Biocompatibility is tested to exclude biological hazards to humans by medical devices, drugs or their ingredients/ raw materials. For this various tests are employed (e.g. in vivo, in vitro). What tests actually need to be performed to attain marketing authorization for a product, depends most of all on the materials used and the intended application/use.

BIOSERV conducts the following range of biocompatibility tests 

Testing for genotoxicity, carcinogenicity, reproductive and immune toxicity acc. to DIN EN ISO 10993-3, OECD-Guidelines 414- 416, 418, 419, 421, 422, 424, 426, 451, 453, 471, 476, 483, 487)  
  •  Detection of carcinogens as mutagens (Ames Test) - OECD 471
  •  Detection of mutagens in mammalian cells (Mouse Lymphoma Test) - OECD 476
  •  micronucleus test in vitro - OECD 487

Testing for haemocompatibility (interaction of blood with non-blood surfaces) (acc. to DIN EN ISO 10993-4) 

  • Haematolysis
  • Haemogram and thrombozyte count (differential blood and blood plate count)
  • partial thromboplastin time (PTT)
  • complement activation
  • Thrombin-Antithrombin Complex (TAT)

Testing for cytotoxicity (acc. to DIN EN ISO 10993-5, USP 38 <87>)

  •  testing of extracts
  •  direct and indirect contact

Testing for local effects after implantation (acc. to DIN EN ISO 10993-6) 

  •  subcutaneous implantation test
  •  intramuscular implantation test

Testing for irritation and sensitization (acc. to DIN EN ISO 10993-10 OECD-Guidelines 404, 405, 406, 429, USP 38, NF 33 (2014), Suppl. 1 <1184>) 

  •  epicutaneous irritation test
  •  intracutaneous irritation test
  •  testing for sensitization (allergic reactions of the delayed type)
  •  sensitization procedures with occlusive lobes
  •  maximization procedure for sensitization 

Testing for systemic toxicity (acc. to DIN EN ISO 10993-11, Pharm. Eur. 5, 2.6.8, 2.6.14 OECD-Guidelines 407, 408, 410-413, 452, 453)

  • abnormal toxicity
  • acute systemic toxicity
  • subacute systemic toxicity
  • subchronical systemic toxicity
  • pyrogenic substances of endotoxic or non-endotoxic origin (pyrogenic test)

Biological  assessment of dental materials (DIN EN ISO 7405) Gross pathology and Histopathology

Being an advancing and customer-oriented company, BIOSERV offers you the service of a fully-equipped, modern histopathology lab as well as independent histopathology evaluation. This enables us to perform your testing for local effect after implantation (acc. to ISO 10993-6), for irritation (acc. to ISO 10993-10), for systemic toxicity (acc. to ISO 10993-11) and genotoxicity/carcinogenicity (acc. to ISO 10993-3) for you in house and under GLP-compliance from the application to the test system up to histopathological evaluation.

Of course you may also request processing and examination of your histology samples. We will supply fixative-containing (usually 4% or 10% neutral-buffered formalin) vessels on request. Please contact us for this purpose. We will be glad to advise and support you concerning also histological specialties.