Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personaliz...Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods.The emerging manufacturing technology of three-dimensional(3D)printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures.However,the application of this new technology has also brought new risks to medical devices,making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry.This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China,and provide ideas to address these challenges.We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices,highlighting the quality system of such devices,and discuss the guidelines that manufacturers should follow,as well as the current limitations and the feasible path of regulation and standardization work based on this perspective.The key points of the whole process quality control,performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized.Furthermore,the significance of regulation and standardization is pointed out.Finally,aspects worthy of attention and future perspectives in this field are discussed.展开更多
A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data w...A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts- such as age, comorbidities, the patients' risk profiles or the hospital profile- are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.展开更多
First, the paper analyzes the advantages and disadvantages of all kinds of reactive power compensation technology, and then proposes a principle and integrated control strategy of the composite operation of TSC and SV...First, the paper analyzes the advantages and disadvantages of all kinds of reactive power compensation technology, and then proposes a principle and integrated control strategy of the composite operation of TSC and SVG, also the paper designs and develops the main controller of Network based composite power quality regulation device, based on RTDS, the real-time digital simulation model of The Device is established, and finally the prototype of the device is developed with the function of filter and split-phase compensation. The main controller determines the cooperative operation of both TSC and SVG, and the switching strategy of TSC. The simulation result in RTDS can verify the precision of the measure system and the validity of the control logic, the prototype has finished the type test according to the national standard.展开更多
The field of terahertz devices is important in terahertz technology.However,most of the current devices have limited functionality and poor performance.To improve device performance and achieve multifunctionality,we d...The field of terahertz devices is important in terahertz technology.However,most of the current devices have limited functionality and poor performance.To improve device performance and achieve multifunctionality,we designed a terahertz device based on a combination of VO_(2)and metamaterials.This device can be tuned using the phase-transition characteristics of VO_(2),which is included in the triple-layer structure of the device,along with SiO_(2)and Au.The terahertz device exhibits various advantageous features,including broadband coverage,high absorption capability,dynamic tunability,simple structural design,polarization insensitivity,and incidentangle insensitivity.The simulation results showed that by controlling the temperature,the terahertz device achieved a thermal modulation range of spectral absorption from 0 to 0.99.At 313 K,the device exhibited complete reflection of terahertz waves.As the temperature increased,the absorption rate also increased.When the temperature reached 353 K,the device absorption rate exceeded 97.7%in the range of 5-8.55 THz.This study used the effective medium theory to elucidate the correlation between conductivity and temperature during the phase transition of VO_(2).Simultaneously,the variation in device performance was further elucidated by analyzing and depicting the intensity distribution of the electric field on the device surface at different temperatures.Furthermore,the impact of various structural parameters on device performance was examined,offering valuable insights and suggestions for selecting suitable parameter values in real-world applications.These characteristics render the device highly promising for applications in stealth technology,energy harvesting,modulation,and other related fields,thus showcasing its significant potential.展开更多
The ionic environment of body fluids influences nervous functions for maintaining homeostasis in organisms and ensures normal perceptual abilities and reflex activities.Neural reflex activities,such as limb movements,...The ionic environment of body fluids influences nervous functions for maintaining homeostasis in organisms and ensures normal perceptual abilities and reflex activities.Neural reflex activities,such as limb movements,are closely associated with potassium ions(K+).In this study,we developed artificial synaptic devices based on ion concentration-adjustable gels for emulating various synaptic plasticities under different K+concentrations in body fluids.In addition to performing essential synaptic functions,potential applications in information processing and associative learning using short-and long-term plasticity realized using ion concentration-adjustable gels are presented.Artificial synaptic devices can be used for constructing an artificial neural pathway that controls artificial muscle reflex activities and can be used for image pattern recognition.All tests show a strong relationship with ion homeostasis.These devices could be applied to neuromorphic robots and human-machine interfaces.展开更多
基金the National Natural Science Foundation of China(No.81827804,U1909218)the Science Fund for Creative Research Groups of the National Natural Science Foundation of China(No.T2121004).
