BIOSERV Medical Device Testing

 

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Detailed parameter listing
Accreditation ISO/IEC 17025.

Detailed listing of the the medical device testing parameters offered by BIOSERV Medical Devices. We offer testing for biocompatibility according to EN ISO 10993 and the biological evaluation of dental materials according to EN ISO 7405:

  • Testing for endotoxins/pyrogens according to the European Pharmacopoeia and the United States Pharmacopeia (USP)

  • Testing for sufficient conservation according to the European Pharmacopoeia (Pharmacopeia Europaea, Pharm. Eur.)  5.1.3, NT 2001, S. 421 - 423

  • Testing for sterility according to the European Pharmacopoeia (Pharmacopoea Europaea, Ph.Eur.), DIN EN ISO 11737-1 (Pharm. Eur. 2.6.1)

  • testing for sterility (direct feeding or filtration method)

  • validation of sterilization processes

  • Testing for acute systemic toxicity according to EN 10993-11, Pharm. Eur. III 2.6.8, Pharm. Eur. 1999, Suppl. 2001, 2.6.14

  • anomalous toxicity

  • acute systemic toxicity

  • subacute systemic toxicity

  • subchronic systemic toxicity

  • pyrogenic substances of endotoxic or non-endotoxic origin (pyrogen test)

  • Biological evaluation of dental materials according to EN ISO 7405

  • Testing for irritation and delayed-type hypersensitivity (sensitization, sensitation, sensibilisation) according to EN ISO 10993-10

  • testing for irritation

  • epicutaneous reaction

  • intracutaneous (intradermal) reaction

  • testing for delayed-type hypersensitivity

  • occlusion lobuli procedure

  • maximization procedure

  • Identification and quantification of potential degradation products according to EN ISO 10993-9

  • Testing for local effects after implantation according to EN ISO 10993-6

  • subcutaneous implantation test

  • intramuscular implantation test

  • Testing for cytotoxicity, cytotoxicity testing according to EN ISO 10993-5, USP XXII (87), AS 2696 App. C. BS 5736 Part 10

  • testing with extracts

  • Testing for hemocompatibility according to EN ISO 10993-4

  • hemolysis

  • platelet count (thrombocyte count)

  • partial thromboplastin time

  • complement activation

  • Testing for genotoxicity according to EN ISO 10993-3

  • Ames test (back mutation test)

  • Testing for teratogenicity

For further information on the testing of medical devices please send us an e-mail: info@bioserv-diagnostics.com