BS EN IEC 63203-402-3:2024
Wearable electronic devices and technologies - Performance measurement of fitness wearables. Test methods for the determination of the accuracy of heart rate

Standard No.

BS EN IEC 63203-402-3:2024

Release Date

2024

Published By

British Standards Institution (BSI)  GB  /  BSI

Latest

BS EN IEC 63203-402-3:2024

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Introduction

Interpretation of the core content of the standard

This standard establishes a complete verification system from laboratory simulation to actual human measurement for wearable heart rate monitoring devices that use photoplethysmography (PPG) sensors:

Test type	Test conditions	Accuracy requirements	Key indicators
PPG simulator test	0.5-3.5Hz sinusoidal wave input	MAPE≤±10%	LED wavelength matching
ECG comparison test	6 sports scenarios including resting/walking/running	MAPE≤±10%	Skin tone coverage

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Technical points of the test method

1. Laboratory simulation verification

A PPG signal generator is used to build a standardized test environment (as shown in Figure 1), with the following requirements:

• The LED wavelength must match the light source of the device under test
• The value of the current limiting resistor must refer to the LED specification sheet
• The temperature, humidity and light intensity of the test environment must be recorded

2. Human body measurement specifications

The comparative test uses a chest strap ECG device as a reference benchmark. The key requirements include:

• Participants need to complete the PAR-Q health questionnaire screening
• Skin tone distribution must comply with Fitzpatrick scale 1-3 and 4-6 ≥ 25% each
• BMI distribution must include <20kg/m²(≥10%) and >25kg/m²(≥25%) people

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Standard implementation recommendations

Test environment control

It is recommended to establish the following environmental parameter recording mechanism:

• Indoor light intensity is maintained at 500-1000lx
• Direct sunlight/shade status must be marked during outdoor testing
• Temperature fluctuation range is controlled within ±2℃

Equipment wearing specifications

According to clause 4.4.7 of the standard:

• Tattoos or skin coloring are prohibited at the sensor contact area
• Natural arm swing posture must be maintained during exercise testing
• The tightness of the device is strictly adjusted according to the manufacturer's instructions

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Analysis of standard evolution

Compared with the traditional medical device standard IEC 60601 series, the innovation of this standard is:

1. For the first time, a multi-dimensional human variable test system
for consumer-grade PPG devices is established
2. The Fitzpatrick skin scale is introduced to solve the problem of skin color adaptability of optical sensors
3. The comparability of test results is ensured through a 7-minute standardized exercise protocol

Note when implementing: When the national standard for testing distinguishes between heart rate (HR) and pulse rate (PR), the definition of the term should be clearly stated in the report.

BS EN IEC 63203-402-3:2024 history

• 2024 BS EN IEC 63203-402-3:2024 Wearable electronic devices and technologies - Performance measurement of fitness wearables. Test methods for the determination of the accuracy of heart rate

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