INAQ
MEDICAL TECHNOLOGY

MEDICAL TECHNOLOGY

Biological Evaluation of Medical Devices

Medical devices intended for use on or in the human body must be assessed for biocompatibility (“biological safety”) prior to approval. Biocompatible substances and materials do not cause harmful reactions when they come into direct or indirect contact with living tissue. Depending on the type of device, its intended use, and the duration of contact with the body, different tests are required to evaluate biocompatibility. These requirements are defined in the 23 individual parts of the EN ISO 10993 series of standards.

inaq has been supporting manufacturers of implantable medical devices for many years with standards-compliant testing, providing reliable support throughout the approval process.

With our comprehensive range of services and the use of state-of-the-art testing methods in accordance with applicable regulatory requirements, we assist you in ensuring the biocompatibility and quality of your medical devices - from sample preparation and chemical and cell-based testing through to endotoxin determination. Rely on the expertise of inaq to support your regulatory approval process and safeguard the quality of your products.


Our Testing Procedures According to EN ISO 10993

EN ISO 10993-12: Sample Preparation and Reference Materials

Extraction of Test Specimens:
Preparation of extracts from the test specimen using various solvents, extraction ratios (surface area/volume or mass/volume), and extraction periods. The extraction conditions are selected in accordance with the classification of the product, its duration of contact with the body, and the specific test requirements

Application:
These extracts serve as the basis for all subsequent laboratory tests in accordance with EN ISO 10993


EN ISO 10993-18: Chemical Characterization of Materials

1. GC-MS Screening (Qualitative & Semi-Quantitative)

  • Method:
    Use of gas chromatography coupled with mass spectrometry (GC-MS) for the detection of unknown volatile to semi-volatile organic compounds that can be analyzed by gas chromatography.
  • Results:
    The method enables qualitative identification as well as semi-quantitative determination of detected substance concentrations using calibrated reference or internal standards.
  • Sample Types:
    Analysis of aqueous samples, extracts obtained with organic solvents, and eluates from solid test specimens.

We are pleased to assist you in selecting the appropriate testing scope in accordance with the relevant sections of EN ISO 10993.

2. Quantitative Multi-Element Analysis (ICP-MS – Quantitative)

  • Objective:
    Precise determination of heavy metals and trace elements in aqueous samples, extracts, or eluates from various solid test specimens using inductively coupled plasma mass spectrometry (ICP-MS).
  • Method:
    An individual calibration curve is established for each element to be quantified using certified reference and internal standards, enabling accurate quantitative analysis of samples with unknown concentrations.

3. Heavy Metal Screening (ICP-MS Survey Scan – Semi-Quantitative)

  • Application:
    Broad-spectrum detection of a wide range of elements (primarily metals, metalloids, and selected non-metals) combined with semi-quantitative estimation of their concentrations.
  • Special Feature:
    For isotopes that are not directly quantified using element-specific calibration curves, instrument-specific response factors are applied, supported by separate calibration curves for selected elements.

EN ISO 10993-5: In Vitro Cytotoxicity Testing

  • Cytotoxicity:
    Determination of the ability of a substance to damage or impair cells or tissues
  • Methods: 
    Cytotoxicity testing is performed in accordance with ISO 10993-5, Annex C (MTT assay) and Annex D (XTT assay).
    In these tests, extracts of the medical device are applied to L929 cells (mouse fibroblasts) at different concentrations.
    Cell viability is subsequently assessed both qualitatively (microscopic evaluation) and quantitatively (using metabolic assays) in comparison with control groups. This approach allows the cytotoxic effects of substances to be identified and quantified

Quantitative Determination of Endotoxins

Endotoxins are heat-stable lipopolysaccharides derived from the cell membrane of Gram-negative bacteria, which are released upon cell death. Even small quantities can cause severe reactions in humans due to their pyrogenic effects, including fever, hypotension, or anaphylactic shock.

  • Test method:
    Our customer-specific endotoxin testing solutions are performed in accordance with United States Pharmacopeia Chapter 85 (USP <85>) using the kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay.
  • Scope of application:
    Endotoxin measurements are carried out either directly on liquid samples or on liquid extracts of solid test specimens, with a detection limit of 0.0050 EU/mL

Your Point of Contact

Christoph Zulmin, MSc
Phone: +43 512 571573-23
E-mail: christoph.zulmin@inaq.at