What Safety Standards Apply to Diagnostic Imaging Equipment?
Ensuring patient and staff safety is a top priority in medical imaging. That’s why diagnostic imaging equipment must meet strict safety standards set by regulatory bodies and industry organizations. These standards help minimize radiation risks, ensure accurate diagnostics, and maintain equipment performance over time. Key Safety Standards for Diagnostic Imaging Equipment 1. FDA Regulations (U.S.) The U.S. Food and Drug Administration (FDA) regulates medical devices, including diagnostic imaging systems like X-ray, CT, and MRI machines. Manufacturers must meet FDA approval before the equipment can be marketed. 2. IEC Standards The International Electrotechnical Commission (IEC) sets global safety benchmarks for electrical medical equipment. Standards like IEC 60601 ensure electrical and mechanical safety in diagnostic imaging systems. 3. Radiation Safety Guidelines Agencies like the International Atomic Energy Agency (IAEA) and National Council on Radiation Protection and Measurements...