ML19210D829

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Maine Regulations 144220in
ML19210D829
Person / Time
Issue date: 06/01/2022
From: Michelle Beardsley
NRC/NMSS/DMSST
To:
M BEARDSLEY MSST
Shared Package
ML19210D817 List:
References
Download: ML19210D829 (11)
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Text

10-144 CMR Ch. 220 i

TABLE OF CONTENTS PART A.

GENERAL PROVISIONS (May 20, 2019)

1. Scope......................................................................................................... A-1
2. Definitions................................................................................................. A-1
3. Exemptions.............................................................................................. A-22
4. Records.................................................................................................... A-22
5. Inspections............................................................................................... A-22
6. Tests......................................................................................................... A-22
7. Additional requirements.......................................................................... A-23
8. Violations................................................................................................. A-23
9. Impounding.............................................................................................. A-23
10. Prohibited uses......................................................................................... A-23
11. Interpretations.......................................................................................... A-23
12. Communications...................................................................................... A-23
13. The international system of units (SI)..................................................... A-23 PART B.

ENFORCEMENT ACTIONS, PROCEDURES AND CIVIL PENALTIES (May 20, 2019)

1. Purpose and scope..................................................................................... B-1
2. Severity of violations................................................................................. B-1
3. Enforcement conferences........................................................................... B-2
4. Enforcement actions.................................................................................. B-3
5. Notice of violation..................................................................................... B-3
6. Civil penalties............................................................................................ B-4
7. Adjustment factors..................................................................................... B-6
8. Orders........................................................................................................ B-8
9. Escalation of enforcement sanctions....................................................... B-10
10. Related administrative actions................................................................. B-12
11. Referrals to department of the attorney general....................................... B-12
12. Public disclosure of enforcement actions................................................ B-12 Appendix 1 severity categories................................................................ B-13 PART C.

LICENSING OF RADIOACTIVE MATERIAL (May 20, 2019)

1.

Purpose and scope..................................................................................... C-1

