EN IEC 63203-402-3:2024
(Main)Wearable electronic devices and technologies - Part 402-3: Performance measurement of fitness wearables - Test methods for the determination of the accuracy of heart rate
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 specifies terms, a measurement protocol, and a test to evaluate the accuracy of wearables that measure heart rate with a photoplethysmography (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.
Tragbare elektronische Geräte und Technologien - Teil 402-3: Performance Messung für Fitness-Wearables - Testmethoden für die Bestimmung der Genauigkeit der Herzfrequenz
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
L'IEC 63203-402-3:2024 spécifie la terminologie, un protocole de mesure et un essai pour évaluer l'exactitude des technologies et dispositifs électroniques qui mesurent la fréquence cardiaque au moyen d'un capteur de photopléthysmogramme (PPG). Même si le présent document peut être utilisé pour mesurer une large gamme de dispositifs différents réputés capables de mesurer la fréquence cardiaque, une attention particulière sera accordée lors des essais effectués dans les pays qui distinguent la fréquence cardiaque et le débit cardiaque. Ce protocole de mesure n'a pas pour objet d'évaluer les appareils médicaux couverts par la série IEC 60601 ou la série ISO 80601.
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)
Standard IEC 63203-402-3:2024 določa pogoje, protokol merjenja in preskus za ocenjevanje točnosti nosljivih naprav, ki merijo srčni utrip s fotopletizmografskim senzorjem (PPG). Čeprav je mogoče ta dokument uporabljati za merjenje različnih naprav, ki naj bi prikazovale srčni utrip, je potrebna pozornost pri preskušanju v državah, ki razlikujejo med srčnim utripom in pulzom. Ta protokol za merjenje je namenjen za ocenjevanje medicinskih pripomočkov, povezanih s skupino standardov IEC 60601 ali skupino standardov ISO 80601.
General Information
Standards Content (Sample)
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
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