Balancing the customization and standardization:exploration and layout surrounding the regulation of the growing field of 3D-printed medical devices in China

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.

New regulations for medical devices: Rationale, advances and impact on research and patient care

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.

The Development of Network based Composite Power quality Regulation Device

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.

Metamaterial terahertz device with temperature regulation function that can achieve perfect absorption and complete reflection conversion of ultrawideband

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.

Using Artificial Neural Networks for Energy Regulation Based Variable-speed Electrohydraulic Drive

In the energy regulation based varibable-speed electrohydraulic drive system, the supply energy and the demanded energy, which will affect the control performance greatly, are crucial. However, they are hard to be obtained via conventional methods for some reasons. This paper tries to a new route： the definitive numerical values of the supply energy and the demanded energy are not required, except for their relationship which is called energy state. A three-layer back propagation（BP） neural network was built up to act as an energy analysis unit to deduce the energy state. The neural network has three inputs： the reference displacement, the actual displacement of cylinder rod and the system flowrate supply. The output of the neural network is energy state. A Chebyshev type II filter was designed to calculate the cylinder speed for the estimation of system flowrate supply. The training and testing samples of neural network were collected by the system accurate simulation model. After off-line training, the neural network was tested by the testing data. And the testing result demonstrates that the designed neural network was successful. Then, the neural network acts as the energy analysis unit in real-time experiments of cylinder position control, where it works efficiently under square-wave and sine-wave reference displacement. The experimental results validate its feasibility and adaptability. Only a position sensor and some pressure sensors, which are cheap and have quick dynamic response, are necessary for the system control. And the neural network plays the role of identifying the energy state.

云调控与变电站设备监测技术融合应用研究

针对变电站设备仿真以及监测系统,结合云技术,展开了云调控与变电站设备监测技术融合应用研究,为智能变电站提供了能量管理和设备管理,实现了对系统有功、无功功率的实时监测,同时也能满足北京电力公司职业技能培训的要求。

集成蓄热装置的火电机组调峰特性分析

【目的】随着新能源的大规模发展,新能源出力不确定性和波动性问题展现出来,而为了弥补新能源出力缺点,火电机组承担起了调峰作用。为了提升火电机组的调峰能力,对其调峰特性进行了研究。【方法】首先,以某350 MW供热机组作为分析对象,应用仿真软件搭建热力系统模型,并验证该模型的精确性。其次,以蓄热系统为辅助系统,研究机组在满足供热需求情况下的机组调峰能力,并分析蓄热等储能单元对机组调峰能力的影响。最后,采用启发式粒子群算法对蓄热水罐运行策略进行优化,得到随热负荷变化的储热罐最优运行模式。【结果】通过蓄热水罐与火电机组耦合的方法有效提升了机组的调峰和供热能力,并提出可以根据实际热负荷数据确定最大化收益的运行模式。【结论】该方法对机组的运行策略具有指导意义。

医疗机构多组学自制试剂实验室的建设实践与思考

实验室自制试剂(laboratory-developed test,LDT)是指由实验室内部开发使用、不需要经过商业注册的体外诊断试剂(in vitro diagnostic medical devices,IVDs)。自制试剂涉及技术广泛,如高通量测序技术、质谱技术、流式细胞分析技术等,能够结合基因组学、转录组学、蛋白质组学、代谢组学等多种组学技术,成为研究遗传病生理病理机制的重要技术方法。中日友好医院被指定为我国10家自行研制使用体外诊断试剂的试点医疗机构之一,率先开展多组学自制试剂实验室建设。本文对医疗机构建设多组学自制试剂实验室的必要性、建设实践和运行风险等进行阐述。

风速可调的地空一体化风力灭火遥控机结构设计与性能分析

风力灭火遥控机作为地面灭火装备的一种创新形式,具备机动性强、远程操作、快速响应等特点,能够在复杂的火情环境中灵活作业,大大提高了灭火效率和安全性。为探讨风力灭火遥控机在应对森林和草原地表火灾地空一体化监测系统中的角色与作用,对风力灭火遥控机进行结构设计,分析旋转开合结构的安装位置和开口大小对出口风速的影响。利用Fluent软件对风力灭火筒进行流体仿真,结合Design Expert软件对仿真数据进行处理,建立了位置S和开口大小d对出口平均风速和出口最大风速的响应曲面和二次模型。结果表明,安装位置和开口大小均为出口风速的重要影响因素,当风筒入口风速设定为70 m/s、旋转开合结构开口大小为30 mm且安装在位置5处时,出口平均风速和出口最大风速达到最大,分别为97.7551 m/s和290.001 m/s。相较于开口大小,安装位置对出口平均风速和出口最大风速的影响更大,且安装位置越靠近风筒出口处风力灭火机的灭火性能越好。

