Bioburden testing according to ISO 11737-1, aerobic bacteria and fungi
The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing plays a crucial role in the quality control of medical devices, pharmaceutical products, and their components.
This analysis follows the ISO 11737-1 standard to detect populations of viable microorganisms on a product before sterilization, indicating the microbiological cleanliness of the product.
ISO 11737-1 is recognized in the EU as a harmonized medical device standard and by the FDA as a consensus standard. This makes it the recommended way to evaluate bioburden under the EU MDR and the FDA 510(k) premarket submission process.
This example testing package includes the following:
Testing of 5 identical specimens
Detecting the presence of aerobic bacteria and fungi (yeasts and molds)
Validating the bioburden determination technique
Results expressed as total CFU/test product (CFU=colony forming units)
Tests under GLP
We can also offer custom bioburden test packages, especially for customers with large annual sample volumes. Please ask our experts for a quotation and estimated turnaround time.
- Suitable sample matrices
- Medical devices, health care products, raw materials, packaging
- Required sample quantity
- The amount of specimens 5 x 4 = 20 pcs
- Typical turnaround time
- 4 weeks after receiving the samples
- Available quality systems
- Accredited testing laboratory
- Device types
- Standard
- Method expert
Price
We also charge a 97 € service fee per order.
Large batches of samples are eligible for discounts.
Questions? We're happy to help.
Questions? We're happy to help.
Business hours: Mon–Fri 9 AM – 5 PM Finnish time (EST/EEST)
Other tests we offer
Face mask tests according to EN 14683 for type II and type IIR masks
Sterility tests according to ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi
Cleaning validation of medical devices according to ISO 17664
Irritation testing according to ISO 10993-23
Antibacterial activity on plastic and non-porous surfaces according to ISO 22196
Biocompatibility evaluation of breathing gas pathways according to ISO 18562
Genotoxicity - Bacterial reverse mutation test (AMES)
Pyrogenicity testing by ISO 10993-11
Ethylene oxide (EO) sterilization and sterilization residues according to ISO 10993-7
Biological evaluation plan (BEP)
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