ISO/ASTM 51818:2020 能量在80keV～300keV之间辐照加工用电子束设备剂量测定规程

标准编号：ISO/ASTM 51818:2020

中文名称：能量在80keV～300keV之间辐照加工用电子束设备剂量测定规程

英文名称：Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV

发布日期：2020-06

标准范围

本规范涵盖了在安装鉴定、操作鉴定和性能鉴定（IQ、OQ、PQ）和电子束设施的常规处理，以确保产品已在可接受的吸收剂量范围内进行处理。还讨论了可能影响产品吸收剂量的与IQ、OQ、PQ和常规产品加工相关的其他程序。本实践中涵盖的电子束能量范围在80至300keV之间，通常称为低能量。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，可能需要其他措施。对于食品的辐照和保健产品的辐照灭菌，存在其他特定的ISO和ASTM标准。关于保健产品的辐射灭菌，参见ISO 11137-1。在ISO 11137-1涵盖的领域，该标准优先。关于食品辐照，参见ISO 14470。有关食品有效或监管剂量限值的信息不在本规范的范围内（参见ASTM F1355和F1356）。本文件是为在辐射处理中正确实施剂量测定提供建议的一组标准之一，并描述了实现符合ISO/ASTM 52628要求的方法。它旨在与ISO/ASTM 52628一起阅读。本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。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》中确立的国际公认的标准化原则制定的。

This practice covers dosimetric procedures to be followed in installation qualification, operational qualification andperformance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. For food irradiation, see ISO 14470. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356).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 ISO/ASTM 52628. It is intended to be read in conjunction with ISO/ASTM 52628.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. 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.

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