In Vitro Cytotoxicity: Cell Safety of Medical Devices

Biocompatibility Test Methods for Medical Devices (ISO 10993 Series)

What is Cytotoxicity?

Cytotoxicity refers to the potential for a substance or device to have a toxic effect on cells. This effect may include

• Induce cell death (necrosis or apoptosis)
• Inhibiting cell growth and proliferation
• Disrupting cell function

Cytotoxicity can occur when the device comes into direct contact or when chemicals released from the device interact with cells.

In vitro Cytotoxicity Tests are based on testing the biological reactions of the medical device to be tested on mammals depending on the duration of contact with the tissue and body fluid to be contacted.

Prepared sample extracts are applied to cultured cells and product-induced toxicity such as cell death, cell growth is affected. Cytotoxicity tests are performed qualitatively and quantitatively. Qualitative tests are categorized under 3 main headings.

• Direct Contact,
• MEM Elution
• Agar Diffusion Tests

Colorimetric methods based on the binding of dye to live cells used for quantitative viability/survival tests.

ISO 10993-5 Standard and its Importance

ISO 10993-5 is an international standard for assessing the safety of medical devices at the cellular level. This standard covers the protocols, methods and evaluation criteria used when testing the biological compatibility of medical devices.

Objectives of the Standard

1. Determining Cellular Toxicity: Understanding whether the device contains toxic components or how these components affect cell health.
2. Identifying Risks in Advance: Identifying potential risks prior to clinical use.
3. Ensuring Regulatory Compliance: ISO 10993-5 testing is part of regulatory requirements such as CE certification.

Evaluation Methods Used in Tests

1. Cell Survival Rate

• It is a widely used method to measure the viability of cells.
• Tests based on color change reactions such asMTT are used.

2. Cellular Morphology Examination

• Changes in the shape, size and structure of cells are examined under a microscope.
• How cells respond to toxic effects is evaluated.

3. Cell Proliferation

• The proliferation rate of cells is measured to determine the effect of the device on cell division.
• The rate of DNA synthesis can be measured.

4. Membrane Integrity Test

• The integrity of the cell membrane is analyzed.
• Lactate dehydrogenase (LDH) release can be measured.

5. Apoptosis and Necrosis Analysis

• Flow cytometry and staining techniques are applied to determine cell death mechanisms.

Nanolab Laboratories Group continues to provide services within the scope of In Vitro Cytotoxicity Tests. We also provide services in Sensitization Testing.

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