What is BS EN 60601‑2‑63 about?
Another aspect of medical electrical equipment that is covered in our 60601 series, is extra-oral X-ray equipment. BS EN 60601‑2‑63 gives you guidelines to ensure that your dental extra-oral X-ray equipment is safe to use. BS EN 60601‑2‑63 applies to the safety and performance of dental extra-oral x-ray equipment.
BS EN 60601‑2‑63 is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. BS EN 60601‑2‑63 is for X-ray equipment where the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor; are pre-set in the design. These cannot be arbitrarily altered by the operator during intended use.
Note: Requirements particular to dental x-ray-equipment which were included in previous editions of the collateral standard IEC 60601-1-3, or the IEC 60601-2-28 have been extracted and moved into BS EN 60601‑2‑63. For X-ray equipment in the scope of this BS EN 60601‑2‑63 X-ray tube assemblies are X-rayed Monoblock assemblies.
Who is BS EN 60601‑2‑63 for?
BS EN 60601‑2‑63 on medical electrical equipment (extra-oral X-ray equipment) is useful for:
- Manufacturers and suppliers of medical electrical equipment
- Manufacturers and suppliers of electrical X-ray equipment
- Dentists
- Technical staff that operates X-ray equipment
Why should you use BS EN 60601‑2‑63?
High quality electrical equipment that has been thoroughly tested ensures patient and staff safety during X-ray procedures. BS EN 60601‑2‑63 provides you with a complete set of safety and essential performance requirements for dental extra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, BS EN 60601‑2‑63 addresses the system level of dental extra-oral X-ray equipment. Components and their functions are addressed as far as necessary.
Minimum safety requirements specified in this BS EN 60601‑2‑63 are considered to provide for a practical degree of safety in the operation of dental extra-oral X-ray equipment
