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Keystone Compliance, a leading authority in regulatory compliance testing, plays a crucial role in ensuring that medical device manufacturers adhere to rigorous industry standards. Medical equipment must undergo a series of tests to ensure proper functionality and compatibility with both medical and non-medical devices.

In the United States, adherence to Food and Drug Administration (FDA) standards is mandatory, while in Europe, compliance with the Medical Devices Directive and IEC 60601-1-2 is required to assess electromagnetic compatibility.

A medical device is any instrument, apparatus, appliance, material, or another article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease;
• Diagnosis, monitoring, treatment, alleviation of or compensation for any injury or handicap;
• Investigation, replacement or modification of the anatomy or of a physiological process;
• Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Key tests under IEC 60601-1-2 for EMC include Electro-static Discharge, Radiated and Conducted Immunity, Electrical Fast Transient, Lightning and Surge, Harmonics and Flicker and Power Frequency Magnetic Fields (voltage dips, interruptions, and variations) for device reliability. Additionally, environmental tests like 

Keystone ensures that products undergo comprehensive safety testing as per a range of standards such as EN 60601-1-2 for EMC testing, IEC 60601-1-3 for diagnostic X-ray equipment, IEC 60601-1-6 for usability, IEC 60601-1-8 for alarm systems, IEC 60601-1-9 for environmental testing, IEC 60601-1-10 for physiologic closed-loop controllers, IEC 60601-1-11 for home healthcare environments, IEC 60601-1-12 for emergency medical services, IEC 60601-2-10 for nerve and muscle stimulators, IEC 60601-2-18 for endoscopic equipment, IEC 60601-2-25 for electrocardiographs, IEC 60601-2-27 for electrocardiographic monitoring, IEC 60601-2-46 for operating tables, IEC 60601-2-47 for ambulatory electrocardiographic systems, and IEC 60601-2-60 for dental equipment. This rigorous testing regimen ensures that all medical devices meet stringent safety and performance standards essential for their reliable and effective use in healthcare settings.

Understanding the complexity, Keystone Compliance specializes in guiding manufacturers through compliance processes, offering expertise in EMC, environmental, and package testing to meet distribution requirements.

Click here to learn more about Keystone's IEC EMC Testing Standards.