ASTM E1649-00

ASTM E1649-00 - 10.1.2000

1. Scope

1.1 This practice covers dosimetric procedures to be followed in facility characterization, process qualification, and routine processing using electron beam radiation to ensure that the entire product has been treated with an acceptable range of absorbed doses. Other procedures related to facility characterization (including equipment documentation), process qualification, and routine product processing that may influence and may be used to monitor absorbed dose in the product are also discussed. Note 1For guidance in the selection and calibration of dosimeters, see Guide E 1261. For further guidance in the selection, calibration, and use of specific dosimeters, and interpretation of absorbed dose in the product from dosimetry, also see Practices E 668, E 1275, E 1276, E 1431, E 1607, E 1631, and E 1650. For use with electron energies above 5 MeV, see Practices E 1026, E 1205, E 1401, E 1538, and E 1540 for discussions of specific large volume dosimeters. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34. When considering a dosimeter type, be cautious of influences from dose rates and accelerator pulse rates and widths (if applicable).

1.2 The electron energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions for other energies.

1.3 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.

1.4 For the irradiation of food and the radiation sterilization of health care products, other specific ISO standards exist. For food irradiation, see ISO 15562:1998, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing (ASTM Practice E 1431). 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.

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.

2. Referenced Documents

F1885-25	Standard Guide for Irradiation of Dried Spices, Herbs, Vegetable Seasonings, and Plant Materials Used in the Production of Dietary Substances to Control Pathogens and Other Microorganisms
51261-13(2020)e1	Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing (Includes all amendments and changes 11/25/2024).
51275-21	Standard Practice for Use of a Radiochromic Film Dosimetry System
51539-23e1	Standard Guidance for Use of Radiation-Sensitive Indicators (Includes all amendments and changes 11/27/2024).
51608-15(2022)e1	Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV (Includes all amendments and changes 11/27/2024).
51702-13(2021)e1	Standard Practice for Dosimetry in a Gamma Facility for Radiation Processing (Includes all amendments and changes 11/27/2024).
51707-22	Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing
51818-20e1	Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV (Includes all amendments and changes 12/6/2024).
52628-19	Standard Practice for Dosimetry in Radiation Processing
52701-13(2020)	Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use 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
ISO 11137-3	Sterilization of Health Care Products-Radiation - Part 3: Guidance on dosimetric aspects
ISO 14470	Food Irradiation - Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
F1736-21e1	Standard Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms (Includes all amendments and changes 12/10/2024).
F1356-22e1	Standard Guide for Irradiation of Fresh, Frozen or Processed Meat and Poultry to Control Pathogens and Other Microorganisms (Includes all amendments and changes 12/10/2024).
F1355-19e1	Standard Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment (Includes all amendments and changes 12/10/2024).
E2303-11	Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
E2232-21e1	Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications (Includes all amendments and changes 12/9/2024).
E170-24	Standard Terminology Relating to Radiation Measurements and Dosimetry
ISO 10012	Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment
ISO/IEC 17025	General Requirements for the Competence of Calibration and Testing Laboratories