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1、BRITISH STANDARD BS ISO 15571:1998 Practice for dosimetry in a gamma irradiation facility for radiation processing ICS 17.240 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 This British Standard, having been prepared under
2、 the direction of the Engineering Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 August 1999 BSI 03-2000 ISBN 0 580 32909 7 National foreword This British Standard reproduces verbatim ISO 15571:1998 and implements it as the UK national stan
3、dard. The UK participation in its preparation was entrusted to Technical Committee NCE/2, Health physics instrumentation, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposa
4、ls for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement internat
5、ional or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include
6、 all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i
7、and ii, the ISO title page, pages ii to iv, pages 1 to 8, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication
8、Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 BSI 03-2000i Contents Page National forewordInside front cover Forewordiii Text of ISO 155711 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41
9、:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 ii BSI 03-20
10、00 Contents Page Forewordiii 1Scope1 2Referenced Documents1 3Terminology2 4Significance and Use2 5Radiation Source Characteristics3 6Types of Facilities and Modes of Operation3 7Dosimetry Systems4 8Installation Qualification4 9Process Qualification5 10Routine Product Processing6 11Certification8 12P
11、recision and Bias8 13Keywords8 ReferencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 BSI 03-2000iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of nation
12、al standards bodies (ISO member bodies). The work of preparing International Standards 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. Internatio
13、nal organizations, governmental and non-governmental, in liaison with ISO, also 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 committe
14、es are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 15571 was prepared by the American Society for Testing and Materials (ASTM) Subcommittee E10.01 (as E 1702-95
15、) and was adopted, under a special “fast-track procedure”, by Technical Committee ISO/TC 85, Nuclear energy, in parallel with its approval by the ISO member bodies. A new ISO/TC 85 Working Group WG 3, High-level dosimetry for radiation processing, was formed to review the voting comments from the IS
16、O “Fast-track procedure” and to maintain these standards. The USA holds the convenership of this working group. International Standard ISO 15571 is one of 20 standards developed and published by ASTM. The 20 fast-tracked standards and their associated ASTM designations are listed below: ISO Designat
17、ionASTM DesignationTitle 15554E 1204-93Practice for dosimetry in gamma irradiation facilities for food processing 15555E 1205-93Practice for use of a ceric-cerous sulfate dosimetry system 15556E 1261-94Guide for selection and calibration of dosimetry systems for radiation processing 15557E 1275-93Pr
18、actice for use of a radiochromic film dosimetry system 15558E 1276-96Practice for use of a polymethylmethacrylate dosimetry system 15559E 1310-94Practice for use of a radiochromic optical waveguide dosimetry system 15560E 1400-95aPractice for characterization and performance of a high-dose radiation
19、 dosimetry calibration laboratory 15561E 1401-96Practice for use of a dichromate dosimetry system 15562E 1431-91Practice for dosimetry in electron and bremsstrahlung irradiation facilities for food processing 15563E 1538-93Practice for use of the ethanol-chlorobenzene dosimetry system 15564E 1539-93
20、Guide for use of radiation-sensitive indicators 15565E 1540-93Practice for use of a radiochromic liquid dosimetry system Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 iv BSI 03-2000 For the purposes of this International
21、Standard, the following amendments to the ASTM text apply. Page 1, subclause 1.1, note 1, and subclause 1.2 Replace note 1 and subclause 1.2 by the following. 1.2 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other controls besides dosimetry may be
22、 required for specific applications such as medical device sterilization and food preservation. 1.3 For the irradiation of food and the radiation sterilization of health care products, other specific ISO standards exist. For food irradiation, see ISO 15554:1998, Practice for dosimetry in gamma irrad
23、iation facilities for food processing (ASTM Practice E 1204). For the radiation sterilization of health care products, see ISO 11137:1995, Sterilization of health care products Requirements for validation and routine control Radiation sterilization. In those areas covered by ISO 11137, that standard
24、 takes precedence. Page 1, subclauses 1.3 and 1.4 Renumber these subclauses as 1.4 and 1.5 respectively. ISO DesignationASTM DesignationTitle 15566E 1607-94Practice for use of the alanine-EPR dosimetry system 15567E 1608-94Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation pr
25、ocessing 15568E 1631-96Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimeter calibrations 15569E 1649-94Practice for dosimetry in an electron-beam facility for radiation processing at energies between 300 keV and 25 MeV 15570E 1650-94Practice for use of
26、 cellulose acetate dosimetry system 15571E 1702-95Practice for dosimetry in a gamma irradiation facility for radiation processing 15572E 1707-95Guide for estimating uncertainties in dosimetry for radiation processing 15573E 1818-96Practice for dosimetry in an electron-beam facility for radiation pro
27、cessing at energies between 80 keV and 300 keV Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 BSI 03-20001 1 Scope 1.1 This practice outlines dosimetric procedures to be followed in irradiator characterization, process qua
28、lification, and routine processing in a gamma irradiation facility. These procedures ensure that all product processed with ionizing radiation from isotopic gamma sources receive absorbed doses within a predetermined range. Other procedures related to irradiator characterization, process qualificati
