What is BS EN IEC 60601‑2‑28-X-ray tube assemblies for medical diagnosis about?
BS EN IEC 60601‑2‑28 is part 2-28 of the multi-series standard that discusses medical electrical equipment. BS EN IEC 60601‑2‑28 outlines the basic safety and essential performance of x-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging.
BS EN IEC 60601‑2‑28 provides basic safety guidance and essential performance requirements for x-ray tube assemblies for medical diagnosis.
Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME equipment is interpreted as x-ray tube assemblies in this standard. If a clause or subclause is specifically intended to apply to ME equipment only or Me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and ME systems, as relevant.
BS EN IEC 60601‑2‑28 is also applicable to the x-ray tube assembly aspects of x-ray source assemblies and x-ray tube heads.
Who is BS EN IEC 60601‑2‑28-X-ray tube assemblies for medical diagnosis for?
BS EN IEC 60601‑2‑28 on X-ray tube assemblies for medical diagnosis is useful for:
- X-ray tube ME, equipment manufacturers
- Medical laboratories for X-ray tube assemblies for medical diagnosis
- Test centres for X-ray ME equipment
- Regulatory authorities
Why should you use BS EN IEC 60601‑2‑28-X-ray tube assemblies for medical diagnosis?
X-ray tubes serve the function of creating x-ray photons from electric energy supplied by the x-ray generator. The process of creating the x-ray beam is very efficient, with only 1% of the electric energy converted to x-ray photons and the remaining 99% converted to heat in the x-ray tube assembly. The characteristics of an x-ray tube assembly shall be considered essential performance, depending on the x-ray system and high-voltage generator characteristics combined with the x-ray tube assembly.
BS EN IEC 60601‑2‑28 guides you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures, and other hazards for X-ray tube assemblies for medical diagnosis. This improves the performance and safety of X-ray tube assemblies for medical diagnosis and minimizes hazards to the patient and operator.
