ANSI HPS N43.10-2001 Safe Design and Use of Panoramic Wet Source Storage Gamma Irradiators (Category IV) and Dry Source Storage Gamma Irradiators (Category II).pdf

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1、 ANSI/HPS N43.10-2001 American National Standard Safe Design and Use of Panoramic, Wet Source Storage Gamma Irradiators (Category IV) and Dry Source Storage Gamma Irradiators (Category II) Approved January 2001 American National Standards Institute, Inc. ii Published by Health Physics Society 1313 D

2、olley Madison Blvd. Suite 402 McLean, VA 22101 Copyright 2001 by the Health Physics Society All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without prior written permission of the publisher. Printed in the United States

3、of America ANSI/HPS N43.10-2001 iii CONTENTS 1. Scope . 1 2. Definitions. 1 3. General Considerations 3 3.1 Health Warning . 3 3.2 Radiation Protection Criteria . 3 3.3 Achieving Safe Operation . 3 3.4 Operator Attendance. 4 4. Sealed Sources 4 4.1 General . 4 4.2 Performance Requirements and Classi

4、fication. 4 4.3 Sealed Source Bend Test . 4 4.4 Certification and Documentation. 5 5. Radiation Measurements . 5 5.1 General . 5 5.2 Surveyor Qualifications . 6 5.3 Instrument Calibration. 6 5.4 Radiation Shielding Survey. 6 5.5 Radioactive Contamination Tests . 7 5.6 Personnel Monitoring 7 5.7 Sour

5、ce Transport Container Tests 7 5.8 Pool Water Conditioning System 8 6. Responsibilities 8 6.1 General . 8 6.2 Quality Assurance. 8 6.3 Records and Reports 9 6.4 Service 9 6.5 Safety and Regulatory Advisories.9 7. Operational Safety Features 9 7.1 Operating Procedures and Sequentially Interlocked Con

6、trols 12 7.2 Multi-Purpose Key. 12 7.3 Portable Radiation Survey Meter and Check Source . 12 iv 7.4 Radiation Monitor With Alarms . 12 7.5 Radiation Warning Signs 13 7.6 Personnel Access Door Interlocks 13 7.7 Back-up Access Control 13 7.8 Safety Delay Timer With Alarms . 13 7.9 Radiation Room Contr

7、ol 13 7.10 Egress Capability 13 7.11 Emergency Stop Device- Radiation Room . 13 7.12 Emergency Stop Device-Control Console 13 7.13 Product Entry/Exit Port Access Control 14 7.14 Product Exit Monitor 14 7.15 Source Exposure System Interlocks . 14 7.16 Indicators. 14 7.17 Removable Radiation Room Shie

8、ld Plugs 14 7.18 Source Holder . 14 7.19 Source Guard 14 7.20 Product Positioning System 14 7.21 Pool Guard 14 7.22 Fire Protection. 15 7.23 Ozone 15 7.24 Source Exposure Mechanism Lock out for Servicing . 15 7.25 Power Failure-Electrical 15 7.26 Power Failure-Non-Electrical 16 7.27 Geologic and Sei

9、smic Site Considerations . 16 7.28 Remote Equipment Protection 16 7.29 Pool Water Controls and Indicators 16 8. Integrity of Radiation Shields and Barriers. 16 8.1 Construction Monitoring and Acceptance . 16 8.2 Source Storage Pool (Category IV) 16 8.3 Source Storage Container (Category II) 16 8.4 R

10、adiation Room Shield . 16 8.5 Personnel Access Door 17 9. Source Storage 17 v 9.1 Wet Source Storage (Category IV) . 17 9.2 Dry Source Storage. 18 10. Control Identification. 18 10.1 Control Console 18 10.2 Labeling. 19 10.3 Status Indicator Colors 19 11. Installation, Removal, and Transfer of Seale

11、d Sources and Safety Related Service. 19 11.1 Authorized Personnel 19 11.2 Qualifications 19 11.3 Responsibility 19 11.4 Underwater Tools and Servicing. 19 12. Administrative Procedures 19 13. Operator Qualifications. 21 14. Removal, Transfer, or Disposal of Damaged Sources and Radioactively Contami

12、nated Material 21 14.1 Damaged or Leaking Source 21 14.2 Contaminated Material 21 15. References 22 FIGURES Figure 1 Bend Test Parameters 5 Figure 2 Safety Features (typical) for Category II Irradiators 10 Figures 3 Safety Features (typical) for Category IV Irradiators . 11 Appendix A Radiation Meas

13、urements . 23 vi Below is the list of Members of Subcommittee N43.10 which had responsibility for the development of ANSI/HPS N43.10-2001. Eric Beers, Co-Chairperson SteriGenics International Vincent Foerst, Co-Chairperson Johnson and Johnson Steven Baggett U.S. Nuclear Regulatory Commission Peter B

