Bioburden testing by ISO 11737-1, aerobic bacteria and fungi

The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing has an important role in the quality control of medical devices, pharmaceutical products, and their components.

This analysis follows the ISO 11737-1 standard and detects populations of viable microorganisms on a product before sterilization, thus indicating the microbiological cleanliness of the product.

Testing of three identical replicate specimens with 2 growth media is included in the price. The presence of aerobic bacteria and fungi (yeasts and molds) on each specimen is analyzed, and the results are given as total CFU/test product (CFU=colony forming units).

It is also possible to analyze anaerobic bacteria and spores. Please ask the method expert for a quotation and estimated turnaround time.

ISO 11737-1 is recognized in the EU as a harmonized medical device standard, which means that if the test is passed, the device can be presumed to conform with Regulation (EU) 2017/745 with regard to bioburden. The standard is also accepted by the FDA as a consensus standard, making it a recommended way to evaluate bioburden during the 510(k) process.

Suitable sample matrices
Medical devices, health care products, raw materials, packaging
Required sample quantity
3 pcs/3 specimens
Typical turnaround time
4 weeks after receiving the samples
Available quality systems
Accredited test method
Standard

Pricing and online order

Price per sample (Excl. VAT):
930 €

We also charge a 97 € service fee per order.

Large batches of samples are eligible for discounts.

Samples are entered during checkout.

Our experts review all orders to ensure the testing method is suitable for your needs and samples.

Questions? We're happy to help.

Questions? We're happy to help.

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Have questions or need help? Email us at or call +358 50 336 6128.