RULE 641-39.3 - Requirements for registration of X-ray and other electronic machines that produce radiation

RULE 641-39.3. Requirements for registration of X-ray and other electronic machines that produce radiation

(1) Exemptions.

a. Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this chapter, provided that the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 millirem (5 ┬ÁSv) per hour at 5 centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

b. Radiation machines while in transit or storage incident thereto are exempt from the requirements of this chapter.

c. Domestic television receivers are exempt from the requirements of this chapter.

(2) Application for registration of radiation machine facilities. Each person having a radiation machine facility shall:

a. Apply for registration of such facility with the agency prior to the operation of a radiation machine facility. In order to register equipment, the person must have a storage area located in Iowa where records of equipment maintenance and quality assurance, personnel monitoring, and personnel certification must be kept for review during an inspection. The records may be stored on a vehicle, if appropriate. An Iowa mailing address is not required. Application for registration shall be completed on forms furnished by the agency, shall contain all information required by the agency as indicated on the forms and accompanying instructions, and shall include the appropriate fee from 641-38.8 (136C).

b. Designate on the application form an individual to be responsible for radiation protection.

c. Each registrant shall prohibit any person from furnishing radiation machine servicing or services as described in 39.3(3) "d" to the registrant's radiation machine facility until such person provides evidence that the person has been registered with the agency as a provider of services in accordance with 39.3(3).

(3) Application for registration of servicing and services.

a. Each person who is engaged in the business of installing or offering to install radiation machines or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this state shall apply for registration of such services with the agency prior to furnishing or offering to furnish any such services.

b. Application for registration shall be completed on forms furnished by the agency and shall contain all information required by the agency as indicated on the forms and accompanying instructions and include the fee required in 641-paragraph 38.8(1)"c."

c. Each person applying for registration under this chapter shall specify:

(1) That the person has read and understands the requirements of these rules;

(2) The services for which the person is applying for registration;

(3) The training and experience that qualify the person to discharge the services for which the person is applying for registration;

(4) The type of measurement instrument to be used, frequency of calibration, and source of calibration; and

(5) The type of personnel dosimeters supplied, frequency of reading, and replacement or exchange schedule.

d. For the purpose of 39.3(3), services may include but shall not be limited to:

(1) Installation and servicing of radiation machines and associated radiation machine components;

(2) Calibration of radiation machines or radiation measurement instruments or devices;

(3) Radiation protection or health physics consultations or surveys; and

(4) Processor or processor servicing, or both.

(5) Calibration and compliance surveys of external beam radiation therapy units.

e. No individual shall perform services which are not specifically stated for that individual on the notice of registration issued by the agency.

f. A registration may be revoked for violating or causing a facility to violate any of the rules in 641-Chapters 38 through 45.

g. Radiation therapy physicists providing services for therapeutic radiation machines must provide proof that the training requirements of 641-subrule 41.3(6) have been met.

(4) Issuance of notice of registration.

a. Upon a determination that an applicant meets the requirements of this chapter, the agency shall issue a notice of registration.

b. The agency may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use, and transfer of radiation machines as it deems appropriate or necessary.

(5) Expiration of notice of registration. Except as provided by 39.3(6)"b," each notice of registration shall expire within 12 months of issuance or at the end of the specified day in the month and year stated therein.

(6) Renewal of notice of registration.

a. Application for renewal of registration shall be filed in accordance with 39.3(2) or 39.3(3).

b. In any case in which a registrant has properly filed an application for renewal of current registration within 90 days prior to the expiration of the existing registration, such existing registration shall not expire until the application status has been finally determined by the agency.

(7) Report of changes. The registrant shall notify the agency in writing before making any change which would render the information contained in the application for registration or the notice of registration no longer accurate.

(8) Approval not implied. No person, in any advertisement, shall refer to the fact that the person or the person's facility is registered with the agency pursuant to the provisions of 39.3(2) or 39.3(3), and no person shall state or imply that any activity under such registration has been approved by the agency.

(9) Assembler and transfer obligation.

a. Any person who sells, leases, transfers, lends, disposes of, assembles, or installs radiation machines in this state shall notify the agency in writing within 15 days of:

(1) The name and address of persons who have received these machines;

(2) The manufacturer, model, and serial number of each radiation machine transferred; and

(3) The date of transfer of each radiation machine.

b. No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment, when properly placed in operation and used, shall meet the requirements of 641-Chapters 38, 39, 40 and 41.

c. In the case of diagnostic X-ray systems which contain certified components, a copy of the assembler's report prepared in accordance with the requirements of the federal diagnostic X-ray standard (21 CFR 1020.30(d)) shall be submitted to the agency within 15 days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

(10) Reciprocity -out-of-state radiation machines.

a. Whenever any radiation machine is to be brought into the state, for any temporary use, the person proposing to bring such machine into the state shall give written notice to the agency at least three working days before such machine is to be used in the state. The notice shall include:

(1) The type of radiation machine;

(2) The nature, duration, and scope of use;

(3) The exact location(s) where the radiation machine is to be used; and

(4) States in which this machine is registered.

b. If, for a specific case, the three-working-day period would impose an undue hardship on the person, upon application to the agency, permission to proceed sooner may be granted.

c. The person referred to in 39.3(10)"a" shall:

(1) Comply with all applicable rules of the agency;

(2) Supply the agency with such other information as the agency may reasonably request; and

(3) Not operate within the state on a temporary basis in excess of 180 calendar days in a 365-day reciprocity period. The 3 65-day reciprocity period starts on the day the agency receives the appropriate fee, as specified in 641-subrule 38.8(8), and ends exactly 365 days later. It is the registrant's responsibility to ensure the 180-day limit is not exceeded during the 365-day reciprocity period and to ensure that the reciprocal recognition is renewed 30 days prior to the expiration of the 3 65-day reciprocity period.

(Rescinded IAB 4/8/98, effective 7/1/98. Amended by IAB June 17, 2020/Volume XLII, Number 26, effective 7/22/2020)

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