1.1本规程涵盖了在设施表征、工艺鉴定和使用电子束辐射的常规处理中应遵循的剂量学程序，以确保整个产品已在可接受的吸收剂量范围内处理。还讨论了与设施特性（包括设备文件）、工艺鉴定和常规产品加工相关的其他程序，这些程序可能会影响并可用于监测产品中的吸收剂量。 注1有关剂量计选择和校准的指南，请参阅指南E 1261。有关特定剂量计的选择、校准和使用以及剂量学产品中吸收剂量的解释的进一步指导，另请参阅规程E 668、E 1275、E 1276、E 1431、E 1607、E 1631和E 1650。对于5 MeV以上电子能量的使用，请参阅规程E 1026、E 1205、E 1401、E 1538和E 1540以了解特定大体积剂量计的讨论。有关脉冲辐射的辐射剂量测定的讨论，请参阅ICRU报告34。 在考虑剂量计类型时，请小心剂量率和加速器脉冲率和宽度（如适用）的影响。 1.2本规程中涵盖的电子能量范围在300千电子伏和25兆电子伏之间，尽管对其他能量也有一些讨论。 1.3剂量测定只是辐照设施全面质量保证计划的一个组成部分。对于医疗器械灭菌和食品保存等特定应用，可能需要剂量测定以外的其他控制。 1.4对于食品的辐照和保健品的辐射灭菌，还存在其他特定的ISO标准。食品辐照见ISO 15562:1998， 食品加工用电子和韧致辐射设施中剂量测定的实施规程 （ASTM规程E 1431）。保健品的辐射灭菌见ISO 11137:1995， 医疗保健产品的灭菌.验证和常规控制辐射灭菌的要求 . 在ISO 11137涵盖的领域中，该标准优先。 本标准并非旨在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。

1.1 This practice covers dosimetric procedures to be followed in facility characterization, process qualification, and routine processing using electron beam radiation to ensure that the entire product has been treated with an acceptable range of absorbed doses. Other procedures related to facility characterization (including equipment documentation), process qualification, and routine product processing that may influence and may be used to monitor absorbed dose in the product are also discussed. Note 1For guidance in the selection and calibration of dosimeters, see Guide E 1261. For further guidance in the selection, calibration, and use of specific dosimeters, and interpretation of absorbed dose in the product from dosimetry, also see Practices E 668, E 1275, E 1276, E 1431, E 1607, E 1631, and E 1650. For use with electron energies above 5 MeV, see Practices E 1026, E 1205, E 1401, E 1538, and E 1540 for discussions of specific large volume dosimeters. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34. When considering a dosimeter type, be cautious of influences from dose rates and accelerator pulse rates and widths (if applicable). 1.2 The electron energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions for other energies. 1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation. 1.4 For the irradiation of food and the radiation sterilization of health care products, other specific ISO standards exist. For food irradiation, see ISO 15562:1998, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing (ASTM Practice E 1431). 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. 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.