EN IEC 63203-402-3:2024

SLOVENSKI STANDARD
01-april-2024
Nosljive elektronske naprave in tehnologije - 402-3. del: Merjenje zmogljivosti
nosljivih izdelkov za fitnes - Preskusne metode za ugotavljanje točnosti srčnega
utripa (IEC 63203-402-3:2024)
Wearable electronic devices and technologies - Part 402-3: Performance measurement
of fitness wearables - Test methods for the determination of the accuracy of heart rate
(IEC 63203-402-3:2024)
Tragbare elektronische Geräte und Technologien - Teil 402-3: Leistungsmessverfahren
für Fitness-Wearables - Testmethoden für die Bestimmung der Genauigkeit der
Herzfrequenz (IEC 63203-402-3:2024)
Technologies et dispositifs électroniques prêts-à-porter - Partie 402-3: Mesurage de
l'aptitude à la fonction des dispositifs prêts-à-porter pour les activités de mise en forme -
Méthodes d'essai pour déterminer l'exactitude des mesures de la fréquence cardiaque
(IEC 63203-402-3:2024)
Ta slovenski standard je istoveten z: EN IEC 63203-402-3:2024
ICS:
31.080.99 Drugi polprevodniški elementi Other semiconductor devices
59.080.80 Inteligentne tekstilije Smart textiles
97.220.01 Športna oprema in Sports equipment and
pripomočki na splošno facilities in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 63203-402-3

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2024
ICS 31.020
English Version
Wearable electronic devices and technologies - Part 402-3:
Performance measurement of fitness wearables - Test methods
for the determination of the accuracy of heart rate
(IEC 63203-402-3:2024)
Technologies et dispositifs électroniques prêts-à-porter - Tragbare elektronische Geräte und Technologien - Teil 402-
Partie 402-3: Mesurage de l'aptitude à la fonction des 3: Leistungsmessverfahren für Fitness-Wearables -
dispositifs prêts-à-porter pour les activités de mise en forme Testmethoden für die Bestimmung der Genauigkeit der
- Méthodes d'essai pour déterminer l'exactitude des Herzfrequenz
mesures de la fréquence cardiaque (IEC 63203-402-3:2024)
(IEC 63203-402-3:2024)
This European Standard was approved by CENELEC on 2024-02-13. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63203-402-3:2024 E

European foreword
The text of document 124/247/FDIS, future edition 1 of IEC 63203-402-3, prepared by IEC/TC 124
"Wearable electronic devices and technologies" was submitted to the IEC-CENELEC parallel vote and
approved by CENELEC as EN IEC 63203-402-3:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-11-13
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-02-13
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 63203-402-3:2024 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601 (series) NOTE Approved as EN 60601 (series)
ISO 80601 (series) NOTE Approved as EN ISO 80601 (series)

IEC 63203-402-3 ®
Edition 1.0 2024-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Wearable electronic devices and technologies –

Part 402-3: Performance measurement of fitness wearables – Test methods for

the determination of the accuracy of heart rate

Technologies et dispositifs électroniques prêts-à-porter –

Partie 402-3: Mesurage de l'aptitude à la fonction des dispositifs prêts-à-porter

pour les activités de mise en forme – Méthodes d'essai pour déterminer

l'exactitude des mesures de la fréquence cardiaque

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 31.020  ISBN 978-2-8322-7962-5

– 2 – IEC 63203-402-3:2024 © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and abbreviated terms . 6
3.1 Terms and definitions . 6
3.2 Abbreviated terms . 7
4 Test methods and procedures. 7
4.1 General . 7
4.2 Other considerations . 7
4.3 Setup and configuration . 8
4.3.1 PPG simulator test . 8
4.3.2 Comparative test with a reference ECG device . 8
4.4 Participant considerations . 9
4.4.1 General considerations . 9
4.4.2 Skin tones . 9
4.4.3 BMI range . 10
4.4.4 Gender balance . 10
4.4.5 Skin influences . 10
4.4.6 Age . 10
4.4.7 Clothing and shoes . 10
4.5 Comparative test protocols . 10
4.5.1 Test environment . 10
4.5.2 Test preparation . 10
4.5.3 Test protocols . 11
5 Accuracy . 13
5.1 HRMD accuracy for PPG simulator test . 13
5.2 Heart rate accuracy for comparative test with a reference ECG device . 13
6 Test report . 14
6.1 General . 14
6.2 PPG simulator test results. 14
6.3 HRMD properties . 14
6.4 Reference device (chest type ECG) . 14
6.5 Descriptions of participant characteristics . 14
6.6 Test conditions . 15
6.7 Detailed description of each test protocol . 15
6.8 Test results . 15
Annex A (informative) Example of PAR-Q . 16
Bibliography . 17

