Md. Code Regs. 26.12.02.02

Current through Register Vol. 51, No. 18, September 6, 2024

Section 26.12.02.02 - State Certification of Radiation Machines

A. Applicability. This regulation does not apply to persons using the following radiation machines:

(1) Those used for dental diagnosis or screening (machines classified in Group 6);

(2) Those used for veterinary diagnosis or screening (machines classified in Group 7);

(3) Those used for mammography diagnostic or screening purposes located in a mammography facility regulated under 21 CFR Part 900 (machines classified in Group 8);

(4) Those used for veterinary dental diagnosis or screening (machines classified in Group 9);

(5) Radiation machines exempted from the requirements of Section B.3 of the Regulations for the Control of Ionizing Radiation 1994, which is incorporated by reference in COMAR 26.12.01.01 a; and

(6) Radiation machines that are licensed by the Department as provided by §C. of the incorporated document in COMAR 26.12.01.01 a.

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

(1) Group 1-Radiation machines 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 §D.602 of the incorporated document in COMAR 26.12.01.01 a.

(2) Group 2-Radiation machines that are used for human medical therapy. These are the radiation machines subject toSections F.8 and F.9 of the incorporated document in COMAR 26.12.01.01 a.

(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 in Groups 1 through 4 but are used:

(i) In industrial applications;

(ii) For research purposes;

(iii) For security fluoroscopy of baggage or parcels; or

(iv) Solely for educational purposes.

C. 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 COMAR 26.12.01.01 a 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 in §C(5) of this regulation if it has not been State certified by the Department.

(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 any major component replaced or substantially rebuilt until the major component that has been affected has been reinspected and the radiation machine has again been State certified.

(4) Interim State Certification.

(a) The following classes of radiation machines are State certified until the time the Department promulgates regulations controlling the use of these radiation machines:

(i) Radiation machines that produce non-ionizing electromagnetic radiation; and

(ii) Radiation machines that produce sonic, ultrasonic, or infrasonic radiation.

(b) A radiation machine shall be considered State-certified by the Department until the first State certification due date established in §C(5) of this regulation, if:

(i) The machine has been registered by the Department under §§B and F of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01 a; or

(ii) The person responsible for the use of the machine has not been notified by the Department that the machine does not meet a provision of this subtitle.

(5) Due Dates for State Certification. Due dates for State certification of radiation machines are established according to the Group as set forth in §B of this regulation. These dates are as follows:

Certification Due Date	Group 1	Group 2	Group 3	Group 4	Group 5
July 1, 2017	All¹	Even³
December 31, 2017	All	Even³	Even³
July 1, 2018	All	Odd²
December 31, 2018	All	Odd²
July 1, 2019	All	Even
December 31, 2019	All	Even	Odd²
July 1, 2020	All	Odd
December 31, 2020	All	Odd	Even
July 1, 2021	All	Even
December 31, 2021	All	Even
July 1, 2022	All	Odd
December 31, 2022	All	Odd	Odd
July 1, 2023	All	Even
December 31, 2023	All	Even	Even
July 1, 2024	All	Odd
December 31, 2024	All	Odd
July 1, 2025	All	Even
December 31, 2025	All	Even	Odd
July 1, 2026	All	Odd
December 31, 2026	All	Odd	Even
July 1, 2027	All	Even
December 31, 2027	All	Even
July 1, 2028	All	Odd
December 31, 2028	All	Odd	Odd
July 1, 2029	All	Even
December 31, 2029	All	Even	Even

¹ "All" means all facilities of that group regardless of registration number. The certification due date for Group 1 machines shall be July 1st of each year. The certification due date for Group 2 machines shall be December 31st of each year.

² "Odd" means facilities with a registration number ending in an odd digit. For such facilities, the certification due date for Group 3 machines shall be as indicated in the table and biennially thereafter beginning December 31, 2018, the certification due date for Group 4 machines shall be as indicated in the table and biennially thereafter beginning July 1, 2018, and the certification due date for Group 5 machines shall be as indicated in the table and triennially thereafter beginning December 31, 2019.

³ "Even" means facilities with a registration number ending in an even digit. For such facilities, the certification due date for Group 3 machines shall be as indicated in the table and biennially thereafter beginning December 31, 2017, the certification due date for Group 4 machines shall be as indicated in the table and biennially thereafter beginning July 1, 2017, and the certification due date for Group 5 machines shall be as indicated in the table and triennially thereafter beginning December 31, 2017.

D. 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 due date established in §C(5) of this regulation.

(2) The application shall be made on forms issued by the Department and shall contain:

(a) All information indicated on the forms; and

(b) A Departmental inspection report that has been completed and signed by an inspector licensed under Regulation .03 of this chapter.

E. Denial of Certification.

(1) The Department 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 this Act.

(2) A determination made by the Department under §E(1) may be made based on information contained on the inspection report, an independent inspection made by the Department, or any other pertinent information known by the Department.

Md. Code Regs. 26.12.02.02

Regulations .02 adopted April 30, 1987 (14:4 Md. R. 418)
Regulation .02 amended effective March 29, 2004 (31:6 Md. R. 510)
Regulation .02B amended effective October 20, 1997 (24:21 Md. R. 1453)
Regulation .02C amended effective February 15, 1993 (20:3 Md. R. 261); October 20, 1997 (24:21 Md. R. 1453); November 15, 2010 (37:23 Md. R. 1613)
Regulation .02D amended effective May 14, 1990 (17:9 Md. R. 1092); amended effective 45:10 Md. R. 504, eff. 5/21/2018; amended effective 48:4 Md. R. 178, eff. 2/22/2021