ISO ASTM 51939-2017 Practice for blood irradiation dosimetry《血液辐照剂量测定的操作规程》.pdf

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1、Practice for blood irradiation dosimetry Pratique de la dosimtrie pour lirradiation du sang INTERNATIONAL STANDARD ISO/ASTM 51939 Reference number ISO/ASTM 51939:2017(E) Fourth edition 2017-02 ISO/ASTM International 2017 ISO/ASTM 51939:2017(E)ii ISO/ASTM International 2017 All rights reserved COPYRI

2、GHT PROTECTED DOCUMENT ISO/ASTM International 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet

3、or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. In the United States, such requests should be sent to ASTM International. ISO copyright office ASTM International Ch. de Blandonnet

4、8 CP 401 100 Barr Harbor Drive, PO Box C700 CH-1214 Vernier, Geneva, Switzerland West Conshohocken, PA 19428-2959, USA Tel. +41 22 749 01 11 Tel. +610 832 9634 Fax +41 22 749 09 47 Fax +610 832 9635 copyrightiso.org khooperastm.org www.iso.org www.astm.orgExplanatory Material This international stan

5、dard is part of the project between ISO and ASTM International to develop and maintain a group of ISO/ASTM dosimetry standards for radiation processing. In accordance with ISO/TC 85 N 1248, Maintenance Procedures for ISO/ASTM Radiation Processing Dosimetry Standards, a joint meeting of ISO/TC 85 WG3

6、 Dosimetry for Radiation Processing and ASTM Committee E61 was held in New Orleans, Louisiana, on January 16-28 to review standards being considered for withdrawal, revision/ amendment, or conrmation. Although ISO/ASTM 51939, published in 2005, had been reapproved in 2013, it was decided that this s

7、tandard should be revised to bring it in line with the new format adopted for the ISO/ASTM standards. A review was conducted to determine if, in addition to the format changes, technical changes would be required. From this review it was decided that major changes should be made to the standard and

8、that it should be revised as a major revision. The new standard covers the irradiation of blood or blood components in self-contained blood irradiators using photons. The previous version also covered the use of teletherapy equipment and electron beams. The standard provides recommendations for prop

9、erly implementing dosimetry in blood irradiation. The practice describes a means of achieving compliance with the requirments of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation and is intended to be read in conjunction with ISO/ASTM 52628. ISO/ASTM 51939:2017(E) ISO/ASTM Intern

10、ational 2017 All rights reserved ii-2 Contents Page 1 Scope . 1 2 Referenced documents 1 3 Terminology 2 4 Signicance and use 3 5 Type of irradiators and modes of operation. 4 6 Radiation source characteristics 4 7 Dosimetry systems. 5 8 Installation qualication 6 9 Operational qualication. 6 10 Per

11、formance qualication. 7 11 Routine product processing . 8 12 Maintenance of validation 9 13 Measurement uncertainty. 9 14 Keywords 9 Annexes 10 Table 1 Examples of reference-standard dosimetry systems 5 Table 2 Examples of routine dosimetry systems 6 Table A2.1 Recommended quality assurance steps fo

12、r blood irradiation 12 ISO/ASTM 51939:2017(E) ISO/ASTM International 2017 All rights reserved iii ISO/ASTM 51939:2017(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International S

13、tandards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, als

14、o take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Internati

15、onal Standard requires approval by at least 75% of the member bodies casting a vote. ASTM International is one of the worlds largest voluntary standards development organizations with global participation from affected stakeholders. ASTM technical committees follow rigorous due process balloting pro

16、cedures. A project between ISO and ASTM International has been formed to develop and maintain a group of ISO/ASTM radiation processing dosimetry standards. Under this project, ASTM Commitee E61, Radiation Processing, is responsible for the development and maintenance of these dosimetry standards wit

17、h unrestricted participation and input from appropriate ISO member bodies. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Neither ISO nor ASTM International shall be held responsible for identifying any or all such patent rights.

