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X-Ray
MEDICAL DIAGNOSTIC X-RAY
     
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STATUTORY REQUIREMENTS FOR THE SAFE OPERATION OF MEDICAL X-RAY MACHINES BY HOSPITALS, CLINICS AND OTHER MEDICAL INSTITUTIONS IN INDIA

Ionising radiation, such as medical X-rays, is used in medicine as an essential tool for protecting and improving human health since its discovery at the end of 19th century. Over 90 % of the workload in diagnostic radiology in many countries is the general radiography and is a major contributor to the collective population dose. It is therefore essential, from the radiological safety view point, to exercise strict regulatory control over the safe use of such beneficial application of ionizing radiation. The regulatory framework for controlling safe use of ionizing radiation sources, including medical X-rays, is mainly based on the following;

The national regulatory authority, i.e., Atomic Energy Regulatory Board (AERB) has been set up to carry out certain regulatory and safety functions envisaged under Sections 16, 17 and 23 of the Atomic Energy Act 1962. Chairman, AERB has been notified as the Competent Authority for the enforcement of radiation protection in the country.

The Safety Code (No. AERB /SC/MED-2(Rev.1), 2001), published by AERB is intended to govern radiation safety in design, installation and operation of X-ray equipment for medical diagnostic purposes. The implementation of provisions of the Safety Code ensures the radiation protection of occupational workers, patients and public at large. Some of the regulatory requirements of the Safety Code are:

  • Only those X-ray units should be procured by the users which have been Type Approved by the Competent Authority.

  • Installation and room lay-out should be in accordance with the specifications of the Safety Code.

  • User should ensure that on acquisition (by purchase, transfer, gift, lease or loan) of X-ray equipment, it is registered with the Competent Authority.

  • The Radiological Safety Officer (RSO) should conduct periodic radiological protection survey of X-ray installation and maintain records on routine Quality Assurance (QA) tests on X-ray unit.

  • All radiation workers should use appropriate personnel monitoring badges (TLD badges).

The Safety Code emphasizes that an ultimate responsibility of ensuring radiation safety, availability of RSO and qualified personnel for handling of X-ray equipment rests with the employer.

It is statutory requirement that Registration for general X-ray diagnostic practice and Licence for CT-scan, interventional radiology practice is obtained from AERB for operation of these equipment.

To facilitate the effective implementation of stipulated regulatory requirements by users of medical X-ray equipment, AERB has evolved standard application forms for obtaining lay-out plan approvals of medical X-ray installations, type approvals of equipment, acceptance test report (ATR) as a part of QA performance tests of equipment and the regulatory consents for operation of such equipment. Regulatory requirements in Diagnostic Radiology, in the form of flow chart are shown in Annexure-1. Applicable forms at each step of the flow chart can be downloaded from AERB website. The applicable prescribed forms for the medical X-ray diagnostic practices are listed in Annexure -2 to this page. These forms may be downloaded and the duly filled forms along with necessary enclosures may be forwarded to the Head, Radiological Safety Division (RSD), Niyamak Bhavan-B, Anushaltinagar, Mumbai-400 094 for further regulatory action. The lead time for issuance of approvals by AERB is normally 6 weeks, if the applications are found to satisfy all the stipulated requirements. The contact details of Head, RSD, AERB are,

  • Fax No. : +91-22-2599 0650
  • Tel. No. : +91-22-2599 0655 / 657
  • Email : dr.avinashs@aerb.gov.in

It may be noted that these forms are subject to periodic review and therefore it is advised that the website of AERB need to be visited frequently to obtain updated information on the current applicable regulatory requirements in the field of radiological safety in diagnostic radiology.


These documents can be purchased from Administrative Officer, Atomic Energy Regulatory Board, Niyamak Bhavan, Anushaktinagar, Mumbai - 400 094.