EN ISO 80601-2-61:2019

SLOVENSKI STANDARD
01-april-2019
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SIST EN ISO 80601-2-61:2011
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Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected
version 2018-02)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO
80601-2-61:2017)
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,
Version corrigée 2018-02)
Ta slovenski standard je istoveten z: EN ISO 80601-2-61:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 80601-2-61
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.55 Supersedes EN ISO 80601-2-61:2011
English Version
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse oximeter equipment (ISO 80601-2-61:2017,
Corrected version 2018-02)
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 80601-2-61:2017, Version corrigée 2018-02) Pulsoximetriegeräten (ISO 80601-2-61:2017)
This European Standard was approved by CEN on 13 December 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 06 March 2019.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-61:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-61:2019) 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 July 2019, and conflicting national standards shall be
withdrawn at the latest by January 2022.
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 80601-2-61:2011.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-61:2017, Corrected version 2018-02 has been approved by CEN as
INTERNATIONAL ISO
STANDARD 80601-2-61
Second edition
2017-12
Corrected version
2018-02
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 essentielles pour les oxymètres de pouls
Reference number
ISO 80601-2-61:2017(E)
©
ISO 2017
ISO 80601-2-61:2017(E)
© ISO 2017
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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
ii
ISO 80601-2-61:2017(E)
Contents Page
Foreword . v
Introduction . vi
201. 1 Scope, object and related standards . 1
201. 2 Normative references . 3
201. 3 Terms and definitions . 4
201. 4 General requirements . 9
201. 5 General requirements for testing of ME EQUIPMENT . 10
201. 6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201. 7 ME EQUIPMENT identification, marking and documents . 11
201. 8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201. 9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201. 10 Protection against unwanted and excessive radiation HAZARDS . 15
201. 11 Protection against excessive temperatures and other HAZARDS . 15
201. 12 Accuracy of controls and instruments and protection against hazardous outputs . 17
201. 13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201. 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201. 15 Construction of ME EQUIPMENT . 21
201. 16 ME SYSTEMS . 23
201. 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
201. 101 * PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS . 23
201. 102 Saturation pulse INFORMATION SIGNAL . 23
201. 103 FUNCTIONAL CONNECTION . 24
202 Electromagnetic disturbances – Requirements and tests . 24
206 Usability . 25
208 General requirements, tests and guidance for alarm systems in medical electrical equipment
and medical electrical systems . 26
211 Requirements for medical electrical equipment and medical electrical systems used in the
home healthcare environment . 26
212 Requirements for medical electrical equipment and medical electrical systems used in the
emergency medical services environment . 27
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS . 28
Annex D (informative) Symbols on marking . 31
Annex AA (informative) Particular guidance and rationale . 32
Annex BB (informative) Skin temperature at the PULSE OXIMETER PROBE . 40
ANNEX CC (informative) Determination of ACCURACY . 44
Annex DD (informative) Calibration standards. 53
Annex EE (informative) Guideline for evaluating and documenting SpO ACCURACY in human subjects . 54
Annex FF (informative) Simulators, calibrators and FUNCTIONAL TESTERS for PULSE OXIMETER EQUIPMENT . 61
© ISO 2017 – All rights reserved iii

ISO 80601-2-61:2017(E)
Annex GG (informative) Concepts of ME EQUIPMENT response time . 70
Annex HH (normative) Data interface requirements . 74
Annex II (informative) Reference to the ESSENTIAL PRINCIPLES . 78
Annex JJ (informative) Terminology — alphabetized index of defined terms . 82
Bibliography . 87
iv © ISO 2017 – All rights reserved

ISO 80601-2-61:2017(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
documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights
identified during the development of the document will be in the Introduction and/or on the ISO list of patent
declarations received (see www.iso.org/patents).
trade name used in this document is information given for the convenience of users and does not constitute
Any
an endorsement.
For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.
This document was prepared jointly by ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3,
Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical equipment in medical
practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting to the national bodies of
both ISO and IEC.
This second edition of ISO 80601‐2‐61 cancels and replaces the first edition(ISO 80601‐2‐61:2011), which has
been technically revised. It includes an alignment with Amendment 1 of both the third edition of IEC 60601‐1 and
the second edition of IEC 60601‐1‐8, as well as the fourth edition of IEC 60601‐1‐2, the third edition of IEC 60601‐
1‐6, the second edition of IEC 60601‐1‐11 and IEC 60601‐1‐12.
The most significant changes are the following modifications:
– updated rationale (Annex AA) and references related to advances in the understanding of hypoxaemia,
electronic health records and ALARM SYSTEMS;
– ingress protection changed from IPX1 to IPX2;
and the following additions:
– Clause 211, requirements for use in the HOME HEALTHCARE ENVIRONMENT;
– Clause 212, requirements for use in the emergency medical services (EMS) environment;
– Annex HH, Data interface requirements.
This corrected version of ISO 80601‐2‐61:2017 incorporates the following correction:
– headers have been corrected.
A list of all the parts of the ISO/IEC 80601 series is available on the ISO website.
© ISO 2017 – All rights reserved v

