Ohio Admin. Code 3701:1-46-40 - Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer
An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under rule 3701:1-46-10 of the Administrative Code will be approved if:
(A) The applicant satisfies the general
requirements specified in rule
3701:1-40-15
of the Administrative Code;
(B)
The applicant submits sufficient information regarding each type of device
pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum
quantity of strontium-90 in the device;
(2) Details of construction and design of the
source of radiation and its shielding;
(3) Radiation profile of a prototype
device;
(4) Procedures for and
results of prototype testing of devices to demonstrate that the strontium-90
contained in each device will not be released or be removed from the device
under the most severe conditions likely to be encountered in normal handling
and use;
(5) Details of quality
control procedures to be followed in manufacture of the device;
(6) Description of labeling to be affixed to
the device;
(7) Instructions for
handling and installation of the device;
(8) Any additional information, including
experimental studies and tests, required by the director to facilitate a
determination of the safety of the device;
(C) Each device will contain no more than
1.85 megabecquerels (fifty microcuries) of strontium-90 in an insoluble
form;
(D) Each device will bear
durable, legible labeling which includes the radiation symbol prescribed by
paragraph (A) of rule
3701:1-38-18
of the Administrative Code, a statement that the device contains strontium-90
and the quantity thereof, instructions for disposal and statements that the
device may be possessed pursuant to a general license, that the manufacturer or
civil authorities should be notified if the device is found, that removal of
the labeling is prohibited and that disassembly and repair of the device may be
performed only by a person holding a specific license to manufacture or service
such devices;
(E) The director
determines that:
(1) The method of
incorporation and binding of the strontium-90 in the device is such that the
strontium-90 will not be released from the device under the most severe
conditions which are likely to be encountered in normal use and handling of the
device;
(2) The strontium-90 is
incorporated or enclosed so as to preclude direct physical contact by any
individual with it and is shielded so that no individual will receive a
radiation exposure to a major portion of his body in excess of five
millisieverts ( 0.5 rem) in a year under ordinary circumstances of
use;
(3) The device is so designed
that it cannot be easily disassembled;
(4)
The device
has
Prototypes of the device have been
subjected to and has
have satisfactorily passed the
prototype tests prescribed
required by
rule
3701:1-46-47
of the Administrative Code; and
paragraph (F)
of this rule.
(5) Quality
control procedures have been established to satisfy the requirements of rule
3701:1-46-41
of the Administrative Code.
(F)
The applicant
shall subject at least five prototypes of the device to tests as follows:
(1)
The devices are
subjected to tests that adequately take into account the individual, aggregate,
and cumulative effects of environmental conditions expected in service that
could adversely affect the effective containment of strontium-90, such as
temperature, moisture, absolute pressure, water immersion, vibration, shock,
and weathering.
(2)
The devices are inspected for evidence of physical
damage and for loss of strontium-90 after each stage of testing, using methods
of inspection adequate for determining compliance with the criteria in
paragraph (F)(3) of this rule.
(3)
Device designs
are rejected for which the following has been detected for any unit:
(a)
A leak resulting
in a loss of 0.1 per cent or more of the original amount of strontium-90 from
the device;
(b)
Surface contamination of strontium-90 on the device of
more than two thousand two hundred disintegrations per minute per one hundred
square centimeters of surface area; or
(c)
Any other
evidence of physical damage.
(G)
The device has
been registered in the sealed source and device
registry.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/2008, 11/08/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08
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