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BFE – Bacterial Filtration Efficiency

A suspension of Staphylococcus aureus was aerosolized using a nebulizer and delivered to the test article at a constant flow rate (28,3 L/min) and challenge delivery. The mean particles size (MPS) is maintained at 3,0 µm ±0,3 µm. The aerosol droplets were drown through a six stage, viable particle, Andersen sampler for collection. this procedure allows a reproducible bacterial challenge to be delivered to test materials. The test is performed on 49 cm² area of internal face of mask in contact with bacterial challenge according to the indications by the customer. If the sample is made of fabric, the test is performed considering as external and internal side according to the indications by the customer. The sample is conditioned at (21 ± 5) ° C and (85 ± 5)% of relative humidity for at least 4 hours. 

Sample – Need min. 5 mask 

BRETHABILITY

The breathability test determines the differential pressure by measuring the differential air pressure using a manometer a constant flow rate (8 L/min on 4,9 cm² standard area).

Sample – Need min. 5 mask 

BIOBURDEN

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.

AnalisiTecniche di provaMetodi di prova
Efficienza di filtrazione batterica (BFE)/Bacterial filtration efficiency (BFE) (>10%) Metodo colturale-conta EN 14683:2019/AC 2019 App B, UNI EN 14683:2019 App BAggiungi
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 11737-1:2018Aggiungi