AERB Guidelines for Hospitals

This guide explains the AERB guidelines for hospitals area by area: diagnostic imaging, radiotherapy, dose management, training, room design, equipment QA and radioactive waste, plus the NABL 136 criteria for QA testing of diagnostic X-ray equipment. Every facility that operates medical diagnostic X-ray equipment needs an AERB licence, applied for through AERB's online eLORA portal.

What is the AERB?

The Atomic Energy Regulatory Board (AERB) is India’s regulator for nuclear and radiation safety. It was constituted by the President of India in November 1983 under the Atomic Energy Act, 1962, with the mission to regulate the use of ionizing radiation and atomic energy in India. For diagnostic X-ray facilities, its main requirements are set out in the safety code AERB/RF-MED/SC-3 (Rev. 2, 2016), which AERB checks during inspections.

AERB’s responsibilities include:

• Licensing facilities and institutions that use radiation.
• Monitoring radiation exposure in medical, industrial, and research settings.
• Ensuring compliance with safety regulations and guidelines.

Importance of AERB Guidelines in Hospitals

Radiation can be extremely harmful if not handled correctly. AERB guidelines for hospitals ensure that:

• Patients are protected from unnecessary radiation exposure.
• Healthcare workers follow best practices to minimize their radiation exposure.
• Hospitals maintain safe environments when using radiation-emitting devices or radioactive substances.

Key Areas Covered by AERB Guidelines for Hospitals

1. Radiation Safety in Diagnostic Imaging

X-ray, CT, fluoroscopy and mammography use ionising radiation and fall under AERB. MRI and ultrasound do not use ionising radiation and are not regulated by AERB.

Key Guidelines for Diagnostic Imaging

• Use of Lead Aprons and Shields: Patients and healthcare workers should be provided with protective gear to minimize radiation exposure.
• Limiting Radiation Exposure: Hospitals should adopt the “As Low As Reasonably Achievable” (ALARA) principle to keep radiation doses minimal.
• Radiation Monitoring: Regular radiation audits and monitoring should be conducted to ensure exposure levels stay within safe limits.
• Signage and Warning Labels: Appropriate signage must be placed in all areas where radiation-emitting devices are used.

2. Radiation Protection in Radiotherapy

Radiotherapy uses high-energy radiation, so errors affect patients directly and shielding failures affect staff.

Key Guidelines for Radiotherapy

• Patient Identification and Verification: Ensuring the correct patient receives the appropriate treatment is critical in radiotherapy.
• Dose Prescription and Delivery: The prescribed radiation dose must be carefully calculated and verified before each session.
• Protective Measures for Healthcare Workers: Healthcare professionals must use personal dosimeters to measure and monitor their radiation exposure.
• Equipment Quality Assurance: Regular calibration and testing of radiotherapy equipment are mandatory to ensure accurate radiation delivery.

3. Radiation Dose Management

AERB mandates that hospitals manage and monitor the radiation dose received by patients and healthcare workers.

Key Guidelines for Dose Management

• Dose Recording Systems: Hospitals should maintain records of radiation doses administered to patients.
• Monitoring Workers’ Exposure: Healthcare workers must be monitored for cumulative radiation exposure through personal dosimetry devices.
• Regular Audits: Hospitals must undergo routine inspections and audits to ensure that radiation doses are within the permissible limits set by AERB.

4. Medical Radiation Safety Training

Key Training Requirements

• Mandatory Safety Training: All staff working with radiological equipment must undergo mandatory radiation safety training.
• Periodic Refresher Courses: Healthcare institutions must offer periodic training updates to keep staff informed of new guidelines and best practices.
• Certification: Staff members should obtain certification in radiation protection techniques as required by the AERB.

5. Hospital Infrastructure Requirements

Infrastructure Guidelines

• Shielded Rooms: X-ray rooms, radiotherapy suites, and other radiation areas must have lead shielding to prevent radiation leakage.
• Access Control: Restricted access to radiation areas should be enforced to prevent unnecessary exposure.
• Ventilation Systems: Areas where radioactive materials are used must have proper ventilation to prevent contamination.