29、on, and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory dose limits is not within the scope of this document. NOTE 1Dosimetry is one component of a total quality assurance program for adherence to good manufacturing pra
30、ctices. Specific applications of gamma radiation processing may require additional controls. 1.2 This practice describes general procedures applicable to all gamma radiation processing requiring absorbed doses within a predetermined range. For procedures specific to food irradiation see Practice E 1
31、204. The sterilization of medical devices is a regulated irradiation process with specific process control requirements. These requirements, including specific dosimetry requirements for medical device sterilization, are given in Refs (1) and (2).1) Guidelines for medical device sterilization are gi
32、ven in Refs (3) and (4). 1.3 For guidance in the selection, calibration, and use of specific dosimeters, and interpretation of absorbed dose in the product from dosimetry measurements, see Guide E 1261 and Practices E 666, E 668, E 1026, E 1205, E 1275, E 1276, E 1310, E 1400, E 1401, E 1538, E 1540
33、, E 1607, and E 1650. For discussion of radiation dosimetry for gamma rays, see ICRU Report 14. 1.4 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 appropriate safety and health
34、practices and determine the applicability of regulatory limitations prior to use. 2 Referenced Documents 2.1 ASTM Standards: E 170, Terminology Relating to Radiation Measurements and Dosimetry2). E 177, Practice for Use of the Terms Precision and Bias in ASTM Test Methods3). E 456, Terminology Relat
35、ing to Quality and Statistics3). E 666, Practice for Calculating Absorbed Dose from Gamma or X Radiation2). E 668, Practice for Application of Thermoluminescence-Dosimetry (TLD) Systems for Determining Absorbed Dose in Radiation Hardness Testing of Electronic Devices2). E 1026, Practice for Using th
36、e Fricke Reference Standard Dosimetry System2). E 1204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing2). E 1205, Practice for Use of a Ceric-Cerous Sulfate Dosimetry System2). E 1261, Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing2). E
37、1275, Practice for Use of a Radiochromic Film Dosimetry System2). E 1276, Practice for Use of a Polymethylmethacrylate Dosimetry System2). E 1310, Practice for Use of a Radiochromic Optical Waveguide Dosimetry System2). E 1400, Practice for Characterization and Performance of a High-Dose Radiation D
38、osimetry Calibration Laboratory2). E 1401, Practice for Use of a Dichromate Dosimetry System2). E 1431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing2). E 1538, Practice for Use of the Ethanol-Chlorobenzene Dosimetry System2). E 1539, Guide for Use
39、of Radiation-Sensitive Indicators2). E 1540, Practice for Use of a Radiochromic Liquid Dosimetry System2). E 1607, Practice for Use of the Alanine-EPR Dosimetry System2). E 1650, Practice for Use of a Cellulose Acetate Dosimetry System. E 1707, Guide for Estimating Uncertainties in Dosimetry for Rad
40、iation Processing. 2.2 ICRU Reports: ICRU Report 14, Radiation Dosimetry: X-Rays and Gamma Rays with Maximum Photon Energies Between 0.6 and 50 MeV. ICRU Report 33, Radiation Quantities and Units. 1) The boldface numbers in parentheses refer to a list of references at the end of this practice. 2) An
41、nual Book of ASTM Standards, Vol 12.02. 3) Annual Book of ASTM Standards, Vol 14.02. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:41:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15571:1998 2 BSI 03-2000 3 Terminology 3.1 Definitions Other terms used in this practice are defined
42、in Terminology E 170 and ICRU Report 33. 3.1.1 absorbed dose quantity of radiation energy imparted per unit mass of a specified material. The unit of absorbed dose is the gray (Gy), where 1 Gy is equivalent to the absorption of 1 J per kg (= 100 rad). The mathematical relationship is the quotient of
43、 by dm, where is the mean energy imparted by ionizing radiation to matter of mass dm (see ICRU 33) D = 3.1.2 absorbed-dose mapping measurement of the absorbed-dose distribution within an irradiation unit through the use of dosimeters placed at specified locations 3.1.3 compensating dummy simulated p
44、roduct used during routine production runs with irradiation units containing less product than specified in the product, loading configuration or used at the beginning or end of a production run to compensate for the absence of product 3.1.4 dosimeter set one or more dosimeters used to measure the a
45、bsorbed dose at a location to a desired confidence level and whose average reading is used as the absorbed dose measurement at that location 3.1.5 dosimetry system a system used for determining absorbed dose, consisting of dosimeters, measurement instruments and their associated reference standards,
46、 and procedures for the systems use 3.1.6 irradiation unit a volume of material with a specified loading configuration irradiated as a single entity 3.1.7 production run (continuous-flow irradiation) a series of irradiation units consisting of materials or products having similar radiation-absorptio
47、n characteristics that are irradiated sequentially to a specified range of absorbed dose 3.1.8 simulated product a mass of material with attenuation and scattering properties similar to those of a particular material or combination of materials. This term is sometimes referred to as dummy product 3.
48、1.9 timer setting parameter varied to control the time during which an irradiation unit is exposed to radiation 4 Significance and Use 4.1 Various products and materials routinely are irradiated at predetermined doses at gamma irradiation facilities to reduce their microbial population or to modify
49、their characteristics. Dosimetry requirements may vary depending upon the irradiation application and end use of the product. Some examples of irradiation applications where dosimetry may be used are: 4.1.1 Sterilization of medical devices; 4.1.2 Treatment of food for the purpose of parasite and pathogen control, insect disinfestation, and shelf life extension; 4.1.3 Disinfection of consumer products; 4.1.4 Cross-linking or degradation of polymers and elastomers; 4.1.5 Polymerization of monomers and grafting of monomers onto polymers; 4.1.6 Control of pathogens in liqu
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