Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 45 - RADIATION CONTROL
Subchapter 2 - LICENSE
Section 11-45-27 - Assembly and transfer
Current through February, 2024
(a) No radiation machines shall be assembled or installed in a facility which does not have a current license.
(b) No source of radiation shall be transferred to a facility which does not have a current license.
(c) No person shall manufacture, sell, lease, transfer, lend, assemble, or install one or more components of radiation machines or the supplies used in connection with such machines without having a current license. Radiation machines and supplies when properly placed in operation and used shall meet the requirements of this chapter.
(d) Any person who sells, leases, transfers, lends, disposes, assembles, or installs one or more components of radiation machines in this State shall notify the department within fifteen days of:
(e) The following items are exempt from the requirements specified in subsection (d):
"Temporarily Installed Component
This certified component has been assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer.
Signature
Company Name
Street Address, P.O. Box
City, State, Zip Code
Date of Installation"
The replacement of the temporarily installed component by a component other than the component originally removed for repair shall be reported as specified by subsection (d).
(f) In the case of diagnostic x-ray systems which contain one or more certified components, a copy of the assembler's report prepared in compliance with requirements of the federal diagnostic x-ray standard, 21 C.F.R. §1020.30(d), shall be submitted to the department within fifteen days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.