MRI systems shall be:
- (a) Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C-Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;
- (b) Registered in accordance with He-P 4040; and
- (c) Maintained and operated in accordance with the manufacturer’s specifications.
Source. #10893, eff 7-21-15