What is this standard about?
BS EN 60601-2-54 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. This latest update to Part 2-54 outlines the most recent guidelines specific to the safe operation of radiography and radioscopy X-ray equipment. It complements BS EN 60601-1.
Who is this standard for?
- Manufacturers, suppliers and operators of radiography and radioscopy equipment
- All healthcare facilities/hospitals
- Health and safety professionals
- Healthcare regulatory bodies
Why should you use this standard?
It applies to the basic safety and essential performance of equipment to be used for projection radiography and radioscopy. This edition of BS EN 60601-2-54 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.
The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in operation of radiography and radioscopy equipment. Requirements for additional provisions are covered by BS EN 60601-2-43.
What’s changed since the last update?
- BS EN 60601-2-54 has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice
- Additions to specifications for cooling conditions, beam limiting devices and high voltage cable connections
- Amendments to specifications for X-ray source assembly and radiation management
- Accompanying documentation must contain quality control procedures to be systematically performed on X-ray equipment