1、BRITISH STANDARD BS ISO 15571:1998 Practice for dosimetry in a gamma irradiation facility for radiation processing ICS 17.240BSISO15571:1998 This British Standard, having been prepared under the directionof the Engineering SectorCommittee, was publishedunder the authorityofthe Standards Committee an
2、dcomes intoeffecton 15August1999 BSI 03-2000 ISBN 0 580 32909 7 National foreword This British Standard reproduces verbatim ISO15571:1998 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee NCE/2, Health physics instrumentation,
3、 which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate
4、 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 international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section
5、 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 all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Co
6、mpliance 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, pagesi andii, theISO title page, pagesii toiv, pages1 to8, an inside back cover and a back cover. This standard has been updated
7、(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 Amd. No. Date CommentsBSISO15571:1998 BSI 03-2000 i Contents Page National foreword Inside front cover Foreword iii Text of ISO
8、15571 1ii blankBSISO15571:1998 ii BSI 03-2000 Contents Page Foreword iii 1 Scope 1 2 Referenced Documents 1 3 Terminology 2 4 Significance and Use 2 5 Radiation Source Characteristics 3 6 Types of Facilities and Modes of Operation 3 7 Dosimetry Systems 4 8 Installation Qualification 4 9 Process Qual
9、ification 5 10 Routine Product Processing 6 11 Certification 8 12 Precision and Bias 8 13 Keywords 8 References Inside back coverBSISO15571:1998 BSI 03-2000 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies
10、). 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. International organizations, governmental and no
11、n-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 committees are circulated to the member bodies
12、 for voting. Publication as an International Standard requires approval by at least75% of the member bodies casting a vote. International Standard ISO15571 was prepared by the American Society for Testing and Materials (ASTM) SubcommitteeE10.01 (as E1702-95) and was adopted, under a special “fast-tr
13、ack procedure”, by Technical Committee ISO/TC85, Nuclear energy, in parallel with its approval by the ISO member bodies. A new ISO/TC85 Working Group WG3, High-level dosimetry for radiation processing, was formed to review the voting comments from the ISO “Fast-track procedure” and to maintain these
14、 standards. The USA holds the convenership of this working group. International Standard ISO15571 is one of20 standards developed and published by ASTM. The20 fast-tracked standards and their associated ASTM designations are listed below: ISO Designation ASTM Designation Title 15554 E 1204-93 Practi
15、ce for dosimetry in gamma irradiationfacilities for food processing 15555 E 1205-93 Practice for use of a ceric-cerous sulfate dosimetrysystem 15556 E 1261-94 Guide for selection and calibration of dosimetrysystems for radiation processing 15557 E 1275-93 Practice for use of a radiochromic film dosi
16、metrysystem 15558 E 1276-96 Practice for use of a polymethylmethacrylatedosimetry system 15559 E 1310-94 Practice for use of a radiochromic optical waveguidedosimetry system 15560 E 1400-95a Practice for characterization and performanceof a high-dose radiation dosimetry calibration laboratory 15561
17、E 1401-96 Practice for use of a dichromate dosimetrysystem 15562 E 1431-91 Practice for dosimetry in electron and bremsstrahlungirradiation facilities for food processing 15563 E 1538-93 Practice for use of the ethanol-chlorobenzenedosimetry system 15564 E 1539-93 Guide for use of radiation-sensitiv
18、e indicators 15565 E 1540-93 Practice for use of a radiochromic liquid dosimetry systemBSISO15571:1998 iv BSI 03-2000 For the purposes of this International Standard, the following amendments to the ASTM text apply. Page1, subclause1.1, note1, and subclause1.2 Replace note1 and subclause1.2 by the f
19、ollowing. 1.2 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation. 1.3 For the irradiation of food and the radiation ste
20、rilization of health care products, other specific ISO standards exist. For food irradiation, seeISO15554:1998, Practice for dosimetry in gamma irradiation facilities for food processing (ASTM Practice E1204). For the radiation sterilization of health care products, seeISO11137:1995, Sterilization o
21、f health care products Requirements for validation and routine control Radiation sterilization. In those areas covered by ISO11137, that standard takes precedence. Page1, subclauses1.3 and1.4 Renumber these subclauses as1.4 and1.5 respectively. ISO Designation ASTM Designation Title 15566 E 1607-94
22、Practice for use of the alanine-EPR dosimetry system 15567 E 1608-94 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing 15568 E 1631-96 Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimeter calibrations 15569 E 1649-94
23、 Practice for dosimetry in an electron-beam facility for radiation processing at energies between300keV and25MeV 15570 E 1650-94 Practice for use of cellulose acetate dosimetry system 15571 E 1702-95 Practice for dosimetry in a gamma irradiation facility for radiation processing 15572 E 1707-95 Guid
24、e for estimating uncertainties in dosimetry for radiation processing 15573 E 1818-96 Practice for dosimetry in an electron-beam facility for radiation processing at energies between80keV and300keVBSISO15571:1998 BSI 03-2000 1 1 Scope 1.1 This practice outlines dosimetric procedures to be followed in
25、 irradiator characterization, process qualification, 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 irradia
26、tor characterization, process qualification, 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 progra
27、m for adherence to good manufacturing practices. 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 spec
28、ific to food irradiation seePracticeE1204. 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 f
29、or medical device sterilization are given 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 GuideE1261 and Practices E666, E668, E1026, E1205, E1275, E1276, E1310, E
30、1400, E1401, E1538, E1540, E1607, and E1650. For discussion of radiation dosimetry for gamma rays, seeICRU Report14. 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 appropria
31、te safety and health 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 Dosimetry 2) . E 177, Practice for Use of the Terms Precision and Bias in ASTM Test Methods 3) .
