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Biocompatibility

BSL BIOSERVICE

Whether your need is the biocompatibility testing according to ISO 10993 or microbiological testing within development, production and finished product testing, BSL BIOSERVICE will support you with individual testing strategies and study designs to fulfill your needs. In addition, BSL BIOSERVICE offers further testing strategies for medical devices as well as for raw materials and semi-finished products.

Biocompatibility Test Panel

  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic Toxicity
  • Subchronic Toxicity
  • Genotoxicity
  • Pyrogenicity
  • Implantation
  • Haemocompatibility
  • Chronic Toxicity

Microbiology Test Panel

  • Test for Sterility
  • Endotoxins
  • Bioburden
  • Test for Specified Microorganisms / Microbial Limit Test
  • Test for Antimicrobial Preservation
  • Validation of Test Methods
  • Identification of Microorganisms
  • Test for Antimicrobial Efficacy
  • Evaluation of Reusables for the intended Reprocessing Procedure (Cleaning, Disinfection, Sterilization)
  • Environmental Monitoring
  • Process Water Testing
  • Analysis of Bioindicators
  • Sterilization Processes
  • Validation of Depyrogenation Processes

Additional Services

  • Functional Implantation Studies (ISO 10993-6)
  • Identification and Quantification of Degradation Products (ISO 10993-15)
  • Packaging Validation (ISO 11607)
  • EO Residue Determination (ISO 10993-7)
  • Ophtalmic Implants – Intraocular Lenses (ISO 11979-5)
  • Various Test Designs acc. to ISO Standards, USP and PH. Eur.
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