Testing for biocompatibility

The use of biocompatible materials in medical devices guarantees a high level of patient safety. We carry out biocompatibility tests as well as skin compatibility tests and check whether the medical devices also meet all other product-specific additional requirements.

 

Testing of biocompatible materials and products

We offer you analyses for your product approvals as well as contract research and research within the framework of funded national and international projects. In the test strategy, care is taken to ensure that animal testing is as unnecessary as possible. In addition to chemical characterization, validated in-vitro and in-chemico methods are also used.

 

Our services

  • Chemical characterization according to ISO 10993-18
    Chemical characterization of migratable ingredients by HPLC-UV/VIS, HPLC-FLD, HPLC-MS/MS or HPLC-MS-TOF on low volatile substances as well as GC-FID-MS or HS-GC-MS after extraction on highly volatile ingredients. We are also happy to perform material characterization studies using REM-EDX or DSC.

  • Degradation studies according to ISO 10993-9, ISO 10993-13
    We would be pleased to develop a study design for you to examine degradable biopolymers such as hyaluronic acid and non-degradable plastics for their degradation and molar mass changes as well as for extractables and leachables. Degradation studies are also required in the context of the stability of active substances and drugs.
  • Sample preparation and extractions according to DIN EN ISO 10993-12
    If required, validated concentration steps or sample preparation according to product standards (e.g. contact lenses ISO 18369-4)

  • Biological assessment of cell damage
    • In-vitro cytotoxicity according to DIN ISO 10993-5 using L929 mouse fibroblasts, accredited process
    • In-vitro skin irritation using an ECVAM validated human 3-D skin model EpiDerm (OECD TG 439)
    • In-vitro skin corrosion using a human 3-D skin model EpiDerm validated by ECVAM (OECD TG 431)
    • In-vitro eye irritation using a human 3-D skin model EpiOcular validated by ECVAM (OECD TG 405)

  • In-vitro / In-chemico Sensitization assessment
    • DPRA method: Investigation of the ability of a hapten (pro-allergen) to bind to a protein/peptide and induce an allergic reaction (OECD TG 442C)
    • ARE: Investigation of the activation of the metabolic pathway that can trigger allergy using dendritic cells (OECD TG 442D)
  • In-vitro assessment of proteins and allergens using immunological methods to reduce discomfort in people with allergies
  • Quantification and identification of particles
  • In-vivo animal experiments under GLP (irritation, sensitization, implantation)
  • Risk management and literature evaluation according to ISO 10993-1
  • Clinical evaluation according to Meddev

 

Additional product-specific requirements for medical devices

  • Mechanical and physical tests: e.g. seal seam strength, tear resistance, mechanical loads, tightness, resistance of printing/labels, abrasion resistance
  • Tests for chemical resistance, disinfectant resistance, UV resistance, accelerated ageing

 

News from research: Biocompatibility without animal experiments

OFI develops new materials and products together with its customers. A special focus in the characterisation of the materials lies in the use of animal-free, alternative methods.

  • Within the FFG project BioRelation (2013-2017) in-vitro methods (ARE assay, assay with dendritic cells) as well as chromatographic in-chemico methods are developed, which are used to check the biocompatibility of plastic, metal and textile materials. Validated test systems can now not only be offered for testing cytotoxicity, but also for investigating irritation and sensitisation without animal testing.

  • Within the framework of the FFG project proTect (2016-2020), further in-vitro test systems for the determination of allergic, inflammatory and toxic reactions for invasive medical devices are being developed together with the FH Campus Wien. Mass spectrometric examination methods and protein expression profiles will be used for the exact identification of the processes in the body.

  • Within the framework of the FFG project Ortho.flex.c (2016-2019), implants are developed together with industrial partners and their biocompatibility is characterized with the help of non-animal methods.