1.1 本标准为JCGM中描述的概念的使用提供了指导( 计量指南联合委员会 )测量数据评估——测量不确定度表达指南（GUM），用于估计辐射处理中吸收剂量测量的不确定度。 1.2 给出了识别、评估和估计与剂量测定系统使用相关的测量不确定度分量的方法，以及基于GUM方法计算剂量测量的组合标准测量不确定性和扩展不确定性的方法。 1.3 举例说明了如何制定测量不确定性预算和不确定性声明。 1.3.1 不确定性的关键组成部分是作为不确定性预算推导的一部分推导出来的。本标准确定了哪些不确定性成分被作为其他分析的一部分（例如，过程能力和过程目标的评估，以及过程可变性），以及哪些来自其他标准的成分被纳入本标准（即。 g.剂量测量的精度、校准曲线拟合和剂量的间接测量）。 1.4 本文件是一套标准之一，为在辐射处理中正确实施剂量测定提供了建议，并为达到ISO 11137-1（医疗保健产品的辐射灭菌）、ISO 14470（食品处理）和ISO/ASTM的要求提供了指导 52628 与用剂量测定系统进行的测量相关的不确定度的评估和记录有关。本手册旨在与ISO/ASTM结合阅读 52628 （辐射处理中剂量测定的标准实施规程）和ISO/ASTM 51261 辐射处理用常规剂量测定系统的校准实施规程。 1.5 为了达到ISO 11137-1（医疗保健产品的辐射灭菌）、ISO 14470（食品处理）和其他应用程序的要求，测量应附带不确定性声明。 1.6 本指南不涉及工艺规范或合格评定的制定。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 4.1 ISO 11137-1（医疗保健产品的辐射灭菌）和ISO 14470（食品的辐照）等标准包含以下要求:在过程的开发、验证和常规控制中使用的剂量测定应具有国家或国际标准的测量可追溯性，并应具有已知的不确定度。 测量不确定度的大小对于评估测量系统的结果很重要。 4.1.1 本指南提供了有关如何满足确定与剂量测量相关的已知不确定度水平的基本要求、如何计算总体不确定度以及不确定度如何因应用而异的信息（例如OQ和PQ剂量测量、常规剂量测量、最小吸收剂量的确定（D 最小 )或最大吸收剂量（D 最大值 )来自监测位置的剂量（D 星期一 )). 提供了关于如何识别和计算用于建立不确定性预算的不确定性的不同组成部分的信息。 4.2 特定剂量测定系统的可实现不确定度值范围的信息在特定剂量测定体系的ISO/ASTM标准中给出。虽然特定剂量测定标准中给出的不确定度值是可以实现的，但应注意的是，根据测量条件和仪器，可能会获得更小和更大的不确定值。 有关更多信息，另请参见ISO/ASTM 52628 . 4.3 本指南使用GUM采用的方法来估计测量中的不确定性（参见 2.4 ). 因此，不确定度的组成部分被评估为A类不确定度或B类不确定度。 4.3.1 量化不确定性的单个分量可以帮助用户识别减少组合测量不确定性的动作。 4.4 尽管本指南提供了一个评估不确定性的框架，但它不能取代批判性思维、智力诚实和经验。不确定度的评估取决于对被测物性质以及所用测量方法和程序的详细了解。因此，测量结果所引用的不确定度的效用最终取决于对其价值分配做出贡献的人员的理解、关键分析和完整性（GUM 3.4.8 JCGM 100:2008）。

1.1 This standard provides guidance on the use of concepts described in the JCGM ( Joint Committee for Guides in Metrology ) Evaluation of Measurement Data – Guide to the Expression of Uncertainty in Measurement (GUM) to estimate the uncertainties in the measurement of absorbed dose in radiation processing. 1.2 Methods are given for identifying, evaluating, and estimating the components of measurement uncertainty associated with the use of dosimetry systems, and for calculating combined standard measurement uncertainty and expanded uncertainty of dose measurements based on the GUM methodology. 1.3 Examples are given on how to develop a measurement uncertainty budget and a statement of uncertainty. 1.3.1 Key components of uncertainty are derived as part of the derivation of the uncertainty budget. This standard identifies which components of uncertainty are carried forward as part of other analyses (e.g., assessment of process capability and process targets, and process variability), and which components from other standards are brought forward into this standard (e.g., precision of the dose measurement, calibration curve fit, and indirect measurement of dose). 1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and provides guidance for achieving compliance with the requirements of ISO 11137-1 (radiation sterilization of health care products), ISO 14470 (treatment of food), and ISO/ASTM 52628 related to the evaluation and documentation of the uncertainties associated with measurements made with a dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628 (Standard Practice for Dosimetry in Radiation Processing), and ISO/ASTM 51261 (Practice for Calibration of Routine Dosimetry Systems for Radiation Processing). 1.5 To achieve compliance with the requirements of ISO 11137-1 (radiation sterilization of health care products), ISO 14470 (treatment of food), and other applications, a measurement is accompanied by a statement of the uncertainty. 1.6 This guide does not address the establishment of process specifications or conformity assessment. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Standards such as ISO 11137-1 (radiation sterilization of health care products) and ISO 14470 (irradiation of food) contain requirements that dosimetry used in the development, validation, and routine control of the process shall have measurement traceability to national or international standards and shall have a known level of uncertainty. The magnitude of the measurement uncertainty is important for assessing the results of the measurement system. 4.1.1 This guide provides information on how to meet the fundamental requirement to determine a known level of uncertainty associated with a dose measurement, how to calculate the overall uncertainty, and how the uncertainty may differ depending on the application (e.g., OQ and PQ dose measurements, routine dose measurement, determination of minimum absorbed dose (D min ) or maximum absorbed dose (D max ) from the monitoring location dose (D mon )). Information is provided on how to identify and calculate different components of uncertainty used to establish an uncertainty budget. 4.2 Information on the range of achievable uncertainty values for specific dosimetry systems is given in the ISO/ASTM standards for the specific dosimetry systems. While the uncertainty values given in specific dosimetry standards are achievable, it should be noted that both smaller and larger uncertainty values might be obtained depending on measurement conditions and instrumentation. For more information, see also ISO/ASTM 52628 . 4.3 This guide uses the methodology adopted by the GUM for estimating uncertainties in measurements (see 2.4 ). Therefore, components of uncertainty are evaluated as either Type A uncertainty or Type B uncertainty. 4.3.1 Quantifying individual components of uncertainty may assist the user in identifying actions to reduce the combined measurement uncertainty. 4.4 Although this guide provides a framework for assessing uncertainty, it cannot substitute for critical thinking, intellectual honesty, and experience. The evaluation of uncertainty depends on detailed knowledge of the nature of the measurand and of the measurement method and procedure used. The utility of the uncertainty quoted for the result of a measurement therefore ultimately depends on the understanding, critical analysis, and integrity of those who contribute to the assignment of its value (GUM 3.4.8 JCGM 100:2008).