IEC 60601-1 Testing Chambers

The safety compliance laboratory for medical products has obtained IAS ISO 17025 accreditation and FDA ASCA recognition from the U.S. government. This enhances confidence in medical device testing and promotes consistency and predictability in the pre-market review process. It encourages the efficient use of FDA resources, supports international harmonization, and improves the efficiency of FDA reviews. This ensures approved products are safe and effective while avoiding unnecessary delays. Consequently, it helps clients smoothly complete company registration, product registration, and FDA Pre-market Notification 510(k) review processes.

Accredited Laboratory Inquiry Link:

https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/asca-accredited-testing-laboratories

Currently Authorized Medical Products and Common Standards (Partial List):

- IEC 60601-1-11: Home medical products, such as blood pressure monitors, forehead thermometers, air pumps, and massage health devices.

- IEC 60601-1-6: Usability evaluation for all medical products.

- IEC 60601-2-25: Electrocardiographs, used to produce ECG reports for diagnostic purposes.

- IEC 60601-2-27: ECG monitoring devices, used to monitor and record a patient’s cardiac electrical activity and display the data.

- IEC 60601-2-47: Dynamic electrocardiographic devices, capable of continuous recording and analysis of ECGs.

- IEC 60601-2-30: Non-invasive blood pressure monitors.

- ISO 60601-2-56: Temperature measurement devices, including forehead thermometers.

- ISO 60601-2-61: Pulse oximeters.