ISO 21501-3-2007 粒径分布测定.单粒子光干扰法.第3部分:消光液载粒子计数器

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标准号:ISO 21501-3-2007
中文标准名称:粒径分布测定.单粒子光干扰法.第3部分:消光液载粒子计数器
英文标准名称:Determination of particle size distribution - Single particle light interaction methods - Part 3: Light extinction liquid-borne particle counter
标准类型:A42
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:A42
国际标准分类号:19.120
适用范围:This part of ISO 21501 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 part of ISO 21501 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 this part of ISO 21501 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 this part of ISO 21501:- 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.

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