When a robot interacts with humans—especially vulnerable populations like the elderly, disabled, or injured—safety isn't negotiable. A single malfunction could lead to falls, injuries, or worse. So how do you verify that a robot is trustworthy?
Look for Certifications (and Understand What They Mean)
Regulatory bodies like the FDA (U.S.), CE (EU), or ISO set standards for medical and assistive devices. For example:
-
FDA clearance:
If a robot is marketed for medical use (like
robotic gait training
or
lower limb exoskeletons
for rehabilitation), it should have FDA clearance under the "medical device" category. This means the manufacturer has provided evidence that it's safe and effective for its intended use.
-
ISO 13485:
This certification ensures the manufacturer follows quality management systems for medical devices—reducing the risk of faulty production.
-
CE marking:
Required for devices sold in the EU, indicating compliance with health, safety, and environmental protection standards.
But beware of "FDA registered" vs. "FDA cleared." Registration means the manufacturer has listed the device with the FDA—it doesn't mean the FDA has evaluated its safety or effectiveness. Always ask for proof of clearance, not just registration.
Safety Features: Plan for the "What Ifs"
Even certified robots need built-in safeguards. Ask about:
-
Emergency stop buttons:
Can the user or caregiver shut down the robot instantly if something goes wrong? For
lower limb exoskeletons
, this is critical—imagine the robot suddenly lurching forward during a walk.
-
Obstacle detection:
Does the robot sense objects in its path and stop? An
incontinence care robot
moving around a bedroom should avoid tripping over a rug or hitting furniture.
-
Overload protection:
Will it shut down if it's strained beyond its limits (e.g., a
lower limb exoskeleton
lifting more weight than it's designed for)?
-
Hygiene standards:
For robots like
incontinence care robots
, materials should be easy to disinfect, and there should be no hidden crevices where bacteria can grow.
Red Flag:
If a manufacturer hesitates to share certification documents or downplays the importance of safety features, walk away. Your peace of mind isn't worth cutting corners.