AS 60601.2.54:2018 PDF
The objective of this Standard is to specify particular basic safety and essential performance requirements for medical electrical (ME) equipment and ME systems for radiography and radioscopy. The minimum safety requirements specified in this Standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy.
This particular standard has been prepared to provide, based on IEC 60601-1:2005 (third edition) and its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of X-RAY EQUIPMENT, which consists of a combination of an X-RAY GENERATOR, ASSOCIATED EQUIPMENT and ACCESSORIES. Component functions are addressed as far as necessary.
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