Consenting Process for Radiation Facilities - Atomic Energy ...

3.6.2 Site and Layout Plan Approval
The room housing the CT/Cath Lab unit should be planned in accordance
with the radiation safety requirements stipulated by AERB in safety code
titled ‘Medical Diagnostic X-ray Equipment and Installations’, [AERB/SC/
MED-2 (Rev.1), 2001]. These are essentially in the nature of access control,
patient flow control and radiation shielding. Adequate distance from the CT
unit/Cath Lab unit to walls and ceiling obviate the need for unnecessary
shielding and lead lining.
The CT/Cath Lab unit should be installed after obtaining layout plan approval
from the AERB. The application format for layout plan approval of the CT/
Cath Lab unit is given in Annexure 23.
3.6.3 Construction
The construction of the facility can be started after obtaining layout plan
approval from regulatory board and no separate regulatory clearance is
required for construction.
3.6.4 Procurement
It is to be ensured that only AERB Type Approved CT/Cath Lab units should
be installed and used for patient diagnosis in India. In case unit is not Type
Approved, Supplier/manufacturer has to submit application for Type Approval
and relevant documents to AERB for issuing Type Approval as referred in
subsection 3.18.1.
3.6.5 Commissioning and Operation
The applicant shall submit an application for Licence for operation of the CT
unit. `Prior to commissioning the Consentee should have a qualified and
trained Radiologist, and a radiography technologist/radiographer. The
radiographer or the radiologist, who is familiar with basic principles of
radiation protection, should be made responsible for radiation safety of the
patient and the medical staff. He may be designated as RSO Level-I with the
approval of the AERB. In response to the Licence application, AERB, as
necessary, will inspect the installation before granting the Licence for
operation of the CT/Cath Lab unit.
QA Test report as per format given in Appendix 8C-I OR 8C-II (as
appropriate) should be prepared and submitted along with application for
Licence. Radiation protection manual (RPM) should be prepared as per the
guidelines in Appendix 8E and updated from time to time. It should be made
available to AERB officials whenever asked during inspection.
The Consentee should submit to AERB periodic reports on the radiation safety
status of the installation. Any unusual occurrences should be promptly reported
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