生物警戒是检测、收集、分析与使用人源性医疗产品相关意外事件信息的框架。生物警戒和监管系统可通过监测不良事件，推动实施预防和纠正措施。欧洲委员会《移植器官质量与安全指南(第8版)》以实用的方式概述这一主题，讨论建立有效的警戒和监管系统，详解生物警戒实践步骤，分析各环节的具体流程、方法和重要性。旨在为各器官获取组织、移植中心医疗专业人员、管理人员及卫生管理部门优化器官移植生物监管系统、降低风险、保障移植安全和质量，提供理论支撑和实践指导。

Biovigilance is a framework for the detection, collection and analysis of information on unexpected and untoward occurrences associated with the use of medical products of human origin (MPHO). Biovigilance and surveillance systems monitor adverse events, thereby promoting the implementation of preventive and corrective measures. The Council of Europe′s Guide to the Quality and Safety of Organs for Transplantation (8th Edition) provides a practical overview of this topic, discusses the establishment of effective biovigilance and surveillance systems, explores the practical steps of biovigilance, and analyzes the specific processes, methods, and importance of each link. It aims to provide theoretical support and practical guidance for medical workers, managers, and health management departments from various organ procurement organizations and transplant centers to optimize the surveillance system for organ transplantation, reduce risks, and ensure the safety and quality of transplantation.