Understanding AERB Compliance for X-Ray Equipment in India

What is AERB?

The Atomic Energy Regulatory Board is the authority responsible for regulating radiation safety in India. It oversees licensing, installation, and operation of radiation-emitting equipment such as medical and industrial X-ray systems.

• Radiation safety standard

• Equipment licensing

• Operational compliance

• Regulatory inspections
  

Topics covered include:

When Do You Need an AERB License?

1.

Operating an X-ray machine in a clinic or hospital

2.

Installing industrial radiography equipment

3.

Operating dental radiography systems

4.

Operating portable X-ray devices

eLORA Registration Explained

AERB manages radiation licensing through the eLORA portal, where facilities register their radiation equipment and obtain necessary approvals.

Basic steps:

Register facility in eLORA

1.

2.

Submit equipment details

3.

Obtain regulatory approval

4.

Maintain compliance records

Radiation Compliance Requirements

Equipment Approval

Ensure every X-ray machine has the required regulatory approval before installation and use.

Appoint a qualified Radiation Safety Officer and follow essential radiation protection measures.

Conduct periodic inspection, quality assurance, and compliance checks to maintain safe operation.

Radiation Safety Oversight

Inspection & QA Checks

Import Regulations for X-Ray Equipment

Importing radiation devices may involve regulatory clearance and compliance with applicable government rules.

Watch AERB Compliance Explained

Frequently asked questions

Is AERB approval mandatory for X-ray machines in India?

Yes, AERB approval is mandatory. Every X-ray machine must have Type Approval and the facility must be licensed through the e-LORA portal before installation and operation.

What is e-LORA registration for X-ray equipment?

e-LORA is AERB’s online portal used for licensing and registration of radiation facilities. It is required for procurement, installation, and operation of X-ray machines in India.

What is the role of CDSCO in regulating X-ray machines?

CDSCO regulates X-ray machines as Class C medical devices and issues manufacturing and import licenses to ensure safety, quality, and compliance with medical device rules.

How often is Quality Assurance (QA) required for X-ray machines?

Quality Assurance testing must be conducted at least once every two years or after major repairs to ensure accurate performance and radiation safety compliance.

Explore X-Ray Technology

Understanding regulatory requirements is closely linked to understanding the technology being used.