oSIST prEN IEC 63203-402-3:2022

SLOVENSKI STANDARD
oSIST prEN IEC 63203-402-3:2022
01-december-2022
Nosljive elektronske naprave in tehnologije - 402-3. del: Metoda merjenja
zmogljivosti nosljivih izdelkov - Serija 2: Točnost ugotavljanja srčnega utripa
Wearable electronic devices and technologies - Part 402-3: Performance measurement
method of wearables - Series 2: Accuracy of Heart Rate Determination
Technologies et dispositifs électroniques prêts-à-porter - Partie 402-3: Méthode de
mesure de l'aptitude à la fonction des technologies et dispositifs électroniques prêts-à-
porter - Série 2: Exactitude des mesures de la fréquence cardiaque
Ta slovenski standard je istoveten z: prEN IEC 63203-402-3:2022
ICS:
31.080.99 Drugi polprevodniški elementi Other semiconductor devices
59.080.80 Inteligentne tekstilije Smart textiles
oSIST prEN IEC 63203-402-3:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 63203-402-3:2022

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oSIST prEN IEC 63203-402-3:2022
124/196/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 63203-402-3 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-10-14 2023-01-06
SUPERSEDES DOCUMENTS:
124/167/CD, 124/193/CC

IEC TC 124 : WEARABLE ELECTRONIC DEVICES AND TECHNOLOGIES
SECRETARIAT: SECRETARY:
Korea, Republic of Mr Jae Yeong Park
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.

TITLE:
Wearable electronic devices and technologies - Part 402-3: Performance measurement method of
wearables - Series 2: Accuracy of Heart Rate Determination

PROPOSED STABILITY DATE: 2027

NOTE FROM TC/SC OFFICERS:

Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

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1
2 CONTENTS
3
4 FOREWORD . 3
5 1  Scope . 5
6 2  Normative references . 5
7 3  Terms and definitions . 5
8 3.1 heart rate . 5
9 3.2 body mass index . 5
10 3.3 heart rate monitoring device . 5
11 3.4 plethysmograph . 5
12 3.5 photoplethysmogram . 5
13 4  Test methods and procedures . 6
14 4.1 General . 6
15 4.2 Other considerations . 6
16 4.3 Setup and configuration . 6
17 4.3.1 PPG simulator test . 6
18 4.3.2 Comparative test with a reference ECG device . 7
19 4.4 Participant considerations . 8
20 4.4.1 General considerations . 8
21 4.4.2 Skin Tones . 8
22 4.4.3 BMI Range . 8
23 4.4.4 Gender balance . 9
24 4.4.5 Skin influences . 9
25 4.4.6 Age. 9
26 4.4.7 Clothing and shoes . 9
27 4.5 Comparative test protocols . 9
28 4.5.1 Test environment . 9
29 4.5.2 Test preparation . 9
30 4.5.3 Test protocols . 10
31 5  Accuracy . 12
32 5.1 HRMD accuracy . 12
33 5.2 Heart rate accuracy . 12
34 6  Test report . 13
35 Annex A (informative)  Example of PAR-Q questionnaire . 15
36 Bibliography . 16
37
38 Figure 1 – A PPG simulator circuit and setup . 7
39 Figure 2 – Wearing both a PPG and a chest type ECG wearable devices . 8
40
41 Table 1 – Table title . Error! Bookmark not defined.
42
43

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44 INTERNATIONAL ELECTROTECHNICAL COMMISSION
45 _____________
46
47 WEARABLE ELECTRONIC DEVICES AND TECHNOLOGIES
48
49 Part 402-3: Performance measurement method of wearables –
50 Series 2: Accuracy of Heart Rate Determination
51
52 FOREWORD
53 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
54 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
55 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
56 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
57 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
58 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
59 in the subject dealt with may participate in this preparatory work. International, governmental and non-
60 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
61 with the International Organization for Standardization (ISO) in accordance with conditions determined by
62 agreement between the two organizations.
63 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
64 consensus of opinion on the relevant subjects since each technical committee has representation from all
65 interested IEC National Committees.
66 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
67 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
68 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
69 misinterpretation by any end user.
70 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
71 transparently to the maximum extent possible in their national and regional publications. Any divergence
72 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
73 the latter.
74 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
75 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
76 services carried out by independent certification bodies.
77 6) All users should ensure that they have the latest edition of this publication.
78 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
79 members of its technical committees and IEC National Committees for any personal injury, property damage or
80 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
81 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
82 Publications.
83 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
84 indispensable for the correct application of this publication.
85 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
86 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
87 International Standard IEC 63203-402-3 has been prepared by IEC technical committee 124:
88 Wearable Electronic Devices and Technologies.
89 The text of this International Standard is based on the following documents:
FDIS Report on voting
XX/XX/FDIS XX/XX/RVD
90
91 Full information on the voting for the approval of this International Standard can be found in
92 the report on voting indicated in the above table.
93 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

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94 The committee has decided that the contents of this document will remain unchanged until the
95 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
96 the specific document. At this date, the document will be
97 • reconfirmed,
98 • withdrawn,
99 • replaced by a revised edition, or
100 • amended.
101

