3701:1-46-37 Calibration or reference sources containing americium-241 or radium-226: requirements for license to manufacture or initially transfer.

 

 

 

3701:1-46-37               Calibration or reference sources containing americium-241 or radium-226: requirements for license to manufacture or initially transfer.

 

 

An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under rule 3701:1-46-08 of the Administrative Code, will be approved if:

 

(A)     The applicant satisfies the general requirements of rule 3701:1-40-15 of the Administrative Code;

 

(B)    The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

 

(1)     Chemical and physical form and maximum quantity of americium-241 or radium-226 in the source;

 

(2)   Details of construction and design;

 

(3)    Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

 

(4)   Procedures for and results of prototype testing of sources, which are designed to contain more than one hundred eighty-five becquerels (0.005 microcurie) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

 

(5)    Details of quality control procedures to be followed in manufacture of the source;

 

(6)   Description of labeling to be affixed to the source or the storage container for the source;

 

(7)   Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the source.

 

(C)   Each source will contain no more than one hundred eighty-five kilobecquerels (five microcuries) of americium-241 or radium-226.

 

(D)   The director determines, with respect to any type of source containing more than one

 

 

hundred    eighty    five-becquerels    (0.005    microcurie)    of    americium-241,     or radium-226 that:

(1)   The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

(2)    The source has been subjected to and has satisfactorily passed the prototype tests prescribed by rule 3701:1-46-46 of the Administrative Code.

Effective:   R.C. 119.032 review dates:	10/04/2010   06/28/2010 and 10/01/2015
CERTIFIED ELECTRONICALLY
Certification
09/24/2010
Date
Promulgated Under:	119.03
Statutory Authority:	3748.04
Rule Amplifies:	3748.04
Prior Effective Dates:	10/20/2002, 1/20/08