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Medical Product Laboratory

The BACL medical product safety laboratory has obtained IAS ISO17025 laboratory accreditation and the US government FDA ASCA accreditation, which can enhance confidence in medical device testing, promote the consistency and predictability of the pre-market review process; encourage effective use of FDA resources, and support international Coordinate, improve the efficiency of FDA review, avoid unnecessary delays while ensuring that approved products are effective and safe, so as to smoothly ensure that customers complete company registration, product registration, and pre-market announcement FDA Pre-market Notification 510 (K) application review Work.

 

BACL officially obtained the FDA ASCA accredited laboratory on September 13, 2021, becoming one of the 10 accredited laboratories in China!

 

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Accredited laboratory website link:

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

 

Currently authorized medical products and common standards are as follows:

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

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

• IEC 60601-2-25: Electrocardiograph, used to make ECG reports for diagnostic purposes.

• IEC 60601-2-27: ECG monitoring equipment, used to monitor and record the patient's cardiac action potential and display the result data.

• IEC 60601-2-47: Holter equipment, which can continuously record and continuously analyze ECG.

• IEC 60601-2-30: Non-invasive blood pressure monitor.

• ISO 60601-2-56: Body temperature measuring instrument, forehead thermometer.

• ISO 60601-2-61: Oximeter.

 

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