ANSI AAMI IEC 60601-1-12 Medical Electrical Equipment, Part 1-12: Standard Test for Medical Electrical Equipment and Medical Electrical Systems

Medical Device Tests

ANSI AAMI IEC 60601-1-12 Medical Electrical Equipment, Part 1-12: Standard Test for Medical Electrical Equipment and Medical Electrical Systems

EUROLAB laboratory provides testing and compliance services within the scope of ANSI AAMI IEC 60601-1-12 test standard. It applies to the essential safety and essential performance of medical electrical equipment and medical electrical systems intended by their manufacturers for use in the EMS environment.

ANSI AAMI IEC 60601-1-12 Medical Electrical Equipment, Part 1-12: Standard Test for Medical Electrical Equipment and Medical Electrical Systems

It does not apply to equipment and systems intended for use only in the home healthcare environment or professional healthcare facilities.

In the emergency medical services environment, it is increasingly using medical electrical equipment and systems to monitor patients, treat and diagnose disease. These uncontrolled and complex environments often raise concerns about the safety of medical electrical equipment.

This standard has been developed with contributions from clinicians, engineers and regulators. The purpose of this assurance standard is to provide general requirements for medical devices and systems that are transported and used in an emergency environment and also used in space conditions different from the ambient conditions.

EUROLAB assists manufacturers with ANSI AAMI IEC 60601-1-12 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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