ASTM E2628-09e1
Practice for Dosimetry in Radiation Processing

Standard No.
ASTM E2628-09e1
Release Date
2009
Published By
American Society for Testing and Materials (ASTM)
Status
 2014-01
Latest
ASTM E2628-09e1
Scope

Radiation processing of articles in both commercial and research applications may be carried out for a number of purposes. These include, for example, sterilization of health care products, reduction of the microbial populations in foods and modification of polymers. The radiations used may be accelerated electrons, gamma-radiation from radionuclide sources such as cobalt-60, or X-radiation.

To demonstrate control of the radiation process, the absorbed dose must be measured using a dosimetry system, the calibration of which, is traceable to appropriate national or international standards. The radiation-induced change in the dosimeter is evaluated and related to absorbed dose through calibration. Dose measurements required for particular processes are described in other standards referenced in this practice.

1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 series of dosimetry standards. In addition, it provides guidance on the selection of dosimetry systems and directs the user to other standards that provide specific information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.

1.2 This practice applies to dosimetry for radiation processing applications using electrons or photons (gamma- or X-radiation).

1.3 This practice addresses the minimum requirements of a measurement management system, but does not include general quality system requirements.

1.4 This practice does not address personnel dosimetry or medical dosimetry.

1.5 This practice does not apply to primary standard dosimetry systems.

1.6 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 limitations prior to use.

ASTM E2628-09e1 Referenced Document

  • ASTM E1026 Standard Practice for Using the Fricke Reference Standard Dosimetry System
  • ASTM E170 Standard Terminology Relating to Radiation Measurements and Dosimetry
  • ASTM E2232 Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
  • ASTM E2303 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities*2024-04-19 Update
  • ASTM E2304 Standard Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System
  • ASTM E2381 Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams
  • ASTM E2449 Standard Guide for Irradiation of Pre-packaged Processed Meat and Poultry Products to Control Pathogens and Other Microorganisms
  • ASTM E2701 Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing
  • ASTM F1355 Standard Guide for Irradiation of Fresh Fruits as a Phytosanitary Treatment
  • ASTM F1356 Standard Guide for the Irradiation of Fresh and Frozen Red Meat and Poultry to Control Pathogens and Other Microorganisms
  • ASTM F1736 Standard Guide for Irradiation of Finfish and Shellfish to Control Pathogens and Spoilage Microorganisms
  • ASTM F1885 Standard Guide for Irradiation of Dried Spices, Herbs, and Vegetable Seasonings to Control Pathogens and Other Microorganisms
  • ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
  • 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 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
  • ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]

ASTM E2628-09e1 history

  • 2009 ASTM E2628-09e1 Practice for Dosimetry in Radiation Processing
  • 2009 ASTM E2628-09 Standard Practice for Dosimetry for Radiation Processing
Practice for Dosimetry in Radiation Processing



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