32、 E 456, Terminology Relating to Quality and Statistics 3) . E 666, Practice for Calculating Absorbed Dose from Gamma or X Radiation 2) . E 668, Practice for Application of Thermoluminescence-Dosimetry (TLD) Systems for Determining Absorbed Dose in Radiation Hardness Testing of Electronic Devices 2)
33、. E 1026, Practice for Using the Fricke Reference Standard Dosimetry System 2) . E 1204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing 2) . E 1205, Practice for Use of a Ceric-Cerous Sulfate Dosimetry System 2) . E 1261, Guide for Selection and Calibration of Dosimetry S
34、ystems for Radiation Processing 2) . E 1275, Practice for Use of a Radiochromic Film Dosimetry System 2) . E 1276, Practice for Use of a Polymethylmethacrylate Dosimetry System 2) . E 1310, Practice for Use of a Radiochromic Optical Waveguide Dosimetry System 2) . E 1400, Practice for Characterizati
35、on and Performance of a High-Dose Radiation Dosimetry Calibration Laboratory 2) . E 1401, Practice for Use of a Dichromate Dosimetry System 2) . E 1431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing 2) . E 1538, Practice for Use of the Ethanol-Chlor
36、obenzene Dosimetry System 2) . E 1539, Guide for Use of Radiation-Sensitive Indicators 2) . E 1540, Practice for Use of a Radiochromic Liquid Dosimetry System 2) . E 1607, Practice for Use of the Alanine-EPR Dosimetry System 2) . E 1650, Practice for Use of a Cellulose Acetate Dosimetry System. E 17
37、07, Guide for Estimating Uncertainties in Dosimetry for Radiation Processing. 2.2 ICRU Reports: ICRU Report 14, Radiation Dosimetry: X-Rays and Gamma Rays with Maximum Photon Energies Between0.6 and50MeV. ICRU Report 33, Radiation Quantities and Units. 1) The boldface numbers in parentheses refer to
38、 a list of references at the end of this practice. 2) Annual Book of ASTM Standards, Vol 12.02. 3) Annual Book of ASTM Standards, Vol 14.02.BSISO15571:1998 2 BSI 03-2000 3 Terminology 3.1 Definitions Other terms used in this practice are defined in Terminology E170 and ICRU Report33. 3.1.1 absorbed
39、dose quantity of radiation energy imparted per unit mass of a specified material. The unit of absorbed dose is the gray (Gy), where1Gy is equivalent to the absorption of1J per kg (=100rad). The mathematical relationship is the quotient of by dm, where is the mean energy imparted by ionizing radiatio
40、n to matter of mass dm (seeICRU33) 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 product used during routine production runs with irradiation unit
41、s 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 absorbed dose at a location to a desired confidence level and who
42、se 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, and procedures for the systems use 3.1.6 irradiation unit a vol
43、ume 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-absorption characteristics that are irradiated sequentially to a specifie
44、d 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 3.1.9 timer setting parameter varied to control the time during wh
45、ich 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 their characteristics. Dosimetry requirements may vary depending
46、 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;
47、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 liquid or solid waste; 4.1.7 Enhancement of color in gemstones and other materials; 4.1.8 Mod
48、ification of characteristics of semiconductor devices; and 4.1.9 Research on materials effects. NOTE 2Dosimetry is required for regulated irradiation processes such as the sterilization of medical devices and the treatment of food. It may be less important for other industrial processes, for example
49、, polymer modification, which can be evaluated by changes in the physical and chemical properties of the irradiated materials. 4.2 Dosimeters are used as a means of quality control of the process by relating the measured response of the dosimeter to radiation to the absorbed dose in the product or in a specified material such as water. 4.3 An irradiation process usually requires a minimum absorbed dose to achieve the desired effect. There also may be a maximum absorbed dose that the product can tolerate and still meet its functional specifications. Dosimetry is essenti
