BIOSERV Medical Device Testing

 

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About BIOSERV Medical Devices
Detailed parameter listing
Accreditation ISO/IEC 17025.

The accredited (ISO/IEC 17025) medical device testing laboratory of BIOSERV Analytics and Medical Devices Ltd. is offering the testing of for biocompatibility of medical devices according to EN ISO 10993 and the biological evaluation of dental materials according to EN ISO 7405:

  • Biological evaluation of dental materials according to EN ISO 7405

  • Testing for endotoxins / pyrogens according to the European Pharmacopeia (Pharmacopoea Europaea, Ph.Eur.)

  • 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.), EN ISO 11737-1 (Pharm. Eur. 2.6.1)

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

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

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

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

  • Testing for sterility and validating of sterilization processes according to the European Pharmacopoeia (Pharmacopeia Europaea, Ph.Eur., E.P.), EN ISO 11737-2  (Pharm. Eur. 2.6.1)

  • Testing for hemocompatibility according to EN ISO 10993-4

  • Testing for Genotoxicity according to EN ISO 10993-3

For more Details on the offered medical device testing parameters please click biocompatibility testing

 

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

 

 

 

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Medical Device Testing

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Last actualization: 28.03.2006

 

BIOSERV Analytik und Medizinprodukte GmbH 2004

For inquiries and suggestions concerning the technical side of this site please send an e-mail to webmaster@medicaldevicetesting.biz