2. Source material.......................................................................................... C-1
3. Radioactive material other than source material........................................ C-4
4. Types of licenses....................................................................................... C-9
5. General licenses - source material............................................................. C-9
6. General licenses - radioactive material other than source material......... C-12
7. Filing application for specific licenses.................................................... C-25
8. General requirements for the issuance of specific licenses..................... C-29
9. Special requirements for the use of sealed sources in industrial radiography.............................................................................................. C-34
10. Special requirements for specific licenses of broad scope....................... C-34
11. Special requirements for a special license to manufacture, assemble repair or distribute commodities, products or devices which contain radioactive material................................................................................................. C-37
12. Special requirements for issuance of specific licenses for source material milling. Reserved....................................................................... C-67 10-144 CMR Ch. 220 ii
13. Issuance of specific licenses.................................................................... C-67
14. Specific terms and conditions of license.................................................. C-68
15. Expiration and termination of licenses.................................................... C-69
16. Renewal of licenses................................................................................. C-72
17. Amendment of licenses at request of licensee......................................... C-72
18. Agency action on application to renew and Amend................................ C-72
19. Persons possessing a license for source, radioactive or special nuclear material in quantities not sufficient to form a critical mass on effective date of this rule........................................................... C-73
20. Persons possessing naturally occurring and accelerator-produced radioactive material on effective date of this rule.................................... C-73
21. Transfer of material................................................................................. C-73
22. Modification, revocation and termination of licenses............................. C-74
23. Deliberate misconduct............................................................................. C-75
24. Reciprocal recognition of licenses........................................................... C-75
25. Records.................................................................................................... C-77 Schedule A Exempt concentrations of radioactive materials which are introduced into products................................... C-79 Schedule B Exempt quantities of individual radioactive materials...... C-83 Schedule C Limits for broad licenses................................................... C-85 Schedule D Quantities of radioactive material requiring consideration of the need for an emergency plan for responding to a release...................................................... C-87 Appendix A General provisions............................................................ C-89 Appendix B Naturally occurring or accelerator produced radioactive material (NARM)............................................................................ C-95 Appendix C Criteria relating to use of financial tests and parent company guarantees for providing reasonable assurance of funds for decommissioning.......................... C-96 Appendix D Criteria relating to use of financial tests and self guarantees for providing reasonable assurance of funds for decommissioning............................................... C-98 Appendix E Quantities for use with decommissioning....................... C-100 PART D. STANDARDS FOR PROTECTION AGAINST RADIATION (May 20, 2019) 1001. Purpose...................................................................................................... D-1 1002. Scope......................................................................................................... D-1 1003. Definitions (as used in Part D)................................................................... D-1 1004. Units of radiation dose............................................................................... D-1 1005. Units of radioactivity................................................................................. D-1 1008. Implementation.......................................................................................... D-1 1101. Radiation protection programs.................................................................. D-2 1201. Occupational dose limits for adults........................................................... D-2 1202. Compliance with requirements for summation of external and internal doses............................................................................................. D-3 1203. Determination of external dose from airborne radioactive material.......... D-4 1204. Determination of internal exposure........................................................... D-4 1206. Planned special exposures......................................................................... D-6 10-144 CMR Ch. 220 iii 1207. Occupational dose limits for minors.......................................................... D-7 1208. Dose equivalent to an embryo/fetus.......................................................... D-7 1301. Dose limits for individual members of the public..................................... D-7 1302. Compliance with dose limits for individual members of the public.......... D-8 1310. Testing for leakage or contamination of sealed sources............................ D-9 1401. General provisions and scope.................................................................. D-11 1402. Radiological criteria for unrestricted use................................................. D-12 1403. Criteria for license termination under restricted conditions.................... D-12 1404. Alternate criteria for license termination................................................. D-14 1501. General..................................................................................................... D-15 1502. Conditions requiring individual monitoring of external and internal occupational dose.................................................................................... D-15 1601. Control of access to high radiation areas................................................. D-16 1602. Control of access to very high radiation areas......................................... D-17 1603. Control of access to very high radiation areas -- irradiators.................... D-17 1701. Use of process or other engineering controls........................................... D-20 1702. Use of other controls................................................................................ D-20 1703. Use of individual respiratory protection equipment................................ D-20 1704. Further restrictions on the use of respiratory protection equipment........ D-23 1705. Application for use of higher assigned protection factors....................... D-23 1801. Security of stored sources of radiation.................................................... D-23 1802. Control of sources of radiation not in storage.......................................... D-23 1901. Caution signs........................................................................................... D-23 1902. Posting requirements............................................................................... D-24 1903. Exceptions to posting requirements......................................................... D-25 1904. Labeling containers and radiation machines............................................ D-25 1905. Exemptions to labeling requirements...................................................... D-26 1906. Procedures for receiving and opening packages...................................... D-26 2001. General requirements............................................................................... D-27 2002. Method for obtaining approval of proposed disposal procedures............ D-28 2003. Disposal by release into sanitary sewerage.............................................. D-28 2004. Treatment or disposal by incineration..................................................... D-29 2005. Disposal of specific wastes...................................................................... D-29 2006. Transfer for disposal and manifests......................................................... D-29 2007. Compliance with environmental and health protection regulations........ D-30 2008. Disposal of certain radioactive material.................................................. D-30 2101. General provisions................................................................................... D-31 2102. Records of radiation protection programs............................................... D-31 2103. Records of surveys................................................................................... D-31 2104. Determination and records of prior occupational dose............................ D-32 2105. Records of planned special exposures..................................................... D-33 2106. Records of individual monitoring results................................................. D-34 2107. Records of dose to individual members of the public............................. D-35 2108. Records of waste disposal........................................................................ D-35 2109 Records of testing entry control devices for very high radiation areas......................................................................................................... D-35 2110. Form of records....................................................................................... D-35 2111. Records of tests for leakage or contamination of sealed sources............. D-36 2201. Reports of theft or loss of licensed or registered material....................... D-36 2202. Notification of incidents.......................................................................... D-37 2203. Reports of exposures, radiation levels, and concentrations of 10-144 CMR Ch. 220 iv radioactive material exceeding the constraints or limits.......................... D-38 2204. Reports of planned special exposures...................................................... D-39 2205. Reports to individuals of exceeding dose limits...................................... D-39 2206. Reports of individual monitoring............................................................. D-39 2207. Reports of transactions involving nationally tracked sources.................. D-40 2208 Notifications and reports to individuals................................................... D-43 2209. Reports of leaking or contaminated sealed sources................................. D-44 2301. Vacating premises.................................................................................... D-44 2302. Public notification and public participation............................................. D-44 2304. Minimization of contamination............................................................... D-44 Appendix A Assigned protection factors for respirators....................... D-45 Appendix B Annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage.............................................. D-47 Appendix C Quantities of licensed or registered material requiring labeling............................................................................. D-82 Appendix D Requirements for transfer of low-level radioactive waste Intended for disposal at licensed land disposal facilities and manifests........................................................................... D-91 Appendix E Nationally tracked source thresholds.............................. D-105 Appendix F Reserved......................................................................... D-106 Appendix G Special requirements involving low-level radioactive waste............................................................. D-107 PART E.

RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS (May 20, 2019)

1. Purpose...................................................................................................... E-1
2. Scope......................................................................................................... E-1
3. Definitions................................................................................................. E-1
4. Application for a specific license.............................................................. E-5
5. Performance requirements for industrial radiography equipment............. E-7
6. limits on external radiation levels from radiographic exposure devices, storage containers and source changers....................................... E-8
7.

locking of radiographic exposure devices, storage containers and source changers.......................................................................................... E-9

8. Radiation survey instruments.................................................................... E-9
9.

Leak testing and replacement of sealed sources...................................... E-10

10. Quarterly inventory.................................................................................. E-11
11. Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.............................. E-11
12. Permanent radiographic installations....................................................... E-12
13. Labeling, storage, and transportation....................................................... E-12
14. Conducting industrial radiographic operations........................................ E-13
15. Radiation safety officer for industrial radiography.................................. E-14
16. Requirements for qualifications of radiographic personnel..................... E-15
17. Operating and emergency procedures...................................................... E-18
18. Personnel monitoring............................................................................... E-18
19. Radiation surveys.................................................................................... E-20 10-144 CMR Ch. 220 v
20. Requirements for underwater, offshore platform, and lay-barge radiography.............................................................................................. E-21
21. Surveillance............................................................................................. E-21
22. Posting..................................................................................................... E-21
23. Reciprocity............................................................................................... E-22
24. Radiation safety requirements for the use of radiation machines............ E-22
25. Reserved.................................................................................................. E-26
26. Records of the specific license for industrial radiography...................... E-26
27. Records of receipt, transfer, and disposal of sealed sources.................... E-26
28. Records of radiation survey instruments................................................. E-26
29. Records of leak testing of sealed sources and devices containing depleted uranium.................................................................................... E-26
30. Records of quarterly inventory................................................................ E-26
31. Utilization logs........................................................................................ E-27
32. Records of inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments............ E-27
33. Records of alarm system and entrance control tests at permanent radiographic installations......................................................................... E-27
34. Records of training and certification....................................................... E-27
35. Copies of operating procedures, emergency procedures, and internal audit requirements................................................................................... E-28
36. Records of personnel monitoring procedures.......................................... E-28
37. Records of radiation surveys................................................................... E-28
38. Form of records....................................................................................... E-28
39. Location of documents and records......................................................... E-28
40. Notifications............................................................................................ E-29
41. Records required at temporary job sites.................................................. E-30
42. Specific requirements for radiographic personnel performing industrial radiography.............................................................................. E-31
43. Special requirements and exemptions for radiation machines in enclosed radiography............................................................................... E-31
44. Prohibitions.............................................................................................. E-32
45. Periodic survey........................................................................................ E-32
46. Radiographer examination and certification............................................ E-33 Appendix A Subjects to be covered during the instruction of radiographer assistants...................................................... E-36 Appendix B Items to be covered during the inspection of radiographic equipment.................................................... E-38 Appendix C Items to be included in operating and emergency procedures......................................................................... E-40 PART F.

X-RAYS IN THE HEALING ARTS (May 20, 2019)

1. Scope.......................................................................................................... F-1
2. Definitions.................................................................................................. F-1
3. General requirements.................................................................................. F-9
4. Certification of qualified experts.............................................................. F-17
5. General requirements for all diagnostic x-ray systems............................. F-19
6. Fluoroscopic x-ray systems...................................................................... F-22
7. Radiographic systems other than fluoroscopic, dental intraoral or 10-144 CMR Ch. 220 vi veterinarian systems................................................................................. F-27
8. Intraoral dental radiographic systems and podiatric systems................... F-34
9. Veterinary medicine radiographic installations........................................ F-37
10. Mobile service.......................................................................................... F-37
11. Mobile vans.............................................................................................. F-38
12. Bone densitometry.................................................................................... F-38 Appendix A Information on radiation shielding required for plan reviews............................................................................... F-39 Appendix B Design requirements for an operator's booth...................... F-40 Appendix C Information to be submitted by persons proposing to conduct healing arts screening........................................... F-42 Appendix D Characteristics for qualifying diagnostic x-ray experience for radiological physicists................................ F-43 Appendix E Characteristics for qualifying diagnostic x-ray experience for x-ray technicians........................................ F-44 Appendix F X-Ray registration fees...................................................... F-45 Appendix G Quality assurance for facilities performing diagnostic x-ray................................................................................... F-46 PART G.

