,
and study design considerations . 80
Annex DD (normative) Method for invasive studies for evaluating and documenting SpO
accuracy in human participants . 100
Annex EE (informative) Simulators, calibrators, and functional testers for pulse oximeter
equipment . 106
Annex FF (informative) Concepts of ME equipment response time . 115
Annex GG (normative) Data interface requirements . 119
Annex HH (informative) Clinical context and rationales of data interface requirements . 125
Annex II (informative) Using a functional tester to assess pulse oximeter equipment conditions
of signal inadequacy over a range of transmitted light and optical modulation . 126
Annex JJ (informative) Using a transfer standard in pulse oximeter equipment development . 130
Annex KK (informative) Reference to the IMDRF essential principles and labelling guidances 135
Bibliography . 138
Terminology — Alphabetized index of defined terms . 147
iv
ISO 80601-2-61:2026(en)
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 3, Respiratory devices and related equipment used for patient care and Technical Committee
IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62D, Particular medical equipment,
software, and systems, in collaboration 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).
This third edition cancels and replaces the second edition (ISO 80601-2-61:2017), which has been technically
revised.
The main changes are as follows:
⎯ alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-8:2006+AMD1:2012
+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-1-6:2010+AMD1:2013 +AMD2:2020.
⎯ increased disclosure requirements;
⎯ increased the required number of participants in the clinical study and their diversity (a means to assure
equal contributions across the range of skin pigmentation);
⎯ reduced the maximum permissible A to enhance measurement accuracy;
rms
⎯ required differential bias determination to enhance measurement accuracy;
v
ISO 80601-2-61:2026(en)
⎯ clarified that accessories need to be included in the clinical performance verification and conformity to the
requirements of the document
⎯ updated the reporting requirements for the clinical performance verification;
⎯ added an Annex describing the use of transfer standard for product development purposes;
[25]
⎯ added an Annex mapping the requirements of this document to the IMDRF essential principles and
[26]
labelling guidances; and
⎯ harmonization with ISO 20417, where appropriate.
A list of all parts in the ISO 80601 series and the 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.
vi
ISO 80601-2-61:2026(en)
Introduction
The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common practice
in many areas of medicine. This document covers basic safety and essential performance requirements
achievable within the limits of existing technology.
The committees recognized the need to revise the first edition of this document because of the publication of
IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-12:2014+AMD1:2020, as well as IEC 60601-1-
2:2014+AMD1:2020, IEC 60601-1-11:2015+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
Annex AA contains a rationale for some of the requirements. It is included to provide additional insight into
the reasoning of the committees that led to a requirement and identifying the hazards that the requirement
addresses.
Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the
interface between a pulse oximeter probe and a patient’s tissue.
Annex CC discusses the formulae used to evaluate the SpO accuracy of pulse oximeter equipment
measurements, differential bias and the names that are assigned to those formulae.
Annex DD presents a guideline for a controlled desaturation study for the calibration of pulse oximeter
equipment.
Annex EE is a tutorial introduction to several kinds of testers used in pulse oximetry.
Annex FF describes concepts of pulse oximeter equipment response time.
Annex GG describes data interface requirements.
Annex HH describing the clinical context of this document and its rationale;
Annex II describing the use of a functional tester;
Annex JJ describing the use of transfer standard;
[25] [26]
Annex KK maps the requirements of this document to the IMDRF essential principles and labelling
guidances
In referring to the structure of this document, the term
– “clause” means one of the six numbered divisions within the table of contents, inclusive of all subdivisions
(e.g. Clause 201 includes subclauses 201.7.1, 201.7.2) and
– “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 7.2 and 201.7.2.1 are all subclauses of
Clause 201.7).
References to clauses within this document are preceded by the term “Clause” followed by the clause number.
References to subclauses within this document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part
2. For the purposes of this document, the auxiliary verb:
– “shall” indicates a requirement;
vii
ISO 80601-2-61:2026(en)
– “should” indicates a recommendation;
– “may” indicates a permission;
– “can” indicates a possibility or capability; and
– “must” is used to express an external constraint.
viii
International Standard ISO 80601-2-61:2026(en)
Medical electrical equipment —
Part 2-61:
Particular requirements for basic safety and essential
performance of pulse oximeter equipment
201.1 Scope, object, and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in AA.2.1.
This document applies to the basic safety and essential performance of pulse oximeter equipment intended for
use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use,
including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter
probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen
haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in
the home healthcare environment and the emergency medical services environment.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only,
the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies
both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of
this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-
1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation
of disease, injury, or disability.