14、aker Allegiance Healthcare Douglas Broaddus U.S. Nuclear Regulatory Commission Michael Cascio, CIH Johnson and Johnson Floyd Hamiter Texas Department of Health Ronald McGregor MDS Nordion Jack Ransohoff Neutron Products, Inc. Jon Seulean Cobe Sterilization Services Mark Smith, CHP SteriGenics Intern

15、ational Michael Wynnyk MDS Nordion Jonathan Young Steris Isomedix Services vii This standard was consensus balloted and approved by the ANSI-Accredited HPS N43 Committee on February 9, 2000. At the time of balloting, the HPS N43 Committee had the following membership: Chair John C. Taschner Vice Cha

16、ir Gordon M. Lodde ABB Industrial Systems Inc. John R. Dukes Alliance of American Insurers Thomas F. Bresnahan American Automobile Manufacturers Association Donald A. Greschaw William Watt (alt.) David A. Felinski (alt.) American Conference of Governmental Industrial Hygienists Gordon M. Lodde Ameri

17、can Crystallographic Association Camden Hubbard American Insurance Services Group Stewart M. Fastman American Iron and Steel Institute Anthony LaMastra Peter A. Hernandez (alt.) American Public Health Assoc., Inc. Jesse Lieberman American Society for Nondestructive Testing, Inc. K. Dieter Markert Am

18、erican Society for Testing and Materials Marvin M. Turkanis American Welding Society Edward L. Criscuolo Atomic Energy Control Board R. E. Irwin Conference of Radiation Control Program Directors Mike Henry Bart Lago (alt.) Health Physics Society Jack Fix David Lee (alt.) National Institute of Standa

19、rds and Technology Douglas M. Eagleson James W. Tracy (alt.) Underwriters Laboratories, Inc. Peter Boden David Dini (alt.) Univ. of California (Los Alamos Natl Lab) John C. Taschner U. S. Dept of the Air Force, Office of the Surgeon General Don Jordan U. S. Dept of the Army, Office of the Surgeon Ge

20、neral Frances Szrom Gregory R. Komp (alt.) U.S. Department of Energy Peter OConnell Joel Rabovsky (alt.) U. S. Department of the Navy David E. Farrand William Morris (alt.) Steven Doremus (alt.) U. S. Dept of Health and Human Services - Public Health H. Thompson Heaton Frank Cerra (alt.) Individual

21、Members John H. Weiler viii Preface (This preface is not a part of American National Standard N43.10, Safe Design and Use of Panoramic, Wet Source Storage Gamma Irradiators (Category IV), and Dry Source Storage Gamma Irradiators (Category II). The 1950s and 1960s can be characterized as the research

22、 era for radionuclide applications. Based on this research, a number of commercial gamma irradiators started operation in the early 1960s. Their number has been increasing with source storage capacity of individual irradiators reaching the multi-petabequerel, (multi-megacurie) range. Gamma irradiato

23、rs are used for a variety of purposes in research, industry, and other fields. Typical uses are: 1. Sterilization or microbial reduction in medical and pharmaceutical supplies and consumer products. 2. Microbial reduction and disinfestation of food products. 3. Radiation effects studies. 4. Chemical

24、 and polymer synthesis and modifications. 5. Insect eradication through sterile male release programs. The number and types of irradiators supporting these and other applications are continually growing. Source requirements for any particular irradiator may vary from a few curies to several million

25、curies. Irradiator designs can be many and varied to suit individual needs; therefore, it is essential to establish basic criteria to ensure a high standard of radiation safety in the design and use of irradiators, but in a way which does not unnecessarily restrict the logical use and growth of radi

26、onuclide applications. This standard sets forth basic safety standards which are recommended in irradiator design and use. Its use by Regulatory Authorities, relative to the review of radionuclide applications, is encouraged. This standard is an industry consensus and does not take precedence over a

27、pplicable federal or state regulations. Because of the variety of designs, four general categories of irradiators have been established to facilitate preparation of standards. Separate standards establish the criteria to be used in the design, fabrication, installation, use, and maintenance for each

28、 irradiator category. The categories are as follows: Category I - Self-contained, dry source storage irradiators. American National Standard N43.7. An irradiator in which the sealed source is completely contained in a dry container constructed of solid materials, the sealed source is shielded at all

29、 times, and human access to the sealed source and the volume undergoing irradiation is not physically possible in its designed configuration. Category II - Panoramic, dry source storage irradiator. American National Standard N43.10. A controlled human access irradiator in which the sealed source is

30、contained in a dry container constructed of solid materials, and the sealed source is fully shielded when not in use; the sealed source is exposed within a radiation volume that is maintained inaccessible during use by an entry control system. ix Category III - Self-contained, wet source storage irr

