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.
The price does not include a method validation. Please ask for a quotation of elution process validation by determination of recovery efficiency and correction factor.
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 testing laboratory
- Standard
Large number of samples or specialized needs?
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