This document is not applicable to pulse oximeter equipment intended for use in laboratory research
applications nor to oximeters that require a blood sample from the patient.
This document is not applicable to pulse oximeter equipment intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO values that are
located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the
appropriate requirements of this document when configured for that function.
This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled
environmental conditions outside the hospital environment or physician’s office, such as in ambulances and
air transport. Additional standards can apply to pulse oximeter equipment for those environments of use.
ISO 80601-2-61:2026(en)
This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance requirements for
pulse oximeter equipment [as defined in 201.3.253] and its accessories.
NOTE 1 Accessories are included because the combination of the pulse oximeter monitor and the accessories needs to
be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of pulse oximeter
equipment.
[25] [26]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling guidances of
the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex KK.
NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of
[27]
European regulation (EU) 2017/745 .
201.1.3 Collateral standards
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 and Clause 201.2 of this document.
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-11+AMD1:2020 and
IEC 60601-1-12+AMD1:2020 apply as modified in Clauses 202, 206, 208, 211 and 212, respectively.
IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace, or delete requirements contained in the
general standard, including the collateral standards, as appropriate for the particular ME equipment under
consideration, and may add other basic safety or essential performance requirements.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
A requirement of a particular standard takes priority over the general standard or the collateral standards.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to those of the general standard with
the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or
applicable collateral standard with the prefix “2xx” where xx is the final digits of the collateral standard
document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601-1-2
collateral standard, 208.4 in this document addresses the content of Clause 4 of the IEC 60601-1-8 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of the following
abbreviated words:
"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is
replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of the general standard or
applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is
amended as indicated by the text of this document.
ISO 80601-2-61:2026(en)
Subclauses or figures that are additional to those of the general standard are numbered starting from 201.101,
additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 2xx,
where “x” is the number of the collateral standard (e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc).
The term "this document" is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the section, clause or subclause of the
general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
NOTE 2 Informative references are listed in the Bibliography.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
Addition:
ISO 14155:2026, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 15223-1:2021+AMD1:2025, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 20417:2026, Medical devices — Information to be supplied by the manufacturer
IEC 60068-2-27:2008, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily
for equipment-type specimens
IEC 60068-2-64:2008+AMD1:2019, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband
random and guidance
IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment — Part 1-11: General requirements for basic
safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
IEC 60601-1-12:2014+AMD1:2020, Medical electrical equipment — Part 1-12: General requirements for basic
safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the emergency medical services environment
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements
IEC 60825-2:2021, Safety of laser products — Part 2: Safety of optical fibre communication systems (OFCS)
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+AMD 1:2012+AMD1:2020, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
ISO 80601-2-61:2026(en)
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
NOTE An alphabetized index of defined terms is found following the Bibliography.
201.3.201
accompanying information
information supplied by the manufacturer with or marked on a medical device or accessory for the user or
responsible organization, particularly regarding safe use
Note 1 to entry: The accompanying information is be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description,
information shown on the packaging or graphical user interface (GUI), installation manual, quick reference guide, etc.
and can address the installation, use, processing, maintenance and disposal of the medical device or accessory.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but can involve auditory,
visual, or tactile materials and multiple media types (e.g. CD-ROM, DVD-ROM, USB drive, website).
Note 4 to entry: Medical devices and accessories that can be used safely without accompanying information are exempted
from having accompanying information by some authorities having jurisdiction.
[SOURCE: ISO 20417:2026, 3.2]
201.3.202
accuracy
closeness of agreement between a test result and an accepted reference value
Note 1 to entry: Subclause 201.12.1.101.4 provides the method of calculating the SpO accuracy of pulse oximeter
equipment.
Note 2 to entry: Additional information is found in Annex CC.
[SOURCE: ISO 3534-2:2006, 3.3.1, modified — Replaced note 1 to note 3 with new notes and ‘or measurement
result and the true’ with ‘and an accepted reference ’.]
