Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Locking of sources of radiation. The control panel of each
radiation machine shall be equipped with a locking device that will prevent the
unauthorized use of an X-ray system or the accidental production of radiation.
The radiation machine shall be kept locked and the key removed at all times
except when under the direct visual surveillance of a radiographer.
(2)
Permanent storage
precautions. Radiation machines shall be secured while in storage to
prevent tampering or removal by unauthorized individuals.
(3)
Requirements for radiation
machines used in industrial radiographic operations.
a. Equipment used in industrial radiographic
operations involving radiation machines manufactured after January 1, 1992,
shall be certified at the time of manufacture to meet the criteria set forth by
ANSI N537-1976.
b. The registrant's
name and city or town where the main business office is located shall be
prominently displayed with a durable, clearly visible label(s) on all vehicles
used to transport radiation machines for temporary job site use.
(4)
Operating and
emergency procedures.
a. The
registrant's operating and emergency procedures shall include instructions in
at least the following:
(1) Operation and
safety instruction on the radiation machine(s) to be used;
(2) Methods and occasions for conducting
radiation surveys;
(3) Methods for
controlling access to radiographic areas;
(4) Methods and occasions for locking and
securing sources of radiation;
(5)
Personnel monitoring and the use of personnel monitoring equipment, including
steps that must be taken immediately by radiography personnel in the event a
pocket dosimeter is found to be off-scale;
(6) Minimizing exposure of individuals in the
event of an accident;
(7) The
procedure for notifying proper personnel in the event of an accident;
(8) Maintenance of records; and
(9) Inspection and maintenance of radiation
machines.
b. Each
registrant shall provide, as a minimum, two radiographic personnel when
radiation machines are used for any industrial radiography conducted other than
at a permanent radiographic installation (shielded room, bay, or bunker). If
one of the personnel is a radiographer's assistant, the other shall be a
radiographer trainer authorized by the certificate of registration.
c. No individual other than a radiographer or
a radiographer's assistant who is under the direct supervision of a
radiographer trainer shall manipulate controls or operate equipment used in
industrial radiographic operations.
d. Rescinded IAB 4/8/98, effective
7/1/98.
(5)
Radiation surveys and survey records.
a. No radiographic operation shall be
conducted unless calibrated and operable radiation survey instrumentation, as
described in 45.1(5), is available and used at each site where radiographic
exposures are made.
b. A physical
radiation survey shall be made after each radiographic exposure using radiation
machines to determine that the machine is "off."
c. All potential radiation areas where
industrial radiographic operations are to be performed shall be posted in
accordance with 45.1(15), based on calculated dose rates, before industrial
radiographic operations begin. An area survey shall be performed during the
first radiographic exposure to confirm that 45.1(15) requirements have been met
and that unrestricted areas do not have radiation levels in excess of the
limits specified in 641-subrule 40.26(1).
d. Records shall be kept of the surveys
required by 45.2(5)"b" and"c. " Such records
shall be maintained for inspection by the agency for two years after completion
of the survey. If the survey was used to determine an individual's exposure,
however, the records of the survey shall be maintained until the agency
authorizes their disposition.
(6)
Special requirements and
exemptions for enclosed radiography.
a. Systems for enclosed radiography,
including shielded-room radiography and cabinet radiography, designed to allow
admittance of individuals shall:
(1) Comply
with all applicable requirements of this chapter and 641-subrule 40.26(1). If
such a system is a certified cabinet X-ray system, it shall comply with all
applicable requirements of this chapter and
21 CFR
1020.40.
(2) Be evaluated at intervals not to exceed
one year to ensure compliance with the applicable requirements as specified in
641-subrule 40.26(1). Records of these evaluations shall be maintained for
inspection by the agency for a period of three years after the
evaluation.
b. Certified
and certifiable cabinet X-ray systems are exempt from the requirements of this
chapter except that:
(1) Operating personnel
must be provided with individual monitoring devices in accordance with the
appropriate provisions of
641-40.37
(136C).
(2) No registrant shall
permit any individual to operate a cabinet X-ray system until such individual
has received a copy of and instruction in the operating procedures for the unit
and has demonstrated competence in its use. Records which demonstrate
compliance with this subparagraph shall be maintained for inspection by the
agency until disposition is authorized by the agency.
(3) Tests for proper operation of interlocks
used to control entry to the high radiation area or alarm systems, where
applicable, shall be conducted and recorded every three months. Records of
these tests shall be maintained for agency inspection until disposal is
authorized by the agency.
(4) The
registrant shall perform an evaluation, at intervals not to exceed one year, to
determine conformance with 641-subrule 40.26(1). If such a system is a
certified cabinet X-ray system, it shall be evaluated at intervals not to
exceed one year to determine conformance with
21 CFR
1020.40. Records of these evaluations shall
be maintained for inspection by the agency for a period of two years after the
evaluation.
c. Certified
cabinet X-ray systems shall be maintained in compliance with
21 CFR
1020.40 unless prior approval has been
granted by the agency pursuant to
641-38.3
(136C).
(7)
Registration for industrial radiographic operations.
a. Radiation machines used in industrial
radiographic operations shall be registered in accordance with 641-Chapter
39.
b. In addition to the
registration requirements in 641-Chapter 39, an application for a certificate
of registration shall include the following information:
(1) A schedule or description of the program
for training radiographic personnel which specifies:
1. Initial training,
2. Periodic training,
3. On-the-job training, and
4. Methods to be used by the registrant to
determine the knowledge, understanding, and ability of radiographic personnel
to comply with agency rules, registration requirements, and the operating and
emergency procedures of the applicant.
(2) Written operating and emergency
procedures, including all items listed in Appendix D.
(3) A description of the internal inspection
system or other management control to ensure that radiographic personnel follow
registration provisions, rules of the agency, and the applicant's operating and
emergency procedures.
(4) A list of
permanent radiographic installations and descriptions of permanent storage and
use locations.
(5) A description of
the organization of the industrial radiographic program, including delegations
of authority and responsibility for operation of the radiation safety
program.
c. A
certificate of registration will be issued if the requirements of 641-Chapter
39 and this subrule are met.