An inside look at the wearable device regulatory guidelines
They're not quite as popular as smartphones and tablets, but wearable devices are already abundant and only growing. Most of us are familiar with the latest line of smart watches from Apple, the innovative eyeglass lens from Google and the bevy of Bluetooth-connected, hands-free ear pieces. But other devices - particularly those used in health monitoring - make up a significant portion of the market. These gadgets, each with its own distinct functionality, call for a special set of standards and compliance.
Because the market is relatively young but still popular in the news, any bad press regarding product safety or malfunction could be hard to shake. Manufacturers of these products should make themselves familiar with any regulations surrounding their sector to preserve end user safety and maximize value. That level of insight requires a thorough investigation of the appropriate guidelines and supporting documents.
Depending on the market, there are often fundamental compliance standards to be on the lookout for. Because "wearable device" implies skin or eye contact, manufacturers should be prepared to test for any material or chemical that could cause irritation or harm - including whether or not the product runs too hot after excessive use. Additionally, when a device is in such close proximity to the user, any kind of electrical or battery malfunction can be severe. There is really no room for error or oversight when it comes to electrical safety.
Other baseline standards may include acoustic sound pressure or RF absorption rate, depending on the category. Wearables may be a new class of device, but in many cases, they fall under the same guidelines as other products. There are exceptions, though.
Commonly referenced test standards
EN 62471:2006 (LEDs and eye/skin contact)
EN 62209-1/-2 SAR (Specific Absorption Rate)
ISO 10993-1 (Biocompatibility)
IEC/EN/UL 60601 (Medical devices)
IEC/EN/UL 60950 (ITE equipment)
EN 60065 (Audio-Video equipment)
EN 62368 (Combined standard - ITE + Audio/Video)
FCC part 15.247 (RF emissions)
EN 300 328, EN 55022 (RF emissions)
EN 301 489-1 (Emissions & immunity)
A new class of requirement
Certain regulations are so specific that, while it might make sense to just extend them to wearable devices, it doesn't really work that way. In other words, some wearables - like those in the medical sector - need their own rules written for them.
For example, in 2014, the IEEE Standards Association announced a new set of guidelines that adhered specifically to "Wearable Cuffless Blood Pressure Measuring Devices. "That came about because previous standards applied specifically to cuffed blood pressure monitors that offered "snapshot measurements of blood pressure," according to the IEEE's Yuanting Zhang.
"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."
New standards aren't limited to just blood pressure monitors, nor the medical field in general. As new products as yet untested in the market, many of them will call for new guidelines - sometimes ones that haven't been created yet. As companies develop these wearables and invent new ones entirely new standards will arise that will govern their manufacture and distribution.
Even when a specific guideline is not in play, consumers have grown smarter about selecting products that are tested to the most rigorous standards. When product safety is on the line - meaning the safety of the consumer and his loved ones - customers will lean toward products that have been vetted as much as possible and display the best available certification measures.
For those interested in learning more about wearable technology regulatory compliance - like R&D professionals, product developers and managers, engineers, and prototyping professionals - consider attending Eptech Montreal on April 19, 2016. TÜV SÜD's Chris MacDonald will present at the conference and discuss everything related to wearable device compliance.
The above advice is a good start, but there is plenty more to consider - like accessory compliance, additional certification, product quality and impending regulation changes. If you want to be as prepared for wearable compliance as possible, these events present great opportunities to link up and ask questions in person.