201.3.203
alarm condition delay
time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or in
the equipment, for technical alarm conditions, to when the alarm system determines that an alarm condition
exists
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.2]
201.3.204
alarm limit
threshold used by an alarm system to determine an alarm condition
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
201.3.205
alarm paused
state of limited duration in which the alarm system or part of the alarm system does not generate alarm signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
ISO 80601-2-61:2026(en)
201.3.206
alarm preset
set of stored configuration parameters, including selection of algorithms and initial values for use by
algorithms, which affect or modify the performance of the alarm system
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.6]
201.3.207
alarm signal generation delay
time from the onset of an alarm condition to the generation of its alarm signal(s)
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.10]
201.3.208
audio paused
state of limited duration in which the alarm system or part of the alarm system does not generate an auditory
alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.13]
201.3.209
colour measurement site
location on the body at which the skin pigmentation is assessed by pigmentation measurement methods (PMMs)
201.3.210
controlled desaturation study
hypoxaemia induced in a cohort of healthy adult human participants performed under well controlled, optimal
or non-optimal laboratory conditions.
201.3.211
CO-oximeter
multiwavelength optical blood analyser that measures total haemoglobin concentration and the
concentrations of various haemoglobin derivatives
Note 1 to entry: The relevant CO-oximetry value is functional saturation of arterial blood, SaO2, which pulse oximeter
equipment estimates and reports as SpO .
201.3.212
data update period
interval in which the pulse oximeter equipment algorithm provides new valid data to the display or the
functional connection
Note 1 to entry: The data update period does not refer to the regular refresh period of the display, which is typically on
the order of 1 s, but rather to the (typically longer) interval defined above.
201.3.213
declared range
portion of the displayed range of SpO and pulse rate values over which there is specified accuracy
201.3.214
default alarm preset
alarm preset that can be activated by the alarm system without operator action
Note 1 to entry: Manufacturer- or responsible organization-configured alarm presets are possible types of default alarm
presets.
ISO 80601-2-61:2026(en)
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.16]
201.3.215
differential bias
measure of the overall dependence of participant-specific mean bias to a factor
201.3.216
displayed range
range of SpO or pulse rate values that can be displayed by the pulse oximeter equipment
Note 1 to entry: The displayed range can extend beyond the declared range.
201.3.217
distributed alarm system
DAS
alarm system that involves more than one item of equipment of a ME system intended for delivery of alarm
conditions with technical confirmation
Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.
Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm condition.
Note 3 to entry: For the purposes of this document, technical confirmation means that each element of a distributed
alarm system confirms or guarantees the successful delivery of the alarm condition to the next element or appropriate
technical alarm conditions are created as described in IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 6.11.2.2.1.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.17]
201.3.218
EMS environment
emergency medical services environment
actual conditions and settings, in which operators interact with the ME equipment or ME system, in and around
the scene of an emergency outside of a professional healthcare facility where a patient can be given medical
care, basic or advanced life support as well as during professional transport to a professional healthcare
facility or between professional healthcare facilities
EXAMPLE 1 Responding to and providing life support at the scene of an emergency to a patient reported as
experiencing injury or illness in a pre-hospital setting, and transporting the patient, while continuing such life support
care, to an appropriate professional healthcare facility for further care.
EXAMPLE 2 Providing monitoring, treatment or diagnosis during transport between professional healthcare
facilities.
Note 1 to entry: For the purposes of this document, use of equipment intended for the EMS environment and temporarily
used in the home healthcare environment by emergency medical personnel is considered use in the EMS environment.
Note 2 to entry: For the purposes of this document, the operators of equipment intended for the EMS environment are
presumed to be professional medical personnel or personnel with relevant specialized training.
Note 3 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres,
dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms and multiple treatment
facilities.
Note 4 to entry: Emergency medical services are known by various names in different countries and regions.
Note 5 to entry: For the purposes of this document, transport includes road, rotary and fixed-wing ambulances.
