Roadmap of Medical Device for Implanted Brain-computer Interface / 中国医疗器械杂志

Implanted brain-computer interface (iBCI) is a system that establishes a direct communication channel between human brain and computer or an external devices by implanted neural electrode. Because of the good functional extensibility, iBCI devices as a platform technology have the potential to bring benefit to people with nervous system disease and progress rapidly from fundamental neuroscience discoveries to translational applications and market access. In this report, the industrialization process of implanted neural regulation medical devices is reviewed, and the translational pathway of iBCI in clinical application is proposed. However, the Food and Drug Administration (FDA) regulations and guidances for iBCI were expounded as a breakthrough medical device. Furthermore, several iBCI products in the process of applying for medical device registration certificate were briefly introduced and compared recently. Due to the complexity of iBCI in clinical application, the translational applications and industrialization of iBCI as a medical device need the closely cooperation between regulatory departments, companies, universities, institutes and hospitals in the future.

Advances in Research of Chitosan-based Composites for Implanted Medical Devices / 中国医疗器械杂志

It is well known that chitosan-based composites are widely used in implantable medical devices. The development of chitosan-based composite materials with different types was summarized in this paper, such as inorganic, organic and composite phases. Then, combined with the research focus, the development of 3D printing technology and chitosan-based composites was summarized. It was also pointed out that the existing problems in our research, which need to be solved urgently. At last, the development direction and broad application prospect of chitosan-based composites were prospected. And we look forward to providing reference for relevant research.

Research Progress of Four-dimensional Hydrogels in Implantable Medical Devices / 中国医疗器械杂志

Four-dimensional (4D) printing is an emerging technology that combines science and engineering techniques. The term, "4D printing" was coined in 2013 and since then it has attracted a lot of interests due to its unique ability to have structural or functional transformations over time in response to external stimuli. The most important element of 4D printing is the responsive material. The recent progress research of hydrogels and related new technologies for 4D printing was summarized in the field of implanted medical devices at home and abroad in this paper. Then, it was pointed out the problems of responsive materials for 4D printing. Finally, it was prospected that the development of 4D printing technology in the field of implantable medical devices.

Simulation Study on Radiated Immunity Test of Active Implantable Medical Device / 中国医疗器械杂志

In the electromagnetic compatibility standards of active implantable medical devices such as ISO 14117,radiated immunity test above 450 MHz frequency is recommended to be carried out in the electromagnetic shielding room.However,different test locations and the shape/size of the shielding room may lead to very different electromagnetic field distribution in the radiation exposure area of the sample,thus affecting the consistency of the test.With the model built by COMSOL software,this paper analyzes the impact of different parameters,such as size of the room and position of torso simulator on the distribution of field intensity,and reaches results about the distribution of field intensity on the torso simulator area under tow sizes of shielding rooms and two typical test positions.The results show that the experimental consistency of the electric field intensity on the surface directly below the center of the antenna is not good enough,which may affect the repeatability of the test.

Research on Field Strength of Radiated Immunity Test for Active Implantable Medical Devices / 中国医疗器械杂志

In order to compare the radiation immunity test level of ISO 14708 series standards and the domestic and international environmental radiation standards and then to ascertain whether the radiated immunity test level has reached the limit of the radiation strength in the relevant radiation environmental standards, this paper calculated the radiation field intensity and power density according to the radiated immunity test of ISO 14708 standards, and compared with the limit of ICNIRP 1998 and GB 8702-2014.

Feasibility of finite element analysis in the application of quality inspection on implantable medical devices / 医用生物力学

For implantable medical devices, traditional mechanical property testing is achieved by mechanical testing devices, while such method is lack of pertinence during sampling of series of products, and also time consuming during experimental testing. With the complete development of finite element analysis (FEA) techniques, introducing FEA to quality supervision and inspection will become a scientific method for saving resources and time, and also improve the pertinence. In this study, the creditability of FEA in application of highest risk sample selection, failure analysis of marketed products and auxiliary optimization of fatigue test testing was verified through case study and experimental testing. The feasibility of FEA during implants inspection was illustrated. In order to ensure the accuracy and reliability of FEA in the application of implants inspection, the essentials of establishing related finite element standards were proposed.