What must happen before radiation therapy equipment can be approved for patient use?

Before radiation therapy equipment can be approved for patient use, it is essential that the equipment is type-approved. Type approval ensures that the manufacturer's equipment adheres to regulatory standards that have been established for safety, reliability, and effectiveness in clinical settings. This approval process typically involves rigorous testing and evaluation of the equipment by designated regulatory bodies to confirm that it meets all necessary specifications. Only after passing these standards can the equipment be deemed safe for clinical use, protecting patient safety and treatment efficacy.

While acceptance tests and maintenance are also vital aspects of ensuring the equipment functions correctly and safely, they occur after the type approval process and do not directly lead to initial approval for patient use. Regular maintenance helps keep already approved equipment in proper working condition but does not have a bearing on the initial approval process. Operating in all settings is not a requirement for approval, as equipment may be designed for specific applications and not every treatment environment.