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102 WEARABLE ELECTRONIC DEVICES AND TECHNOLOGIES
103
104 Part 402-3: Performance measurement of wearables –
105 Series 2: Accuracy of Heart Rate Determination
106
107 1  Scope
108 This part of IEC 63203 specifies terms and a measurement protocol, and a test to evaluate
109 the accuracy of wearables that measure heart rate with a photoplethysmography (PPG)
110 sensor. This measurement protocol is not intended to evaluate medical devices associated
111 with IEC 60601 or IEC/ISO 80601 series.
112 2  Normative references
113 The following documents, in whole or in part, are normatively referenced in this document and
114 are indispensable for its application. For dated references, only the edition cited applies. For
115 undated references, the latest edition of the referenced document (including any
116 amendments) applies.
117 ANSI/CTA-2065 Physical Activity Monitoring for Heart Rate
118 3  Terms and definitions
119 For the purposes of this document, the following terms and definitions apply.
120 ISO and IEC maintain terminological databases for use in standardization at the following
121 addresses:
122 • IEC Electropedia: available at http://www.electropedia.org/
123 • ISO Online browsing platform: available at http://www.iso.org/obp
124
125 3.1 heart rate
126 HR
127 the speed of the heartbeat measured by the number of contractions of the heart per unit time
128 (typically per minute), or frequency of contractions of the ventricles
129 3.2 body mass index
130 BMI
131 person’s weight in kilograms (kg) divided by his or her height in meters squared
132 3.3 heart rate monitoring device
133 HRMD
134 device that captures pulsation signals and calculates the pulse rate at regular intervals
135 3.4 plethysmograph
136 device to produce an plethysmogram
137 3.5 photoplethysmogram
138 PPG
139 graphic record of the variation with time of optically measured volume of blood circulation at
140 the skin’s surface

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141 4  Test methods and procedures
142 4.1 General
143 A wearable device with heart rate monitoring based on photoplethysmogram (PPG) is tested
144 with a PPG simulator at various frequencies. The PPG wearable device is used for
145 comparative test with a chest type electrocardiogram (ECG) device. A participant wearing
146 both a PPG wearable device and a chest type ECG wearable device performs various
147 physical activities including walking, jogging, and running as well as no physical activity
148 (being sedentary).
149 4.2 Other considerations
150 Even though this standard is limited in scope, manufacturers should consider factors that
151 could impact testing.
152 • Test conditions: variable ambient light (e.g., direct, indirect, and sun/shadow
153 transitions), wide ranging temperatures (cold and warm), wide range of ambient noises,
154 incorporation of clothing that may have the potential to interfere with devices (e.g.,
155 tightness, thickness, or that which restricts ideal wearing of device), body or wrist
156 positions during certain protocols (e.g., for cycling applications: bent wrist or straight
157 arms), position of device on the body electrical interference from outside sources,
158 potential for signal loss between the measurement device and data repository (e.g.,
159 mobile app or other).
160 4.3 Setup and configuration
161 4.3.1 PPG simulator test
162 • A PPG simulator is prepared as shown in Figure 1. A light emitting diode is connected
163 with a current limiting resistor in series and powered with a function generator. The
164 wavelength (or color) of the LED shall match that of the PPG device under test. The
165 value of the current limiting resistor is determined considering the LED forward voltage
166 and current found in the LED data sheet. A PPG wearable device manufacturer may
167 use a commercially available simulator.
168 • A PPG wearable device is placed over a PPG simulator that is located in a chamber or
169 room wherein humidity, temperature, and light intensity is measured and recorded.
170 • By using the function generator, the frequency is configured to 0,5 Hz, 1,0 Hz, 1,5 Hz,
171 2,0 Hz, 2,5 Hz, 3,0 Hz, and 3.5 Hz, sequentially. At each frequency, a sinusoidal wave
172 between 0 and 5 V is supplied to the PPG simulator circuit to blink the LED.
173 • At 5~10 seconds after the PPG simulator starts to operate at a frequency and the PPG
174 function of the device is on, the heart rate readout on the PPG device is recorded for 1
175 minute.
176 • The accuracy of the PPG device is analysed by comparing the measured heart rate
177 and the frequency setting in the simulator.

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178
179 Key
180 1. PPG wearable device;
181 2. Jig for the PPG simulator;
182 3. Light emitting diode;
183 4. Current limiting resistor (100 ~ 500 ohm);
184 5. Function generator (sine wave with 5 Vp-p and 2,5 Voffset);
185 Figure 1 – A PPG simulator circuit and setup
186 4.3.2 Comparative test with a reference ECG device
187 • A participant wears both a PPG wearable device and a chest type ECG wearable
188 device as shown in Figure 2 and following the manufacturer’s instruction manual. The
189 chest type ECG wearable device used as a control device shall have a certified,
190 approved or verified accuracy as base reference device for comparison.
191 • For physical activities, humidity, temperature, and light intensity is measured and
192 recorded.
193 • The participant performs a described physical activity for a given duration as noted in
194 the comparative test protocols below.
195 • While performing the physical activity, heart rates displayed in the PPG device under
196 test and the reference ECG device are simultaneously recorded.
197 • The accuracy in the heart rate measurement of the PPG device is analysed by
198 comparing measured heart rates from the PPG device under test and the reference
199 ECG device.

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200
201 Key
202 1. Reference ECG wearable device (a chest belt type shown in this examp
...