Sensitization Test: Medical Device Allergic Potential Assessment

Biocompatibility Test Methods for Medical Devices (ISO 10993 Series)

What is Sensitization?

Sensitization is a process in which chemicals released from a device come into contact with skin or other tissues, causing an allergic response in the immune system. This reaction usually develops some time after the first contact with the device and may be manifested by the following symptoms

• Redness (erythema)
• Itching
• Swelling
• Skin blistering or rash

Allergic reactions may be caused by the substances contained in the device or by chemicals released from the device during prolonged use.

Sensitization Testing is used to determine the sensitizing activity of medical devices. These tests assess the potential of a material or product to cause a delayed hypersensitivity reaction.

Sensitization testing exposes animals to multiple induction phases and test substances. At 24±2 and 48±2 hours after removal of the test substances/extracts, the application sites of each animal will be observed for evidence of skin sensitization reactions. Sensitization reactions are noted by observing erythema and edema (redness and swelling) as they interact with the body's immune system.

Sensitization tests are performed with 3 different methods for all categories of medical devices:

• The Guinea Pig Maximization Test (Magnusson-Kligman Method),
• Closed Patch Test,
• Murine Local Lymph Node Assay (LLNA) test

ISO 10993-10 Standard and Sensitization Tests

ISO 10993-10 is the standard used to assess the potentially allergic effects of medical devices. Sensitization tests performed under this standard are applied to determine the risk of sensitization of devices or their components on human skin. These tests are particularly important for devices with skin contact.

Purposes of the Test

• To determine whether the components of the device may cause an allergic reaction when in contact with the skin.
• To identify potential sensitization risks to human health.
• Ensuring the biological safety of the device.

Evaluation of Sensitization Test

The test results are analyzed in detail to determine the sensitization potential of the device. These analyses include

1. Degree of Sensitization:
• Sensitizing substances and their effects on the skin are classified.
• As a result of the test, the potential for an allergic reaction is assessed as low, medium or high.
2. Clinical Findings:
• Redness, swelling, or other signs of sensitization are recorded.
3. Histological Analysis:
• Skin samples are examined under a microscope to analyze the response of immune cells.

Nanolab Laboratories Group continues to provide services within the scope of Sensitization Test. We also provide services in Irritation Testing.

Contact us for more information.

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