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Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing 辐射加工剂量测量系统的选择和校准导则
发布日期: 2002-01-22
1.1本指南涵盖了选择和校准用于测量γ射线或X射线场以及用于辐射处理的电子束中吸收剂量的剂量测定系统的基础。它讨论了校准期间或作为产品商业辐射处理质量保证的一部分的常规基础上可能使用的剂量学系统的类型。本指南还讨论了吸收剂量的解释,并简要概述了与剂量测定相关的不确定度的测量。分析仪器的校准细节在个人剂量测定系统标准实践中进行了阐述。 1.2所涵盖的吸收剂量范围高达1 MGy(100 Mrad)。涵盖的源能量为0.1至50MeV光子和电子。 1.3本指南应与其他标准中涵盖的特定剂量测定系统和应用的标准实践和指南一起使用。 1.4本指南不包括中子或重带电粒子辐射处理的剂量测定。 1.5 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。 ====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。示例包括医疗产品的灭菌、食品加工、聚合物的改性、电子设备的辐照以及油墨、涂料和粘合剂的固化(1,2)。这些应用中使用的吸收剂量范围约为10 Gy至100 kGy以上。 4.2许多国家都有关于医疗产品灭菌和食品辐射加工的规定。这些法规可能要求对剂量测定系统的响应进行校准,并可追溯至国家标准(3、4、5)。有必要进行适当的剂量测定,并进行适当的统计控制和记录,以确保产品得到适当处理。 4.3必须进行适当的剂量学测量,以确保产品获得所需的吸收剂量。必须校准剂量计。常规剂量计系统的校准可以通过常规剂量计的标准化辐照直接在国家或认证的标准实验室中进行。或者,可以通过使用本地(内部)校准设施(6)或在生产辐照器中进行。 应了解并考虑可能影响剂量计响应的所有可能因素,包括环境条件和处理设施内此类条件的变化。还必须校准相关的分析仪器。
1.1 This guide covers the basis for selecting and calibrating dosimetry systems used to measure absorbed dose in gamma-ray or X-ray fields and in electron beams used for radiation processing. It discusses the types of dosimetry systems that may be employed during calibration or on a routine basis as part of quality assurance in commercial radiation processing of products. This guide also discusses interpretation of absorbed dose and briefly outlines measurements of the uncertainties associated with the dosimetry. The details of the calibration of the analytical instrumentation are addressed in individual dosimetry system standard practices. 1.2 The absorbed-dose range covered is up to 1 MGy (100 Mrad). Source energies covered are from 0.1 to 50 MeV photons and electrons. 1.3 This guide should be used along with standard practices and guides for specific dosimetry systems and applications covered in other standards. 1.4 Dosimetry for radiation processing with neutrons or heavy charged particles is not covered in this guide. 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 include the sterilization of medical products, processing of food, modification of polymers, irradiation of electronic devices, and curing of inks, coatings, and adhesives (1, 2). The absorbed doses employed in these applications range from about 10 Gy to more than 100 kGy. 4.2 Regulations for sterilization of medical products and radiation processing of food exist in many countries. These regulations may require that the response of the dosimetry system be calibrated and traceable to national standards (3, 4, 5). Adequate dosimetry, with proper statistical controls and documentation, is necessary to ensure that the products are properly processed. 4.3 Proper dosimetric measurements must be employed to ensure that the product receives the desired absorbed dose. The dosimeters must be calibrated. Calibration of a routine dosimetry system can be carried out directly in a national or accredited standards laboratory by standardized irradiation of routine dosimeters. Alternatively, it may be carried out through the use of a local (in-house) calibration facility (6) or in a production irradiator. All possible factors that may affect the response of dosimeters, including environmental conditions and variations of such conditions within a processing facility, should be known and taken into account. The associated analytical instrumentation must also be calibrated.
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归口单位: E61.01
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