10993reeks

10993reeks refers to the ISO 10993 series of international standards focused on the biological evaluation of medical devices. The series provides a framework to assess biocompatibility by guiding the selection and performance of biological tests and chemical characterization of device materials within the broader risk management process defined in ISO 14971.

Scope and purpose: The standards apply to devices or materials that contact living tissue, body fluids, or are implanted, and they address factors such as duration of exposure, routes of contact, and material composition. They aim to ensure that medical devices do not introduce unacceptable biological risks to patients or users.

Structure and key parts: The core element, ISO 10993-1, covers the overall framework for biocompatibility assessment within risk management. Other parts specify particular tests, including tests for cytotoxicity (ISO 10993-5), irritation and sensitization (ISO 10993-10), systemic toxicity (ISO 10993-11), and implantation effects (ISO 10993-6). Additional parts address genotoxicity (ISO 10993-3) and chemical characterization of materials (ISO 10993-18), among others. The exact tests chosen depend on device type, contact duration, and where the device is placed in the body.

Regulatory and practical context: The ISO 10993 series is widely used by manufacturers to support regulatory submissions and ongoing compliance in many regions. Testing is typically conducted in accordance with Good Laboratory Practice (GLP) and integrated with the device’s overall risk assessment and post-market considerations.

Governance: ISO/TC 194, the technical committee responsible for biological evaluation of medical devices, maintains and updates the series to reflect advances in biology, toxicology, and testing methods.