AERB Authorization

Case File Number: AP-23330-SA-XRE-001 Issuance Date: 18/10/2014Document Number: 14-AFSXE-20436 Expiry Date: 18/10/2017AUTHORIZATION OF SERVICE AGENCIES FOR MEDICAL DIAGNOSTIC X-RAY EQUIPMENT In exercise of the powers conferred under section 16 of the Atomic Energy Act, 1962 read in conjunction with Rule-3 of the Atomic Energy (Radiation Protection) Rules, 2004, the Atomic Energy Regulatory Board (AERB) hereby grants the Authorization in favor of MR. RAJESH BAPU, ADITHISRI RADIATION SERVICES, Chittoor hereinafter referred to as the Licensee, for providing the services as given in Table 1 of Annexure-1. This Authorization is applicable for Type of x-ray equipment as specified in Table 2 of Annexure-1. PARTNER, ADITHISRI RADIATION SERVICES Chittoor and MR. RAJESH BAPU are hereby identified as the Employer and Licensee respectively, for the purpose of assigning the responsibilities specified in the Atomic Energy (Radiation Protection) Rules, 2004. The Employer and Licensee are responsible for,1. Ensuring compliance with the relevant provisions of the i. Atomic Energy Act, 1962ii. Atomic Energy (Radiation Protection) Rules, 2004;iii. AERB Safety Code (AERB/SC/Med-2), 2001, Amendment 2012, and the revisions thereofiv. All applicable Safety Codes, Guides issued by AERB for the above practice and regulatory documents issued by AERB from time to time. v. Directives issued by Competent Authority from time to time.2. Ensuring compliance with terms and conditions stated overleaf.Note: This Authorization is issued ONLY from the RADIATION SAFETY VIEW POINT. All other clearances shall be obtained from concerned state/central/local authorities as applicable.A copy of this Authorization shall be displayed in a prominent location in the Company premises.Dr. Avinash U. SonawaneHead MR. RAJESH BAPU ADITHISRI RADIATION SERVICES 18 5281 6 SAPTHAGIRI NAGAR TIRUPATI, CHITTOOR, ANDHRA PRADESH-517501Copy to: PARTNER, ADITHISRI RADIATION SERVICES, CHITTOORTERMS AND CONDITIONS1. No activity shall be carried out by your institute for purposes other than those specified in this Authorization.2. The regulatory responsibilities of the employer, licensee and RSO as laid down in the Atomic Energy (Radiation Protection) Rules, 2004 or the latest revision of AERB Safety Code (AERB/SC/Med-2) shall be adhered to. 3. The spare parts used shall be those of OEM or equivalent.4. All models of x-ray tube and x-ray tube inserts to be imported shall be registered with AERB through eLORA5. For procurement/import of x-ray tube(s), the service agency shall obtain procurement permission from the competent authority 6. Availability of qualified and trained personnel and Personnel Monitoring Services to Radiation Workers shall be ensured all the time.7. The Annexure-I will require amendment whenever there is any change in the details provided. 8. In case there is change in information specified in this Authorization after its issuance, such as change of Employer, Licensee, name of institution it shall be ensured by licensee that the necessary amendment to this effect to the Authorization is obtained from the Competent Authority.9. The inventory report in the prescribed format and frequency shall be submitted to AERB. 10. The Authorization shall be renewed before expiry.11. Full facilities shall be accorded to any authorised inspector of the competent authority to inspect the facility at any time. Records on supply/installation/servicing/QA shall be made available12. Any incident involving radiation exposure to person shall be intimated to AERB immediately.13. Service agency shall have authorization from OEM for providing the services to x-ray equipment manufactured by them.14. This Authorization may be suspended, modified or withdrawn as specified in the Atomic Energy (Radiation Protection) Rules, 2004, in the event of contravention of the provisions of the above Act / Rules / Codes or terms and conditions of the Authorization. Where deemed appropriate, AERB may also initiate penal action against the Employer/licensee in such an event. Additional Terms and Conditions for suppliers of pre-owned medical diagnostic x-ray equipment 1. The supplier shall re-sell to the customer only AERB Type approved models anda) Every equipment re-sold, shall be labeled as PRE-OWNED before installation.b) on installation of the equipment, shall carry out acceptance testing/quality assurance as part of commissioning of x-ray equipment; c) shall ensure that the customer has the requisite radiation protection devices as applicable. In case of computed tomography equipment, the supplier shall provide the required phantoms for image quality checksd) shall check for layout and shielding adequacy at the utility site before installation of x-ray equipment.e) shall submit after every installation, an installation report to the regulatory body in the specified format.f) shall submit confirmation of decommissioning to regulatory body, in case of decommissioning of the x-ray equipment. g) In case of imported pre-owned equipment, the Service Agency should provide the relevant certificate from country of origin to utilities.h) provide Technical catalogues, service, QA and Design manuals of the equipment.i) undertaking that the equipment will be under warranty j) provide exposure protocols for patient examinationsk) provide operational training to operator(s)2. In case equipment does not perform in compliance with specifications, equipment will be taken back by the supplier.3. AERB Authorization will be valid for that duration for which OEM authorisation exists. Quality Assurance Service Provider, shall1. Present the copy of the AERB certificate to utility on demand2. Ensure availability of QA equipment with valid calibration certificate while providing the services.3. Maintain all records of utilities to which the services were provided, in the format as specified by regulatory body for specified period. Case File Number: AP-23330-SA-XRE-001 Issuance Date: 18/10/2014Document Number: 14-AFSXE-20436 Annexure-ITable 1ADITHISRI RADIATION SERVICES, CHITTOOR is authorized to provide the following services Sr No. Services to be provided 1 Quality Assurance services of medical diagnostic x-ray equipmentTable 2ADITHISRI RADIATION SERVICES,CHITTOOR is authorized to provide the services for following type of equipment Sr No. Type of equipment1 Radiography (Fixed)2 Radiography (Mobile)3 Radiography (Portable)4 Radiography and Fluoroscopy5 Interventional Radiology6 C-Arm7 O-Arm8 Computed Tomography9 Mammography 10 Dental Cone Beam CT11 Ortho Pantomography (OPG)12 Dental (Intra Oral)13 Dental (Hand-held)14 Bone Densitometer (BMD) Note: You are required to apply for ‘Modification of Authorization’ in case of any change in the details of Annexure-1 Case File Number: AP-23330-SA-XRE-001 Issuance Date: 18/10/2014 Document Number: 14-AFSXE-20436 Expiry Date: 18/10/2017 Case File Number: AP-23330-SA-XRE-001 Issuance Date: 18/10/2014 Document Number: 14-AFSXE-20436