Medical Electrical Devices

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Medical electrical devices include a wide range of products, such as ultrasonic physiotherapy Equipment, operating tables, blood pressure monitors, and x-ray equipment. They differ from medicines as they generally have a physical or mechanical effect on the body or are used to measure (or monitor) the body and its functions. Lives and health depend on the safe and accurate functioning of such instruments, and your company is dedicated to providing doctors, hospitals and paramedics with life-saving tools of the highest standard.

Compliance Engineering has introduced the test facility to conduct key safety tests on medical devices where recommended tests as per national and international standards have been defined.

 

No. Product Category Standards
1 Medical electrical equipment -General AS/NZS IEC EN 60601.1
2 Medical electrical equipment for use in home care IEC EN 60601-1-11
3 Medical electrical equipment and medical electrical system used in the emergency medical services environment IEC EN 60601-1-12

Our safety test lab is accredited by A2LA. Our test scope covers a wide range of products. Equipped with modern test instruments, we conduct testing and inspections for product safety according to Australian and international standards. Our experts check the products for every technical detail, including the PCB design, rating label, instruction manual and components. We are here to make sure your products are safe to enter the Australian and international markets.