文摘Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods.The emerging manufacturing technology of three-dimensional(3D)printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures.However,the application of this new technology has also brought new risks to medical devices,making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry.This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China,and provide ideas to address these challenges.We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices,highlighting the quality system of such devices,and discuss the guidelines that manufacturers should follow,as well as the current limitations and the feasible path of regulation and standardization work based on this perspective.The key points of the whole process quality control,performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized.Furthermore,the significance of regulation and standardization is pointed out.Finally,aspects worthy of attention and future perspectives in this field are discussed.
文摘A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts- such as age, comorbidities, the patients' risk profiles or the hospital profile- are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.
文摘First, the paper analyzes the advantages and disadvantages of all kinds of reactive power compensation technology, and then proposes a principle and integrated control strategy of the composite operation of TSC and SVG, also the paper designs and develops the main controller of Network based composite power quality regulation device, based on RTDS, the real-time digital simulation model of The Device is established, and finally the prototype of the device is developed with the function of filter and split-phase compensation. The main controller determines the cooperative operation of both TSC and SVG, and the switching strategy of TSC. The simulation result in RTDS can verify the precision of the measure system and the validity of the control logic, the prototype has finished the type test according to the national standard.
基金support from the National Natural Science Foundation of China(Nos.51606158,11604311,and 12074151)Sichuan Science and Technology Program(No.2021JDRC0022)+3 种基金Natural Science Foundation of Fujian Province(No.2021J05202)Research Project of Fashu Foundation(No.MFK23006)Open Fund of the Key Laboratory of Metallurgical Equipment and Control Technology of Ministry of Education in Wuhan University of Science and Technology(No.MECOF2022B01)the project supported by Guangxi Key Laboratory of Precision Navigation Technology and Application,Guilin University of Electronic Technology(No.DH202321).
文摘The field of terahertz devices is important in terahertz technology.However,most of the current devices have limited functionality and poor performance.To improve device performance and achieve multifunctionality,we designed a terahertz device based on a combination of VO_(2)and metamaterials.This device can be tuned using the phase-transition characteristics of VO_(2),which is included in the triple-layer structure of the device,along with SiO_(2)and Au.The terahertz device exhibits various advantageous features,including broadband coverage,high absorption capability,dynamic tunability,simple structural design,polarization insensitivity,and incidentangle insensitivity.The simulation results showed that by controlling the temperature,the terahertz device achieved a thermal modulation range of spectral absorption from 0 to 0.99.At 313 K,the device exhibited complete reflection of terahertz waves.As the temperature increased,the absorption rate also increased.When the temperature reached 353 K,the device absorption rate exceeded 97.7%in the range of 5-8.55 THz.This study used the effective medium theory to elucidate the correlation between conductivity and temperature during the phase transition of VO_(2).Simultaneously,the variation in device performance was further elucidated by analyzing and depicting the intensity distribution of the electric field on the device surface at different temperatures.Furthermore,the impact of various structural parameters on device performance was examined,offering valuable insights and suggestions for selecting suitable parameter values in real-world applications.These characteristics render the device highly promising for applications in stealth technology,energy harvesting,modulation,and other related fields,thus showcasing its significant potential.
基金supported by the National Science Foundation for Distinguished Young Scholars of China(T2125005)Tianjin Science Foundation for Distinguished Young Scholars(19JCJQJC61000)the Shenzhen Science and Technology Project(JCYJ20210324121002008).
文摘The ionic environment of body fluids influences nervous functions for maintaining homeostasis in organisms and ensures normal perceptual abilities and reflex activities.Neural reflex activities,such as limb movements,are closely associated with potassium ions(K+).In this study,we developed artificial synaptic devices based on ion concentration-adjustable gels for emulating various synaptic plasticities under different K+concentrations in body fluids.In addition to performing essential synaptic functions,potential applications in information processing and associative learning using short-and long-term plasticity realized using ion concentration-adjustable gels are presented.Artificial synaptic devices can be used for constructing an artificial neural pathway that controls artificial muscle reflex activities and can be used for image pattern recognition.All tests show a strong relationship with ion homeostasis.These devices could be applied to neuromorphic robots and human-machine interfaces.
