1.1 This document provides guidance in determining absorbed-dose distributions in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1 – For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing. 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. ISO/ASTM Practice 51608, ISO/ASTM Practice 51649, and ISO/ASTM Practice 51702 also contain dose mapping requirements.
1.2 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.
1.3 Dose mapping for bulk flow processing and fluid streams is not discussed.
1.4 Dosimetry is only one component of a total quality program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
1.5 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 requirements prior to use.
Product Details
- Published:
- 07/10/2003
- Number of Pages:
- 9
- File Size:
- 1 file , 150 KB