ISO 80601-2-61:2017(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 the
first edition of IEC 60601‐1‐12, as well as the fourth edition of IEC 60601‐1‐2, the second edition of IEC 60601‐1‐
11 and the first Amendments to both the third edition of IEC 60601‐1, the third edition of IEC 60601‐1‐6 and the
second edition of IEC 60601‐1‐8.
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 both the formulae used to evaluate the SpO ACCURACY of PULSE OXIMETER EQUIPMENT
measurements, and the names that are assigned to those formulae.
Annex DD presents guidance on when in vitro blood calibration of PULSE OXIMETER EQUIPMENT is needed.
Annex EE presents a guideline for a CONTROLLED DESATURATION STUDY for the calibration of PULSE OXIMETER EQUIPMENT.
Annex FF is a tutorial introduction to several kinds of testers used in pulse oximetry.
Annex GG describes concepts of PULSE OXIMETER EQUIPMENT response time.
Annex HH describes data interface requirements.
Annex II contains Reference to the ESSENTIAL PRINCIPLES formerly found in Annex HH.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– 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;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
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).
The general standard is IEC 60601‐1:2005 and IEC 60601‐1:2005/AMD1:2012, Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance.
vi © ISO 2017 – All rights reserved

ISO 80601-2-61:2017(E)
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” means that compliance with a requirement or a test is mandatory for compliance with this document;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this document; and
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is
guidance or rationale related to that item in Annex AA.
© ISO 2017 – All rights reserved vii

INTERNATIONAL STANDARD ISO 80601-2-61:2017(E)
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, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
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 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.
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.
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.
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 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 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 2017 – All rights reserved 1

ISO 80601-2-61:2017(E)
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/IEC 80601 series of standards.
201.1.2 Object
Subclause 1.2 of the general standard is replaced by:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for
PULSE OXIMETER EQUIPMENT [as defined in 201.3.217] and its ACCESSORIES.
NOTE 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.
201.1.3 Collateral standards
IEC 60601‐1:2005+AMD1:2012, subclause 1.3 applies with the following addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the general
standard and Clause 201.2 of this document.
IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, IEC 60601‐1‐11 and IEC 60601‐1‐12 apply as modified in
[2]
Clauses 202, 206, 208, 211 and 212 respectively. IEC 60601‐1‐3 does not apply. All other published
collateral standards in the IEC 60601‐1 series apply as published.
201.1.4 Particular standards
IEC 60601‐1:2005+AMD1:2012, subclause 1.4 is replaced by:
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.
A requirement of a particular standard takes priority over the general standard or the collateral standards.
For brevity, IEC 60601‐1:2005+AMD1:2012 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
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.
2 © ISO 2017 – All rights reserved

ISO 80601-2-61:2017(E)
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, Clause 2 applies, except as follows:
Replacement:
IEC 60417, Graphical symbols for use on equipment
IEC 60529:2013, Degrees of protection provided by enclosures (IP code)
IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
IEC 60601‐1‐6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
+ Amendment 1:2013
IEC 60601‐1‐8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
+ Amendment 1:2012
IEC 60825‐1:2014, Safety of laser products - Part 1: Equipment classification and requirements
Addition:
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs
© ISO 2017 – All rights reserved 3

ISO 80601-2-61:2017(E)
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 15223‐1:2016, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied — Part 1: General requirements
IEC 60068‐2‐27:2008, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
+ Amendment 1:2013
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, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and
guidance
IEC 60601‐1‐11:2015, 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, 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 60825‐2:2004, Safety of laser products — Part 2: Safety of optical fibre communication systems (OFCS) +
Amendment 1:2006+ Amendment 2:2012
IEC 62366‐1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 3744:2010, ISO 4135:2001,
IEC 60601‐1:2005+AMD 1:2012, IEC 60601‐1‐2:2014, IEC 60601‐1‐6:2010+AMD 1:2013,
IEC 60601‐1‐8:2006+AMD 1:2012, IEC 60601‐1‐11:2015, IEC 60601‐1‐12:2014, IEC 62366‐1:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
 ISO Online browsing platform: available at http://www.iso.org/obp
 IEC Electropedia: available at http://www.electropedia.org/
NOTE An alphabetized index of defined terms is found in Annex JJ.
201.3.201
accuracy
closeness of agreement between a test result and an accepted reference value
Note 1 to entry: Subclause 201.12.1.101.2 provides the method of calculating the SpO ACCURACY of PULSE OXIMETER
EQUIPMENT.
Note 2 to entry: Additional information is found in Annex CC.
[3]
[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 ’.]
4 © ISO 2017 – All rights reserved

