1.1本规程规定了校准辐射处理中使用的常规剂量测定系统的要求，包括建立测量可追溯性和使用校准剂量测定系统估计测量剂量的不确定度。 注1-许多国家都有管理某些辐射加工应用的法规或其他指令，如医疗产品的灭菌和食品的辐射加工，要求吸收剂量测量可追溯到国家或国际标准（ISO 11137-1，参考文献（1-3）2）。 1.2所涵盖的吸收剂量范围高达1 MGy。 1.3所涵盖的辐射类型为光子和电子，能量为80千电子伏至25兆电子伏。 1.4本文件是一套标准之一，提供了在辐射处理中正确实施剂量测定的建议，并描述了实现符合ASTM E2628“辐射处理中剂量测定惯例”要求的方法，用于校准常规剂量测定系统。本标准旨在与ASTM E2628和第2节中引用的被校准剂量测定系统的相关ASTM或ISO/ASTM标准惯例一起阅读。 1.5本标准无意解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1电离辐射用于在产品中产生各种预期效果。应用实例包括医疗产品的灭菌、微生物还原、聚合物和电子设备的改性以及油墨、涂料和粘合剂的固化。 4.2有必要进行吸收剂量测量，并进行统计控制和记录，以确保产品获得所需的吸收剂量。 这些控制包括解决常规剂量测定系统校准要求的程序。 4.3本文件中所述的常规剂量测定系统校准程序为用户提供了一个剂量测定系统，其剂量测量可追溯到国家或国际使用条件标准（见附件A4）。剂量测定系统校准是用户测量管理系统的一部分。

1.1 This practice specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system. NOTE 1—Regulations or other directives exist in many countries that govern certain radiation processing applications such as sterilization of healthcare products and radiation processing of food requiring that absorbed-dose measurements be traceable to national or international standards (ISO 11137-1, Refs (1-3)2). 1.2 The absorbed-dose range covered is up to 1 MGy. 1.3 The radiation types covered are photons and electrons with energies from 80 keV to 25 MeV. 1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ASTM E2628 “Practice for Dosimetry in Radiation Processing” for the calibration of routine dosimetry systems. It is intended to be read in conjunction with ASTM E2628 and the relevant ASTM or ISO/ASTM standard practice for the dosimetry system being calibrated referenced in Section 2. 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 limitations prior to use. ====== Significance And Use ====== 4.1 Ionizing radiation is used to produce various desired effects in products. Examples of applications include the sterilization of medical products, microbial reduction, modification of polymers and electronic devices, and curing of inks, coatings, and adhesives. 4.2 Absorbed-dose measurements, with statistical controls and documentation, are necessary to ensure that products receive the desired absorbed dose. These controls include a program that addresses requirements for calibration of routine dosimetry system. 4.3 A routine dosimetry system calibration procedure as described in this document provides the user with a dosimetry system whose dose measurements are traceable to national or international standards for the conditions of use (see Annex A4). The dosimetry system calibration is part of the user’s measurement management system.