標準號：BS ISO 21501-3-2007
中文標準名稱：粒度分布測定.單粒子光干擾法.消光液載粒子計數器
英文標準名稱：Determination of particle size distribution. Single particle light interaction methods. Light extinction liquid-borne particle counter
標準類型：N33
發布日期：2007/8/31 12:00:00
實施日期：2007/8/31 12:00:00
中國標準分類號：N33
國際標準分類號：19.120
適用范圍：ISO 21501-3:2007 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 ISO 21501-3:2007 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.Instruments that conform to ISO 21501-3:2007 are 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 ISO 21501-3:2007:size calibration;verification of size setting;counting efficiency;size resolution;maximum particle number concentration;sampling flow rate;sampling time;sampling volume;calibration interval;test report.