Volume 2 - Atomic Energy Regulatory Board

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B.2. B.2.1 MANAGEMENT FUNCTIONS This section should specify the management’s policy statement and organisation plan. Organisational plan should be documented addressing the following aspects: (a) (b) (c) (d) Organisational structure Functional responsibility Levels of authority Lines of internal and external communication. It should also address requirements related to availability of competent manpower for commissioning and operation of the facility. The functional responsibilities of all the personnel distinguishing task including their assigned administrative powers should be identified and documented. The necessary resources required by these personnel to discharge the following responsibilities need to be identified: (a) (b) Commissioning and operation of the facility is carried out in accordance with approved procedures, design specifications, designers’ instructions. Controlling access to the operating facility. Procedures need to be documented for formal reviews of QA programme by management as often as necessary or any changes in the regulatory requirements that may have been introduced after the previous approval of QA programmes. Identification and control of compliance with applicable codes, standards, specification and practices; acceptance criteria (qualitative and/or quantitative as appropriate) for determining satisfactory completion of the commissioning and operation activity should be described in the QAM. Interfaces The interface arrangements should be agreed with the licensee and various agencies involved (namely design, construction, commissioning, operation, decommissioning, AERB and statutory agencies as applicable). Handover/ transfer responsibilities after completion of construction/ installation to operating organisation. B.3 PERFORMANCE FUNCTIONS B.3.1 Document Control (a) Procedures for the preparation, review, approval, issue, modification and control of documents pertaining to activities affecting commissioning and operation should be established. 195
B.3.2 (b) (c) (d) Document release and distribution system shall be established utilising up-to-date distribution lists. Individuals responsible for issue of documents shall be identified. Documents important for commissioning and operation include among others, final safety analysis report (FSAR), acceptance test report (ATR), and radiation protection manual (RPM), commissioning reports and technical specifications for operation. Procedures for making interface with various components and systems should be prepared. Verification and validation of software used for operational control should be done by the independent agencies. Process Control B.3.2.1 Commissioning Control Procedures should be established to ensure that appropriate tests are performed during commissioning to demonstrate that design intent and, regulatory and other statutory requirements are met. Satisfactory demonstration of functional capability of safety systems is a prerequisite for considering the medical cyclotron facilites to be suitable for the operating phase. Measures shall be established to ensure that all commissioning activities including beam extraction, transport and dumping are planned, controlled and implemented in accordance with approved documents such as procedures, instructions and checklists, and results documented. Commissioning activities shall commence only after due completion of respective construction activities supported by certified documents. Inspection and surveillance shall be performed by the facility and documented to verify compliance with specification requirements. Measures shall be established to identify, review, resolve and document all non-conformances and design changes. A system for audit of commissioning, follow-up and record of corrective actions shall be established. B.3.2.2 Operation Control Documented procedure shall be established for safe operation of the medical cyclotron facilites in accordance with the design intent and specified operational limits. Provisions should be included to ensure interface among agencies for operation, maintenance, technical services, plant management, design, inspection, testing, verification and audit. 196
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GUIDE NO. AERB/RF/SG/G-3 (Vol. 2 of
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4. Performance of Safety System/Int
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APPENDIX-3D-I & II (Refer section 3
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APPENDIX-3D-III (Refer section 3.7.
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APPENDIX-3E (Refer section 3.2.2.5
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APPENDIX-3F (Refer sections 3.2.2.3
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1.6 Non-conformance Control and Cor
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and that of product specifications.
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4. Hazard Assessment (a) (b) (c) (d
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(h) 4. Safety Analysis (a) (b) (c)
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APPENDIX-4C (Refer section 3.3.4) F
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APPENDIX-4F (Refer section 3.3.2 to
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established which includes the arra
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conditions adverse to quality, such
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B.3.2 (d) report (ATR), and radiati
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for review and disposition of non-c
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Leakage radiation and other paramet
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- Dose rate profiles anticipated at
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other action to be taken (e.g. Ozon
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APPENDIX-5D (Refer section 3.4.1.4)
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(c) (d) (e) (f) (g) (h) (i) (j) Fac
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(b) Structural design: Seismic and
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20. Pre-operational radiation surve
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APPENDIX-5E (Refer section 3.4.1.4)
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APPENDIX-5F (Refer section 3.4.1.3,
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A.3.2 A.3.3 control of documents sh
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A.7. for review and disposition of
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B.3.2 (b) (c) (d) Document release
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for review and disposition of non-c
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(c) (d) (iii) (iv) (v) (vi) (vii) (
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APPENDIX-6B (Refer section 3.4.3.3)
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- Prevention of accidental fall of
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- Type of detectors used and their
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APPENDIX-6D (Refer section 3.4.3.4)
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- Prevention of accidental fall of
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- Type of detectors used and their
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Provisions including adequate finan
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Price Order for this guide should b
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such as industrial safety and envir
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Betatron An electron accelerator in
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Manufacture, possess, store, use, t
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adioactive substances and has an ac
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Treatment Simulation Methods by whi
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CONTENTS FOREWORD .................
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3.3.8 Lead Time for Submission/Avai
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3.8.3 Construction ................
