Volume 2 - Atomic Energy Regulatory Board

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(k) 15. Chemical Safety Analysis of potential radiation exposure scenarios List of chemicals used with quantities, their toxicity and hazards, safety considerations, analysis of potential release scenarios and preventive and other action to be taken [e.g. ozone production and ozone depleting substance, flammable gases, liquids, oxygen deficiency hazard (SF6), biologically hazardous material, cryogenic fluids, etc.] 16. Fire Safety Fire and explosion hazards, means of escape, access, fire detection and alarm system, fire fighting system- fire hydrants, dry risers, fire extinguishers etc. 17. Personnel Safety Safety policy, organisation, functions of safety personnel, responsibilities, general safety rules, accident prevention program, safety equipment and procurement, safety inspection, housekeeping, accident reporting, investigation, preventive measures, training, medical facilities including first aid. 18. Safety in Operation and Maintenance (i) (ii) (iii) (iv) (v) (vi) Startup procedure Shutdown procedure Emergency shutdown procedure Search and secure Procedure for entry into cyclotron vault Others (eg. gas handling procedure), please specify. 19. Emergency Planning and Procedures (types of emergencies envisaged, preventive measures, handling of emergencies, investigation etc.) (i) (ii) (iii) (iv) (v) (vi) During major leaks, foil rupture, contamination, target rupture, loss of shielding integrity During explosion and fire During general fires During emergency in tanks and equipment etc. During radiation emergency Crisis management in case of major emergency 185
20. Pre-operational radiation survey report (background radiation in and vicinity of the medical cyclotron facility) 21. Quality assurance manual for construction of the facility (as per format given in item A of Appendix 6A of AERB/RF/SG/G-3) 22. Details of waste disposal pocedures and provisions including adequate financial arrangement for safe disposal of spent/ disused sources. 23. Details of storage facility for activated components and procedure (identifying long half life radioisotopes) 24. Details to be furnished regarding the decommissioning of the facility. B. OPERATING AND SAFETY PERSONNEL (i) Cyclotron operator : (ii) Radiopharmacist : (iii) Radiological safety officer : AERB Approval Ref. : Date of issue : Valid up to : DETAILS OF DOCUMENTS TO BE SUBMITTED Required documents Technical description of medical cyclotron design and working procedure with drawings Electrical circuit diagram and other interlocks of the medical cyclotron device (inbuilt safety features) Electrical circuit diagram and other interlocks of the medical cyclotron vault Calibration and periodic checks Provisions and procedures for (particle beam energy, beam current) Quality assurance manual (operation) Arrangements for personal and environmental monitoring system Periodic surveys of radioactive contamination if applicable Availability of local safety committee and their safety evaluation report Details of deviations from approved medical cyclotron components, medical cyclotron vault, shielding design, etc. Decommissioning procedures of the medical cyclotron facility 186
Page 1 and 2: GUIDE NO. AERB/RF/SG/G-3 (Vol. 2 of
Page 3 and 4: 4. Performance of Safety System/Int
Page 5 and 6: APPENDIX-3D-I & II (Refer section 3
Page 7 and 8: APPENDIX-3D-III (Refer section 3.7.
Page 9 and 10: APPENDIX-3E (Refer section 3.2.2.5
Page 11 and 12: APPENDIX-3F (Refer sections 3.2.2.3
Page 13 and 14: 1.6 Non-conformance Control and Cor
Page 15 and 16: and that of product specifications.
Page 17 and 18: 4. Hazard Assessment (a) (b) (c) (d
Page 19 and 20: (h) 4. Safety Analysis (a) (b) (c)
Page 21 and 22: APPENDIX-4C (Refer section 3.3.4) F
Page 23 and 24: APPENDIX-4F (Refer section 3.3.2 to
Page 25 and 26: established which includes the arra
Page 27 and 28: conditions adverse to quality, such
Page 29 and 30: B.3.2 (d) report (ATR), and radiati
Page 31 and 32: for review and disposition of non-c
Page 33 and 34: Leakage radiation and other paramet
Page 35 and 36: - Dose rate profiles anticipated at
Page 37 and 38: other action to be taken (e.g. Ozon
Page 39 and 40: APPENDIX-5D (Refer section 3.4.1.4)
Page 41 and 42: (c) (d) (e) (f) (g) (h) (i) (j) Fac
Page 43: (b) Structural design: Seismic and
Page 47 and 48: APPENDIX-5E (Refer section 3.4.1.4)
Page 49 and 50: APPENDIX-5F (Refer section 3.4.1.3,
Page 51 and 52: A.3.2 A.3.3 control of documents sh
Page 53 and 54: A.7. for review and disposition of
Page 55 and 56: B.3.2 (b) (c) (d) Document release
Page 57 and 58: for review and disposition of non-c
Page 59 and 60: (c) (d) (iii) (iv) (v) (vi) (vii) (
Page 61 and 62: APPENDIX-6B (Refer section 3.4.3.3)
Page 65 and 66: - Prevention of accidental fall of
Page 67 and 68: - Type of detectors used and their
Page 69 and 70: APPENDIX-6D (Refer section 3.4.3.4)
Page 73 and 74: - Prevention of accidental fall of
Page 75 and 76: - Type of detectors used and their
Page 77 and 78: Provisions including adequate finan
Page 79 and 80: Price Order for this guide should b
Page 81 and 82: such as industrial safety and envir
Page 83 and 84: Betatron An electron accelerator in
Page 85 and 86: Manufacture, possess, store, use, t
Page 87 and 88: adioactive substances and has an ac
Page 89 and 90: Treatment Simulation Methods by whi
Page 91 and 92: CONTENTS FOREWORD .................
Page 93 and 94: 3.3.8 Lead Time for Submission/Avai
Page 95 and 96:
3.8.3 Construction ................
Page 97 and 98:
3.15.2 Procurement and Registration
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FUNCTIONAL PERFORMANCE OF SAFETY SY
Page 101 and 102:
APPENDIX-5E (Refer section 3.4.1.4)
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GAMMA RADIATION PROCESSING FACILITY
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FACILITY FOR RADIATION TECHNOLOGY (
Page 107 and 108:
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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Page 147 and 148:
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
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4. Performance of Safety System/Int
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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
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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)
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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
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(b) Structural design: Seismic and
Page 213 and 214:
20. Pre-operational radiation surve
Page 215 and 216:
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 and 222:
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) (
Page 229 and 230:
APPENDIX-6B (Refer section 3.4.3.3)
Page 231 and 232:
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 239 and 240:
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
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(APPENDIX 8C-I, 8C-II, 8C-III AND 8
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2. Pre-patient/post-patient collima
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APPENDIX-8C-I (Refer section 3.6.3)
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C.3 Measurement of Timer Linearity
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Tolerance : ± 20% of the quoted va
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(a) Shift in the edges of the radia
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6. LINEARITY OF TIMER Operating par
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(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
Page 281 and 282:
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
Page 293 and 294:
ADVISORY COMMITTEE ON PREPARATION O
Page 295 and 296:
PROVISIONAL LIST OF CODES, GUIDES A
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Volume 2 - Atomic Energy Regulatory Board

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