Per RHB 1.6.3, prior to the sale and operation of x-ray producing equipment not specifically covered in the regulations, the seller shall submit the following information to the Department for review and approval:
a) Manufacturer’s specifications for the equipment
b) An analysis of exposure rates for the equipment
c) Independent radiation safety studies of the equipment
d) Training materials in the use of the equipment
e) Verification of compliance with the U.S. Food and Drug Administration, if applicable
f) Written procedures for the use of equipment
g) User’s manual of the equipment
h) A completed application using the current version of the forms provided by the Department
Facilities who install, purchase, and/or utilize equipment that was approved according to RHB 1.6.3 shall adhere to the guidelines of use document issued by the Department at the time of the unit’s approval.
Additional information may be requested as deemed necessary. Please send this information to XrayEquipmentReview@dhec.sc.gov.
The South Carolina Technical Advisory Radiation Control Council members may review the submitted information. Any company that will sell, install, and/or provide maintenance for x-ray systems must complete the vendor registration process and be issued a vendor registration approval prior to providing services. Equipment reviews are done in order of receipt and may be extensive.
If you have any questions, contact the Department at 803-545-4400.