[SOURCE: IEC 60601-1-12:2014+AMD1:2020, 3.1]
ISO 80601-2-61:2026(en)
201.3.219
essential function
function or capability that is required to maintain basic safety, essential performance, a minimum of clinical
functionality as specified by the manufacturer, and operational availability for the medical device
Note 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic safety and
essential performance), the control function and the availability of urgently needed functions and such allowing the
operator to view and manipulate the medical device safely with the most urgently needed performance (operational
availability). The loss of essential function is commonly termed loss of protection, loss of control and loss of view
respectively.
Note 2 to entry: The term is derived from IEC 62443-4-2:2019, 3.1.20, and has been refined for the purpose and scope
of this document.
[SOURCE: IEC/TR 60601-4-5:2021, 3.10]
201.3.220
essential principles
essential principles of safety and performance
fundamental high-level requirements that, when conformed with, ensure a medical device or accessory is safe
and performs as intended
[SOURCE: ISO 20417:2026, 3.10]
201.3.221
false positive alarm condition
presence of an alarm condition when no valid triggering event has occurred in the patient, the equipment or
the alarm system
Note 1 to entry: A false positive alarm condition can be caused by spurious information produced by the patient, the
patient-equipment interface, other equipment or the alarm system itself.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.21]
201.3.222
firecall
method established to provide emergency access to a secure medical device
Note 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the problem.
When a firecall is used, there is usually a review process to ensure that the access was used properly to correct a problem.
These methods generally either provide a one-time use user identifier (ID) or one-time password or other suitable
measures.
Note 2 to entry: Also referred to as "break glass" feature.
[SOURCE: IEC/TR 60601-4-5:2021, 3.11]
201.3.223
fractional oxyhaemoglobin
DEPRECATED :FO Hb fractional saturation
oxyhaemoglobin concentration cO Hb divided by the total haemoglobin concentration, ctHb, in the blood
cO Hb
FO Hb=
ctHb
Note 1 to entry: cO Hb is the concentration of oxyhaemoglobin; ctHb is the total haemoglobin concentration.
ISO 80601-2-61:2026(en)
Note 2 to entry: This is sometimes reported as a percentage (multiplying the fraction by 100).
Note 3 to entry: Fractional oxyhaemoglobin is the term used by the Clinical and Laboratory Standards Institute (CLSI),
(formerly NCCLS or National Committee for Clinical Laboratory Sciences) for this ratio.
Note 4 to entry: CLSI denotes “concentration” by a prefixed letter c, while in the past the convention of square brackets
(e.g. [O Hb] ) was used.
[3]
Note 5 to entry: CLSI uses the following notations:
− oxyhaemoglobin (O Hb);
− deoxyhaemoglobin (HHb);
− carboxyhaemoglobin (COHb);
− methaemoglobin (MetHb);
− sulfhaemoglobin (SulfHb); and
− total haemoglobin concentration (ctHb), which is derived by the cyanmethaemoglobin method of
[23]
CLSI H15 .
201.3.224
functional oxygen saturation
percentage saturation given by the oxyhaemoglobin concentration (cO Hb) divided by the sum of the
oxyhaemoglobin concentration and the deoxyhaemoglobin concentration (cHHb)
100 cO Hb
ccO Hb+ HHb
[3]
Note 1 to entry: The CLSI term for this ratio is haemoglobin oxygen saturation, and its notation is SO .
Note 2 to entry: As related to SpO , this percent saturation is for arterial blood.
201.3.225
functional tester
test equipment which presents pulse oximeter equipment with a signal having a predictable value of
modulation ratio so that the operator can observe the resulting displayed value of SpO , and compare it to the
expected value derived from the calibration curve for that particular pulse oximeter equipment
Note 1 to entry: The accuracy of the SpO value given by the pulse oximeter equipment depends in part on whether the
calibration curve of the pulse oximeter monitor properly reflects the optical characteristics of the pulse oximeter probe
and pulse oximeter probe-tissue interaction. Functional testers are not able to confirm the SpO2 accuracy of the calibration
curve or sufficiently assess the optical characteristics of pulse oximeter probes to determine their proper calibration.
Additional information is found in EE.4.
Note 2 to entry: Not all functional testers and pulse oximeter equipment are compatible. Functional testers can vary in pulse
simulation methods, pulse contours, and amplitude. It is possible that a functiona
...