An
application for a specific license to manufacture or distribute devices
containing radioactive material, excluding special nuclear material, to persons
generally licensed under NAC
459.216 or equivalent regulations
of the Nuclear Regulatory Commission or an agreement state will be approved
if:
1. The applicant satisfies the
general requirements of NAC
459.238.
2. The applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control, labels, proposed uses, installation, servicing, leak testing,
operating and safety instructions and potential hazards of the device to
provide reasonable assurance that:
(a) The
device can be safely operated by persons not having training in radiological
protection;
(b) Under ordinary
conditions of handling, storage and use of the device, the radioactive material
contained in the device will not be released or inadvertently removed from the
device, and it is unlikely that any person will receive in any period of 1 year
a dose in excess of 10 percent of the limits specified in NAC
459.325; and
(c) In an accident such as fire or explosion,
associated with handling, storage and use of the device, it is unlikely that
any person would receive an external radiation dose or dose commitment in
excess of the following organ doses:
(1) Whole
body, head and trunk, active blood-forming organs, gonads or lens of eye
..............................................................................................................................
15 rems
(2) Hands and forearms,
feet and ankles, localized areas of skin averaged over areas not larger than 1
square centimeter
.......................................................................200
rems
(3) Other organs
...............................................................................................................50
rems
3. Each
device bears a durable, legible, clearly visible label or labels approved by
the Division which contain in a clearly identified and separate statement:
(a) Instructions and precautions necessary to
assure safe installation, operation and maintenance of the device. Documents
such as operating and service manuals may be identified in the label and used
to provide this information.
(b)
The requirement, or lack of requirement, for leak testing, or for testing any
on-and-off mechanism and indicator, including the maximum time interval for
such testing, and the identification of radioactive material by isotope,
quantity of radioactivity and date of determination of the quantity.
(c) The information called for in the
following statement, in the same or substantially similar form:
The
receipt, possession, use and transfer of this device model, serial number, are
subject to a general license or the equivalent and the regulations of the
Nuclear Regulatory Commission or a state with which the Nuclear Regulatory
Commission has entered into an agreement for the exercises of regulatory
authority. This label must be maintained on the device in a legible condition.
Removal of this label is prohibited.
CAUTION - RADIOACTIVE
MATERIAL
.............................................................................................................................
(Name of manufacturer or distributor)
(d) The model, serial number and name of the
manufacturer or distributor may be omitted from the label required by this
subsection if the information is specified elsewhere and labeling is affixed to
the device.
4. Each
device that has a separable source housing that provides primary shielding for
the source also bears, on the source housing, a durable label listing the model
number and serial number of the device, the isotope and quantity, the radiation
symbol described in NAC
459.355, the words "CAUTION -
RADIOACTIVE MATERIAL" and the name of the manufacturer or initial distributor
of the device.
5. Each device
described in paragraph (a) of subsection 13 of NAC
459.218 bears a permanent label,
including, without limitation, an embossed, etched, engraved or a stamped
label, affixed to the source housing if separable or to the device if the
source housing is not separable, which contains the words "CAUTION -
RADIOACTIVE MATERIAL" and the radiation symbol described in NAC
459.355, if
practicable.
6. The device has been
registered in the Sealed Source and Device Registry maintained by the Nuclear
Regulatory Commission.
Notes
Nev. Admin. Code §
459.282
Bd. of Health, Radiation Control
Reg. §§ 3.5.5.4-3.5.5.4.1.3.3.1, eff. 2-28-80-NAC A 1-18-94; R085-06,
11-13-2006; R185-08, 5-7-2010; A by
R144-13A,
eff. 10/13/2016
NRS
459.201