31、adiator. American National Standard N43.15. An irradiator in which the sealed source is contained in a storage pool (usually containing water), the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its desi

32、gned configuration and proper mode of use. Category IV - Panoramic, wet source storage irradiator. American National Standard N43.10. A controlled human access irradiator in which the sealed source is contained in a storage pool (usually containing water), and the sealed source is fully shielded whe

33、n not in use; the sealed source is exposed within a radiation volume that is maintained inaccessible during use by an entry control system. AMERCIAN NATIONAL STANDARD ANSI N43.10-2001 1 1. Scope This standard applies to panoramic, wet source storage gamma irradiators (Category IV) and dry source sto

34、rage gamma irradiators (Category II) that contain sealed gamma emitting sources for the irradiation of objects or materials. The standard establishes the criteria to be used in the proper design, fabrication, installation, use, and maintenance of these irradiators which will ensure a high degree of

35、radiation safety. This standard is not a substitute for regulations. Nothing in this standard relieves persons from complying with applicable Federal and State requirements governing the use of these facilities to irradiate products, for example, foodstuff and medical devices. 2. Definitions The def

36、initions and terms contained in this standard, or in other American National Standards referred to in this document, are not intended to embrace all legitimate meanings of the terms. They are applicable only to the subject treated in this standard. This standard applies to irradiator designs produce

37、d after the date of this publication. Existing irradiator owners may wish to review this standard for possible upgrades. Accessible Surface - that surface of the irradiator to which human access is possible without the use of tools or without penetration of the structural radiation shield. Authorize

38、d Personnel (Authorized person) - those individuals authorized by the pertinent regulatory or controlling authority to: a. operate and control access to the irradiator, b. perform periodic contamination detection tests on the irradiator, c. install, maintain, and service the irradiator. Capsule - pr

39、otective envelope used for prevention of leakage of radioactive material from a sealed source. Contaminated Material - any material or object other than a sealed source that contains a radioactive substance (or substances) in average concentration or total quantity in excess of the limits establishe

40、d by the pertinent regulatory or controlling authority. Fully Shielded - the condition in which the source is stored so that the radiation level in the radiation room does not exceed the levels specified in Part 5.4.2 of this standard. Fully Vented - a design characteristic of hollow tools, tubes, o

41、r control rods, that allows air to escape from the tool at a rate sufficient to allow water to flood the immersed section as it enters the water. Installation of Irradiator - the construction, source loading, and the commissioning of an irradiator. Interlock - see Safety Interlock. Irradiator - a de

42、vice or facility which contains and uses sealed sources for the irradiation of objects or materials. See Panoramic Wet Source Storage Irradiator or Panoramic Dry Storage Irradiator. Irradiator Shut Down - stops conveyors, returns the source to the fully shielded position. Licensee - individual or or

43、ganization to whom the pertinent regulatory authority has issued a license authorizing receipt, possession, use, and/or transfer of sealed sources and operation of an irradiator. Operator - an authorized person who controls the use of the irradiator. Panoramic - the volume undergoing irradiation is

44、large enough to accommodate a reference man as defined in ICRP 23. ANSI N43.10-2001 2 Panoramic Wet Source Storage Irradiator - a controlled human access irradiator in which the sealed source is contained in a storage pool (usually containing water), and the sealed source is fully shielded when not

45、in use; the sealed source is exposed within a radiation room that is maintained inaccessible during use by interlocked controls. Panoramic Dry Source Storage Irradiator - a controlled human access irradiator in which the sealed source is contained in a dry storage container constructed of solid mate

46、rials, and the sealed source is fully shielded when not in use; the sealed source is exposed within a radiation room that is maintained inaccessible during use by interlocked controls. Product - the objects or materials which are intentionally irradiated in a commercial or research process. Product

47、Positioning System - the means by which the product to be irradiated is conveyed around the sealed source under the source-in-use condition. (Also referred to as conveyor.) Qualified Expert - a person having the knowledge, training, and experience necessary to perform a task in his/her field or spec

48、ialty, in a competent and proficient manner. Quality Assurance - all those planned and systematic actions necessary to provide adequate confidence that an item or a facility will perform satisfactorily in service. Quality Control - those quality assurance actions which provide a means to control, me

49、asure and document the characteristics of an item, process, or facility to establish requirements. Radiation Room - that region of the irradiator that is enclosed by radiation shields and is made inaccessible when the source is in use. Radiation Shields - the materials which have as their primary function the attenuation of radiation emitted by the sealed source to acceptable levels. Restricted Area - that region of the irradiator to which human access is controlled for radiation safety purposes. Safety Interlock - a device for precluding exposure of an indi