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State Certification of Radiation Machines

1. Those used for dental diagnosis or treatment;
2. Radiation machines exempted from the requirements of Section B.3 of the Maryland State Department the Environment Regulations for Control of Ionizing Radiation (1995) which is incorporated by reference in Regulation 26.12.01.01; and
3. Radiation machines that are licensed by the Agency as provided by Section C. of the incorporated document in Regulation 26.12.01.01.

Classification of Radiation Machines - Radiation machines are classified according to the following system:

1. Group 1 - Radiation machine that can generate radiation levels of 500 rems in one hour at one meter from the source of radiation and are used to irradiate materials. These are the radiation machines subject to Section D.203(c)(6) of the incorporated document in Regulation 26.12.01.01.
2. Group 2 - Radiation machines that are used for human medical therapy. These are the radiation machines subject to Section F.8 and F.9 of the incorporated documents in Regulation 26.12.01.01.
3. Group 3 - Radiation machines other than those in Group 2 that are used for healing arts purposes in hospitals certified by the Joint Commission on Accreditation of Hospitals.
4. Group 4 - Radiation machines that are not included in Group 3 or Group 5, but their use is prescribed by a physician, chiropractor, or podiatrist.
5. Group 5 - Radiation machines that are not included above, but are used:
   1. for research purposes;
   2. in health care facilities operated by a local government;
   3. solely for educational purposes.

State Certification Required for Radiation Machines -

1. Exemptions from other regulations not implied. A person is not exempted from complying with an applicable provision of the incorporated document in Regulation 26.12.01.01 because of compliance with this regulation.
2. General State Certification -- Other than during inspections for compliance with these regulations, a person may not cause or permit the use of any radiation machine after the State Certification due date specified for that machine (per the following table) if it has not been State Certified by the Agency.
3. Recertification After Replacement or Rebuilding of Major Components -- Except for routine X-ray tube replacement, a person may not cause or permit the use of any radiation machine that has had major components replaced or substantially rebuilt until the major component that has been effected has been reinspected and the radiation machine has again been State Certified.
4. Interim State Certification -- A radiation machine shall be considered State Certified by the Agency until the first State Certification due date scheduled (per the following table) provided that the machine has been registered by the Agency under Section B. and F. of the Maryland State Department of The Environment Regulations for Control of Ionizing radiation (1995) which is incorporated by reference in Regulation 26.12.01.01 and provided that the person responsible for the use of the machine has not been notified by the Agency that the machine does not meet a provision of this chapter.

Application for State Certification -

1. Each person responsible for the use of a radiation machine shall apply for State Certification of the machine at least 45 days, but not more than 180 days, before the scheduled date shown (per the following table) and again after that according to the repeat cycle shown.
2. The application shall be made on a form issued by the Agency and shall contain:
   1. All information indicated on the form;
   2. A Departmental inspection report form that has been completed and signed by an inspector licensed under Regulation 26.12.01.03.
3. Except for applications for recertification following replacement or rebuilding of a major component, each person submitting an application shall remit a State Certification Fee with the application based on the following fee schedule:
   1. Group 1 and Group 2 machine - $250.00
   2. Group 4 and Group 5 machine - $100.00

Denial of Certification -

1. The Agency shall deny State Certification of a radiation machine if it determines that the use of the machine will result in a violation of either the Maryland Radiation Act, or any regulation promulgated under the Act.
2. A determination made by the Agency under 1) above may be made based on information contained on the inspection report form from an independent inspection made by the Agency, or any other pertinent information known by the Agency.

The Radiation Safety Office at UM Campus will be responsible for ensuring compliance with these regulations and all submittal for registration and certification will be completed by this Office.

Table 1
Certification Due Date

All refers to facilities of that group regardless of registration number.

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