Liu Tingting, Wang Jun, Huang Xiuling
Huashan Hospital, Fudan University, Shanghai, 201907.
Shanghai University, Shanghai, 200444.
Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Jul 30;47(4):449-453. doi: 10.3969/j.issn.1671-7104.2023.04.019.
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.
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.
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.
It can improve the test quality of the laboratory and ensure the authenticity and reliability of the test data and conclusions.
以人工髋关节测试为对象，融合ISO/IEC 17025和GLP，建立一套新的测试影响因素管理要求。
对ISO/IEC 17025和GLP法规中关于影响因素的要求进行比较分析，找出异同点，将两者融合，为各影响因素制定新的管理要求。
从人员、设备、材料、方法、报告、存档等因素出发，制定了一套符合ISO/IEC 17025和GLP的管理要求，使实验室能够为医疗设备制造商和监管机构提供客观、真实、准确的测试数据。
可提高实验室的测试质量，确保测试数据和结论的真实性与可靠性。
