WAC 246-224-0100
What are the responsibilities of the
X-ray agent? (1) Within fifteen calendar days, any agent who
sells, leases, transfers, lends, disposes of, assembles,
repairs, replaces, or installs radiation machines or
components in Washington state must notify the department of
the:
(a) Recipient's name and facility address;
(b) Manufacturer, model, and serial number of each
radiation machine master control; and
(c) Date of transfer of the radiation machine.
Note:
An FDA form 2579 or equivalent may be used for this notification requirement.
(2) Any agent who installs X-ray systems, controls, or
components must ensure that machines, accessories, or
components (including exposure switch placement) meet the
applicable requirements of chapter 246-225 WAC, Radiation
protection -- X rays in the healing arts; chapter 246-227 WAC,
Radiation protection -- Industrial X ray; chapter 246-228 WAC,
Radiation protection -- Analytical X-ray equipment; and chapter 246-229 WAC, Radiation protection -- Particle accelerators.
(3) Agents shall not install or transfer a radiation
machine if the registrant does not complete:
(a) A required plan review according to chapter 246-225
WAC, Radiation protection -- X rays in the healing arts or
chapter 246-227 WAC, Radiation protection -- Industrial
radiography; or
(4) Agents must assemble certified X-ray systems
according to 21 CFR, subchapter J so that manufacturer's
specifications and intended performance designs are met.