Biological testing of medical devices
CleanControlling Medical GmbH & Co. KG is an accredited and GLP- and ZLG-recognized testing laboratory that tests the biological and microbiological-hygienic cleanliness and safety of medical devices.
The biological analytics established at CleanControlling since 2014 and accredited since 2015 include tests within the scope of validation and monitoring of cleaning processes, reprocessing and sterilization of reusable medical devices as well as the simulation of reprocessing cycles in the end-of-life examination with a focus on maintaining biocompatibility. In addition, tests within the scope of validation of sterilization containers also fall within the service portfolio.
In the field of hygiene, we support you with products and evaluations for testing hygienic environmental cleanliness as well as with the provision and evaluation of validation sets for the validation of washer-disinfectors (RDG and RDG-E).
Biological test methods
- In-vitro cytotoxicity test according to DIN EN ISO 10993-5
- Bioburden determination and validation according to DIN EN ISO 11737-1
- Endotoxin test (LAL test) according to USP 85 / Ph. Eur. 2.6.14
- Sterility testing according to DIN EN ISO 11737-2
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