IEC, AERB and FDA Standards in Maintenance

Body	Full form	Region / scope	Role in maintenance
IEC	International Electrotechnical Commission	International standards	Safety and performance standards for medical electrical equipment (IEC 60601 series, e.g. 60601-1 general safety, 60601-2-44 CT, 60601-2-54 X-ray) and acceptance/constancy test methods (IEC 61223)
AERB	Atomic Energy Regulatory Board	India	Licenses radiation facilities; sets QA tests and periodic inspections; requires RSO, dosimetry and records; approves equipment type
FDA	Food and Drug Administration	USA	Regulates device approval (510(k), PMA), performance standards for X-ray equipment (21 CFR 1020), service and recall rules; requires maintenance records and reporting of faults

How they guide maintenance

1. Define acceptable limits for kVp, mA, timer, dose output, leakage and image quality.
2. Specify test frequency (acceptance, annual and constancy tests).
3. Require documentation, traceable calibration and trained personnel.
4. Require safety interlocks, labelling and electrical safety (earth leakage).
5. Enforcement through audits, licence renewal and penalties.

Exam tip

Write a 3-row table (IEC standards, AERB regulator, FDA regulator) with one line on maintenance duties each.