10993Standard

The 10993 standard, commonly referred to as ISO 10993, is a family of international standards for the biological evaluation of medical devices. It provides guidance on assessing the biocompatibility of devices and materials intended for human use, with the aim of ensuring safety and performance.

The core framework is established by ISO 10993-1, which outlines how biocompatibility evaluations should be conducted within a risk management process. The level and scope of testing depend on factors such as the device type, the duration and location of body contact, and the route of exposure. The evaluation is typically aligned with the broader risk management requirements in ISO 14971.

The 10993 series covers a range of biocompatibility endpoints and testing areas. These include cytotoxicity, sensitization, irritation or systemic toxicity, implantation effects, and compatibility with blood. The standards also address considerations related to material characterization and potential degradation products, as well as animal welfare requirements in certain parts of the series. The exact tests and their sequence are selected based on the device’s intended use and risk assessment.

In regulatory practice, ISO 10993 informs safety claims in submissions to authorities and supports design decisions to minimize biocompatibility risks. While the framework is widely referenced by regulators in regions such as the European Union and the United States, compliance typically requires a device-specific plan and justification rather than a one-size-fits-all package.

Overall, the 10993 standard series provides a structured, science-based approach to evaluating the safety of medical devices in contact with human tissues and fluids, emphasizing risk-based decision making and ongoing assessment as part of product development and regulatory clearance.