一种绳驱动AUV布放回收装置的结构设计与动力学分析

为了提高自主式水下航行器(AUV)布放回收的安全性和效率,以船舶起重机为基础,设计一种不仅能通过绳索自主调整吊笼的姿态,而且具有良好减摇效果的AUV水面布放回收装置。分析该装置的结构特性和机械理论模型,采用坐标转换法对吊笼的运动学位置、速度和加速度进行分析,并通过MATLAB软件对其进行仿真验证。在运动学模型的基础上对装置进行动力学分析,并利用ADAMS搭建绳索系统的虚拟样机并进行无激励和存在激励仿真验证。研究结果表明:在受船舶激励的情况下,横摇的减摇效果为78%,纵摇的减摇效果为75%;在给定轨迹下,4根绳索的变化比较稳定,能通过绳索调整吊笼的姿态,进而安全高效地完成AUV布放回收工作。

合规语境下的医疗器械行业数字化转型思考

本文聚焦于行业观瞻,直入探讨合规与质量的“悖论”现象,回顾了FDA质量案例计划,厘清合规与质量的辩证关系,提出在一个卓越制造运营体系中满足合规和质量要求的概念,就卓越运营的数字化考量提供管窥之见,以一例医疗器械制造商质量观念的转变,印证从“关注合规”到“保证质量”转变的可行性。

A neuromorphic device mimicking synaptic plasticity under different body fluid K^(+) homeostasis for artificial reflex path construction and pattern recognition

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.

全共轭二维有机框架材料在有机电子器件中的应用

有机电子器件已成为当今社会与工业中不可或缺的组成部分,在显示、通讯、能源和环境等方面都具有广泛的应用。有机电子器件的核心是有机半导体材料,开发具有高电荷传输特性的有机半导体材料是提升有机电子器件性能的关键。作为材料领域的研究前沿,有机多孔晶态材料由于具有确定的化学结构、功能可设计性、大的比表面积、高的孔隙率以及结构可修饰性等特征吸引了广泛的研究,在众多领域都展现出了广阔的应用前景。其中,由于具有高的结构平面性、电子离域性、电荷传输性质以及化学稳定性,全共轭二维有机框架材料作为有机电子学中的载流子传输材料受到广泛关注。当前,人们基于不同结构与功能的全共轭二维有机框架材料,构筑了多种有机电子器件并展现出了巨大的应用潜力。本文首先介绍目前发展的全共轭二维有机框架材料的主要结构,随后重点综述全共轭二维有机框架材料在有机电子器件包括有机场效应晶体管、有机光电探测器、有机光伏电池、化学阻抗传感器及一些新兴电子器件中的最新研究进展。最后阐述实现全共轭二维有机框架材料在有机电子器件的实际应用中所面临的挑战并提出了未来的研究方向。

智慧监管视角下医疗器械上市后质量风险防控指标体系构建研究

随着我国医疗器械产业规模持续增长,产品不断创新升级,对医疗器械监管和风险管理提出了更高要求。当前,风险管理已经成为医疗器械质量安全的重要抓手。本文通过对国内外医疗器械监管、风险管理理论相关文献、政策进行分析,并结合成都市医疗器械智慧监管平台框架及信息数据等归纳梳理医疗器械风险防控监测要点,从智慧监管角度构建了一套医疗器械质量风险防控指标体系。该医疗器械质量风险防控指标体系可以用于监管机构识别质量安全风险点,降低风险识别难度以及预测医疗器械检验检测和监管的重点,为建立和完善医疗器械质量风险的识别、评估、预警机制提供参考。

双高有源台区电能质量综合治理装置相关研究

此处首先分析了统一电能质量调节器(UPQC)的工作原理和多种类型的拓扑结构,并提出一种左串右并型UPQC可接入三相三线或三相四线系统中并可以实现串并联侧的电能质量调节。随后对UPQC的控制策略进行了分析,选用了无需检测电源电压及负载电流的扰动畸变等信息的间接补偿控制策略,其中串联逆变器被控制为受控电压源,并联逆变器被控制为受控电流源。最后对UPQC进行仿真与实验验证,从结果论证了此装置和控制策略的可行性。