ISO 80601-2-61:2017(E)
201.3.202
controlled desaturation study
hypoxaemia induced in a human subject performed under laboratory conditions
Note 1 to entry: This can also be referred to as a controlled hypoxaemia (breathedown) study. Additional information is
found in Annex EE.
201.3.203
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, SaO , which PULSE OXIMETER
EQUIPMENT estimates and reports as SpO .
201.3.204
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: This definition 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.
201.3.205
declared range
portion of the DISPLAYED RANGE of SpO and pulse rate values over which there is specified ACCURACY
201.3.206
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.
201.3.207
fractional oxyhaemoglobin
FO Hb fractional saturation (deprecated)
oxyhaemoglobin concentration cO Hb divided by the TOTAL HAEMOGLOBIN CONCENTRATION, ctHb, in the blood
cOHb
FOHb
ctHb
Note 1 to entry: cO Hb is the concentration of oxyhaemoglobin; ctHb is the concentration of total haemoglobin.
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.
[4]
Note 5 to entry: CLSI uses the following notations:
 oxyhaemoglobin (O Hb);
 deoxyhaemoglobin (HHb);
© ISO 2017 – All rights reserved 5

ISO 80601-2-61:2017(E)
 carboxyhaemoglobin (COHb);methaemoglobin (MetHb);
 sulfhaemoglobin (SulfHb); and
[5]
 total haemoglobin (ctHb), which is derived by the cyanmethaemoglobin method of CLSI H15 .
201.3.208
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
ccOHb HHb
[4]
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.
201.3.209
functional tester
test equipment which presents PULSE OXIMETER EQUIPMENT with a signal having a predictable value of 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 SpO 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 FF.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. A FUNCTIONAL TESTER might not accurately reproduce the
calibration of the PULSE OXIMETER EQUIPMENT and can yield different results between PULSE OXIMETER EQUIPMENT.
201.3.210
local bias
b
difference between the expectation of a test result (SpO ) and an accepted reference value (SaO )
2 2
Note 1 to entry: For PULSE OXIMETER EQUIPMENT, this is, at a given value of the reference oxygen saturation, the difference
between the y‐value of the regression line at that coordinate and the y‐value of the line of identity, in a plot of SpO versus
S , or given by:
R
bSSpO
ii2fit, Ri
where
th
SpO is the value of the curve fitted to the test data at the i reference oxygen saturation value, S .
2fit,i Ri
Note 2 to entry: Additional information is found with the term MEAN BIAS and in the discussion in Annex CC.
[3]
[SOURCE: ISO 3534‐2:2006 , 3.3.2, modified — Replaced note 1 to note 3 with new notes and ‘or
measurement result and the true value’ with ‘(SpO ) and an accepted reference value (SaO )’.]
2 2
201.3.211
mean bias
B
mean difference between the test and reference values, preserving sign
6 © ISO 2017 – All rights reserved

ISO 80601-2-61:2017(E)
n
SpO  S


2Rii
i1
B
n
where
n is the number of data pairs in the sample within the range of interest;
SpO is the ith SpO datum; and
2i 2
th
S is the i reference oxygen saturation value.
Ri
Note 1 to entry: Additional information also is found with the term LOCAL BIAS and in the discussion in Annex CC.
Note 2 to entry: When defined in this way, MEAN BIAS is the average of all LOCAL BIAS values, b.
i
201.3.212
normalized
displayed at constant amplitude independent of the actual magnitude of the signal being displayed
201.3.213
operator settings
current state of any PULSE OXIMETER MONITOR controls, including ALARM SETTINGS
201.3.214
precision
closeness of agreement between independent test results obtained under stipulated conditions
n
SpOO Sp


22iifit,
i1
s 
res
n2

where
n is the number of data pairs in the sample within the range of interest;
th
(SpO � SpO ) is the difference between the i SpO datum and the value of the fitted curve corresponding to
2i 2fit,i 2
th
the i reference oxygen saturation value, S .
Ri
Note 1 to entry: Additional information is found in Annex CC.
[3]
[SOURCE: ISO 3534‐2:2006 , 3.3.4, modified — Replaced note 1 to note 3 with a new note, deleted
‘/measurement results’ and added formula.]
201.3.215
probe cable extender
cable that connects a PULSE OXIMETER MONITOR to a PULSE OXIMETER PROBE
Note 1 to entry: Not every PULSE OXIMETER EQUIPMENT utilizes a PROBE CABLE EXTENDER.
Note 2 to entry: A PROBE CABLE EXTENDER can be an APPLIED PART.
201.3.216
probe fault
abnormal condition of the PULSE OXIMETER PROBE or PROBE CABLE EXTENDER, which if not detected, could cause
PATIENT HARM
© ISO 2017 – All rights reserved 7

