Iowa Code r. 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 µSv) 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 365-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
365-day reciprocity period.
Notes
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