Permissions and Approvals
Radiation Sources Operations
Information and Documents Required for Shielding Conformity Report of Indoor Areas Where Industrial Applications are Made and Areas Established for the Production, Maintenance and Repair of Radiation Sources or Reloading of Radioactive Sources
- "Application project CD (site plan, floor plans, sections) in dwg format", prepared in accordance with the Requirements to be Found in the Architectural Project Regarding the Shielding of Indoor Areas Where Industrial Applications are Made, containing the information regarding the shielding of the placement of the device in the room (Annex 7.1)
- Shielding Conformity Report Application Form for Indoor Areas Where Industrial Applications are Made (Annex-7.2) (must be filled separately for different radiation sources).
- Detailed information and catalog about the technical features and purpose of use
Required Information and Documents for the Evaluation of Revised Project Shielding in Licensed Units and Facilities
the Evaluation of Revised Project Shielding in Licensed Units and Facilities
In case the following changes are made in the projects of accelerator facilities, radioisotope and radiopharmaceutical production facilities, PET, PET/CT and Inpatient treatment units; the changes are notified to the NDK by the applicant company.
The applicant company is required to send following forms with the Revised Architectural Project CD in dwg format for application.
- Shielding Conformity Report Application Form of Accelerator Facilities for the acceleration facilities (Annex-1.2)
- Shielding Conformity Report Application Form for Radioisotope Production or Radiopharmaceutical Preparation Facilities for radioisotope and radiopharmaceutical production facilities (Annex-2.2)
- Shielding Conformity Report Application Form of the Units (Diagnostic and Outpatient Treatment) where Nuclear Medicine Applications are made for PET and PET/CT units (Annex- 4.2)
- Shielding Conformity Report Application Form for Inpatient Treatment Units for Inpatient Treatment Units (Annex. 5.2)
For Accelerator Facilities
- Changing the location and size of the cyclotron room, changing the device characteristics or increasing the production capacity
- Addition of New cyclotron room
- Changing the location and size of the production laboratory or adding a new synthesis cell, a second production laboratory
- Quality control, changing the location and size of the solid radioactive waste room or adding a new room for the same purpose
Radioisotope Production or Radiopharmaceutical Preparation Facilities
- Changing the location and size of the production laboratory or adding a new synthesis cell, a second production laboratory
- Quality control, changing the location and size of the solid radioactive waste room or adding a new room for the same purpose
PET and PET/CT units
- Changing the location of current PET and PET/CT
- Any Change in current dose rate in the room (for example changing PET with PET/CT system) or any device change
- Addition of new imaging device
- Changing the hot cell location and size
- Addition of new hot cell
- Change in size and the location of the following rooms; radioactive patient waiting room, injection room, patient toilet, late imaging room and waste room additional of a new room
Inpatient Treatment Units
- Changing the location and size of the inpatient treatment room or adding a new treatment room
- Addition of new treatment room for Lu-177, In-111 etc.to current I-131 treatment room
- Change of size or location of hot cell
- Addition of a new hot cell.
- Change in the location of solid waste room or addition of a new room.
