標準號：BS ISO 15571-1999
中文標準名稱：輻射處理過程中γ輻射設備劑量測定操作規程
英文標準名稱：Practice for dosimetry in a gamma irradiation facility for radiation processing
標準類型：F81
發布日期：1999/8/15 12:00:00
實施日期：1999/8/15 12:00:00
中國標準分類號：F81
國際標準分類號：17.240
適用范圍：1 This practice outlines dosimetric procedures to be followed in irradiator characterization, process qualification, and routine processing in a gamma irradiation facility. These procedures ensure that all product processed with ionizing radiation from isotopic gamma sources receive absorbed doses within a predetermined range. Other procedures re-lated to irradiator characterization, process qualification, and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory dose limits is not within the scope of this document. Note 1—Dosimetry is one component of a total quality assurance program for adherence to good manufacturing practices. Specific applications of gamma radiation processing may require additional controls. 2 This practice describes general procedures applicable to all gamma radiation processing requiring absorbed doses within a predetermined range. For procedures specific to food irradiation, see Practice E 1204. The sterilization of medical devices is a regulated irradiation process with specific process control requirements. These requirements, including specific dosimetry requirements for medical device sterilization, are given in Refs (1) and (2). Guidelines for medical device sterilization are given in Refs (3) and (4). 3 For guidance in the selection, calibration, and use of specific dosimeters, and interpretation of absorbed dose in the product from dosimetry measurements, see Guide E 1261 and Practices E 666, E 668, E 1026, E 120S, E 1275, E 1276, E 1310, E 1400, E 1401, E 1538, E 1540, E 1607, and E 1650. For discussion of radiation dosimetry for gamma rays, see ICRU Report 14. 4 This standard does not purport to address all of the safely concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro-priate safely and health practices and determine the applica-bility of regulatory limitations prior to use.