Figure 1 – PPG simulator circuit and setup . 8
Figure 2 – Example of PPG to be tested and reference ECG devices . 9

IEC 63203-402-3:2024 © IEC 2024 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
WEARABLE ELECTRONIC DEVICES AND TECHNOLOGIES –

Part 402-3: Performance measurement of fitness wearables –
Test methods for the determination of the accuracy of heart rate

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC 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, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 63203-402-3 has been prepared by IEC technical committee 124: Wearable electronic
devices and technologies. It is an International Standard.
The text of this International Standard is based on the following documents:
Draft Report on voting
124/247/FDIS 124/259/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.

– 4 – IEC 63203-402-3:2024 © IEC 2024
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
A list of all parts in the IEC 63203 series, published under the general title Wearable electronic
devices and technologies, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

IEC 63203-402-3:2024 © IEC 2024 – 5 –
INTRODUCTION
The intent of this document is to evaluate the accuracy of wearables that measure heart rate
with a photoplethysmogram (PPG) sensor.
Heart rate is a widely used physiological variable that non-invasively assesses the cardiac
autonomic nervous system by measuring changes in the cardiac rhythm through time. Heart
rate can be measured from an electrocardiographic signal (ECG). However, the use of
physiological signals other than ECG to extract heart rate information is common. The term
“pulse rate” has been used in literature to reference heart rate obtained through PPG.
Researchers have been using PPG to extract as much information as possible given its
widespread use in clinical and everyday activities. PPG is a simple, non-invasive, optical
measurement technique used for the detection of blood volume changes in peripheral tissue.
Pulse rate has been treated as a synonym to heart rate and these two terms are often used
interchangeably by manufacturers in describing device features to consumers. However, it is
possible that the relationship or differences between heart rate and pulse rate will not be clear
based on intent. Because some countries and manufacturers can use the term pulse rate rather
than heart rate, the reader is encouraged to clarify preferential term, if the term is being used
as a synonym, and testing expectations.
Heart rate measures the rate of contractions or heartbeats whereas pulse rate measures
changes in blood pressure. For an unhealthy person, these two factors could be different. The
reader is reminded that according to 4.4.1 of this document, test participants are asked to fill
out the Physical Activity Readiness Questionnaire (PAR-Q) to determine their eligibility for the
comparative test. Anyone deemed unhealthy per the PAR-Q will be disqualified from testing.

– 6 – IEC 63203-402-3:2024 © IEC 2024
WEARABLE ELECTRONIC DEVICES AND TECHNOLOGIES –

Part 402-3: Performance measurement of fitness wearables –
Test methods for the determination of the accuracy of heart rate

1 Scope
This part of IEC 63203 specifies terms, a measurement protocol, and a test to evaluate the
accuracy of wearables that measure heart rate with a photoplethysmogram (PPG) sensor. While
this document can be used to measure a variety of different devices claiming to report heart
rate, care will be taken when testing in countries that differentiate between heart rate and pulse
rate. This measurement protocol is not intended to evaluate medical devices associated with
the IEC 60601 series or ISO 80601 series.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1.1
heart rate
HR
speed of the heartbeat measured by the number of contractions of the heart per unit time
(typically per minute), or frequency of contractions of the ventricles
3.1.2
body mass index
BMI
person’s weight divided by their height in meters squared
Note 1 to entry: It is expressed in kilograms per square meter.
3.1.3
heart rate monitoring device
HRMD
device that captures pulsation signals and calculates the pulse rate at regular intervals
Note 1 to entry: HRMD is used in this document for PPG wearable devices under test only.
3.1.4
plethysmograph
device which produces a plethysmogram

IEC 63203-402-3:2024 © IEC 2024 – 7 –
3.1.5
photoplethysmogram
PPG
graphic record of the variation with time of an optically measured volume of blood circulation at
the skin’s surface
3.1.6
pulse rate
PR
increase in arterial pressure that can be felt and measured by a pulse (typically measured per
minute)
Note 1 to entry: Pulse rate is used interchangeably with the term heart rate by many manufacturers describing
features of wearables. However, some countries use the term pulse rate differently than heart rate.
3.2 Abbreviated terms
BMI body mass index
ECG electrocardiogram
HR heart rate
HRMD heart rate monitoring device
LED light emitting diode
MAPE mean absolute percentage error
PPG photoplethysmogram
PR pulse rate
4 Test methods and procedures
4.1 General
A wearable device with heart rate monitoring based on a photoplethysmogram (PPG) is tested
with a PPG simulator at various
...