| 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 Electronic brachytherapy device operators |
(h)(1)(C) (h)(i)(E)(iii) |
Until 2 years after the individuals leave the facility 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) Electronic brachytherapy device |
(h)(3)(C)(iii)(VII) (k)(2)(C)(v) |
5 years after the spot checks 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 |