TEST.LAB BIOSERV (V2)

TEST.LAB BIOSERV

Biocompatibility tests in vitro and in vivo

Independent, Certified Test Lab (The Animation Below this Text is Copyrighted, Do not use in Production Release)

Test-Lab Bioserv is the USA representative of Bioserv Analytics and Medical Devices in GERMANY. Providing technical support and seamless communication.

Bioserv’s comprehensive know-how lies at the root of its excellent reputation with clients and partners in the Development, Manufacturing, Trade, and Service industries.

Bioserv offers the full range of in vitro and in vivo tests, executed in the German facility by highly qualified and specialized Bioserv personnel.

Medical Device and Drug Testing

BIOSERV provides qualified services in evaluating the safety of medical devices and drugs. BIOSERV assists you in developing and optimizing new materials and products.

Our laboratories are accredited according to ISO 17025. There we carry out numerous biological, but also chemical and physical tests, the methods of which correspond to national and international standards and provisions. Clean rooms of the classes A to D are available for specific requirements.

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

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

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.