Abstract: With the rapid development of organ donation and transplantation, it becomes increasingly important to improve the management system and ensure the quality and safety of organs for transplantation. Guide to the Quality and Safety of Organs for Transplantation (6th Edition) by European Committee provides the definitions of severe adverse reactions and severe adverse events in the perspective of biosafety early warning, delivers management and reporting processes, and encourages medical staff involved in organ transplantation to identify the adverse reactions and adverse events as soon as possible, and to carry out investigation, assessment and feedback. At the same time, it also systematically illustrates the warning and monitoring of organ transplantation risk, which is worthy of application in clinical study and practice.