ISO/FDIS 80601-2-61
(Main)Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-61:2017 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 also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. 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. ISO 80601-2-61:2017 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. 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 will say 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 and in 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance. ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. ISO 80601-2-61:2017 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 pulse oximeter equipment for those environments of use. ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.
Appareils électromédicaux — Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls
ISO 80601-2-61:2017 s'applique à la sécurité de base et aux performances essentielles des oxymètres de pouls conçus pour une utilisation chez les êtres humains, ci-après dénommés appareils em. Sont inclus tous les éléments de l'appareil nécessaires pour une utilisation normale, y compris le moniteur de l'oxymètre de pouls, le capteur de l'oxymètre de pouls et le câble de raccordement du capteur. Ces exigences s'appliquent de la même manière aux oxymètres de pouls, y compris aux moniteurs d'oxymètre de pouls, aux capteurs d'oxymètre de pouls et aux câbles de raccordement du capteur, qui ont été remis en état. L'utilisation prévue des oxymètres de pouls inclut notamment, sans toutefois s'y limiter, l'estimation de la saturation en oxygène de l'hémoglobine artérielle et de la fréquence du pouls chez des patients en établissement de soins professionnel ainsi que chez les patients dans l'environnement des soins à domicile et dans l'environnement des services médicaux d'urgence. ISO 80601-2-61:2017 ne s'applique pas aux oxymètres de pouls destinés à être utilisés dans le cadre de recherches en laboratoire, de même qu'aux oxymètres nécessitant un échantillon de sang du patient. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils em ou uniquement aux systèmes em, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils em et aux systèmes em, selon le cas. Les dangers inhérents à la fonction physiologique prévue de l'appareil em ou des systèmes em dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11 et de 7.2.13 et 8.4.1 de la norme générale. NOTE 1 Voir également 4.2 de la norme générale. La norme générale est l'IEC 60601-1:2005+AMD1:2012, Appareils électromédicaux ? Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. ISO 80601-2-61:2017 peut également être appliqué aux appareils em et à leurs accessoires utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité. ISO 80601-2-61:2017 ne s'applique pas aux oxymètres de pouls destinés uniquement à la surveillance de f?tus. ISO 80601-2-61:2017 ne s'applique pas aux appareils distants ou esclaves (secondaires) qui affichent les valeurs de la SpO2 et qui sont situés à l'extérieur de l'environnement du patient. NOTE 2 Il est attendu que les appareils em qui permettent une sélection entre des fonctions de diagnostic et de surveillance satisfassent aux exigences du document approprié lorsqu'ils sont configurés pour ladite fonction. ISO 80601-2-61:2017 est applicable aux oxymètres de pouls destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l'extérieur de l'environnement hospitalier ou d'un cabinet de médecin, telles que dans des ambulances ou dans les transports aériens. Des normes supplémentaires peuvent s'appliquer aux oxymètres de pouls pour ces environnements d'utilisation. ISO 80601-2-61:2017 est une norme particulière des séries de normes de l'IEC 60601-1 et de l'ISO/IEC 80601.
General Information
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Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS
80601-2-61
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-61:
Voting begins on:
2025-12-22
Particular requirements for basic
safety and essential performance of
Voting terminates on:
2026-02-16
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/FDIS
80601-2-61
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-61:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
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ii
Contents Page
201.1 Scope, object, and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 18
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 . 25
201.10 Protection against unwanted and excessive radiation hazards . 25
201.11 Protection against excessive temperatures and other hazards . 25
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 27
201.13 Hazardous situations and fault conditions for ME equipment . 42
201.14 Programmable electrical medical systems (PEMS) . 43
201.15 Construction of ME equipment . 43
201.16 ME systems . 45
201.17 Electromagnetic compatibility of ME equipment and ME systems . 45
201.101 Pulse oximeter probes and probe cable extenders . 45
201.102 Saturation pulse information signal . 46
201.103 Functional connection . 46
202 Electromagnetic disturbances – Requirements and tests . 47
202.4.3.1 Configurations . 47
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems . 47
202.8.1.101 Additional general requirements . 48
202.8.2 Patient physiological simulation . 48
206 Usability . 48
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 49
208.6.1.2.101 Additional requirements for alarm condition priority . 49
208.6.5.4.101 Additional requirements for default alarm preset . 49
208.6.8.5.101 Additional requirements for alarm signal inactivation states,
indication and access . 49
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 49
iii
212 Requirements for medical electrical equipment and medical electrical systems used
in the emergency medical services environment . 50
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 51
Annex D (informative) Symbols on marking . 55
Annex AA (informative) Particular guidance and rationale . 56
Annex BB (informative) Skin temperature at the pulse oximeter probe . 78
Annex CC (informative) Determination of accuracy, pigmentation differential bias, sample
size, and study design considerations . 82
Annex DD (normative) Method for invasive studies for evaluating and documenting SpO
accuracy in human participants . 103
Annex EE (informative) Simulators, calibrators, and functional testers for pulse oximeter
equipment . 109
Annex FF (informative) Concepts of ME equipment response time . 118
Annex GG (normative) Data interface requirements . 122
Annex HH (informative) Clinical context and rationales . 128
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 . 129
Annex JJ (informative) Using a transfer standard in pulse oximeter equipment development . 134
Annex KK (informative) Reference to the IMDRF essential principles and labelling guidances 140
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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
ISO 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes 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 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. ISO 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.
