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Modeling the magnetocaloric effect of spinel ferrites for magnetic refrigeration technology using extreme learning machine and genetically hybridized support vector regression computational methods 利用极限学习机和遗传杂交支持向量回归计算方法对磁制冷技术中尖晶石铁氧体的磁热效应进行建模
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-10-05 DOI: 10.1080/23311916.2023.2257955
Wasiu Adeyemi Oke, Nahier Aldhafferi, Saibu Saliu, Taoreed O. Owolabi, Abdullah Alqahtani, Abdullah Almurayh, Talal F. Qahtan
Spinel ferrites are magnetic oxide materials with potentials to promote green technology in magnetic refrigeration which is known to be economically clean, energy saving and efficient. Maximum magnetic entropy change of spinel ferrites decides and controls the applicability as well as the strength of spinel ferrite magnetic oxide since it measures the hugeness of magnetocaloric effect. However, experimental determination of maximum magnetic entropy change requires intensive procedures, costly equipment and consumes appreciable time. Intelligent models are presented in this work using spinel-ferrite-molecular-based descriptors such as the ionic radii of spinel ferrites constituents, applied magnetic field and their concentrations. The developed intelligent models for prediction of spinel ferrite maximum magnetic entropy change include extreme learning machine (ELM) and hybrid genetic-algorithm-coupled support vector regression (GSVR). The developed ELM model has correlation coefficient (CC) and mean absolute error (MAE) of 98.45% and 0.117 J/kg/K, respectively, while the developed GSVR model has CC of 80.87% and MAE of 0.129 J/kg/J. The developed ELM model which is based on empirical risk minimization principle shows better performance over GSVR model that premises on structural minimization risk principle with improvement of 0.06%, 17.86% and 8.765% using root mean square error, CC and MAE yardsticks, respectively. Closeness of the estimates of the developed models with the experimental values is a strong indication of the potentials of the proposed intelligent methods in facilitating practical implementation of magnetic cooling refrigeration to solve energy crisis which promote efficiency and environmental friendliness.
尖晶石铁氧体是一种极具推广绿色磁制冷技术潜力的磁性氧化物材料,具有经济清洁、节能高效的特点。尖晶石铁氧体的最大磁熵变化决定和控制着尖晶石铁氧体磁性氧化物的适用性和强度,它反映了磁热效应的大小。然而,最大磁熵变化的实验测定需要密集的程序,昂贵的设备和消耗可观的时间。利用尖晶石铁氧体分子描述符,如尖晶石铁氧体成分的离子半径、外加磁场及其浓度,提出了智能模型。建立了尖晶石铁氧体最大磁熵变化的智能预测模型,包括极限学习机(ELM)和混合遗传算法耦合支持向量回归(GSVR)。ELM模型的相关系数(CC)和平均绝对误差(MAE)分别为98.45%和0.117 J/kg/K, GSVR模型的相关系数(CC)和平均绝对误差(MAE)分别为80.87%和0.129 J/kg/J。基于经验风险最小化原则的ELM模型比以结构风险最小化原则为前提的GSVR模型表现出更好的性能,在均方根误差、CC和MAE尺度上分别提高了0.06%、17.86%和8.765%。所建立的模型的估计与实验值的接近程度强烈表明,所提出的智能方法在促进实际实施磁冷却制冷以解决能源危机方面具有潜力,从而提高效率和环境友好性。
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引用次数: 0
Soft computing approach for optimization of turning characteristics of elastomers under different lubrication conditions 不同润滑条件下弹性体车削特性优化的软计算方法
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-10-05 DOI: 10.1080/23311916.2023.2264066
Malikasab Bagawan, Suresh T. Dundur, Rajesh Gurani, Raviraj Shetty, Rajesh Nayak, S. V. Udaya Kumar Shetty, Madhukara Nayak, Adithya Hegde
Elastomers are the class of materials that are widely used in a variety of industrial, commercial, and consumer applications due to their unique mechanical properties, including high elasticity, high flexibility, and high resilience. However, there are many challenges in machining of elastomers such as poor surface finish, build up of heat, degradation of elastomers, etc. To overcome these challenges, cryogenic cooling assistance has been introduced as a means of improving the machinability of elastomers. This paper presents a soft computing approach for optimizing the surface roughness and cutting force during turning of elastomers under different lubrication conditions. Three types of elastomers, namely Nitrile Rubber (NBR), Polyurethane Rubber (PU), and Neoprene Rubber (CR), are studied, and a cryogenic fluid delivery system is employed to improve the machining process. Taguchi’s L27 array is used to vary the input parameters, and a Back-Propagation Artificial Neural Network (BPANN) model is developed to predict the cutting force and surface roughness. The cutting force and surface roughness are analyzed under different cooling conditions, cutting speeds, feeds, and depths of cut for various elastomers. The results show that changes in cutting conditions significantly affect the cutting force and that the type of lubrication used affects the cutting force by altering the material’s physical properties. Cutting force is significantly influenced by cutting conditions, and NBR requires the highest cutting force compared to PU and CR. Further, at a cutting speed of 55 m/min, a feed of 0.11 mm/rev, and a depth of cut of 0.25 mm, the cutting force for NBR (85.1 N), while for PU (75.1 N) and CR (80.3 N), respectively. Finally, with LN2 lubrication conditions, the Cutting Force decreased by 45% and Surface Roughness decreased by 16.9%. This study provides insights into the factors affecting the elastomer machining process, which can be useful for optimizing the machining process parameters and improving machining efficiency.
