Biological evaluation of medical devices - Part 1: Evaluation and testing

This document establishes the fundamental framework for assessing the biological compatibility of medical devices used in contact with the human body. It outlines the systematic approach required to evaluate potential risks arising from materials, manufacturing processes, and device design. The standard defines a comprehensive strategy that includes identifying relevant biological endpoints, selecting appropriate testing methods, and interpreting results within the context of the device's intended use. It emphasizes the importance of considering the duration and nature of contact, such as surface, external communicating, or implantable interactions. By providing a structured methodology, it guides manufacturers and regulatory bodies in determining necessary safety assessments prior to clinical application. The guidance covers a wide range of biological responses, ensuring that devices meet specific safety criteria relative to their exposure characteristics. This foundational text serves as a prerequisite for more detailed evaluation procedures and helps harmonize global assessment practices without prescribing specific test protocols for every scenario.