ISO 21501-3:2019
2019-11
ISO 21501-3:2019
Résumé
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.
Informations générales
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État actuel: PubliéeDate de publication: 2019-11Stade: Norme internationale en cours d'examen systématique [90.20]
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Edition: 2
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Comité technique :ISO/TC 24/SC 4ICS :19.120
- RSS mises à jour
Cycle de vie
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Précédemment
AnnuléeISO 21501-3:2007
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Actuellement
PubliéeISO 21501-3:2019
Les normes ISO sont réexaminées tous les cinq ans
Stade: 90.20 (En cours d'examen)