弹性体是一类广泛应用于各种工业,商业和消费应用的材料,由于其独特的机械性能,包括高弹性,高柔韧性和高弹性。然而,在弹性体的加工中存在许多挑战,如表面光洁度差、热量积累、弹性体降解等。为了克服这些挑战,低温冷却辅助已经被引入作为提高弹性体可加工性的一种手段。提出了一种软计算方法来优化弹性体在不同润滑条件下车削时的表面粗糙度和切削力。对丁腈橡胶(NBR)、聚氨酯橡胶(PU)和氯丁橡胶(CR)三种弹性体进行了研究,并采用低温流体输送系统改进了加工工艺。利用田口L27阵列改变输入参数,建立了反向传播人工神经网络(BPANN)模型来预测切削力和表面粗糙度。分析了各种弹性体在不同冷却条件、切削速度、进给量和切削深度下的切削力和表面粗糙度。结果表明,切削条件的变化对切削力有显著影响,所使用的润滑类型通过改变材料的物理性质来影响切削力。切削力受切削条件影响较大,NBR对切削力的要求高于PU和CR,且在切削速度为55 m/min、进给量为0.11 mm/rev、切削深度为0.25 mm时,NBR的切削力为85.1 N, PU为75.1 N, CR为80.3 N。最后,在LN2润滑条件下,切削力降低了45%,表面粗糙度降低了16.9%。研究结果揭示了弹性体加工过程的影响因素,为优化加工工艺参数,提高加工效率提供了依据。
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引用次数: 0
Scanning electron microscopy as a valuable tool to optimize the properties of the polymer/clay nanocomposites 扫描电子显微镜是优化聚合物/粘土纳米复合材料性能的重要工具
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-10-04 DOI: 10.1080/23311916.2023.2265231
Mohammed M. Sabri, Alaa M. Almansoori, Riyadh Aziz Ghadban
The current research utilizes a low voltage scanning electron microscopy (LV-SEM) with an electron beam along with low loading energy of lower than 2.2 KeV to minimize damage and specimen surface charging. The NovaSEM, is used as an efficient tool in the current study due to the high resolution information it can gather as images and its high magnification nanometers. Polyamide 12 (PA12), as a polymer matrix, and Cloisite 30B (C30B) nanoclay, as a filling material, were the materials tested in this study. From the results obtained, CBS was found to be a significant and valuable tool for certain complex tasks when studying and analyzing polymer/clay interfaces. CBS in conjunction with beam deceleration in a LV-SEM was used to map the C30B clay distribution on PA12 particles and within PA12-nanoclay nanocomposites manufactured from the latter’s clay distribution particles within the polymer particles’ surfaces. This SEM experimentation has demonstrated that using the clay’s air plasma design preceding the composite preparation resulted in removing the large clay assemblages. The plasma treatment has improved the interfacial adhesion and dispersion in the nanoclay/PA12 composite, resulting in similar maximum stress values which were both higher than the pure PA12. Thus, the mechanical tests exhibited performance enhancement for the resulting composites defined in the present work, and the enhancement of this method can be identified via SEM imaging.
