CN China
  • 11 - Medizintechnik
  • 90 - Optische, fotografische oder kinematografische Instrumente, Apparate und Geräte; Mess-, Prüf- oder Präzisionsinstrumente, -apparate und -geräte; medizinische und chirurgische Instrumente, Apparate und Geräte; Teile und Zubehör für diese

X-ray equipment for interventional procedures; (HS: 9022); (ICS: 11.040.50)

National Standard of the P.R.C., Medical Electrical Equipment — Part 2-43: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Interventional Procedures (41 page(s), in Chinese)

This part applies to the basic safety and essential performance of X-ray equipment that are declared by the manufacturer to be suitable for radioscopically guided interventional procedures. This scope does not include, in particular:

  • Radiotherapy equipment;

  • Computer tomography equipment;

  • Attachments expected to enter the patients' bodies;

  • Mammography X-ray equipment;

  • Dental X-ray equipment.