Reaffirmed 2023

1. SCOPE

1.1 This practice outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process products with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the product are also discussed.

NOTE 1 - Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications.

NOTE 2 - ISO/ASTM Practices 51818 and 51649 describe dosimetric procedures for low and high enery electron beam facilities for radiation processing and ISO/ASTM Practice 51608 describes procedures for X-ray (bremsstrahlung) facilities for radiation processing.

1.2 For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence.

1.3 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ASTM Practice E2628.

1.4 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

2.1 ASTM Standards:

E170 Terminology Relating to Radiation Measurements and Dosimetry

E2232 Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications

E2303 Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

E2628 Practice for Dosimetry in Radiation Processing

E2701 Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing

2.2 ISO/ASTM Standards:

51261 Practice for Calibration of Routine Dosimetry Systems for Radiation Processing

51539 Guide for Use of Radiation-Sensitive Indicators

51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing

51649 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 KeV and 25 KeV

51707 Guide for Estimating Uncertainties in Dosimetry for Radiation Processing

51818 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV

2.3 International Commission on Radiation Units and Measurements (ICRU) Reports:

ICRU Report 85a Fundamental Quantities and Units for Ionizing Radiation

2.4 ISO Standards:

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

2.5 Joint Committee for Guides in Metrology (JCGM) Reports:

JCGM 100:2008, GUM 1995, with minor corrections, Evaluation of measurement data – Guide to the Expression of Uncertainty in Measurement