Information and Documents Required for Shielding Conformity Report of Acceleration Facilities
- “Application project CD in dwg format (site plan, floor plans, sections)", prepared in accordance with the Required Issues in the Architectural Project for Shielding of Accelerator Facilities, containing information on the layout and shielding of the facility (annex-1.1)
- Shielding Conformity Report Application Form of Accelerator Facilities for the acceleration facilities (Annex 1-2)
- Detailed information and catalog specifying the technical specifications of the cyclotron device(s) and production cells
- Flow chart showing procedures in detail covers; production, packaging, distribution, liquid and solid waste system, ventilation and chimney system etc. in the facility. Flow chart showing procedures in detail
Information and Documents Required for Shielding Conformity Report of Radioisotope Production or Radiopharmaceutical Preparation Facilities
- "Application project CD in dwg format (site plan, floor plans, sections)", prepared in accordance with the Required Considerations in the Architectural Project for shielding of Radioisotope Production or Radiopharmaceutical Preparation Facilities, containing information on the layout and shielding of the facility (Annex-2.1)
- Shielding Conformity Report Application Form for Radioisotope Production or Radiopharmaceutical Preparation Facilities for radioisotope and radiopharmaceutical production facilities (Annex2.2)
- Detailed information and catalog on the equipment of the facility
- Flow chart showing procedures in detail covers; production, packaging, distribution, liquid and solid waste system, ventilation and chimney system etc. in the facility
Information and Documents Required for Shielding Conformity Report of Inpatient Treatment Units
- "Application project CD (site plan, floor plans, sections) in dwg format, including the tank system, prepared in accordance with the Requirements for the Architectural Project for Shielding of the Inpatient Treatment Units with Radioactive Substances (Annex 5.1), containing information on the placement and shielding of the inpatient treatment unit, and the characteristics of the liquid radioactive waste holding tank system”
- Shielding Conformity Report Application Form for Inpatient Treatment Units for Inpatient Treatment Units (Annex-5.2)
Information and Documents Required for the Shielding Conformity Report of the Rooms of Radiotherapy Applications and/or Simulation Devices
- Application project CD (site plan, floor plans, sections) in dwg format, prepared in accordance with the Architectural Project Regarding the Shielding of the Rooms of Radiotherapy Applications and/or Simulation Devices , containing information on the location of the radiation source and shielding)"
- Shielding Conformity Report Application Form of Rooms of Radiotherapy Applications and/or Simulation Devices (Annex-3.2) (must be filled separately for each device)
- Detailed information and catalog specifying the technical characteristics of the radiation source
In the license application, It is sufficient to send the project, which shows the room where the simulation device is installed and the adjacent areas, and which has been prepared in accordance with the Requirements to be included in the Architectural Project Regarding the Shielding of the Rooms of the Radiotherapy Practices and/or the Simulation Devices (Annex-3.1)
Information and Documents Required for the Shielding Conformity Report of the Units (Diagnostic and Outpatient Treatment) of Nuclear Medicine Unit
- Application project CD (situation plan, floor plans) in dwg format, prepared in accordance with the Architectural Project Required Considerations for the Shielding of the Nuclear Medicine Units (Diagnostic and Outpatient Treatment), containing information on the placement and Shielding of the nuclear medicine unit)"
- Shielding Conformity Report Application Form of the Units (Diagnostic and Outpatient Treatment) Nuclear Medicine Units (Annex-4.2) Note: The shielding conformity report is not mandatory for SPECT or SPECT/CT units.
It is sufficient to send the architectural project prepared in accordance with the Requirements to be in the Architectural Project (Annex-4.1) regarding the Shielding of Nuclear Medicine Units (Diagnostic and Outpatient Treatment), showing the rooms and adjacent areas in the SPECT or SPECT/CT units.
Information and Documents required for the Shielding Conformity Report of Diagnostic Radiology Rooms.
- "Application project CD in dwg format (site plan, floor plans, sections)", which contains information about the placement of the device in the room and the shielding, prepared in accordance with the Requirements to be Found in the Architectural Project for the Shielding of Diagnosic Radiology Applications (annex-6.1).
- Shielding Conformity Report Application Form of Diagnosic Radiology Applications (Annex-6.2) (must be filled separately for each device).
- Detailed information and catalog specifying the technical characteristics of the device
Note: It is not mandatory to receive a “Shielding Conformity Report” from the Authority. In the license application, the architectural project showing the room and adjacent areas where the radiation source will be used and kept should be prepared in accordance with the Required Items in the Architectural Project (Annex-6.1) and sent to the Authority. In order to provide practical information about shielding to the companies for the rooms where the radiology devices will be installed, standard room sizes and shield thicknesses that may be sufficient depending on the type of device, workload and shield material. It is given in detail in the document named (RSGD-KLV-007). Organization may determine the shielding conditions before applying for a license by using this document.