Microbial cleanliness indicates freedom from a population of viable microorganisms on a product or a package (in this case, a medical mask). In practical use, microbial cleanliness is often referred to as bioburden.

The principle of this test is extracting the full medical mask in an extracting liquid. The extraction liquid is filtered through a 0.45 µm filter. The membrane filter is put above the TSA plate for the total viable aerobic microbial count and above SDA for fungi enumeration. The total bioburden is expressed by the addition of the TSA and SDA counts.

How SIG can help

SIG Laboratory can perform analysis of microbial cleanliness/bioburden of medical masks. We also ascertain the medical mask meets the criteria of EN 14683:2019+AC.

Method of Analysis

SIG Laboratory performs analysis of microbial cleanliness/bioburden of medical masks according to EN 14683:2019+AC, annex D.