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, Electrical equipment in medical practice, Subcommittee SC 62D, Electric equipment, 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 80601-2-61:2018), 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 ;
rms
required differential bias determination;
v
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 website.
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.
vi
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 60601-1-12:2014+AMD1:2020, as well as IEC 60601-1-2:2014+AMD1:2020,
IEC 60601-1-11:2015+AMD1:2020, IEC 60601-1:2005+AMD1:2012+AMD2:2020,
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:
vii
– “shall” indicates a requirement;
– “should” indicates a recommendation;
– “may” indicates a permission;
– “can” indicates a possibility or capability; and
– “must” is used express an external constraint.
viii
FINAL DRAFT International Standard ISO/FDIS 80601-2-61:2025(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 will say 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 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.
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.
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 14155:2020, 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:— , 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
Under preparation. Stage at the time of publication: ISO/FDIS 20417:2025.
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 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:—, 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, 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]
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 SpO2.
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.
[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]
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 complied with ensure a medical device or accessory is safe
and performs as intended
[SOURCE: ISO 20417:—, 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.
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 SpO2, 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 functional tester cannot accurately reproduce the
calibration of the pulse oximeter equipment and can yield different results between pulse oximeter equipment.
201.3.226
healthcare professional, adj
appropriately trained, knowledgeable, and skilled, providing systematic preventive, curative, promotional or
rehabilitative healthcare services
[SOURCE: ISO 80601-2-12:2023, 201.3.247]
201.3.227
HF surgical equipment
medical electrical equipment which generates high frequency currents intended for the performance of
surgical tasks, such as the cutting or coagulation of biological tissue by means of these high frequency currents
Note 1 to entry: HF surgical equipment is also variously known as surgical diathermy, electrosurgical equipment,
electrosurgical generator, RF generator or HF generator.
Note 2 to entry: A footswitch is an example of an associated accessory that is part of HF surgical equipment.
[SOURCE: IEC 60601-2-2:2017, 3.224]
201.3.228
home healthcare environment
dwelling place in which a patient lives or other places where patients are present, excluding professional
healthcare facility environments where operators with medical training are continually available when
patients are present
EXAMPLE In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
Note 1 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, multiple treatment
facilities and emergency medical services.
Note 2 to entry: For the purpose of this document, nursing homes are considered home healthcare environments.
Note 3 to entry: Other places where a patient is present include the outdoor environment, while working and in vehicles.
[SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.1, modified — replaced ' collateral standard' with 'document'.]
201.3.229
immunity
ability of ME equipment or a ME system to perform without degradation in the presence of an electromagnetic
disturbance
[SOURCE: IEC 60601-1-2:2014+AMD1:2020, 3.8, modified — deleted 'the'.]
201.3.230
immunity test level
level of a test signal used to simulate an electromagnetic disturbance when performing an immunity test
[SOURCE: IEC 60601-1-2:2014+AMD1:2020, 3.9, modified — deleted 'the'.]
201.3.231
individual typology angle
ITA
objective colourimetry measure of skin pigmentation that is inversely related to the amount of pigmentation
*
180 L − 50
[8][52]
ITA= • arctan
*
π
b
where
L* is the luminance ranging from black (0) to white (100); and
b* is the yellow/blue component.
Note 1 to entry: ITA is the vector direction on the L*-b* plane where ITA is given in degrees.
