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3.1.1 Type Approvals<br />

For the purpose of ensuring that the radiation doses<br />

received by workers and members of the public do not exceed<br />

the prescribed dose limits and further that such doses are<br />

kept As Low As Reasonably Achievable (ALARA), design<br />

safety is accorded primary importance and operational<br />

control measures are monitored. With this in view, all devices<br />

including radiation generating equipment and those<br />

incorporating radioactive sources are subjected to a type<br />

approval procedure. AERB permits only type-approved<br />

devices to be marketed in India. The criteria for type<br />

approval are stipulated in the Standards Specifications (SS)<br />

documents on a variety of devices, issued by AERB. These<br />

SS documents are periodically reviewed and revised, w<strong>here</strong><br />

necessary, in order to meet internationally accepted and<br />

current standards. SARCAR examines the design safety<br />

features of each device and recommends issuance of type<br />

approval. SARCAR held 5 meetings during the year. Based<br />

on the recommendations of SARCAR, AERB issued type<br />

approval certificates to the manufacturers/suppliers of devices<br />

incorporating radioactive materials and radiation generating<br />

equipment. Number of the devices type approved during<br />

the year is given in Table 3.2.<br />

Table 3.2: Type Approvals Granted<br />

(Radiation Generating Equipment and Equipments<br />

Containing Radioactive Material)<br />

Sr. Type of Equipment Number of<br />

No.<br />

Approvals<br />

1 Medical diagnostic X-ray Units 100<br />

2 Radiotherapy Simulators 3<br />

3 Computed Tomography 7<br />

(CT) Units<br />

4 Telegamma Therapy Units 10<br />

5 Gamma Knife Units 1<br />

6 Medical Linear Accelerators 16<br />

7 Remote Controlled after-loading 9<br />

Brachytherapy Units<br />

8 Gamma Chambers 1<br />

9 Nucleonic Gauging Devices 32<br />

10 Baggage Inspection Systems -<br />

11 Industrial Radiography 9<br />

Exposure Devices<br />

12 Industrial Accelerators 1<br />

13 Industrial X-ray Units 2<br />

14 Blood Irradiators 6<br />

15 Medical Cyclotron 5<br />

3.1.2 Approval of Radiological Safety Officers<br />

During the year 2006-07, approval certificates were<br />

issued to 379 RSOs. Details of the approval are given in<br />

Table 3.3.<br />

Table 3.3: Approval Certificates Issued to RSOs<br />

Sr. RSO Level Number<br />

No.<br />

Approved<br />

1 RSO Level-III (Medical) 142<br />

2 RSO Level-III 13<br />

(Industrial Radiography)<br />

3 RSO Level-III 05<br />

(Gamma Irradiators)<br />

4 RSO Level-II 35<br />

(Industrial Radiography)<br />

5 RSO Level-II 40<br />

(Nuclear Medicine Diagnosis)<br />

6 RSO Level-I 124<br />

(Nucleonic Gauge)<br />

7 RSO Level-I 25<br />

(Research Applications)<br />

3.1.3 Approval of Packages for Transport of<br />

Radioactive Material<br />

As per AERB regulations, Type-A packages, which<br />

are permitted to transport radioactive material of activity<br />

not exceeding the specified limits, need to be registered with<br />

AERB. All Type-B packages are subjected to a stringent<br />

approval procedure and are required to fulfill the regulatory<br />

standards. Three registration certificates for Type-A packages<br />

were issued by AERB during the year. Nine validity<br />

certificates of approval of design of Type-B packages were<br />

renewed and 1 approval for the design of the Type-B package<br />

was issued.<br />

3.2 LICENSING / AUTHORISATION AND<br />

REGULATORY INSPECTIONS<br />

3.2.1 Licensing / Authorization<br />

Licenses for operation were issued to 3 medical<br />

cyclotrons and 2 high capacity gamma radiation processing<br />

plants.<br />

AERB issued 331 regulatory licenses as Certificate<br />

of Registration to diagnostic X-ray installations upon<br />

confirming that the applicable regulatory requirements are<br />

duly satisfied. Details of Licences/NOCs issued by AERB<br />

during the year 2006 are given in Table 3.4.<br />

25

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