Categories: Blog
Published 7 May 2024

Nowadays, medical devices are already using x-rays in the treatment of patients such as those used in CT-Scan tools to diagnose. A CT scan is an examination procedure that uses a computer and X-rays to view structures and tissues in the body from various angles. The device used in medicine as a diagnostic tool is an X-ray machine. This aircraft uses a vacuum tube as a source of electrons. These electrons will be accelerated and hit the metal anode. This perfectly spongy collision produces X-rays. X-ray machine CT-Scan is an X-ray machine that uses tomographic imaging methods with digital processes to create 3 (three) dimensional images of internal organs of the body from the acquisition of a number of 2 (two) dimensional images. 

Radiology is a branch of medicine that deals with the use of all modalities that use radiation for diagnostic and therapeutic procedures using radiology guidelines, including imaging techniques and the use of radiation with X-rays and radioactive substances. If you are in a hospital or clinic if you hear, see and read "X-rays" then you are in the Radiology service area. Diagnostic Radiology is a radiology technique to diagnose a disease or morphological abnormality in the patient's body by using X-ray machines such as CT scans.

Interventional Radiology is a Radiology technique using X-ray machines for real-time image-guided imaging in diagnosing and performing therapeutic measures by placing guide wires, stents, and related components inside the patient's body.

Nuclear Energy Regulatory Agency

Nuclear Energy Monitoring Agency (BAPETEN) is a body that regulates radiation safety requirements that must be met by license holders for the use of X-ray Device in diagnostic radiology and interventional radiology. The Radiation Safety Requirements regulated by BAPETEN are management requirements, Radiation Protection requirements, Engineering requirements and safety verification of General Radiography X-Rays, Fluoroscopic X-Rays, Mammography X-Rays, CT-Scan X-Rays, and Aircraft Dental X-Rays.

Regulation 

Before making a distribution permit for radiation health devices, business actors must have a standard permit/certificate as one of the requirements for applying for a medical device distribution permit. Examples of medical devices that have radiation are Ultrasonography (USG), CT-Scan, and Fluoroscopy. The Nuclear Energy Supervisory Agency (BAPETEN) has launched the BAPETEN Licensing and Inspection System Online (Balis Online) application which has been integrated with the Risk-Based Online Single Submission (OSS-RBA) to simplify the application for standard certificates. 

Business actors/applicants submit applications for NIB, Permits and Standard Certificates Through the OSS that have been integrated into the BAPETEN BaLis Application, the Applicants Complete the Requirements at BaLis Bapeten and make payments after BAPETEN conducts an assessment and Appraiser Approval. For Business Actor to obtain a Standard Certificate from OSS and Non Business Actor to obtain a permit from BAPETEN BALIS. 

Security & Safety 

The Person in Charge of Radiation Safety is the License Holder and other parties related to the Use of X-rays in Diagnostic Radiology and Interventional Radiology. Permit holders are required to fulfill management requirements which include, those in charge of Radiation Safety, Safety Culture, Health Monitoring, personnel, education and training on radiation protection and safety, recordings and reports. Permit holders are required to apply Radiation Protection and Safety Optimization to Medical Exposure through X-ray machines operational considerations, diagnostic guidance levels and patient companions. X-ray machines operational considerations include safety procedures for operating X-ray machines, so as to achieve optimization of radiation protection and safety for patients.