标准摘要
[中文适用范围]： 本文件描述了一种光消光液载粒子计数器（LELPC）的校准和验证方法，用于测量悬浮在液体中的粒子的尺寸和粒子数浓度。 本文件中描述的消光方法基于单粒子测量。 通过此方法测量的颗粒的典型尺寸范围为 1 µm 至 100 µm。 本方法适用于评价药品（如注射剂、注射用水、大输液）清洁度的仪器，以及测定各种液体中颗粒数量和粒径分布的仪器。 以下情况均属于本文件的范围： ——尺寸设置错误； ——计数效率； ——尺寸分辨率； ——最大颗粒数浓度； ——采样流量误差； ——采样时间误差； ——取样体积误差； ——校准间隔； ——报告测试和校准的结果。 [外文原描述]： This document describes a calibration and verification method for a light extinction liquid-borne particle counter (LELPC), which is used to measure the size and particle number concentration of particles suspended in liquid. The light extinction method described in this document is based on single particle measurements. The typical size range of particles measured by this method is between 1 µm and 100 µm in particle size. The method is applicable to instruments used for the evaluation of the cleanliness of pharmaceutical products (e.g. injections, water for injections, infusions), as well as the measurement of number and size distribution of particles in various liquids. The following are within the scope of this document: — size setting error; — counting efficiency; — size resolution; — maximum particle number concentration; — sampling flow rate error; — sampling time error; — sampling volume error; — calibration interval; — reporting results from test and calibration.
英文名称Determination of particle size distribution — Single particle light interaction methods — Part 3: Light extinction liquid-borne particle counter