Accredited biological test laboratory
We offer our customers a product and services portfolio which allows supporting your product development and product authorization in a highly efficient process. Therefore we attach great value to comprehensive person-to-person consultation, a high degree of customer orientation, high quality and flexibility.
Biological tests of medical devices according to the DIN EN ISO 10993 are one of the main preconditions for the medical device authorization process.
As an accredited laboratory we can offer you in-vitro testings of all medical devices.
Is your medical device safe?
We will test you products or materials according to the following standards:
DIN EN ISO 10993-3, Test for gentoxicity - details
DIN EN ISO 10993-4, Test for interaction with blood (hemocompatibility) - details
DIN EN ISO 10993-5, Test for in vitro-cytotoxicity- details
DIN EN ISO 10993-10, Test for in-vitro irritation - details
OECD 442D, Test for in vitro skin sensitisation KeratinoSensTM
USP 40-NF35:2017, Test for endotoxin-mediated pyrogenetiy - details
Questions about our tests and services?
Please call us +49 721 957919 500 or
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