What is BS EN 60601‑2‑65 about?
The 60601 series on medical electrical equipment covers electrical X-ray machines. BS EN 60601‑2‑65 is about dental intra-oral X-ray equipment. BS EN 60601‑2‑65 discusses safety and performance requirements for dental intra-oral radiography equipment. BS EN 60601‑2‑65 covers X-ray equipment that has electrical applied parts.
BS EN 60601‑2‑65 is restricted to X-ray equipment where the X-ray tube assembly contains high-voltage transformer assembly.
The minimum safety requirements specified in BS EN 60601‑2‑65 are considered to provide for a practical degree of safety in the operation of dental intra-oral x-ray equipment.
Note 1: Dental extra-oral X-ray equipment is excluded from the scope of this standard.
Note 2: Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard, since they have no electrical applied parts in the patient environment and are not medical electrical equipment.
Who is BS EN 60601‑2‑65 for?
BS EN 60601‑2‑65 on medical electrical equipment (intra-oral X-ray equipment) is useful for:
- Manufacturers and suppliers of dental X-ray equipment
- Manufacturers and suppliers of medical electrical equipment and systems
- Technical staff in hospitals
- Dentists
Why should you use BS EN 60601‑2‑65?
User-safety is a priority when radiation exposure is involved. BS EN 60601‑2‑65 gives information on protection against unwanted and excessive radiation and temperature hazards for intra-oral X-ray equipment. BS EN 60601‑2‑65 elaborates on protection against electrical and mechanical hazards for intra-oral X-ray equipment. BS EN 60601‑2‑65 gives you information about the electromagnetic compatibility of medical electrical equipment and systems. BS EN 60601‑2‑65 outlines general requirements for testing medical electrical equipment – namely, intra-oral X-ray equipment
