10993serien

10993serien, or the ISO 10993-series, is a collection of international standards for the biological evaluation of medical devices. It provides a framework for assessing biocompatibility—the potential for a device to cause harm when in contact with the human body—through material characterization, risk assessment, and targeted testing.

Scope and intent: The standards apply to devices that contact body tissues or fluids, for any duration, and across various applications from implants to external devices. They guide the selection of appropriate biocompatibility tests based on the device’s material composition, contact duration, and anatomical site.

Test categories: The series covers endpoints such as cytotoxicity, sensitization, irritation, and systemic toxicity, as well as implantation effects and longer-term toxicology where relevant. Tests may include extraction studies to evaluate leachables and interactions with biological systems. The exact tests are chosen within a risk-management process that also considers existing literature and device design.

Regulatory role: ISO 10993 is widely used by manufacturers to support safety claims in regulatory submissions. In Europe it exists as EN ISO 10993, and in many other regions it informs regulatory guidance and conformity assessments.

Relationship to risk management: The series is designed to be used alongside ISO 14971, which governs risk management for medical devices, ensuring that biocompatibility evaluation aligns with overall safety assessments.

Overall, 10993-serien is essential for manufacturers to demonstrate that devices intended for body contact are biocompatible.