Despite being a relatively “young” market, wearable devices – smartwatches, Google Glass, Bluetooth hands-free ear pieces, and health monitoring devices – are rapidly growing in popularity. With each device possessing its own distinct functionalities, these gadgets call for a special set of standards and compliance.
Manufacturers of wearable devices are encouraged to familiarize themselves with the regulations that operate within the market to ensure that they uphold user safety and maximize value.
Depending on the device and market, there are often fundamental compliance standards that manufacturers should be aware of. Because a “wearable device” implies contact with the skin or eye, manufacturers should be prepared to test for any material or chemical that could cause irritation or harm – and take safety concerns such as possible battery malfunction into consideration. Baseline standards including acoustic sound pressure or RF absorption rate should also be taken into consideration, depending on the category.
Although wearable devices are a new class of device, in many cases they fall under the same guidelines as other products. However, there are some exceptions.
Commonly referenced test standards include:
- Biometric: EN 62471:2006 (LEDs and eye/skin contact), EN 62209-1/-2 SAR (Specific Absorption Rate), and ISO 10993-1 (Biocompatibility).
- Electrical Safety: IEC/EN/UL 60601 (Medical devices), IEC/EN/UL 60950 (ITE equipment), EN 60065 (Audio-Video equipment), and EN 62368 (Combined standard – ITE + Audio/Video).
- EMC/RF: FCC part 15.247 (RF emissions), EN 300 328, EN 55022 (RF emissions), and EN 301 489-1 (Emissions and immunity).
Some wearable devices – such as those in the medical sector – require their own rules to be written. As an example – in 2014, the IEEE Standards Association announced a new set of guidelines that adhered specifically to wearable cuffless blood pressure measuring devices.
According to the IEEE’s Yuanting Zhang, the guidelines came about because previous standards applied specifically to cuffed blood pressure monitors that offered “snapshot measurements of blood pressure.”
“There is a clear need for a new standard for evaluating the performance of the emergent wearable, cuffless devices that could provide “continuous” estimation of arterial blood pressure and for calibrating the devices with standardized reference and defined procedures,” Zhang said.
However it is important to note that, the need for new standards isn’t limited to the medical field. As many wearable device types are new to the market, they will call for new guidelines to govern their manufacture and distribution.
The need for standardization goes beyond the manufacturer, with consumers increasingly favoring products that display recognizable certification measures.