Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

SIGNIFICANCE AND USE
Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.
Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.
Radiation processing may require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum dose that can be tolerated (while the product, material or substance still meets functional specifications or to fulfill a legal requirement).
Dose mapping is used to characterize the radiation process and assess the reproducibility of absorbed-dose results, which may be used as part of operational qualification and performance qualification.
Dose mapping is used to determine the spatial distribution of absorbed doses and the zone(s) of maximum and minimum absorbed doses throughout a process load, which may consist of an actual or simulated product.
Dose mapping is used to establish the relationship between the dose at a reference position and the dose within the minimum and maximum dose zones established for a process load.
Dose mapping is used to verify mathematical dose calculation methods. See Guide E 2232.
Dose mapping is used to determine the process shutdown and startup transit dose effect on the distribution of absorbed dose and the magnitude of the minimum and maximum doses.
Dose mapping is used to assess the impact on the distribution of absorbed dose and the magnitude of the minimum and maximum doses resulting from the transition from on...
SCOPE
1.1 This document provides guidance in determining absorbed-dose distributions in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1—For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing. 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 takes precedence. ISO/ASTM Practice 51608, ISO/ASTM Practice 51649, and ISO/ASTM Practice 51702 also contain dose mapping requirements.
1.2 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.
1.3 Dose mapping for bulk flow processing and fluid streams is not discussed.
1.4 Dosimetry is only one component of a total quality program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
1.5 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 practices and determine the applicability of regulatory requirements prior to use.

General Information

Status
Historical
Publication Date
09-Jul-2003
Technical Committee
Current Stage
Ref Project

Relations

Buy Standard

Guide
ASTM E2303-03 - Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
English language
9 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
An American National Standard
Designation:E2303–03
Standard Guide for
1
Absorbed-Dose Mapping in Radiation Processing Facilities
This standard is issued under the fixed designation E2303; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
1.1 This document provides guidance in determining
E178 Practice for Dealing With Outlying Observations
absorbed-dose distributions in products, materials or sub-
E666 PracticeforCalculatingAbsorbedDoseFromGamma
stances irradiated in gamma, X-ray (bremsstrahlung) and
or X Radiation
electron beam facilities.
E668 Practice for Application of Thermoluminescence-
NOTE 1—Forirradiationoffoodandtheradiationsterilizationofhealth
Dosimetry(TLD)SystemsforDeterminingAbsorbedDose
care products, other specific ISO and ISO/ASTM standards containing
in Radiation-Hardness Testing of Electronic Devices
dose mapping requirements exist. For food irradiation, see ISO/ASTM
E1026 Practice for Using the Fricke Reference-Standard
51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food
Dosimetry System
ProcessingandISO/ASTM51431,PracticeforDosimetryinElectronand
Bremsstrahlung Irradiation Facilities for Food Processing. For the radia- E2232 Guide for Selection and Use of Mathematical Meth-
tion sterilization of health care products, see ISO11137: 1995, Steriliza-
odsforCalculatingAbsorbedDoseinRadiationProcessing
tion of Health Care Products Requirements for Validation and Routine
Applications
Control Radiation Sterilization. In those areas covered by ISO11137, that
3
2.2 ISO/ASTM Standards:
standard takes precedence. ISO/ASTM Practice 51608, ISO/ASTM Prac-
ISO/ASTM 51204 Practice for Dosimetry in Gamma Irra-
tice 51649, and ISO/ASTM Practice 51702 also contain dose mapping
diation Facilities for Food Processing
requirements.
ISO/ASTM 51205 Practice for Use of a Ceric-Cerous Sul-
1.2 Methods of analyzing the dose map data are described.
fate Dosimetry System
Examples are provided of statistical methods that may be used
ISO/ASTM 51261 Guide for Selection and Calibration of
to analyze dose map data.
Dosimetry Systems for Radiation Processing
1.3 Dose mapping for bulk flow processing and fluid
ISO/ASTM51275 PracticeforUseofaRadiochromicFilm
streams is not discussed.
Dosimetry System
1.4 Dosimetry is only one component of a total quality
ISO/ASTM 51276 Practice for Use of a Polymethylmeth-
program for an irradiation facility. Other controls besides
acrylate Dosimetry System
dosimetry may be required for specific applications such as
ISO/ASTM 51310 Practice for Use of a Radiochromic
medical device sterilization and food preservation.
Optical Waveguide Dosimetry System
1.5 This standard does not purport to address all of the
ISO/ASTM 51400 Practice for Characterization and Perfor-
safety concerns, if any, associated with its use. It is the
mance of a High-Dose Radiation Dosimetry Calibration
responsibility of the user of this standard to establish appro-
Laboratory
priate safety and health practices and determine the applica-
ISO/ASTM51401 PracticeforUseofaDichromateDosim-
bility of regulatory requirements prior to use.
etry System
ISO/ASTM 51431 Practice for Dosimetry in Electron and
2. Referenced Documents
Bremsstrahlung Irradiation Facilities for Food Processing
2
2.1 ASTM Standards:
ISO/ASTM 51538 Practice for Use of the Ethanol-
E170 TerminologyRelatingtoRadiationMeasurementsand
Chlorobenzene Dosimetry System
Dosimetry
ISO/ASTM 51540 Practice for Use of a Radiochromic
Liquid Dosimetry System
ISO/ASTM 51607 Practice for Use of the Alanine-EPR
1
This guide is under the jurisdiction of ASTM Committee E10 on Nuclear
Dosimetry System
TechnologyandApplicationandisthedirectresponsibilityofSubcommitteeE10.01
on Dosimetry for Radiation Processing.
Current edition approved July 10, 2003. Published August 2003 DOI: 10.1520/
3
E2303-03. Standards on Dosimetry for Radiation Processing. ASTM International 2002.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontact
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM ASTM Customer Service at service@astm.org. For Annual Book of ASTM Stan-
Standards volume information, refer to the standard’s Document Summary page on dards volume information, refer to the standard’s Document Summary page on the
the ASTM website. ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

-----------
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.