The Safety Standard That Protects Your Users
On the Skin. Under Our Microscope.
When your product operates on someone’s ear, chest, or skin surface—often for hours on end—safety is non-negotiable. Any wearable device with a battery, sensor, or wireless connection falls under IEC 62368-1, the global standard for IT and AV equipment safety. It’s more than a random piece of regulation. This certification insulates consumers from heat, shock, electrical hazards, and more.
Replacing the IEC 60950-1 certification, the IEC 62368-1 is more risk assessment than rulebook. This means we look at what could actually go wrong with your specific device and design tests around those real-world risks.
The Wild West of Wearable Safety Certification
Wearables present a unique set of safety mazes that desktop computers never face. Your device sits directly on someone's skin, often for 12-16 hours a day. It has to handle sweat, movement, and temperature changes while maintaining electrical safety.
That’s why we put your wearables through a workout of our own design, with key safety concerns in mind:
Skin Contact Safety
Are Your Safety Standards Skin Deep? Sometimes it’s good to feel the burn. But not where your wearables are concerned. We ensure your device can't get hot enough to cause discomfort. A good rule of thumb is keeping maximum temperatures cooler than that of a laptop, even in extreme conditions.
Battery Safety
Full Charge. Low Risk: Wearable batteries are small but mighty. We verify they won't overheat, leak, or cause fires, especially if the device is wet, dropped, or wirelessly charged.
Electrical Safety
Keep it Current: Even though wearables use low voltages, we still test for electrical shock protection. This is especially important for devices with exposed charging contacts or metal components.
Durability
Worn. Not Worn Out.: Wearables are bound to suffer everyday abuse. They get dropped, bumped, and exposed to moisture. We test that safety systems still work after the device experiences real-world wear and tear.
Acing the Testing Process
Typical timeline? 6-8 weeks. Here’s what to expect:
1) Design Review
We flag potential risks in your battery, charger, enclosure, and more—before you hit the lab.
2) Lab Testing
We run heat, shock, and stress tests under real and fault conditions. We even review your user manual. Yes, that counts toward safety.
3) Problems? We Have Solutions
If something fails, we don’t hand you a red X and walk away. We work with your team to find safe, practical, and cost-effective fixes
Rule Out the Repeat Offenders
Most wearable manufacturers run into a few predictable issues:
Charging System Problems: Wireless and magnetic charging are fantastic for convenience. But poor isolation or overheating can create big risks. We see this one a lot.
Thermal Management: Processors, displays, and wireless radios all generate heat in a small space. The trick is managing this heat without compromising comfort
Water Resistance vs. Electrical Safety: Making a device waterproof while maintaining electrical safety requires careful design. We help manufacturers strike the right balance
Documentation: The IEC 62368-1 standard requires specific documentation and risk assessments. Many manufacturers underestimate this requirement.
If it Plugs In. If it Powers Up. We Certify It’s Safe to Wear.
Any wearable device with electrical components needs IEC 62368-1 certification if it's going to be sold commercially. This includes:
- Fitness trackers with heart rate monitoring
- Smartwatches with cellular connectivity
- Health monitoring devices (blood pressure, glucose monitors)
- Smart jewelry with notification features
- Hearing aids with Bluetooth connectivity
- Sleep tracking devices
- Posture monitoring wearables
Even simple devices like basic fitness trackers need certification because they charge via USB and store personal data.
Product Safety Consulting: Smart. Safe. Certified.
We know wearables. We've been certifying wearable devices since the category emerged. Our engineers understand both the technical requirements and the practical challenges of bringing wearables to market.
Do you need fast results before a launch? We’ll get you preliminary insights quickly. Bottom line: we catch defects before they become money pits or major delays.
Our reports are accepted by regulatory bodies worldwide, so you can use our certification for multiple markets without additional testing.
Ready to Get Started?
Contact Product Safety Consulting at 877-804-3066 to discuss your wearable device certification needs. We can be on-site in 48 hours and provide a comprehensive testing plan that addresses all applicable standards and regulatory requirements. Put our 36 years of experience to work today.