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Bioburden determination & validation

Bioburden determination & validation

Bioburden determination according to DIN EN ISO 11737-1, validation according to DIN EN ISO 11737-1

DIN EN ISO 11737-1 Bioburden is a global standard for the measurement of microorganisms on products and their packaging. This standard defines the method for the determination of bioburden based on the method of quantification, characterization and revalidation. The procedure involves a minimum recovery rate of 50% and requires that different process parameters be evaluated. The revalidation process must be performed on a fixed time basis.

In a typical bioburden test, a device will contain the number of bacteria that would survive if it were not sterilised. This method may include the inside of the product packaging, as well as the surface of the product. In the process, a sample of the product is rinsed with a clear solution to remove germs from the surface of the product. The sample is then placed on a membrane filter, and culture medium is used. The incubation period is sufficient to determine the amount of germ-forming units.

When a product contains multiple contaminants, bioburden testing is important. The method must be accurate in determining the amount of microorganisms present. It should be sensitive enough to identify any harmful organisms present. The method should be accurate and reproducible to ensure a safe and effective product. Depending on the type of bioburden test, a more comprehensive method may be necessary. The ISO 11737-1 test is a mandatory requirement for medical device manufacturers.

This standard is derived from ISO 10993. The revised version of this standard was designed to provide additional guidance to laboratories and manufacturers. Understanding bioburden concepts can help manufacturers ensure that the tests they conduct are relevant for their products. Moreover, the standard helps them ensure that their bioburden testing responsibilities have been addressed. A complete understanding of the ISO 11737-1 standard will be beneficial for both laboratories and manufacturers.

A detailed bioburden test can be used to evaluate the quality of a product. The microbial contamination of a product depends on the type of material. It can be caused by several factors. For example, a device made of plastic may be more susceptible to the effects of certain chemicals. Using a bioburden test will help ensure that a product has been manufactured in a clean environment that is free of environmental pollutants.

The ISO 11737-1 standard provides guidance for the identification and characterization of viable microorganisms in products. It does not, however, cover microbiological monitoring of a manufacturing environment. The standard applies to microbiological monitoring of a manufacturing environment, not to sterilization. The ISO 11737-1 bioburden determination is an international standard for microorganisms and is a requirement for medical device manufacturers.

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