18、 International Standard ISO/ASTM 51939 was developed by ASTM Committee E61, Radiation Processing, through Subcommittee E61.04, Specialty Application, and by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies and radiological protection. This fourth edition cancels and replaces the t

19、hird edition (ISO/ASTM 51939:05(2013), which has been technically revised. iv ISO/ASTM International 2017 All rights reservedISO/ASTM 51939:2017(E) Standard Practice for Blood Irradiation Dosimetry 1 This standard is issued under the xed designation ISO/ASTM FDIS 51939; the number immediately follow

20、ing the designation indicates the year of original adoption or, in the case of revision, the year of last revision. 1. Scope 1.1 This practice outlines the irradiator installation quali- cation program and the dosimetric procedures to be followed during operational qualication and performance qualic

21、ation of the irradiator. Procedures for the routine radiation process- ing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a spe

22、cied range. 1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137 Cs and 60 Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.

23、 1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV . 1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539). 1.5 This doc

24、ument is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conj

25、unction with ISO/ASTM Practice 52628. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro- priate safety and health practices and to determine the applicability or regulato

26、ry limitations prior to use. 2. Referenced documents 2.1 ASTM Standards: 2 E170 Terminology Relating to Radiation Measurements and Dosimetry 2.2 ISO/ASTM Standards: 2 51026 Practice for Using the Fricke Dosimetry System 51261 Practice for Calibration of Routine Dosimetry Sys- tems for Radiation Proc

27、essing 51275 Practice for Use of a Radiochromic Film Dosimetry System 51310 Practice for Use of a Radiochromic Optical Wave- guide Dosimetry System 51539 Guide for the Use of Radiation-Sensitive Indicators 51607 Practice for Use of the Alanine-EPR Dosimetry Sys- tem 51707 Guide for Estimating Uncert

28、ainties in Dosimetry for Radiation Processing 51956 Practice for Use of Thermoluminescence-Dosimetry Systems (TLD Systems) for Radiation Processing 52116 Practice for Dosimetry for a Self-Contained Dry- Storage Gamma-Ray Irradiator 52628 Practice for Dosimetry in Radiation Processing 52701 Guide for

29、 Performance Characterization of Dosim- eters and Dosimetry Systems for Use in Radiation Pro- cessing 2.3 International Commission on Radiation Units and Mea- surements Reports (ICRU): 3 ICRU 80 Dosimetry Systems for Use in Radiation Process- ing ICRU 85a Fundamental Quantities and Units for Ionizin

30、g Radiation 1 This practice is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.04 on Specialty Application, and is also under the jurisdiction of ISO/TC 85/WG 3. Current edition approved by ASTM Jan. 1, 2016. Published XX. Ori

31、ginally published as ASTM E 193998. Last previous ASTM edition E 193998. The present International Standard ISO/ASTM 51939:2016(E) is a revision of the last previous edition ISO/ASTM 51939:05(2013)(E). 2 For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact AST

32、M Customer Service at serviceastm.org. For Annual Book of ASTM Standards volume information, refer to the standards Document Summary page on the ASTM website. 3 Available from the International Commission on Radiation Units and Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A. I

33、SO/ASTM International 2017 All rights reserved 12.4 ISO Standards: 4 12749-4 Nuclear energy V ocabulary Part 4: Dosimetry for radiation processing 2.5 ISO/IEC Standards: 4 17025 General Requirements for the Competence of Testing and Calibration Laboratories 2.6 Guidelines on Blood Irradiation: Guide

34、lines on the Use of Irradiated Blood Components (2013), Prepared by the BCSH Blood Transfusion Task Force 5 Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products, (1993) US Food and Drug Administration 6 Guidance for Industry, Gamma Irradiation of Blood

35、and Blood Components: A Pilot Program for Licensing (2000) US Food and Drug Administration 6 2.7 Joint Committee for Guides in Metrology (JCGM) Reports: JCGM 100:2008 GUM 1995, with minor corrections, Evalu- ation of measurement data Guide to the expression of uncertainty in measurement 7 JCGM 200:2

