ASTM/ISO 51818-13

A variety of irradiation processes uses low energy electron beam facilities to modify product characteristics. Dosimetry requirements, the number and frequency of measurements, and record keeping requirements will vary depending on the type and end use of the products being processed. Dosimetry is often used in conjunction with physical, chemical, or biological testing of the product, to help verify specific treatment parameters.

Note 1—In many cases dosimetry results can be related to other quantitative product properties; for example, gel fraction, melt flow, modulus, molecular weight distribution, or cure analysis tests.

Radiation processing specifications usually include a minimum or maximum absorbed dose limit, or both. For a given application these limits may be set by government regulation or by limits inherent to the product itself.

Critical process parameters must be controlled to obtain reproducible dose distribution in processed materials. The electron beam energy, beam current, beam width and process line speed (conveying speed) affect absorbed dose.

Before any electron beam facility can be routinely utilized, it must be validated to determine its effectiveness. This involves testing of the process equipment, calibrating the measuring instruments and the dosimetry system, and demonstrating the ability to consistently deliver the required dose within predetermined specifications.

In order for a dosimetry system to be effective in low-energy electron irradiation applications and to measure doses with an acceptable level of uncertainty, it is necessary to calibrate the dosimetry system under irradiation conditions that are consistent with those encountered in routine use. For example, a dosimetry system calibration conducted using penetrating gamma radiation or high energy electrons may result in significantly inaccurate dose measurement when the dosimetry system is used at low energy electron beam facilities. Details of calibration are discussed in Section 5.

1.1 This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.

1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.

1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.

1.4 Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137. In those areas covered by ISO 11137, that standard takes precedence. For food irradiation, see ISO 14470:2011. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356).

1.5 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 E2232, “Practice for Dosimetry in Radiation Processing”.

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.