ISO 80601-2-61:2017(E)
Note 1 to entry: PATIENT HARM can be caused by providing incorrect values, by exposing the PATIENT to high PULSE OXIMETER
PROBE temperatures or by introducing a RISK of electric shock.
201.3.217
pulse oximeter equipment
ME EQUIPMENT for the non‐invasive estimation of FUNCTIONAL OXYGEN SATURATION of arterial haemoglobin (SpO )
from a light signal interacting with tissue, by using the time‐dependent changes in tissue optical properties
that occur with pulsatile blood flow
Note 1 to entry: PULSE OXIMETER EQUIPMENT comprises a PULSE OXIMETER MONITOR, a PROBE CABLE EXTENDER, if provided, and a
PULSE OXIMETER PROBE, which can be combined in a single assembly.
Note 2 to entry: Light is more technically referred to as electromagnetic radiation (optical radiation). This document uses
the common term.
201.3.218
pulse oximeter monitor
part of the PULSE OXIMETER EQUIPMENT that encompasses the electronics, display and OPERATOR‐EQUIPMENT
INTERFACE, excluding the PULSE OXIMETER PROBE and PROBE CABLE EXTENDER
Note 1 to entry: A PULSE OXIMETER MONITOR can consist of multiple pieces of hardware in separate locations, e.g. a telemetry
system in which the APPLIED PART and primary display are in physically separated.
201.3.219
pulse oximeter probe
part of the PULSE OXIMETER EQUIPMENT that includes the APPLIED PART and transducer component
Note 1 to entry: The terms sensor and transducer have also been used for PULSE OXIMETER PROBE.
Note 2 to entry: The PULSE OXIMETER PROBE typically consists of a cable and a rigid or flexible assembly containing two photo
emitters and a photo detector.
201.3.220
ratio
modulation ratio
ratio of ratios
R
basic quantity derived by PULSE OXIMETER EQUIPMENT from time‐dependent light intensity measurements
Note 1 to entry: PULSE OXIMETER EQUIPMENT uses an empirical calibration curve to derive SpO from R. Additional
information is found in FF.4.
201.3.221
* reprocessing
any activity, which is not specified in the ACCOMPANYING DOCUMENT, that renders a product suitable for use or
reuse
Note 1 to entry: Such activities are often referred to as refinishing, restoring, recycling, refurbishing, repairing or
remanufacturing.
Note 2 to entry: Such activities can occur in healthcare facilities.
Note 3 to entry: The term “REPROCESSED” is used to designate the corresponding status.
201.3.222
SaO
fraction of functional haemoglobin in arterial that is saturated with oxygen
8 © ISO 2017 – All rights reserved

ISO 80601-2-61:2017(E)
Note 1 to entry: Subclause 201.12.1.101.3 provides the method for determining acceptable methods of measurement of
SaO .
Note 2 to entry: SaO is FUNCTIONAL OXYGEN SATURATION in arterial blood. Additional information is found 201.3.209.
Note 3 to entry: SaO is normally expressed as a percentage (by multiplying the fraction by 100).
201.3.223
SpO
estimate of SaO made by PULSE OXIMETER EQUIPMENT
Note 1 to entry: Two‐wavelength PULSE OXIMETER EQUIPMENT cannot compensate for the interference caused by the presence
[6][7]
of dyshaemoglobins in their estimation of SaO .
Note 2 to entry: SpO is normally reported as a percentage (multiplying the fraction by 100).
201.3.224
total haemoglobin concentration
ctHb
sum of concentrations of all haemoglobin species in the blood including, but not limited to, oxyhaemoglobin
(cO Hb), methaemoglobin (cMetHb), deoxyhaemoglobin (cHHb), sulfhaemoglobin (cSHb) and
[8]
carboxyhaemoglobin (cCOHb)
201.3.225
validation
confirmation, through the provision of OBJECTIVE EVIDENCE, that the requirements for a specific intended use or
application have been fulfilled
Note 1 to entry: The OBJECTIVE EVIDENCE needed for a VALIDATION is the result of a test or other form of determination such as
performing alternative calculations or reviewing documents.
Note 2 to entry: The term “VALIDATED” is used to designate the corresponding status.
Note 3 to entry: The
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