中国结合医学杂志（英文版）Chinese Journal of Integrative Medicine

Author Name	Affiliation	E-mail
LI Jing-xian, QIAO Zhi-cheng, MA Hong-xia
HUANG Gang	Collaborative Innovation Center of Network and Big Data Applications, Lingnan Normal University, Zhanjiang, Guangdong Province (524048), China	huanggang6108@126.com

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Abstract:

Objective: To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Methods: Exploratory factor analysis (EFA) and first-order confirmatory factor analysis (CFA) based on a structure equation model (SEM), higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre l5.3. Results: There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. Conclusion: This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.