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:
Computer tomography equipment;
Attachments expected to enter the patients' bodies;
Mammography X-ray equipment;
Dental X-ray equipment.