Note 2 to entry: ITA is collected with the use of equipment that provides the measure directly or derived from the
parameters L* and b* according to Reference [52].
Note 3 to entry: For the purposes of this document, skin pigmentation and the quantification thereof by ITA only refers
to melanin.
201.3.232
information supplied by the manufacturer
information related to the identification and use of a medical device or accessory, in whatever form provided,
intended to ensure the safe and effective use of the medical device or accessory
Note 1 to entry: e-documentation is included in the information supplied by the manufacturer.
Note 2 to entry: Shipping documents (e.g. packing list and customs documents) and promotional material are excluded
from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such
supplemental information as information supplied by the manufacturer.
Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device or
acc
...
ISO /FDIS 80601-2-61:2025(Ed 3en)
ISO/TC 121/SC 3/JWG 10
IEC 62D/JWG 5
Date: 2025-10-1023
Secretariat: ANSI
Medical Electrical Equipment — 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
essentiellesxessentielles pour les oximètres de pouls
FDIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights
of which they are aware and to provide supporting documentation.
ii © ISO 2010 – All rights reserved
ISO 80601-2-61:2025(E) ISO/TC 121/SC 3/ N3248
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland.
ii © ISO 2025 – All rights reserved
ISO 80601-2-61:2025(E)
Contents Page
201.1 Scope, object, and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
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) . 41
201.15 Construction of ME equipment . 42
201.16 ME systems . 43
201.17 Electromagnetic compatibility of ME equipment and ME systems . 43
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 . 45
202.4.3.1 Configurations . 45
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems . 46
202.8.1.101 Additional general requirements . 46
202.8.2 Patient physiological simulation . 46
206 Usability . 47
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 47
208.6.1.2.101 Additional requirements for alarm condition priority . 47
208.6.5.4.101 Additional requirements for default alarm preset . 47
208.6.8.5.101 Additional requirements for alarm signal inactivation states,
indication and access . 48
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 48
ii © ISO 2025 – All rights reserved
ISO /FDIS 80601-2-61:2025(Een)
212 Requirements for medical electrical equipment and medical electrical systems used
in the emergency medical services environment . 48
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 49
Annex D (informative) Symbols on marking . 53
Annex AA (informative) Particular guidance and rationale . 54
Annex BB (informative) Skin temperature at the pulse oximeter probe . 76
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 . 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 . 131
Annex KK (informative) Reference to the IMDRF essential principles and labelling guidances 136
Figure 201.101 — Example finger pulse oximeter probe locations and orientation .22
Figure 201.102 — Dorsal distal phalanx location .34
Figure AA.1 — Probability of obtaining an observed A for fingerclip vs reference CO-oximeter
rms
less than or equal to 3,0, as a function of the true A , by sample size .64
rms
Figure CC.1 — Synthesized calibration data (base case) .82
Figure CC.2 — Constant offset has been added to base case .83
Figure CC.3 — Tilt has been added to base case .84
Figure CC.4 — Graphical representation for the definition of local bias (Test pulse oximeter probe
SpO as a function of reference S ) .85
R
Figure CC.5 — Graphical representation for the definition of local bias and mean bias (Test probe
SpO as a function of reference S ) .86
R
Figure CC.6 Two examples of modified Bland-Altman graphs of the controlled desaturation study
data, delineating participants, and bias by skin tone .92
iii
ISO 80601-2-61:2025(E)
Figure CC.7 — Point estimates and 90 % confidence intervals of differential bias from LME, LR,
and MLR analysis of 34 unlabelled pulse oximeter equipment at 85 % SaO .94
Figure CC.8 Example graph of simulated per-participant bias versus per-participant ITA within a
particular SaO span .95
Figure CC.9 — Example graph of the observed pigmentation differential bias versus SaO .96
Figure CC.10 Power curves for the participant-level ITA vs participant-level bias regression
analysis method (MLR). .98
Figure DD.1 — Example of desaturation-time profile . 103
Figure EE.1 — Sample calibration curve for pulse oximeter equipment . 108
Figure EE.2 — Interface of a functional tester that uses a photodiode and LED to interact with a
pulse oximeter probe . 110
Figure EE.3 — Interface of a functional tester that uses a dye mixture . 111
Figure EE.4 — Interface of a functional tester that uses a liquid crystal modulator . 111
Figure EE.5 — Absorbency of blue bandage material (measured in reflection) used in a special
test pulse oximeter probe with great patient-to-patient variability . 113
Figure EE.6 —High-variability production pulse oximeter probe in a controlled desaturation study
on five test participants . 114
Figure FF.1 — Illustration of fidelity of pulse oximeter equipment performance in tracking
saturation changes . 116
Figure FF.2 — Illustration of effect of different averaging times on fidelity . 116
Figure FF.3 — Graphic representation of components of alarm system delay . 117
Figure FF.4 — Illustration of the effects of different averaging times on a more rapid and noisier
desaturation signal . 118
Figure JJ.1 — Distribution of root mean square error of SpO . 134