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3.15.2 Procurement and Registration
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FUNCTIONAL PERFORMANCE OF SAFETY SY
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GAMMA RADIATION PROCESSING FACILITY
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FACILITY FOR RADIATION TECHNOLOGY (
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ANNEXURE-33b APPLICATION FOR PROCUR
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BIOMEDICAL RESEARCH STUDIES ON HUMA
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ANNEXURE-59 APPLICATION FOR NO (3.1
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VOLUME - 2
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tools should conform to the relevan
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(c) (d) (ii) (iii) (iv) (v) (vi) (v
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APPENDIX-2B (Refer section 3.2.1.3)
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- Overhead water storage tank detai
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- Ozone concentration (maximum) ant
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APPPENDIX-2C (Refer section 3.2.1.4
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1. SAFETY SYSTEMS/INTERLOCKS (CONTD
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2. AREA/ZONE MONITORS S. No. 1. 2.
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3. EMERGENCY WATER LEVEL SENSOR (CO
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5 (i) SEARCH OPERATION - 1 (Hydraul
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S. No. 1. 2. 3. 4. 5. 6. Audio / Co
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the design, statement declaring com
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- Gravity/accidental fall of rack i
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5. Design Basis Accident Analysis A
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h. Quantity of activity : —— PB
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F. EMERGENCY PLANNING AND PROCEDURE
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(g) (h) 1.2 Organisation The need t
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(i) (ii) (iii) 1.3 Interfaces Ensur
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(iii) (iv) (v) (vi) All constructio
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Standards to which the accelerator
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(b) Accelerator facility (c ) Elect
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15. Details of Disposal Procedures
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Details of beam energy and current
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(h) Laboratory, workshops, stores e
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(i) (ii) (iii) (iv) (v) (vi) During
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4. Documentation Detail Design Deta
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8. Normal and Emergency Operation P
Page 171 and 172: 4. Performance of Safety System/Int
Page 173 and 174: APPENDIX-3D-I & II (Refer section 3
Page 175 and 176: APPENDIX-3D-III (Refer section 3.7.
Page 177 and 178: APPENDIX-3E (Refer section 3.2.2.5
Page 179 and 180: APPENDIX-3F (Refer sections 3.2.2.3
Page 181 and 182: 1.6 Non-conformance Control and Cor
Page 183 and 184: and that of product specifications.
Page 185 and 186: 4. Hazard Assessment (a) (b) (c) (d
Page 187 and 188: (h) 4. Safety Analysis (a) (b) (c)
Page 189 and 190: APPENDIX-4C (Refer section 3.3.4) F
Page 191 and 192: APPENDIX-4F (Refer section 3.3.2 to
Page 193 and 194: established which includes the arra
Page 195 and 196: conditions adverse to quality, such
Page 197 and 198: B.3.2 (d) report (ATR), and radiati
Page 199 and 200: for review and disposition of non-c
Page 201 and 202: Leakage radiation and other paramet
Page 203 and 204: - Dose rate profiles anticipated at
Page 205 and 206: other action to be taken (e.g. Ozon
Page 207 and 208: APPENDIX-5D (Refer section 3.4.1.4)
Page 209 and 210: (c) (d) (e) (f) (g) (h) (i) (j) Fac
Page 211 and 212: (b) Structural design: Seismic and
Page 213 and 214: 20. Pre-operational radiation surve
Page 215 and 216: APPENDIX-5E (Refer section 3.4.1.4)
Page 217 and 218: APPENDIX-5F (Refer section 3.4.1.3,
Page 219 and 220: A.3.2 A.3.3 control of documents sh
Page 221: A.7. for review and disposition of
Page 225 and 226: for review and disposition of non-c
Page 227 and 228: (c) (d) (iii) (iv) (v) (vi) (vii) (
Page 229 and 230: APPENDIX-6B (Refer section 3.4.3.3)
Page 233 and 234: - Prevention of accidental fall of
Page 235 and 236: - Type of detectors used and their
Page 237 and 238: APPENDIX-6D (Refer section 3.4.3.4)
Page 241 and 242: - Prevention of accidental fall of
Page 243 and 244: - Type of detectors used and their
Page 245 and 246: Provisions including adequate finan
Page 247 and 248: (b) Contamination monitoring - On l
Page 249 and 250: 1.3 Organisation The responsible or
Page 251 and 252: (ii) (iii) 1.4 Interfaces Ensuring
Page 253 and 254: 1.6 Accident statistics should be m
Page 255 and 256: adiation zone monitors and radiatio
Page 257 and 258: (APPENDIX 8C-I, 8C-II, 8C-III AND 8
Page 259 and 260: 2. Pre-patient/post-patient collima
Page 261 and 262: APPENDIX-8C-I (Refer section 3.6.3)
Page 263 and 264: C.3 Measurement of Timer Linearity
Page 265 and 266: Tolerance : ± 20% of the quoted va
Page 267 and 268: (a) Shift in the edges of the radia
Page 269 and 270: 6. LINEARITY OF TIMER Operating par
Page 271 and 272: (c) (d) Recommended performance sta
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TABLE 3 : HVT AS A FUNCTION OF FILT
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2.5 Locking facility of the compres
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6. ACCELERATING VOLTAGE Result : Se
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Result : Coefficient of linearity f
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APPENDIX-8E (Refer section 3.6.3 )
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(THIS IS THE ONLY APPENDIX FOR INDU
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APPENDIX-10 (Refer section 3.18.1)
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APPENDIX-10 (CONTD.) (Refer section
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Containing Radioactive Substances
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LIST OF PARTICIPANTS DRAFT DOCUMENT
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ADVISORY COMMITTEE ON PREPARATION O
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PROVISIONAL LIST OF CODES, GUIDES A
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Volume 2 - Atomic Energy Regulatory Board

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