基于ISO/IEC 17025和GLP的人工髋关节检测质量影响要素研究  

Study on Influencing Factors of Artificial Hip Joint Test Quality Based on ISO/IEC 17025 and GLP

作　　者：刘婷婷 王军[2] 黄秀玲[2] LIU Tingting;WANG Jun;HUANG Xiuling(Huashan Hospital,Fudan University,Shanghai,201907;Shanghai University,Shanghai,200444)

机构地区：[1]复旦大学附属华山医院,上海市201907 [2]上海大学,上海市200444

出　　处：《中国医疗器械杂志》2023年第4期449-453,共5页Chinese Journal of Medical Instrumentation

摘　　要：目的 以人工髋关节检测为对象,融合ISO/IEC 17025和GLP,建立一套新的检测影响要素管理要求。方法 对比分析ISO/IEC 17025和GLP法规针对影响要素的要求,找出异同点,并将两者融合,针对每个影响要素制定新的管理要求。结果 从人员、设备、物料、方法、报告、归档等影响因素,制定了一套既符合ISO/IEC 17025又符合GLP的管理要求,使得实验室可以为医疗器械生产企业、监管部门等提供客观、真实、准确的检测数据。结论 可提高实验室的检测质量,保证检测数据和结论的真实可靠。Objective Taking artificial hip joint test as the object,integrating ISO/IEC 17025 and GLP,and establishing a new set of management requirements for test influence factors.Methods The requirements of ISO/IEC 17025 and GLP regulations for influencing factors were compared and analyzed,the similarities and differences were found,and the two were integrated to formulate new management requirements for each influencing factor.Results From the personnel,equipment,materials,methods,reports,filing and other factors,a set of management requirements in line with ISO/IEC 17025 and GLP was formulated,so that the laboratory can provide the objective,real and accurate test data for medical equipment manufacturers and regulatory authorities.Conclusion It can improve the test quality of the laboratory and ensure the authenticity and reliability of the test data and conclusions.

关 键 词：人工髋关节 检测 质量 影响因素 

分 类 号：R318.1[医药卫生—生物医学工程] TH781[医药卫生—基础医学]