In Vitro Testing

What is an In Vitro Test?

In vitro tests refer to the testing of medical devices on biological materials in a laboratory environment instead of on living organisms. This method is carried out under controlled conditions, such as cell cultures, enzyme systems, or artificial biological environments. They are faster, more cost-effective, and ethically preferable to in vivo tests. In vitro tests are performed “using cell lines in a laboratory environment.” In vitro tests are fast and animal-friendly. Cytotoxicity Testing is designed to evaluate the overall toxicity of medical devices and materials.

Purposes of In Vitro Testing

1. Biocompatibility Analysis: To determine whether the device causes harm to biological environments such as skin, tissue, or blood.
2. Toxicity Test: To evaluate the effects of toxic substances released from the device on human health.
3. Functional Performance: To test whether the device functions as intended.
4. Regulatory Compliance: Provide data to demonstrate that medical devices comply with legal requirements.

Advantages of In Vitro Testing

• Ethical Compliance: Reduces the need for animal testing.
• Speed and Cost Effectiveness: Provides faster results and is more economical compared to in vivo testing.
• Repeatability: Standardized results are obtained thanks to controllable environments.
• Risk Reduction: Determines whether the device is safe before moving on to clinical trials.

Standards and Regulations Used in In Vitro Testing

1. ISO 10993 Series: Basic guidelines for the biological evaluation of medical devices. Tests such as cytotoxicity, genotoxicity, and hemocompatibility are evaluated under this standard.
2. FDA Regulations: Defines the requirements for biocompatibility and safety testing of medical devices in the US.
3. European MDR (Medical Device Regulation): Requires biological safety and performance testing of devices in the European Union.

Test: Involves removing a medical device from a cell culture medium and then exposing the extract solution to mouse fibroblast cells (L929). The cells are allowed to grow in the extract solution for a specific period of 24–72 hours. The cytotoxicity test is performed on all medical devices that come into contact with patients and on raw materials.

• In vitro Cytotoxicity Test - TS EN ISO 10993-5, TS EN ISO 10993-12

Nano-lab Laboratories Group continues to provide services within the scope of In Vitro Tests for Medical Devices.

For more information, please contact us.