ASTM E2303-11
Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
- Standard No.
- ASTM E2303-11
- Release Date
- 2011
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM E2303-11e1
- Latest
- ASTM E2303-11e1
- Scope
This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM Practice E2628, which describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 series of dosimetry standards. In addition, ASTM Practice E2628 provides guidance on the selection of dosimetry systems and directs the user to other standards that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.
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.
Note 28212;Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation.
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.
Many radiation processing applications 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 values, which may be used as part of operational qualification and performance qualification.
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.
Establish the relationship between the dose at a routine monitoring position and the dose within the minimum and maximum dose zones established for a process load.
Verify mathematical dose calculation methods. See ASTM Guide E2232.
Determine the effect of process interruptions on the distribution of absorbed dose and the magnitude of the minimum and maximum doses.
Assess the impact on the distribution of absorbed dose and the magnitude of the minimum and maximum doses resulting from the transition from one process load to another where changes, for example, in product density or product loading pattern may occur.
1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 18212;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 irradia......
ASTM E2303-11 Referenced Document
- ASTM E170 Standard Terminology Relating to Radiation Measurements and Dosimetry
- ASTM E178 Standard Practice for Dealing With Outlying Observations
- ASTM E2232 Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
- ASTM E2628 Practice for Dosimetry in Radiation Processing
- ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
- ISO/ASTM 51204 Practice for dosimetry in gamma irradiation facilities for food processing
- ISO/ASTM 51261 Practice for calibration of routine dosimetry systems for radiation processing
- ISO/ASTM 51431 Practice for dosimetry in electron beam and X-ray (bremsstrahlung) irradiation facilities for food processing
- ISO/ASTM 51608 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
- ISO/ASTM 51649 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
- ISO/ASTM 51702 Practice for dosimetry in a gamma facility for radiation processing
- ISO/ASTM 51707 Guide for estimation of measurement uncertainty in dosimetry for radiation processing
- ISO/ASTM 51818 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
ASTM E2303-11 history
- 2011 ASTM E2303-11e1 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
- 2011 ASTM E2303-11 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
- 2003 ASTM E2303-03 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