MEDICAL USE OF RADIOACTIVE MATERIAL (May 20, 2019)

1. Purpose and Scope..................................................................................... G-1
2. Definitions................................................................................................. G-1
5. Maintenance of records.............................................................................. G-5
6. Provisions for the protection of human research subjects......................... G-5
7.

Reserved.................................................................................................... G-5

8.

Reserved.................................................................................................... G-6

9.

Reserved.................................................................................................... G-6

10. Implementation.......................................................................................... G-6
11. License required........................................................................................ G-6
12. Application for license, amendment, or renewals...................................... G-6
13. License amendments.............................................................................. G-7
14. Notifications.............................................................................................. G-8
15. Exemptions regarding Type A specific license of broad scope................. G-9
16. Reserved.................................................................................................... G-9
17. Reserved.................................................................................................... G-9
18. License Issuance........................................................................................ G-9
19. Specific exemptions................................................................................. G-10
24. Authority and responsibilities for the radiation protection program... G-10
26. Radiation protection program changes.................................................... G-11
27. Supervision.............................................................................................. G-12
28. Duties of an authorized user and authorized medical physicist............... G-12 29-39. Reserved............................................................................................... G-13
40. Written directives.................................................................................... G-13
41. Procedures for administrations requiring a written directive................... G-14
49. Suppliers for radioactive material, sealed sources or devices for medical use.............................................................................................. G-15
50. Training for radiation safety officer......................................................... G-15
51. Training for an authorized medical physicist.......................................... G-17
55. Training for an authorized nuclear pharmacist........................................ G-18 10-144 CMR Ch. 220 vii
57. Training for experienced radiation safety officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist................ G-20
59. Recentness of training.............................................................................. G-22
60. Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material................................................. G-22
61. Calibration survey instruments................................................................ G-22
62. Quality control of diagnostic equipment................................................. G-23
63. Determination of doses of unsealed radioactive material for medical use......................................................................................... G-23
65. Authorization for calibration, transmission, and reference sources..................................................................................................... G-24
67. Requirements for possession of sealed sources and brachytherapy sources................................................................................................. G-24
69. Labeling of vials and syringes................................................................. G-25
70. Surveys for ambient radiation dose rate.................................................. G-25
75. Release of individuals containing unsealed radioactive material or implants containing radioactive material................................................. G-26
80. Provisions of mobile nuclear medicine service....................................... G-27
92. Decay in storage...................................................................................... G-27 100. Use of unsealed radioactive material for uptake, dilution, or excretion studies for which a written directive is not required................ G-28 110. Possession of survey instrument.............................................................. G-28 111-189. Reserved........................................................................................... G-28 190. Training for uptake, dilution, and excretion studies................................ G-28 200. Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required................................ G-30 204. Permissible molybdenum-99 concentration............................................. G-30 220. Possession of a survey instrument........................................................... G-31 290. Training for imaging and localization studies......................................... G-31 300. Use of unsealed radioactive material for which a written directive is required.................................................................................................... G-33 310. Safety instruction..................................................................................... G-33 315. Safety precautions.................................................................................... G-34 320. Possession of survey instrument.............................................................. G-35 390. Training for use of unsealed radioactive material for which a written directive is required..................................................................... G-35 392. Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 Millicuries)......................................... G-37 394. Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)................................................................ G-38 396. Training for the parenteral administration of unsealed byproduct material requiring a written directive...................................................... G-40 400. Use of sources for manual brachytherapy................................................ G-41 404. Surveys after source implant and removal............................................... G-41 406. Brachytherapy sources accountability..................................................... G-42 410. Safety instruction..................................................................................... G-42 415. Safety precautions.................................................................................... G-42 420. Possession of survey instruments........................................................... G143 432. Calibration measurements of brachytherapy sources............................... G-43 10-144 CMR Ch. 220 viii 433. Decay of strontium-90 sources for ophthalmic treatments...................... G-46 457. Therapy-related computer systems.......................................................... G-44 490. Training for use of manual brachytherapy sources.................................. G-44 491. Training for ophthalmic use of strontium-90........................................... G-45 500. Use of sealed sources for diagnosis......................................................... G-46 590. Training for use of sealed sources for diagnosis...................................... G-46 600. use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit...................................................... G-47 604. Survey of patients and human research subjects treated with a remote afterloader unit............................................................................. G-47 605. Installation, maintenance, adjustment and repair..................................... G-47 610. Safety procedures and instructions for remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units.................. G-48 615. Safety precautions for remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units.............................................. G-49 630. Dosimetry equipment............................................................................... G50 632. Full calibration measurements on teletherapy units................................ G-51 633. Full Calibration Measurements on remote afterloader units................... G-52 635. Full calibration measurements on gamma stereotactic radiosurgery units......................................................................................................... G-53 642. Periodic spot checks for teletherapy units............................................... G-55 643. Periodic spot checks for remote afterloader units.................................... G-56 645. Periodic spot checks for gamma stereotactic radiosurgery units............. G-57 647. Additional requirements for mobile remote afterloader units.................. G-58 652. Radiation surveys.................................................................................... G-59 655. Five year inspection for teletherapy and gamma stereotactic radiosurgery units.................................................................................... G-59 657. Therapy-related computer systems.......................................................... G-60 690. Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.............................................. G-60 1000. Other medical uses of radioactive material or radiation from radioactive material.................................................................................................. G-62 2024. Records of authority and responsibilities for radiation protection programs................................................................................................ G-62 2026. Records of radiation protection program changes................................. G-62 2031. Records of mobile nuclear medicine services........................................ G-63 2040. Records of written directives................................................................. G-63 2041. Records for procedures for administrations requiring a written directive............................................................................................. G-63 2060. Records of calibrations of instruments used to measure activity Of unsealed radioactive material........................................................... G-63 2061. Records of radiation survey instrument calibrations.............................. G-63 2063. Records of dosages of unsealed radioactive material for medical use........................................................................................ G-63 2067. Records of leak tests and inventory of sealed sources and brachytherapy sources........................................................................... G-63 2070. Records of surveys for ambient radiation exposure rate........................ G-64 2075. Records of the release of individuals containing unsealed radioactive material or implants containing radioactive materials........ G-64 2092. Records of decay-in-storage.................................................................. G-64 2204. Records of molybdenum-99 concentrations.......................................... G-64 10-144 CMR Ch. 220 ix 2310. Records of safety instruction................................................................. G-65 2404. Records of surveys of patients and human research subjects after source implant and removal.......................................................... G-65 2406. Records of brachytherapy source accountability................................... G-65 2432. Records of calibration measurements of brachytherapy sources........... G-65 2433. Records of decay of strontium-90 sources for ophthalmic treatments........................................................................ G-66 2605. Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units........................................................................................................ G-66 2610. Records of safety procedures................................................................. G-66 2630. Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units....................................................................................................... G-66 2632. Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.............................................. G-66 2642. Records of periodic spot-checks for teletherapy units........................... G-67 2643. Records of periodic spot-checks for remote afterloader units............... G-68 2645. Records of periodic spot-checks for gamma stereotactic radiosurgery units.............................................................................. G-68 2647. Records of additional technical requirements for mobile remote afterloader units..................................................................................... G-69 2652. Records of surveys of therapeutic treatment units................................. G-69 2655. Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units............................................................... G-70 3045. Report and notification of a medical event............................................ G-70 3047. Report and notification of a dose to an embryo/Fetus or a nursing child.......................................................................................... G-72 3067. Report of a leaking source..................................................................... G-74 3075. Reports of patient departure prior to authorized release or patient death......................................................................................... G-74 PART H.

RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL AND OTHER INDUSTRIAL RADIATION MACHINES (May 20, 2019)

1. Purpose and scope..................................................................................... H-1
2. Definitions................................................................................................. H-1
3. Equipment requirements............................................................................ H-2
4.

Hand held XRF analyzers (Non medical).................................................. H-4

5. Area requirements...................................................................................... H-5
6. Operating requirements............................................................................. H-6
7. Personnel requirements.............................................................................. H-6
8. Periodic inspection.................................................................................... H-7
9. Annual registration fees............................................................................. H-8 PART I.

RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS (May 20, 2019)

1. Purpose and scope.......................................................................................I-1
2. License requirements...................................................................................I-1
3. General requirements for the issuance of a license for particle accelerators..................................................................................................I-1
4. Human use of particle accelerators..............................................................I-1 10-144 CMR Ch. 220 x
5. Reserved......................................................................................................I-2
6. Limitations...................................................................................................I-2
7. Shielding and safety design requirements...................................................I-2
8. Particle accelerator controls and interlock systems.....................................I-2
9. Warning devices..........................................................................................I-3
10. Operating procedures...................................................................................I-3
11. Radiation monitoring requirements.............................................................I-4
12. Ventilation systems......................................................................................I-4 PART J.

NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; AND INSPECTIONS (May 20, 2019)

1. Purpose and scope...................................................................................... J-1
2. Posting of notices to workers...................................................................... J-1
3. Instructions to workers............................................................................... J-1
4. Notification and reports to individuals....................................................... J-2
5.

Presence of representative of licensees or registrants and workers during inspections....................................................................................... J-3

6. Consultation with workers during inspections............................................ J-4
7. Requests by workers for inspections.......................................................... J-4
8. Inspections not warranted; informal review............................................... J-5 PART K.

RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUBSURFACE TRACER STUDIES (May 20, 2019)

1. Purpose and scope..................................................................................... K-1
2. Effect of incorporation of 10 CFR Part 39................................................ K-1 PART L.

TRANSPORTATION OF RADIOACTIVE MATERIAL (May 20, 2019)

1. Purpose...................................................................................................... L-1
2. Effect of incorporation of 10 CFR Part 71................................................ L-1 PART N.

REGULATION AND LICENSING OF TECHNOLOGICALLY ENHANCED NATURALLY OCCURRING RADIOACTIVE MATERIALS (TENORM) (May 20, 2019)

1. Purpose...................................................................................................... N-1
2. Scope......................................................................................................... N-1
3. Definitions................................................................................................. N-1
4. Exemptions................................................................................................ N-2
5. Standards for radiation protection for TENORM...................................... N-3
6. Protection of workers during operations.................................................... N-3
7. Unrestricted use and conditional release................................................... N-3
8. Disposal and transfer of waste for disposal............................................... N-4
9. Prohibition................................................................................................. N-5
10. General license.......................................................................................... N-5
11. Specific licenses........................................................................................ N-6
12. Filing application for specific license........................................................ N-7
13. Requirements for the issuance of specific licenses.................................... N-7
14. Safety criteria for products...................................................................... N-10
15. Table of doses.......................................................................................... N-10
16. Issuance of specific licenses.................................................................... N-10
17. Conditions of specific licenses issued under N.13.................................. N-11 10-144 CMR Ch. 220 xi
18. Expiration and termination of specific licenses....................................... N-13
19. Renewal of specific licenses.................................................................... N-15
20. Amendment of specific licenses at request of licensee............................ N-15
21. Agency action on applications to renew and amend specific licenses..................................................................................................... N-15
22. Modification and revocation of specific licenses.................................... N-15
23. Agency action to remove an authorized user or a radiation safety officer............................................................................................ N-16
24. Record keeping requirements for site reclamation.................................. N-17
25. Reciprocal recognition of specific licenses............................................. N-17
26. Financial assurance arrangements........................................................... N-18
27. Effective date........................................................................................... N-18 Appendix A Acceptable surface contamination levels for TENORM......................................................................... N-19 PART X.

THERAPEUTIC RADIATION MACHINES (May 20, 2019)

1. Scope............................................................................................................ X-1
2. Definitions................................................................................................... X-1
3. Administrative requirements........................................................................ X-3
4. General requirements................................................................................... X-4
5. Quality management program...................................................................... X-6
6. Therapeutic radiation machines of less than 500kV.................................... X-6
7. Therapeutic radiation machines, photon therapy systems (500 kV and above) and electron therapy systems (500 kV and Above)............... X-13
8. Calibration of survey instruments.............................................................. X-25
9. Shielding and safety design requirements.................................................. X-25 Appendix A Information on radiation shielding required for plan reviews...................................................................... X-26 Appendix B Quality management program.......................................... X-29 Appendix C Alternative quality management program........................ X-33
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