中国食品药品企业质量安全促进会《自体骨组织库》团体标准的解读

Interpretation of the group standard Autologous Bone Tissue Bank by China Association for Quality and Safety Promotion of Food and Drug Enterprises

摘要

中国食品药品企业质量安全促进会于2025年5月26日发布了《自体骨组织库》团体标准，适用于自体骨组织库的建设和管理，规定了建设和运行自体骨组织库所需的总体原则、质量管理体系和基础设施设备，规范了自体骨组织收集、处理、储存、包装与灭菌、标签标识及随行文件、分发、使用和废弃等环节的操作流程等。对《自体骨组织库》团体标准进行解读，有助于建设及运行自体骨组织库，期望能提升区域自体骨组织保存与应用能力，解决临床骨资源紧缺的难题。

Abstract

On May 26, 2025, the China Association for Quality and Safety Promotion of Food and Drug Enterprises released the group standard Autologous Bone Tissue Bank, which applies to the establishment and management of autologous bone tissue banks. It specifies the general principles, quality management system, and infrastructure and equipment required for the construction and operation of such facilities. The standard also regulates operational procedures for various stages, including the collection, processing, storage, packaging and sterilization, labeling and accompanying documentation, distribution, use, and disposal of autologous bone tissues. This article provides an interpretation of the group standard 《Autologous Bone Tissue Bank》, aiming to assist in the establishment and operation of autologous bone tissue banks. The goal is to enhance regional capabilities in preserving and applying autologous bone tissues, thereby addressing the critical shortage of clinical bone resources.

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