Installing high-end diagnostic modalities involves strict regulatory compliance and safety engineering. In India, ionizing radiation equipment (CT scanners, Cath Labs, PET-CT) is strictly regulated by the Atomic Energy Regulatory Board (AERB). Non-compliance can lead to machine sealing, heavy fines, and operational delays.
Meanwhile, MRI scanners—though non-ionizing—require specialized high-attenuation copper Faraday shielding cages and cryogenic quench venting. In this guide, we provide a step-by-step roadmap for hospital site planning and AERB eLORA approval.
1. AERB eLORA Approval Roadmap for CT & Cath Lab
Every ionizing medical diagnostic installation in India must follow a statutory 4-stage lifecycle on the AERB eLORA portal:
• Stage 1: Institute Registration — Filing hospital credentials and appointing an AERB-certified Radiation Safety Officer (RSO).
• Stage 2: Site & Layout Plan Approval — Submitting architectural CAD drawings demonstrating room dimensions, wall thickness, lead glass placement, and radiation occupancy surrounding the room.
• Stage 3: Procurement Permission — Obtaining formal approval to import or transfer the X-ray equipment to the hospital site.
• Stage 4: Commissioning & License to Operate — On-site radiation survey testing by an accredited QA agency, followed by grant of a 5-year operating license.
2. Radiation Shielding Specifications (Lead & Concrete)
For CT Scanners and Cath Labs, perimeter walls directly adjoining public corridors, waiting areas, or staff consoles must have a minimum of 2.0 mm to 2.5 mm lead equivalence (or 23 cm solid brick / 15 cm high-density concrete). Doors must be lead-lined with overlapping lead astragals.
Observation windows must feature certified radiation shielding lead glass with a minimum of 2.0 mm lead equivalence, securely framed in lead-lined casings to prevent scatter leakage.
3. MRI Siting: RF Faraday Cages & Quench Exhaust
MRI systems demand different, non-radiological physical safeguards:
• Copper / Galvanized RF Shielding: An MRI room must be enclosed in an RF cage attenuating external radio noise across frequencies up to 128 MHz by > 100 dB. Any RF leak causes image artifacts (zipper artifacts).
• Cryogenic Helium Quench Pipe: In the event of a sudden loss of superconductivity (magnet quench), thousands of liters of liquid helium rapidly vaporize into cold gas. A certified stainless steel quench pipe (minimum 20 cm diameter) must vent directly to a secure outdoor rooftop location away from windows and air intake vents.
Critical Site Prerequisites Checklist
Ensure floor slabs are rated for 5,000 to 7,000 kg concentrated point loads for MRI magnets and CT gantries without structural deflection.
Dedicated clean instrumentation earth pit (< 2.0 ohms) separate from the general building lightning and elevator earth.
Frequently Asked Questions
Final Clinical Takeaway
Rigorous site planning and proactive regulatory compliance prevent costly structural retrofits and licensing delays. Partnering with an experienced turnkey engineering provider ensures your facility opens on schedule.
Reach out to Elixmed Healthcare's project engineering wing for architectural site surveys and complete AERB layout drawings.
With over 15 years directing medical engineering and operations across Philips Healthcare, Abbott, and Medtronic, Rahul specializes in high-field MRI siting, multidetector CT calibration, and healthcare equipment finance in India.