36、012 (JCGM 200:2008 with minor revisions), VIM, International vocabulary of metrology Basis and general concepts and associated terms 8 3. Terminology 3.1 Denitions: 3.1.1 absorbed dose (D)quotient of d by dm, where d is the mean energy imparted by ionizing radiation to matter of mass dm (see ICRU 85

37、a). D5 d /dm (1) 3.1.1.1 DiscussionThe SI unit of absorbed dose is the gray (Gy), where 1 gray is equivalent to the absorption of 1 joule per kilogram of the specied material (1 Gy = 1 J/kg). 3.1.2 absorbed-dose rate (D )quotient of dD by dt, where dD is the increment of absorbed dose in the time in

38、terval dt, thus D 5 dD/dt (2) 3.1.2.1 DiscussionThe SI unit is Gys 1 . However, the absorbed-dose rate is often specied in terms of its average value over longer time intervals, for example, in units of Gymin 1 or Gyh 1 . 3.1.3 absorbed-dose mappingmeasurement of absorbed dose within an irradiated p

39、roduct to produce a one, two, or three-dimensional distribution of absorbed dose, thus rendering a map of absorbed-dose values. 3.1.3.1 DiscussionFor a blood canister, such a dose map is obtained using dosimeters placed at specied locations within the canister. 3.1.4 activity (A) (of an amount of ra

40、dionuclide in a particular energy state at a given time)quotient of dN by dt, where dN is the mean change in the number of nuclei in that energy state due to spontaneous nuclear transitions in the time interval dt (see ICRU 85a). A52 dN/dt (3) Unit: s 1 The special name for the unit of activity is t

41、he becquerel (Bq). 1 Bq=1s 1 . 3.1.4.1 Discussion (1) The former special unit of activity was the curie (Ci). 1C i=3 . 71 0 10 s 1 (exactly). (2) The particular energy state is the ground state of the nuclide unless otherwise specied. (3) The activity of an amount of radionuclide in a particular ene

42、rgy state is equal to the product of the decay constant, , for that state and the number of nuclei in that state (that is, A=N). 3.1.5 approved laboratorylaboratory that is a recognized national metrology institute; or has been formally accredited to ISO/IEC 17025; or has a quality system consistent

43、 with the requirements of ISO/IEC 17025. 3.1.5.1 DiscussionA recognized national metrology insti- tute or other calibration laboratory accredited to ISO/IEC 17025 should be used in order to ensure traceability to a national or international standard. A calibration certicate provided by a laboratory

44、not having formal recognition or accreditation will not necessarily be proof of traceability to a national or international standard. 3.1.6 bremsstrahlungbroad-spectrum electromagnetic ra- diation emitted when an energetic charged particle is inu- enced by a strong electric or magnetic eld, such as

45、that in the vicinity of an atomic nucleus. 3.1.6.1 Discussion (1) In radiation processing, bremsstrahlung photons with sufficient energy to cause ionization are generated by the deceleration or deection of energetic electrons in a target material. When an electron passes close to an atomic nucleus,

46、the strong coulomb eld causes the electron to deviate from its original motion. This interaction results in a loss of kinetic energy by the emission of electromagnetic radiation. Since such encounters are uncontrolled, they produce a continuous photon energy distribution that extends up to the maxim

47、um kinetic energy of the incident electron. (2) The bremsstrahlung spectrum depends on the electron energy, the composition and thickness of the target, and the angle of emission with respect to the incident electron. 3.1.7 calibrationset of operations that establish under specied conditions, the re

48、lationship between values of quan- tities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards. 4 Available from International Organization for Standardization (ISO), ISO Centr

49、al Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, http:/www.iso.org. 5 Available from the National Blood Transfusion Service, East Anglian Blood Transfusion Centre, Long Road, Cambridge, CB2 2PT United Kingdom. 6 Available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville