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Biological Safety Testing

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Chemical Characterization for Materials

As part of the biological evaluation of medical devices, Eurofins Medical Device Testing offers chemical characterization services, as outlined in ISO 10993 Part 18: Chemical Characterization of Materials.

While analytical methods and concepts are consistent with extractables and leachables studies for containers and closure systems, quick and affordable solutions are needed for the comparison of medical device products after design and material changes, as well as change of raw material, production lot or aging.

To achieve this, we utilize the GC/HPLC/ICP fingerprint, a standardized analytical service under consideration of existing material and production data leading to complete chemical characterization of medical device products.

In some situations, a customized study outline is recommended to complete the characterization and the safety evaluation of the device. Thanks to our expertise in both medical devices and pharmaceutical packaging areas, we will be able to support you in designing a tailored study protocol (extraction temperature and duration, simulants to be used, etc.) for the analytical evaluation of the extractables and their toxicological assessment.

Our chemical characterization services include:

  • Chemical Characterization of Material
    (ISO 10993-18, 19)
  • Identification and Quantification of Degradation Products
    (ISO 10993-13, 14, 15)
  • Determination of Tolerable Intake for Extractable Substances
    (ISO 10993-17)

Risk Assessment & Toxicological Assessment

Our Toxicologist will help you to perform risk and toxicological assessments to help understand the safety profile of the medical device product. Such profiles can be used to drive additional analytical testing for further investigations of unknown entities, as well as biocompatibility program strategies, or they can be combined with pre-clinical data for a comprehensive risk assessment. These assessments are based on ISO 10993-17 to identify and critically evaluate any existing toxicity and human exposure data on the final medical device product, on individual chemical compounds, additives, colorants, processing aids and potential leachables.

Biocompatibility Testing

Within the Eurofins network of laboratories, we offer the full range of Biocompatibility Testing required by the Medical Device Industry. In addition to conducting biological studies according to the matrix of ISO 10993, FDA Blue Book Memorandum, MHLW requirements, USP classification of plastics, including Class VI and other international guidelines, we offer a variety of cell-based alternative methods or models under GLP to examine the hazardous effects of medical devices. The suitable customized test strategy design is chosen depending on the material of the product, manufacturing methods and the aim of the study.

Our services include standard testing methods, tailor-made studies as well as alternative in vitro testing methods or comprehensive histopathological services:

  • Cytotoxicity
    (various cell lines, validation acc. to ICH guidelines)
  • Genetic Toxicology
    (new methods e.g. Pig-a)
  • Hemocompatibility
    (Static and Dynamic Studies)
  • Sensitization
  • Irritation and Local Tolerance Tests
    (various routes of application)
  • in vitro Test System for Substitution of Animal Models
  • Acute Systemic Toxicity
  • Pyrogenicity
  • Subacute, Subchronic and Chronic Toxicity*
  • Implantation*
  • Implantation in Combination with Systemic Toxicity*

*combined with comprehensive histopathology

Additionally, we offer certificates, expert statements and toxicological evaluation of the test results, literature and material data. Our clients can be sure that Eurofins Medical Device Testing provides the best test strategy for your medical devices, which is in line with the latest scientific trends.

Bridging Studies

Eurofins Medical Device Testing also conducts bridging studies to determine scientific background for the biological evaluation of a medical device.
Biocompatibility is evaluated through expert reports based on material and literature data, along with actual study results.
These studies provide essential information for assessing risks and benefits as well as achieving the ethical conduct of the planned evaluation as required by the animal welfare regulation (i.e.  ISO 10993-2).

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