Description

The Biological Risk Assessment Template, in accordance with ISO 10993-1, provides a structured framework for evaluating the biological safety of medical devices. This template guides manufacturers through the systematic identification, analysis, and control of potential risks associated with the biological hazards of their devices. It includes sections for assessing the materials used in device construction, potential contact duration, and the intended use environment. By utilizing the Biological Risk Assessment Template, manufacturers can demonstrate compliance with regulatory requirements and ensure the safety of their devices for patients and users.