Twenty new ISO standards on dosimetry for radiation processing

Abstract

Abstract Twenty standards on essentially all aspects of dosimetry for radiation processing were published as new ISO standards in December 1998. The standards are based on 20 standard practices and guides developed over the past 14 years by Subcommittee E10.01 of the American Society for Testing and Materials (ASTM). The transformation to ISO standards using the ‘fast track’ process under ISO Technical Committee 85 (ISO/TC85) commenced in 1995 and resulted in some overlap of technical information between three of the new standards and the existing ISO Standard 11137 Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization. Although the technical information in these four standards was consistent, compromise wording in the scopes of the three new ISO standards to establish precedence for use were adopted. Two of the new ISO standards are specifically for food irradiation applications, but the majority apply to all forms of gamma, X-ray, and electron beam radiation processing, including dosimetry for sterilization of health care products and the radiation processing of fruit, vegetables, meats, spices, processed foods, plastics, inks, medical wastes, and paper. Most of the standards provide exact procedures for using individual dosimetry systems or for characterizing various types of irradiation facilities, but one covers the selection and calibration of dosimetry systems, and another covers the treatment of uncertainties using the new ISO Type A and Type B evaluations. Unfortunately, nine of the 20 standards just adopted by the ISO are not the most recent versions of these standards and are therefore already out of date. To help solve this problem, efforts are being made to develop procedures to coordinate the ASTM and ISO development and revision processes for these and future ASTM-originating dosimetry standards. In the meantime, an additional four dosimetry standards have recently been published by the ASTM but have not yet been submitted to the ISO, and six more dosimetry standards are under development.