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Medical Devices

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The medical benefits of medical devices are unchallenged in today's world. Because of direct contact with the human being, a medical device must be able to prove that no harmful effects (on a cellular basis, local tissue response or systemic effects) are caused by the device after contact with a patient.

An essential step in the certification of a medical device is the thorough evaluation of the biological safety (biocompatibility) as described in the ISO 10993 series.

Based on the active membership of Eurofins biopharmaceutical laboratories in various national and international bodies, we can guarantee that our service is carefully coordinated with the requirements necessary for the approval procedures. We help you to select the right test and develop the optimal test strategy for your products.

Whether biocompatibility test according to ISO 10993 or microbiological tests in the development and production phase or in the finished product, we support you with individual test strategies and study designs to meet your requirements. In addition we offer you additional test strategies for medical products as well as for raw materials and semi-finished products: Identification and quantification of degradation products (ISO 10993-15), EO residue determination (ISO 10993-7) and USP plastic tests of class I-VI (USP 87, 88).

 

Microbiological tests for Medical Devices

  • Test for Sterility
  • Endotoxins
  • Bioburden
  • Test for Specified Microorganisms/Microbial Limit Test
  • Test for Antimicrobial Preservation
  • Validation of Test Methods/Suitability Tests
  • 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: Microbiological Studies within Performance Qualification
  • Validation of Depyrogenation Processes

Biocompatibility testing

  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic Toxicity
  • Subchronic Toxicity
  • Genotoxicity
  • Pyrogenicity*
  • Implantation
  • Hemocompatibility
  • Chronic Toxicity

Weitere Informationen zu Biokompatibilität finden Sie unter folgendem Gruppen-Link: Eurofins BioPharma Product Testing

 

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)
  • OphtaImic Implants - Intraocular lenses* (ISO 11979-5)
  • USP Plastic Class I-VI (USP 87, 88)
  • Various Test Designs according to ISO standards, USP and Ph. Eur.

*analysis performed within a laboratory of the Eurofins group

**partly done within the Eurofins group