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Guest Page of the accredited1 medical device biocompatibility testing laboratory of BIOSERV Analytics and Medical Devices Ltd.

Please also visit www.biocompatibility.biz

Detailed listing of the the medical device testing (testing for biocompatibility according to DIN EN ISO 10993) parameters offered by BIOSERV Medical Devices:

  • Testing for genotoxicity according to EN ISO 10993-3

  • Ames test (back mutation test)

  • Testing for teratogenicity

  • Testing for hemocompatibility according to EN ISO 10993-4

  • hemolysis

  • platelet count (thrombocyte count)

  • partial thromboplastin time

  • complement activation

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

  • subcutaneous implantation test

  • intramuscular implantation test

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

  • 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

  • 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)

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

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

  • Biological evaluation of dental materials according to EN ISO 7405

 

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

1    The biocompatibility testing service laboratory of BIOSERV Analytics and Medical Products Ltd. is accredited according to ISO/IEC 17025, IVD Directive regarding medical devices 93/42/EWG Annex XI