Table 201.101 — Distributed essential performance requirements .18
Table 201.C.101 — Marking on the outside of pulse oximeter equipment or its parts or accessories
...........................................................................................................................................................................49
Table 201.C.102 — Accompanying documents, general .49
Table 201.C.103 — Accompanying documents, instructions for use .50
Table 201.C.104 — Accompanying documents, technical description .52
Table 201.D.1.101 — Additional symbols on marking .53
iv © ISO 2025 – All rights reserved
ISO /FDIS 80601-2-61:2025(Een)
Table AA.1 — Probability of detection per sample size .63
Table AA.2 — Qualitative assessment of pulse oximeter equipment shock and vibration
environment .71
Table BB.1 — Pulse oximeter probe safe application time and source .78
Table DD.1 — Example of target plateaus and ranges . 103
Table GG.1 — Parameters and units of measurement . 120
Table GG.2 — Equipment identification . 121
Table GG.3 — Operator-adjustable equipment settings . 121
Table GG.4 — Equipment configuration . 122
Table GG.5 — Equipment specifications . 123
Table GG.6 — Service monitoring indicators . 123
Table GG.7 — External device information . 124
Table II.1 — Results following the outlined testing procedure. 128
Table II.2 — Categorization of the observations shown in Table II.1 . 128
Table II.3 — Categorization of the observations shown in Table II.2 using a deviation threshold of
±4 digits . 129
Table JJ.1 — Quantiles of RMS values from bootstrap samples of size 30 (10 dark / 20 light
skinned) . 134
Table KK.1 — Correspondence between this document and the essential principles . 135
Table KK.2 — Correspondence between this document and the labelling principles . 137
v
ISO 80601-2-61:2025(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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
ISO 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes 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 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. ISO 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 A standards, the meaning of ISO specific terms and expressions
rms
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.
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, Electrical equipment in medical practice, Subcommittee SC 62D, Electric equipment, 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 80601-2-61:2018), which has been technically
revised.
The main changes compared to the previous edition 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 ;
rms
required differential bias determination;
clarified that accessories need to be included in the clinical performance verification and conformity to the
requirements of the document
vi © ISO 2025 – All rights reserved
ISO /FDIS 80601-2-61:2025(Een)
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][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 website.
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.
vii
ISO 80601-2-61:2025(E)
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 60601-1-12:2014+AMD1:2020, as well as IEC 60601-1-2:2014+AMD1:2020,
IEC 60601-1-11:2015+AMD1:2020, IEC 60601-1:2005+AMD1:2012+AMD2:2020,
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][26]
Annex KK maps the requirements of this document to the IMDRF essential principles and labelling
guidances
In this document, the following print types are used:
– requirements and definitions: roman type;
– terms defined in Clause 3 of the IEC 60601-1:2005+AMD1:2012+AMD2:2020 in this document or as noted:
italic type; and
– informative material appearing outside of tables, such as notes, examples and references: in smaller type; normative
text of tables is also in a smaller type.
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).
viii © ISO 2025 – All rights reserved
ISO /FDIS 80601-2-61:2025(Een)
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;
– “should” indicates a recommendation;
– “may” indicates a permission;
– “can” indicates a possibility or capability; and
– “must” is used express an external constraint.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
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.
ix
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 will say 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 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.
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
[27][27]
requirements of 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.
2 © ISO 2025 – All rights reserved
"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.
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 14155:2020, 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:— , 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
Under preparation. Stage at the time of publication: ISO/FDIS 20417:2025.
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 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:—, 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, 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]
4 © ISO 2025 – All rights reserved
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]
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.
[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.
6 © ISO 2025 – All rights reserved
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]
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 complied with ensure a medical device or accessory
is safe and performs as intended
[SOURCE: ISO 20417:—, 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 spuriou
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