The Bioburden test determines the total number of viable microorganisms in or on a medical device, container, or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
|Analisi||Tecniche di prova||Metodi di prova|
|Valutazione della popolazione di microrganismi (Bioburden)/Determination of a population of microorganism (Bioburden) : Batteri anaerobi/Anaerobic bacteria, Carica batterica aerobia mesofila/Mesophilic aerobic bacterial count, Lieviti/Yeasts, Muffe/Moulds||Metodo colturale-conta||UNI EN ISO 11737-1:2018||Aggiungi|