ISO 28218:2010 辐射防护 放射生物测定的性能标准
标准编号：ISO 28218:2010
中文名称：辐射防护 放射生物测定的性能标准
英文名称：Radiation protection — Performance criteria for radiobioassay
发布日期：2010-10
标准范围
本国际标准为放射生物测定服务实验室的质量保证和控制以及性能评估提供了标准。体内放射性生物测定和体外放射性生物测定的标准和指南在单独的条款中给出。以下内容属于本国际标准的范围:的准确性测试体模中选定的重要放射性核素的活性和数量的体内测量，以及测试样品中选定的重要放射性核素的活性和数量的体外测量；检测限的最低要求；最低测试水平和测试范围；服务实验室报告放射性生物测定结果的要求；服务实验室的质量保证；服务实验室的质量控制；服务实验室向测试实验室报告测试评估的协议；服务实验室客户未指定性能标准时的默认程序；y#在不同方法中的应用（见附件A和B）。以下不在本国际标准范围内:从生物样品中分离放射性核素的详细放射化学方法；体内和体外放射性测量的详细程序；用于将放射性生物测定结果转换为剂量（剂量评估）的生物动力学数据和数学模型；测试实验室制备和分发测试样品和模型的程序。
This International Standard provides criteria for quality assurance and control, and evaluation of performance of radiobioassay service laboratories.Criteria and guidance for in vivo radiobioassay and in vitro radiobioassay are given in separate clauses.The following are within the scope of this International Standard:- the accuracy of
- in vivo measurements of activity and quantities of selected important radionuclides in test phantoms, and
- in vitro measurements of activity and quantities of selected important radionuclides in test samples;
- minimal requirements for detection limit;
- minimum testing levels and testing ranges;
- requirements for reporting radiobioassay results by service laboratories;
- quality assurance in service laboratories;
- quality control in service laboratories;
- protocol for reporting test evaluations by service laboratories to the testing laboratory;
- default procedures when the service laboratory customer does not specify the performance criteria;
- applications of y# for different methods (see Annexes A and B).
- detailed radiochemical methods for separating radionuclides from biological samples;
- detailed procedures for in vivo and in vitro radioactivity measurements;
- biokinetic data and mathematical models for converting radiobioassay results into dose (dose assessment);
- procedures for the preparation and distribution of test samples and phantoms by the testing laboratories.
标准预览图
