India AERB Registration: Step-by-Step Comprehensive Guide for Radiation Equipment
What is AERB?
AERB (Atomic Energy Regulatory Board) is the governing agency in India. It is responsible for nuclear and radiation safety. Formed in 1983 under the Atomic Energy Act of 1962. It is responsible for regulating nuclear and radiation safety in India, ensuring that the use of ionizing radiation and nuclear energy does not pose risks to public health or the environment. In operation, this translates into AERB authorizing and checking all India radiation plant and equipment AERB issues safety codes, guidelines and regulations (e.g., the Atomic Energy (Radiation Protection) Rules, 2004) and conducts reviews with a view to imposing standards. Short answer: Operation of X-ray, CT, radiotherapy machines, industrial radiography devices, nuclear gauges, irradiators, or any other radiation-producing apparatus in India must conform to AERB regulations.
Types of AERB Licenses
Industrial Licenses: Must be applied for use in procedures such as radiography, gauging, and irradiation. Usage is primarily for construction work on buildings, manufacture, etc.
Medical Licenses: Cover the medical use of radiation. Diagnostic radiology, radiation therapy, and nuclear medicine are all included within it. Ensure healthcare personnel and patient safety.
Licenses for research: Required for research institutions and academic centers. To use in experiments and research with radioactivity. To meet safety specifications in research centers.
Who Should Register with AERB?
Any organization dealing with radiation-emitting devices is required to be registered with AERB. These organizations include:
- Medical Centers: Hospitals, clinics, diagnostic centers with X-ray machines, CT scanners, mammography units, radiotherapy equipment, etc.
- Industrial Units: Entity engaging equipment like nuclear gauges, industrial radiography, or irradiators.
- Research Institutions: Laboratory and institutions employing radioactive sources.
- Radiation Equipment Providers: Companies that manufacture and supply radiation-related devices and machinery.
The RSO Function
An RSO is a trained professional whose role is to provide radiation safety in a facility. His or her role is:
- Implementation of radiation protection programs.
- Safety inspections and audits.
- Compliance with AERB guidelines.
- Radiation exposure and safety monitoring.
In order to become an RSO, one should be trained and AERB-approved certified. AERB-approved RSO certification courses are conducted by the Bhabha Atomic Research Centre (BARC).
A hospital or radiation facility must at least temporarily have an RSO who is trained in an AERB-approved course of radiation safety. A facility is not registered by AERB if there is no designated RSO holding such a qualification.
AERB Certificate for X-Ray Equipment
X-ray machine installation requires an AERB certificate to ensure the safety of the equipment. The process entails:
- Procurement Permission: A person requires permission from AERB to install a machine.
- Installation Report: Upload the installation report via the e-LORA portal.
- Quality Assurance (QA) Testing: Conduct QA tests for confirmation of the safety and functionality of equipment.
- License Application: Submit an operating license through e-LORA.
Radiation Equipment Registration Procedures
AERB registration is processed via the e-LORA (e-Licensing of Radiation Applications) portal. The steps are as follows:
- Institution Registration: Submitting registration of the institute on the e-LORA portal.
- Equipment Declaration: Declare all the radiation equipment (new/old) used in facility.
- RSO Registration: Register your Radiation Safety Officer.
- Document Upload: The necessary documents listed below need to be submitted online.
- Application Submission: Submit the application for consideration.
- Inspection and Approval: AERB inspects the application and can conduct inspections before providing approval.
Documents for AERB Registration
The following documents listed below are required for AERB registration:
- YKYC Documents: ID and address proof of the applicant and facility.
- Certificate of Incorporation: Organizations and companies.
- Equipment Details: Make, model, specs, and serial numbers.
- Quality Assurance Reports: Recent QA test reports of all equipment.
- RSO Approval Certificate: Proof of approval is required, and the RSO must be qualified.
- Radiation Survey Reports: Conducted by known agencies.
- Type Approval/NOC: Equipment, especially imported equipment.
- Plan of Facility Layout: Shading shielding and safety aspects.
- Employee Information: Information about radiation staff and designation.
- OEM Authorization
- all models of X-ray equipment intended to be supplied must be cleared by the Original Equipment Manufacturer (OEM) by the suppliers.
- Radiation Testing Facility
- The test site must be isolated from the entire working area.
