Medical Devices Product Safety Standards

Last Updated: May 3rd, 2022 First Published :


Medical Devices

Medical devices are crucial to applying various medical techniques; therefore, special attention needs to be paid to their design and manufacturing process. The standards are specified for the safety and performance evaluation of medical devices. Adequate measures are taken to ensure the safe handling and efficient usage of a wide range of medical equipment. The periodic check of the medical equipment proves fruitful in the timely amendments and industrial innovations while administering public health.


IEC 60601 is a widely accepted series of international standards for the Basic Safety and Essential Performance of Medical Electrical devices. Medical devices are evaluated as per IEC 60601, a widely accepted series of international standards.

Risk perception and control are the essential areas to be focused on for the safety and performance enhancement of medical equipment. Experience guides are issued to bring improvements in the usage of medical devices. Quality Management systems are devised to address innovation. Documentation and record-keeping are initiated to ensure a proper check on the reliability of various medical devices.


Efficient studies, globally accepted standards, and practical techniques are applied to evaluate the performance and quality of medical equipment. Medical device products must be tested following the internationally accepted standards for the basic safety and efficient performance.

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