What biocompatibility tests (ISO 10993) apply to wearable medical displays

When evaluating wearable medical displays for biocompatibility, the following ISO 10993 tests are particularly relevant:

Skin Irritation and Sensitization (ISO 10993-5): Essential for devices in direct skin contact to prevent irritation.

Prolonged Skin Contact (ISO 10993-10): Crucial for wearables used for extended periods, assessing skin tolerance over time.

Cytotoxicity (ISO 10993-4): Important for materials that may come into contact with bodily fluids or tissue.

Blood Compatibility (ISO 10993-24): Necessary for devices interacting with blood or blood components.

Repeated Irritation (ISO 10993-13): Evaluates potential irritation from long-term wear, especially if the device is abrasive.

Extracts (ISO 10993-12): Checks for harmful substances that may leach from the device.

Mucosal Irritation (ISO 10993-3): Required if the display contacts mucous membranes.

Sterilization (ISO 10993-7): Ensures the device can be sterilized without compromising performance.

The choice of tests depends on the device's intended use and contact type. Starting with cytotoxicity as a baseline, additional tests are selected based on the device's interaction with the body. Conducting these tests ensures the wearable medical display is safe, fostering user trust and effective functionality.