ASTM_E_2628_-_09e1.pdf

Designation:E2628 091An American National StandardStandard Practice forDosimetry in Radiation Processing1This standard is issued under the fixed designation E2628;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1NOTEAn editorial change was made to the title in December 2009.INTRODUCTIONThe use of ionizing radiation for the treatment of commercial products such as the sterilization ofmedical devices,the reduction of microbial contamination in food or the modification of polymers isreferred to as radiation processing.The types of radiation used may be gamma radiation(typicallyfrom cobalt-60 sources),X-radiation or accelerated electrons.It is necessary to ensure that the specified absorbed dose is applied in each of the radiationprocessing applications.The absorbed dose must be measured,and measurement systems have beendeveloped for this purpose.Much of the development of these systems rests on the early developmentof dosimetry systems for personnel radiation protection and for medical treatment.However,theabsorbed doses used in radiation processing are generally higher,ranging from 10 Gy up to 100 kGyor more and new dosimetry systems have been developed for measurements of these doses.Note that the terms“dose”and“absorbed dose”are used interchangeably in this standard(see3.1.1).The dose measurements required in radiation processing concern characterization of radiationfacilities in installation qualification(IQ)and operational qualification(OQ),measurement of dosedistribution in irradiated products in performance qualification(PQ)and routine monitoring of theirradiation process.The literature is abundant with articles on dosimeters for radiation processing,and guidelines andstandards have been written by several organizations(the International Atomic Energy Agency(IAEA)and the International Commission on Radiation Units and Measurements(ICRU),forexample)for the operation of the dosimetry systems and for their use in the characterization andvalidation of the radiation processing applications.In particular,ICRU Report 80 provides informationon the scientific basis and historical development of many of the systems in current use.ASTM Subcommittee E10.01 on Radiation Processing:Dosimetry and Applications was formed in1984 initially with the scope of developing standards for food irradiation,but its scope was widenedto include all radiation processing applications.The subcommittee has under its jurisdictionapproximately 30 standard practices and standard guides,collectively known as the E10.01 standardson radiation processing.A number of these standards have been published as ISO/ASTM standards,thereby ensuring a wider international acceptance.These practices and guides describe the dosimetrysystems most commonly used in radiation processing,and the dose measurements that are required inthe validation and routine monitoring of the radiation processes.Acurrent list of the E10.01 standardson radiation processing is given in 2.1 and 2.2.The development,validation and routine control of a radiation process comprises a number ofactivities,most of which rely on the ability to measure the delivered dose accurately.It is thereforenecessary that dose is measured with traceability to national,or international,standards,and theuncertainty is known,including the effect of influence quantities.The E10.01 standards on radiationprocessing dosimetry serve to fulfill these requirements.The practices describing dosimetry systems have several common attributes,and there is a need tohave one general standard that can act as a common reference and that can be used as a basis for theselection of dosimetry systems for defined tasks.Practice E2628 serves this purpose.It outlinesgeneral requirements for the calibration and use of dosimetry systems and for the estimation of1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.Copyright ASTM International Provided by IHS under license with ASTM Licensee=Committee on Institutional Cooperation/5967164001 Not for Resale,02/21/2012 00:13:57 MSTNo reproduction or networking permitted without license from IHS-,-,-measurement uncertainties.Details relating to each dosimetry system are found in the respectivestandards and each of these refer to Practice E2628 for the general requirements.1.Scope1.1 This practice describes the basic requirements that applywhen making absorbed dose measurements in accordance withthe ASTM E10.01 series of dosimetry standards.In addition,itprovides guidance on the selection of dosimetry systems anddirects the user to other standards that provide specific infor-mation on individual dosimetry systems,calibration methods,uncertainty estimation and radiation processing applicat