Operating License for In Vivo Diagnostic Nuclear Medicine Facility

  1. UMKU PB Details
    • Parameter: All
    • Authority: Minister/Head of Agency
    • Requirements:
      1. 1. Report on the implementation of commissioning; Duration: -
      2. 2. As-built drawings; Duration: -
      3. 3. Certificate of quality compliance for Ionizing Radiation Source; Duration: -
      4. 4. Competence and authorization data for personnel;
        • Radiation protection personnel;
        • Personnel responsible for the security of radioactive materials;
        • Other personnel
        Duration: -
      5. 5. Documentation for radiation protection and safety, and/or safety of radioactive materials programs; Duration: -
      6. 6. Proof of ownership and/or control of Ionizing Radiation Source; Duration: -
      7. 7. Safety assessment documents for Ionizing Radiation Source and safety assessment for radioactive materials; Duration: -
      8. 8. Management system documentation; Duration: -
      9. 9. Maintenance program documentation; and Duration: -
      10. 10. Documentation for the decommissioning of Ionizing Radiation Source facilities. Duration: -
    • Obligations:
      1. 1. Produce products in accordance with the license issued by the Regulatory Body; Duration: -
      2. 2. Implement the provisions contained in the management system; Duration: -
      3. 3. Ensure that radiation protection and safety, and safety of radioactive materials requirements are met; Duration: -
      4. 4. Provide an opportunity for the Head of the Regulatory Body to conduct inspections during the validity of the license; Duration: -
      5. 5. Take necessary measures to prevent unauthorized transfer, theft, and sabotage of radioactive materials; Duration: -
      6. 6. Ensure that activities are conducted in accordance with the issued license; and Duration: -
      7. 7. Submit safety and security verification reports for radioactive materials to the Regulatory Body periodically each year, starting from the Business Permit issuance. Duration: -
Sector: Nuclear Energy Regulatory Agency
Status: Available
Belongs to:
86101
86103
86104

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