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      FDA Premarket Pathways for Combination Products
      LIN Yuan
      2022, 46(4): 355-360,364. DOI: 10.3969/j.issn.1671-7104.2022.04.001
      Abstract PDF
      Overview of the Work Related to Regulatory Scientific Research of Combination Products
      TIAN Jiaxin, WANG Yongqing
      2022, 46(4): 361-364. DOI: 10.3969/j.issn.1671-7104.2022.04.002
      Abstract PDF
      Thoughts on Improving Joint Review of Combination Products
      TIAN Jiaxin, WANG Yongqing, XU Wei
      2022, 46(4): 365-367. DOI: 10.3969/j.issn.1671-7104.2022.04.003
      Abstract PDF
      Development of Respiratory Signal Monitoring System Based on Photoplethysmography
      LIU Chenqin, YUAN Sinian, LIN Gaozang, CAI Shijie, YE Jilun, ZHANG Xu, JIN Hao
      2022, 46(4): 368-372. DOI: 10.3969/j.issn.1671-7104.2022.04.004
      Abstract PDF
      Development of a Wireless Wearable Body Temperature Measurement System Based on NTC
      LIU Zichen, LI Ruowei, LE Hangyu, ZHU Zifu, YE Jilun, ZHANG Xu
      2022, 46(4): 373-376. DOI: 10.3969/j.issn.1671-7104.2022.04.005
      Abstract PDF
      Infrared Imaging Meibomian Gland Segmentation System Based on Deep Learning
      ZHANG Hetong, YAO Kang, DING Shangshang, PEI Ronghao, FU Weiwei
      2022, 46(4): 377-381,427. DOI: 10.3969/j.issn.1671-7104.2022.04.006
      Abstract PDF
      Simulation Study on the Influence of Sampling Delay on the Accuracy of Energy Metabolism Measurement
      ZHANG Anqi, CHEN Yanyan, WANG Yuan, FANG Wei, SUN Yining, MA Zuchang, YANG Xianjun
      2022, 46(4): 382-387. DOI: 10.3969/j.issn.1671-7104.2022.04.007
      Abstract PDF
      The Effect of Torsion of Blood Vessel after Stent Implantation on Mechanical State of Stent
      YU Long, WAN Jun, QIN Wang, WANG Shengzhang
      2022, 46(4): 388-394. DOI: 10.3969/j.issn.1671-7104.2022.04.008
      Abstract PDF
      Design and Application of Ultrasound Audit Workstation System
      LU Xiao, ZHANG Yong, LI Xin, DING Boyuan, QIU Li, LUO Yan
      2022, 46(4): 395-398. DOI: 10.3969/j.issn.1671-7104.2022.04.009
      Abstract PDF
      Development of Nasal Continuum Minimally Invasive Surgical Robot System
      ZHOU Yuan, HONG Wuzhou, XIE Le, FENG Fan, LIANG Haiting, LUO Dan, LI Keyong, LOU Binbin
      2022, 46(4): 399-403. DOI: 10.3969/j.issn.1671-7104.2022.04.010
      Abstract PDF
      Portable Multi Channel EEG Signal Acquisition System
      LE Hangyu, ZHU Zifu, YUAN Sinian, LIU Zichen, LIN Gaozang, YE Jilun, ZHANG Xu
      2022, 46(4): 404-407. DOI: 10.3969/j.issn.1671-7104.2022.04.011
      Abstract PDF
      Design and Verification of Lung Diffusion Function Detection System
      FANG Wei, CHEN Yanyan, WANG Yuan, ZHANG Anqi, WANG Mu, SUN Yining, MA Zuchang, YANG Xianjun, XU Yubing
      2022, 46(4): 408-412. DOI: 10.3969/j.issn.1671-7104.2022.04.012
      Abstract PDF
      Design Concept of CT Plate Detector and CT Machine
      LIU Hongbin
      2022, 46(4): 413-416. DOI: 10.3969/j.issn.1671-7104.2022.04.013
      Abstract PDF
      Review of Leachable Substances in Hemodialyzer
      LIU Ziqi, CHEN Zhuoying, FU Haiyang, FU Bufang
      2022, 46(4): 417-421. DOI: 10.3969/j.issn.1671-7104.2022.04.014
      Abstract PDF
      Technical Difficulties in the Implementation of the Continuous Glucose Monitoring System
      FU Yacheng, QUAN Changyun, LIU Lixia, ZHANG Wei
      2022, 46(4): 422-427. DOI: 10.3969/j.issn.1671-7104.2022.04.015
      Abstract PDF
      Study on the Medical Device Registration Submission Dossier Requirements in China
      CHEN Min, ZHANG Chenguang, LIU Yinghui, YUAN Peng, DENG Gang
      2022, 46(4): 428-432. DOI: 10.3969/j.issn.1671-7104.2022.04.016
      Abstract PDF
      Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation
      MA Xiaobin, HONG Liang
      2022, 46(4): 433-437. DOI: 10.3969/j.issn.1671-7104.2022.04.017
      Abstract PDF
      Status Analysis and Improvement Suggestions on Filing Review Trial Implementation of Shanghai's Class II Passive Medical Device Registration
      JIANG Xin
      2022, 46(4): 438-440. DOI: 10.3969/j.issn.1671-7104.2022.04.018
      Abstract PDF
      Comparison Study on Differences between the Latest Edition of ASTM Standards and YY/T 0987—2016 Series Standards for Magnetic Resonance Compatibility of Surgical Implants
      YIN Yong, DENG Jin, WU Xiaomei
      2022, 46(4): 441-448,453. DOI: 10.3969/j.issn.1671-7104.2022.04.019
      Abstract PDF
      Research on Self-tapping Performance Test of Self-tapping Bone Screws
      YAO Tianping
      2022, 46(4): 449-453. DOI: 10.3969/j.issn.1671-7104.2022.04.020
      Abstract PDF
      Consideration on Animal Experiment in PET/CT
      GU Xiaofang, BAO Yaqing, HE Liping
      2022, 46(4): 454-458. DOI: 10.3969/j.issn.1671-7104.2022.04.021
      Abstract PDF
      Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020
      LI Xiao, ZHANG Xintao, HAO Qing, ZHU Jiong, HONG Wei
      2022, 46(4): 459-463. DOI: 10.3969/j.issn.1671-7104.2022.04.022
      Abstract PDF
      Clinical Investigation of Key Parameter Range of AMG Muscle Relaxant Monitor
      CEN Jian, YAO Zuming, HE Yuxiang, TAO Hua, LIU Qiling, YUAN Qiu
      2022, 46(4): 464-468,472. DOI: 10.3969/j.issn.1671-7104.2022.04.023
      Abstract PDF
      The Tertiary Hospital's Medical Materials Supply in the Prevention of Public Health Emergencies
      MA Xianli, LU Jun, ZHONG Hui, CHENG Dingsheng, GE Wenjun, YU Jing, CHEN Lixing, QIU Guoli, LIU Min, WEI Runze
      2022, 46(4): 469-472. DOI: 10.3969/j.issn.1671-7104.2022.04.024
      Abstract PDF