X-Ray unit is inside a hospital (in-house diagnostic facility), then requirements, Documents & Approvals Needed for an In-House Hospital X-Ray Unit, AERB,

If the X-Ray unit is inside a hospital (in-house diagnostic facility), then requirements are slightly different because some licenses get clubbed under hospital permissions, but AERB approvals and safety compliances remain mandatory.

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🔹 Documents & Approvals Needed for an In-House Hospital X-Ray Unit

1. Hospital Legal Documents

• Hospital registration certificate (as per Clinical Establishments Act / State Medical Council rules).

• PAN, GST, and trade license (hospital’s existing documents can cover the X-ray unit too).

• Fire NOC and Building Safety Certificate (already needed for hospital setup).

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2. AERB (Atomic Energy Regulatory Board) Requirements

• eLORA Registration of Hospital (facility must be registered on AERB portal).

• AERB Equipment Approval – The X-ray machine must be AERB type-approved.

• Layout Plan Approval – X-ray room design with proper shielding must be approved.

• Radiation Safety Officer (RSO) – Hospital must appoint at least one certified RSO.

• Radiation Protection Program – Records of radiation surveys, safety protocols, and personnel monitoring (TLD badges).

• License to Operate – Final operation approval from AERB.

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3. Biomedical & Safety Compliance

• Biomedical Waste Management Authorization – Already required for hospital, but X-ray related waste (developer/ fixer in CR/DR if analog systems exist) must be included.

• Pollution Control Board Consent – Hospital’s authorization should mention radiology unit.

• Fire Safety & Disaster Management Plan – Hospital-wide but must include radiology.

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4. Staff & HR Documents

• Radiographer Qualification Certificates (Degree/Diploma in Radiography).

• Radiologist Registration – MCI / NMC / State Medical Council registration.

• RSO Certificate – May be a radiographer or physicist who has completed AERB-recognized training.

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5. Technical & Operational Records

• Equipment purchase invoice + service agreement.

• Annual Quality Assurance (QA) test reports of X-ray machine.

• Radiation survey reports (leakage test of X-ray room).

• Personnel monitoring records (TLD badge reports).

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✅ Summary for Hospital:
If the hospital already has legal permissions (trade license, fire NOC, biomedical waste), then for the X-ray department you mainly need:

1. AERB approvals (facility + equipment + RSO + layout).

2. Radiology staff documents (radiographer + radiologist).

3. Safety & QA records (radiation survey, TLD, QA test reports).