Skin Sensitization Study Service

Skin sensitization studies are conducted to assess whether a medical device material or chemical has the potential to cause an allergic skin reaction, also known as delayed hypersensitivity, after repeated exposure. These reactions typically occur when the immune system becomes sensitized to a substance, leading to inflammation or irritation upon subsequent contact.

Such studies are a critical part of ensuring the biocompatibility and safety of materials used in medical devices, especially those in prolonged or repeated contact with the skin. The evaluation helps identify substances that could trigger adverse immune responses in sensitive individuals.

ISO 10993-10 provides the specific guidelines for conducting these tests as part of the overall biological evaluation of medical devices. By adhering to this standard, manufacturers can demonstrate compliance with regulatory requirements and ensure patient safety during device use. Skin sensitization testing plays an essential role in risk assessment and product development in medical and pharmaceutical industries.