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Standard Terminology Relating to Radiation Processing: Dosimetry and Applications 关于辐射处理的标准术语:剂量和应用
发布日期: 2017-10-01
1.1 本术语标准列出了与辐射处理概念,特别是辐射剂量测量有关的术语和定义。使用本标准和通用术语将促进更清晰的沟通,并消除歧义。 1.2 将电离辐射用于商业产品的处理,如医疗器械的灭菌、减少食品中的微生物污染或聚合物的改性,称为辐射处理。使用的辐射类型可能是伽马辐射(通常来自钴-60源)、X辐射或加速电子。 1.3 本标准提供了辐射处理概念剂量测定的术语和定义,涉及与操作鉴定、性能鉴定和可能影响产品吸收剂量的常规处理相关的程序,以及在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使用的剂量学系统的类型。 1.4 在选择术语和定义时,特别注意包括需要定义的术语,也就是说,因为定义对于正确理解相应概念至关重要,或者因为需要解决一些具体的歧义。 1.5 某些定义后面的“讨论”提供了澄清或示例,以便于理解所描述的概念。在某些情况下,还包括其他信息,例如,通常测量数量的单位、建议的参数值、参考等。 1.6 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、健康和环境实践,并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 3.1 本标准旨在促进辐射处理研究和工业专业人员之间的沟通和共识。 3.2 考虑到对涉及辐射处理活动任何主题的标准中涉及的设备和材料的误解可能产生的相关影响,明确的概念交流至关重要。E61和ISO/TC85/WG3制定的所有标准中都有涉及辐射处理相关剂量学的概念以及制备、测试和使用剂量学系统确定吸收剂量的程序,需要用通用术语指定,并用统一定义描述,以避免误解。
1.1 This terminology standard lists terms and definitions related to radiation processing concepts, especially radiation dose measurements. Use of this standard, and the common terminology, will foster clearer communication, and remove ambiguity. 1.2 The use of ionizing radiation for the treatment of commercial products such as the sterilization of medical devices, the reduction of microbial contamination in food or the modification of polymers is referred to as radiation processing. The types of radiation used may be gamma radiation (typically from cobalt-60 sources), X-radiation or accelerated electrons. 1.3 This standard provides terms and definitions for dosimetry for radiation processing concepts dealing with procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the products, and types of dosimetry systems that may be used during calibration or on a routine basis as part of quality assurance in commercial radiation processing of products. 1.4 When selecting terms and definitions, special care has been taken to include the terms that need to be defined, that is to say, either because the definitions are essential to the correct understanding of the corresponding concepts or because some specific ambiguities need to be addressed. 1.5 The “Discussion” appended to certain definitions offers clarification or examples to facilitate understanding of the concepts described. In certain cases, miscellaneous information is also included, for example, the units in which a quantity is normally measured, recommended parameter values, references, etc. 1.6 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. 1.7 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 ====== 3.1 The purpose of this standard is to facilitate communication and promote common understanding within the professionals in radiation processing research and industry. 3.2 Unambiguous communication of concepts is crucial taking into account the relevant implications that may arise from misunderstandings with regard to equipment and materials involved in the standards dealing with any subject regarding radiation processing activities. Concepts dealing with dosimetry related to radiation processing and procedures for preparation, testing, and using dosimetry systems to determine the absorbed dose are present in all standards developed by E61 and ISO/TC85/WG3 and need to be designated by common terms and described by harmonized definitions in order to avoid misunderstandings.
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归口单位: E61.01
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