- Radiation exposure limits must be set for the personnel.
- Public access to the test site must be restricted.
- Protection gear (e.g., aprons, shields, gloves) must be provided.
- Warning signs in the shape of radiation symbols must be posted near regions where radiation procedures are conducted.
- Beware of any contamination or exposure by taking precautions.
- Personnel and Qualified Personnel
- Hire well-qualified personnel for QA, testing, and maintenance of X-ray machines.
- Staff qualifications and training must be according to AERB-prescribed standards./li>
- Radiological Safety Officer (RSO)
- In the event that the supplier has an in-house radiating facility, a certified RSO will be appointed.
- The RSO will be AERB-approved and meet all the eligibility criteria.
- Conditions for Authorization of Suppliers
- Supply only AERB-approved models.
- Ensure lifetime servicing of diagnostic X-ray facilities.
- Ensure that clients are equipped with proper safety equipment, including:
- no Lead aprons
- no Protective shields
- no Rubber covers
- Check for shielding and design accuracy in the client's organization.
- Furnish installation reports in AERB-recommended format.
- Decommission and deconstruct the facility as and when required.
- Report activities post-decommissioning or disposal of equipment.
- Comply with additional conditions as specified by AERB.
- No Objection Certificate (NOC) / E-Approval
- Before sale of equipment, the sellers must have a No Objection Certificate (NOC) or e-approval of the AERB.
- Obtain a Type Approval Certificate based on performance of the prototype.
- Import the prototype only if they hold an NOC of the concerned authority.
- Periodic imports could be permitted after-Type Approval on an approved procurement basis for each consignment.
- Type Approval is withdrawn when any design change is done to the approved version.
- Safety Reports
- The licence holder shall submit periodic safety status reports to AERB on the given form.
- Technical Problems: Navigating the e-LORA portal and accurate data entry.
- Documentation: Obtaining and uploading all the documents in the right way.
- Compliance: All the facilities and equipment being within AERB standards.
- Training: Availability of suitable qualified personnel for RSO jobs and staff training.
- Radiation Protection Rules, 2004: Defining the procedures for safety and exposure levels.
- Safety Codes and Manuals: Providing entire procedures for individual radiation practices.
- Frequency Inspection: Ensuring continuous compliance through frequent inspection.
- Training Programs: Mandating training of RSOs and radiation workers.
- End-to-End Support: Complete support with AERB licensing and registration through the e-LORA portal.
- Institute & Equipment Registration: Support in registering your facility and informing all radiation equipment.
- Preparing document & Filing: Retrieving, authenticating, and uploading all documents as per requirements.
- RSO Registration: Support in recommending and registering a competent Radiation Safety Officer (RSO).
- QA Testing & Radiation Surveys: Arrangement with recognized laboratories for mandatory QA and radiation surveys.
- Type Approval & NOC: Support in obtaining Type Approval Certificates and import NOCs for X-ray and radiation equipment.
- Ongoing Compliance Support: Assistance in filing periodic safety reports and post-approval requirements within due time.
- Renewal & Modifications: On-time renewal of licenses and equipment or facility layout change.
- Liaison with Authorities: Timely coordination and communication with AERB officers to settle questions or objections.
- Expert Advice: Compliance consulting with AERB standards and delay avoidance from a legal or operational perspective.
Note: Documents mentioned above may vary depending on the nature of equipment and facility. Quoting AERB or the e-LORA portal is best in case of specific requirements.
X-Ray Equipment & Devices: Supply permission
If you are in X-ray equipment supplying business, you must fulfill the following AERB-recommended requirements to establish that you can provide radiation safety standards:
Suppliers must possess a special radiation testing facility which should be of the following standard:
Suppliers should meet the following important conditions:
Domestic and Imported Equipment
For the Imported Equipment:
AERB Registration Challenges
Even though e-LORA streamlines the registration process, applicants can experience problems such as:
Active planning with experts and consultancy can make such issues easier.
AERB Radiation Protection and Safety Guidelines
AERB has drawn up sophisticated radiation protection and safety guidelines, which include:
These guidelines are to be complied with for ensuring safe use of radiation equipment and personnel and protecting the public.
How SKMC Global Advisory Can Help
AERB was set up with regards to sensitivity and hazardous ranges of the radiation equipment. This is how the SKMC Global can prove to be useful in this regard: