What are the regulatory standards for medical temperature sensors?

What are the regulatory standards for medical temperature sensors?

Medical temperature sensors must comply with standards set by organizations like the FDA and ISO. These ensure accuracy and safety.

Can you tell me more about the FDA regulations?

The FDA requires that medical devices, including temperature sensors, undergo rigorous testing for safety and effectiveness before approval.

What ISO standards apply to these sensors?

ISO 13485 is a key standard for quality management systems in medical devices, while ISO 80601-2-61 specifically addresses temperature measuring devices.

Are there any specific testing requirements?

Yes, testing requirements include performance testing, calibration, and ensuring compliance with electromagnetic compatibility standards.

How often do these sensors need to be calibrated?

Calibration frequency depends on the manufacturer's guidelines, but it's generally recommended to calibrate at least once a year or after significant use.