行星变频调速给水泵性能试验方法研究及其应用

行星齿轮变频调速装置作为一种先进电动机调速节能技术,因其优良的可靠性已在能源环保工业电动机节能领域得到广泛应用。为定量分析其节能效果,基于能量平衡和质量平衡,针对某600 MW机组给水泵采用平行对比法(A液力耦合器传动调速,B行星齿轮传动调速)对给水泵进行性能评价。试验过程中,将两台给水泵组的功能倒换,但环境温度、入炉煤质等边界条件难免改变,两台给水泵组出力也会随之发生偏差。为此,引入一个新概念——泵水功耗系数,该系数可兼顾两台给水泵组的出力偏差,较准确地开展机组同负荷下的给水泵组能耗之间的横向对比及节能评价。试验表明:文中所提出的试验方法,可以实现对行星变频调速给水泵性能定量分析,为能源化工行业动力机械设备节能改造奠定基础。

正态分布规律变量调节式多功能条播装置设计与试验

针对条播装置成条的需求,设计了一种基于正态分布规律变量调节的多功能条播装置,该装置能够实现均匀和不均匀等多种成条效果。该装置无需更换复杂配件,只需要改变调节单元结构布局,操作简单灵活,能够一机多用。从条播装置整体结构设计、原理阐述和仿真分析与台架测试方面开展研究,通过颗粒进料口喂入角仿真试验选定了进料口角度,并选取复合肥颗粒与水稻种子颗粒,经离散元仿真软件(Enhances discrete element method,EDEM)仿真和台架试验测试了变量调节性能,对条播装置在不同变量调节下的成条效果进行动态测试。进料口喂入角仿真试验结果表明,在70°喂入角下,网格间变异系数差异达18%,颗粒流变化相对较小,颗粒流相对均匀。条播装置变量调节性能试验结果表明,各排料管之间的复合肥颗粒流量差异最大为组合8(变异系数为92%),最大差值为0.214 kg,变量范围最大(6%~41%);各排料管之间的复合肥颗粒流量差异最小为组合11(44%),最小差值为0.100 kg,变量范围最小(11%~27%);各排料管之间的水稻种子颗粒流量差异最大为组合8(90%),变量范围最大(5%~40%);各排料管之间的水稻种子颗粒流量差异最小为组合11(40%),变量范围最小(11%~27%);12个组合的变异系数与变量范围差异显著,复合肥颗粒的变异系数整体为44%~92%,变量范围整体为6%~42%;水稻种子的变异系数整体为40%~90%,变量范围整体为5%~40%,装置可实现多样化变量调节。变量成条效果动态测试试验结果表明,所有组合下的复合肥颗粒与水稻种子颗粒的成条效果都明显,条带波动小,条带宽度和间距稳定。

超表面偏振器件研究进展与展望

偏振作为光的基本特性之一,其产生、调控和探测被广泛应用于通信、成像、光学加密等领域。然而传统的偏振器件存在体积大、集成度低等问题。亚波长尺度的超表面由于其独特的光场调控机制,为偏振器件的小型化和低成本提供了创新性的解决方案。本文对近年来基于超表面的偏振器件研究进展及超表面制备工艺进行综述。从超表面相位调控机理入手,简单介绍了传输相位、几何相位、广义几何相位和共振相位的调控方法,重点总结了偏振转换、偏振分束、矢量涡旋光发生器、高阶庞加莱球光学加密、偏振多通道全息、偏振探测等不同超表面偏振器件及其制备工艺,最后展望了该领域可能的发展趋势和应用前景。

中美两国儿科用医疗器械监管现状及临床研究探讨

儿科医疗器械的发展面临挑战,不能满足儿科临床需求,然而开展儿科人群医疗器械临床研究较为困难。本文介绍了国内儿科医疗器械的发展现状,国内和美国儿科医疗器械相关的法规指南,并探讨儿科人群医疗器械临床研究设计的注意事项,以期为相关临床研究的开展提供借鉴。

高压干式移磁无级调压软起动装置和就地无功补偿装置在制氧站的应用

以某铅冶炼厂制氧站改扩建项目为例,介绍高压干式移磁无级调压软起动装置和就地无功补偿装置的工作原理及其在罗茨鼓风机上的应用、高压干式移磁无级调压软起动装置和就地无功补偿装置的选型及参数计算、罗茨鼓风机配电系统设计、罗茨鼓风机现场运行效果。