Licensing of a type B(U) package design for the transport and transfer of medical 60Co sealed sources in Argentina

This paper points out the relevant regulatory issues related to the licensing process of a type B(U) package design (hereinafter called CONTRAS), approved for the transport by all modes and the transfer of 60Co sealed sources of up to 555 TBq, as a special form radioactive material, for medical use in a circular section drawer of a cobalt-therapy equipment, as carried-out by the Nuclear Regulatory Authority (hereinafter called ARN) of Argentina, the former Nuclear Regulatory Entity (ENREN), of Argentina. A description is made of both, the decisions taken during the different stages of the main technical development areas for the licensing process and the requirements and conditions that must be fulfilled by applicants prior a CONTRAS licensing be issued, in accordance with the 1985 Edition (As Amended 1990) of the IAEA Regulations for the Safe Transport of Radioactive Material (hereinafter called IAEA Regulations). Further on, the paper describes the most relevant activities performed by the ARN during the licensing process, among others: packaging manufacturing inspections; handling performance test; shielding behaviour and tests prior first shipment. Finally, brief comments are made on the experience gained from previous Type B(U) package design developments. And, finally, some ARN aspects of the applicants documentation revision and assessment, as well as main conclusions after the above mentioned licensing process. (authors)