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The use of medical devices in normal everyday clinical practice requires the absence of viable micro-organisms. EN ISO 11737 regulates the determination of the population of micro-organisms on medical devices. Inactivation of microbial contamination occurs by means of suitable sterilisation procedures. These transform the medical device from an unsterile state to a sterile state.
In the process, bacterial load is defined as the sum of all micro-organisms from a number of possible sources, such as raw materials, components, production processes and packaging.
An article, which was published in issue 1/2 2009 of Chemische Rundschau, provides insights into microbiological procedures to determine bacterial load. Sampling, cultivating, incubating and evaluating bacteria are described in particular detail. Finally, suitable preconditions are defined that allow validation of the bacterial sampling procedure.
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