IEC EN 60601-2-64 Medical Electrical Equipment - Light Ion Beam Special Requirements for Basic Safety of Medical Electrical Equipment

Medical Device Tests

IEC EN 60601-2-64 Medical Electrical Equipment - Light Ion Beam Special Requirements for Basic Safety of Medical Electrical Equipment

EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 60601-2-64 testing. IEC EN 60601-2-64 applies to the essential safety and essential performance of Ion Beam Medical Electrical equipment used for the treatment of patients, hereinafter referred to as ME equipment.

IEC EN 60601-2-64 Medical Electrical Equipment - Light Ion Beam Special Requirements for Basic Safety of Medical Electrical Equipment

This particular standard applies to the manufacture and certain aspects of installation, respectively, of ME equipment for radiotherapy purposes in human medical applications, including equipment where the selection and display of operating parameters can be automatically controlled, including type tests and field tests.

Use of the light ion device for radiotherapy purposes may endanger patients if the ME equipment fails to deliver the required dose or if the design of the ME equipment does not meet electrical and mechanical safety standards. If the ME equipment itself cannot adequately control RADIATION or if there are deficiencies in the treatment room design, ME equipment can also pose a hazard to the surrounding people.

This particular standard specifies requirements that must be followed by manufacturers in the design and construction of ion beam equipment for use in radiotherapy; does not attempt to define optimum performance requirements. Its purpose is to determine the currently accepted design features as necessary for the safe operation of such ME equipment; ME sets limits on equipment performance degradation, beyond which a fault condition can be assumed and then a lockout is activated to prevent ME equipment from continuing to operate.

EUROLAB assists manufacturers with IEC EN 60601-2-64 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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