6. Equipment Calibration and Maintenance

Key Guidelines for Equipment Maintenance

• Periodic QA Testing: Radiological equipment must undergo quality assurance tests at the intervals AERB specifies and after major repairs, and the QA tools used are declared in eLORA.
• Routine Checks: Routine maintenance should be performed to prevent equipment malfunction.
• Record-Keeping: Hospitals must maintain records of equipment maintenance and calibration for AERB inspections.

7. Radioactive Waste Disposal

Key Guidelines for Radioactive Waste Disposal

• Segregation and Containment: Radioactive waste must be stored in special containers and segregated from other medical waste.
• Proper Disposal Methods: Hospitals must follow AERB-approved methods for the safe disposal of radioactive materials.
• Documentation: Records of radioactive waste disposal must be kept and available for AERB review.

Benefits of Complying with AERB Guidelines

Compliance with AERB guidelines offers numerous benefits, such as:

• Improved Patient Safety: Following AERB standards reduces the risk of radiation overexposure and associated health risks.
• Enhanced Reputation: Hospitals that comply with regulatory standards are perceived as more trustworthy by patients and healthcare professionals.
• Avoidance of Legal Penalties: Non-compliance with AERB guidelines can result in penalties, suspension of licenses, or other legal consequences.
• Better Healthcare Outcomes: Proper radiation use can improve diagnostic and treatment outcomes, leading to better overall healthcare.

NABL 136: QA Testing Of Diagnostic X-Ray Equipment

Quality assurance (QA) testing of diagnostic X-ray equipment has its own accreditation criteria, issued by the National Accreditation Board for Testing and Calibration Laboratories (NABL). NABL 136, "Specific Criteria for Accreditation of Quality Assurance Testing Facilities for Diagnostic Radiology X-Ray Equipment", sets sector-specific criteria, per ISO/IEC 17025:2017, for facilities that check the performance and safety of diagnostic X-ray equipment.

It matters to independent QA testing labs, hospitals and diagnostic centres with in-house QA, OEMs and authorised suppliers, and government and private health institutions seeking NABL accreditation.

What Changed In The April 2025 Amendment To NABL 136

Amendment No. 01, effective from April 4, 2025, was formulated with inputs from AERB and a technical committee. The main changes:

• Wider scope: QA facilities can be accredited for radiography (fixed, portable, mobile and handheld), CT and CBCT, mammography including tomosynthesis, dental imaging systems (IOPA, OPG, RVG and others), and interventional radiology and fluoroscopy units.
• Infrastructure: more detailed infrastructure and equipment lists, including specific phantoms and sensors for different imaging modalities.
• Personnel: technical staff need a minimum of 6 months' experience and a certified QA training programme (for example, by BARC or an AERB-recognised institute). Report review and authorisation must be assigned to qualified individuals.
• Records and reporting: raw data and QA reports must be retained for a minimum of 5 years, and unusual findings such as radiation leakage must be reported to AERB immediately.
• Management systems: quality manuals covering SOPs, calibration protocols and safety guidelines, plus mandatory internal quality controls such as intra-lab comparisons and functional checks.
• Test witnessing: NABL assessment teams witness on-site QA tests during accreditation audits to verify technical competence.

Next Steps For Hospitals With In-House QA

1. Review the amended NABL 136 document in full.
2. Update the equipment inventory to match the listed requirements.
3. Train technical staff to the new qualification criteria.
4. Revise SOPs and quality manuals.
5. Coordinate with NABL for surveillance, reassessment or reapplication for accreditation.

Conclusion

To stay compliant with AERB guidelines for hospitals, keep every radiation unit licensed in eLORA, appoint a radiological safety officer, issue personal dosimeters to all radiation workers, test equipment on schedule and keep the records ready for inspection.

Frequently Asked Questions