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IEC 60601-2-54 X-Ray Equipment for Radiography and Radioscopy Testing

Medical electrical equipment – Part 2-54: the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-54 Scope:

IEC 60601 2 54 and EN 60601 2 54 testing applies to the basic safety and essential performance of medical electronic equipment and medical equipment systems intended to be used for projection radiography and radioscopy. IEC 60601-2-43 applies to medical electronic equipment and medical equipment systems intended to be used for interventional applications and refers to applicable requirements in IEC 60601-2-54 testing.

Medical electronic equipment and medical equipment systems intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental applications are excluded from the scope of EN 60601-2-54. The scope of EN 60601-2-54 tests also exclude radiotherapy simulators.

NOTE Taking into account economic and social factors, the scope of this particular standard includes medical electronic equipment intended to be used for direct radioscopy. In some countries examinations performed with direct radioscopy are prohibited.

Keystone Compliance assists manufacturers with IEC 60601-2-54 and EN 60601-2-54 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-54 test lab needs.