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Testing of Medical Devices for Legal Compliance

The biological safety of medical devices is essential not only during the times of the Corona pandemic. Nevertheless especially in crisis situations the safety, sterility and biocompatibility of medical devices is under special surveillance.

In this context Tentamus offers a sophisticated and accredited platform for biological safety testing of medical devices within the framework of the DIN ISO 10993 comprising the following test platforms:

  • Chemical characterization of Medical Devices (ISO 10993-18)
  • Determination of cytotoxicity in vitro (ISO 10993-5)
  • Determination of Bioburden (ISO 11737-1/2)
  • Determination of Bacterial Endotoxin – LAL (Ph. Eur. 2.6.14)
  • Determination of Pyrogens – MAT (Ph. Eur. 2.6.30)
  • Determination of Skin Irritation (OECD TG 439 / ISO 10993-23 as draft)
  • Determination of Skin Sensitization (OECD TG 442d/e
  • Determination of Hemocompatibility (ISO 10993-4)
  • Determintaion of Genotoxicity (ISO 10993-3)

 

If you wish to learn more about this, please contact our expert:

Dr. Wolfgang Rudy
Chief Scientific Officer Tentamedix
wolfgang.rudy@tentamedix.com
+49 721 957 919 550

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