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. ISO 11737-1 is 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.
Testing includes elution process validation by determination of recovery efficiency and correction factor. Testing of three identical replicate specimens 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.
- Suitable sample matrices
- Medical devices, health care products, raw materials, packaging
- Minimum sample amount
- 4 pcs/4 specimens
- Typical turnaround time
- 8 weeks after receiving the samples
- Quality system
- Accredited test method
- Device types