IS/IEC 62368-1:2023 for Wearables: Smartwatches, Fitness Bands, and Health Monitors

Wearable devices — smartwatches, fitness bands, health monitors, and hearables — require BIS CRS registration under IS/IEC 62368-1:2023. This is a high-growth category with specific safety requirements due to body contact and small battery designs.

Products Covered

• Smartwatches with health monitoring (heart rate, SpO2, ECG)
• Fitness bands and activity trackers
• True wireless stereo (TWS) earbuds and their charging cases
• Wireless headphones (over-ear and on-ear)
• Smart glasses and AR glasses
• GPS trackers (personal and pet)

Body Contact Safety — ES1 Requirements

Wearables are worn directly on skin. IS/IEC 62368-1:2023 requires that any accessible surface in contact with skin during normal use must present only ES1 (electrically safe, below pain threshold) energy levels. This means:

• Touch current at the wrist band contact area must be below ES1 limits
• Surface temperature at skin contact must not cause burns even during extended wear
• Charging pins on smartwatches must be ES1 during charging

Small Battery Safety

Wearables use very small lithium batteries — typically 50-300mAh for fitness bands, 200-500mAh for smartwatches. Despite the small size, battery safety evaluation is thorough:

• Cell certification documentation
• BMS (battery management system) overcharge and over-discharge protection
• Thermal management within the tight form factor
• Charging circuit safety

TWS Earbuds — Charging Case Evaluation

TWS earbuds come with a charging case that houses a larger battery (typically 300-600mAh) and charges the earbuds wirelessly or via pins. The system must be evaluated as a whole — the charging case with earbuds docked is the complete product for safety evaluation purposes. The charging case USB-C port safety and battery management are critical evaluation areas.

Acoustic Safety for Earbuds and Headphones

IS/IEC 62368-1:2023 includes acoustic safety requirements — maximum sound pressure levels that audio devices can produce. Earbuds and headphones must demonstrate they cannot produce sound levels that cause hearing damage under normal and abnormal operating conditions.

WPC Type Approval

Wearables with Bluetooth require WPC type approval alongside BIS CRS. Initiate both simultaneously. House of Testing handles IS 62368 wearable testing.