Name of Record | Rule Cross-Reference | Time Interval Required for Record Keeping |
---|---|---|
Accelerators used for research and development and Industrial Operations | ||
(A) Initial surveys | (f)(2)(C)(iii) | Until termination of registration |
(B) Tests and repairs | (f)(3)(A)(x) | 5 years |
(C) Calibration, surveys | (f)(3)(F) | 5 years |
(D) Contamination smear for units operating greater than 10 MeV |
(f)(3)(G) | Until termination of registration |
(E) Receipt, transfers, and disposal | (f) (3)(H) | Until termination of registration |
(F) Training for operators | (f)(4)(B) | Until 2 years after the individual terminates employment |
Therapeutic radiation machines, simulators, and electronic brachytherapy devices | ||
(G) Credentials of operators | (h)(1)(C) | Until 2 years after the individuals leave the facility |
Electronic brachytherapy device operators |
(h)(i)(E)(iii) | Until 2 years after the individuals leave the facility |
(H) Review of quality assurance program |
(h)(1)(F)(vii) | 5 years |
(I) FDA Variances | (h)(1)(H) | Until transfer of machine or termination of registration |
(J) Initial Surveys | ||
Therapy (below 1 MeV) | (h)(2)(D)(i)(II) | Until termination of registration |
Therapy (1 MeV) and above | (h)(3)(C)(i)(III) | Until termination of registration |
Electronic brachytherapy device | (k)(2)(A)(ii) | Until termination of registration |
(K) Calibration | ||
Therapy (below 1 MeV) | (h)(2)(D)(i)(II) | 5 years |
Therapy (1 MeV and above) | (h)(3)(C)(ii)(VI) | 5 years |
Electronic brachytherapy device | (k)(2)(B)(vi) | 5 years |
(L) Contamination Smears for units operating greater than 10 MeV |
(h)(1)(I) | Until termination of registration |
(M) Spot checks and corrective actions | ||
Therapy (below 1 MeV) | (h)(2)(D)(iii)(VI) | 5 years after the spot checks |
Therapy (1 MeV and above) | (h)(3)(C)(iii)(VII) | 5 years after the spot checks |
Electronic brachytherapy device | (k)(2)(C)(v) | 5 years after the spot checks |
(N) Leakage measurements | ||
Therapy (1 MeV and above) | (h)(3)(A)(i) | 5 years |
(O) Protective devices for simulators |
(h)(4)(A)(iii)(II) | 3 years |
(P) Film processing records for simulators |
(h)(4)(A)((viii)(VI) and (ix) |
3 years |
(Q) Digital imaging acquisition systems |
(h)(4)(A)(x) | 3 years |
(R) CT dose measurements | (h)(4)(D)(iii)(III) | 5 years |
(S) CT films resulting from quality control tests |
(h)(4)(D)(iv)(II) | 1 year or until a new phantom image is performed |
(T) Record of device-specific training for electronic brachytherapy-devices |
(h)(1)(E)(iii) | Until 2 years after the individual leaves the facility |