目前的研究利用低电压扫描电子显微镜(LV-SEM),电子束和低于2.2 KeV的低加载能量,以最大限度地减少损伤和样品表面充电。NovaSEM是目前研究中使用的有效工具,因为它可以以图像的形式收集高分辨率信息,并且具有高纳米放大倍率。以聚酰胺12 (PA12)为聚合物基体,以Cloisite 30B (C30B)纳米粘土为填充材料。从所获得的结果来看,在研究和分析聚合物/粘土界面时,CBS是一种重要而有价值的工具。CBS与LV-SEM中的光束减速相结合,用于绘制PA12颗粒上的C30B粘土分布和PA12纳米粘土纳米复合材料内的C30B粘土分布,而PA12纳米粘土是由聚合物颗粒表面的粘土分布颗粒制成的。SEM实验表明,在复合材料制备之前使用粘土的空气等离子体设计可以去除大的粘土组合。等离子体处理改善了纳米粘土/PA12复合材料的界面粘附性和分散性,导致最大应力值相似,均高于纯PA12。因此,力学测试显示了本工作中定义的复合材料的性能增强,并且这种方法的增强可以通过扫描电镜成像来识别。
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引用次数: 0
Progressive Hartley image secret sharing for high-quality image recovery 渐进式哈特利图像秘密共享,用于高质量图像恢复
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-10-03 DOI: 10.1080/23311916.2023.2262805
Raviraja M Holla, D Suma
This paper introduces a highly efficient approach for progressive image secret sharing through the Discrete Hartley Transform (DHT), offering distinct advantages over existing methods. Leveraging DHT in the color domain, our approach achieves progressive sharing of color images while maintaining robustness and minimal visual impact. By optimizing quantization table selection, our method focuses on maximizing image recovery fidelity. Our extensive experiments showcase the efficacy of our proposed method, highlighting its potential for secure image sharing and superior image quality enabled by the real-number DHT transformation. Notably, our approach demonstrates strong security robustness and high-quality image reconstruction through histogram analysis. Objective assessment values of 88.106 (PSNR), 0.884 (NCC), 0.095 (NAE), and 0.895 (SSIM) underscore the superiority of our method. These results, coupled with its unique contributions and key factors, position our work as a promising solution in the field of image security and distribution, motivating further exploration and inspiring related research endeavors.
本文介绍了一种利用离散哈特利变换(DHT)进行图像渐进秘密共享的高效方法,与现有方法相比具有明显的优势。利用颜色域的DHT,我们的方法实现了彩色图像的渐进式共享,同时保持了鲁棒性和最小的视觉影响。该方法通过优化量化表选择,实现图像恢复保真度的最大化。我们的大量实验展示了我们提出的方法的有效性,突出了其通过实数DHT变换实现安全图像共享和卓越图像质量的潜力。值得注意的是,我们的方法通过直方图分析显示了强大的安全鲁棒性和高质量的图像重建。88.106 (PSNR)、0.884 (NCC)、0.095 (NAE)和0.895 (SSIM)的客观评价值显示了我们方法的优越性。这些结果,加上其独特的贡献和关键因素,使我们的工作成为图像安全和分发领域的一个有前途的解决方案,激励着进一步的探索和激励着相关的研究工作。
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引用次数: 0
Microstructural stages of intermetallic fracture during sheared deformation of AA6082 sheet AA6082板材剪切变形过程中金属间断裂的显微组织阶段
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-09-30 DOI: 10.1080/23311916.2023.2262820
Vijayalaxmi Sonkamble, K. Narasimhan, Asim Tewari
The progressive deformations of a shear band formation were studied to understand the fracture mechanism of AA6082(T6) sheets. The fracture characteristics of the alloys can be dictated by the intermetallic particles. Damage evolution of the alloy is quantitatively characterized as a function of strain. Larger, elongated, and favorably oriented particles fracture first (with initial deformation), and with progressive deformation (blanking), smaller and rounded particles start breaking. These broken particles become a crack nucleus for matrix cracking and coalescences. In the initial deformation stages, fragmentation of particles takes place without significant void growth. However, with subsequent deformation stages, the fragmentation process has been enhanced with multi-fragmentation and re-fracturing of previously broken particles. Larger particles nucleate voids at much lower strains with void growth. Crack has initiated in the shear band, preferably from the punch side (the punch side is sharper than the die side), and cracks are found almost parallel to the loading axis.
为了解AA6082(T6)板材的断裂机理,研究了剪切带的渐进变形过程。合金的断裂特征可由金属间颗粒决定。该合金的损伤演化过程定量表征为应变函数。较大的、细长的、取向良好的颗粒首先断裂(具有初始变形),随着逐渐变形(落料),较小的、圆形的颗粒开始断裂。这些破碎的颗粒成为裂纹核,使基体开裂和凝聚。在初始变形阶段,颗粒碎裂发生,但没有明显的孔洞生长。然而,在随后的变形阶段,破碎过程随着先前破碎颗粒的多次破碎和再破裂而增强。更大的颗粒在更低的应变下随孔洞生长而形成孔洞。裂纹在剪切带中开始,最好是从冲头侧开始(冲头侧比模具侧更锋利),并且发现裂纹几乎平行于加载轴。
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引用次数: 0
A group acceptance sampling plan based on flexible new Kumaraswamy exponential distribution: An application to quality control reliability 基于柔性新Kumaraswamy指数分布的组验收抽样方案:在质量控制可靠性中的应用
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-09-28 DOI: 10.1080/23311916.2023.2257945
Sidra Naz, M.H. Tahir, Farrukh Jamal, Muhammad Ameeq, Shakaiba Shafiq, John T. Mendy
In this study, we presented a group acceptance sampling plan for situations in which the lifetime of an item followed a flexible new Kumaraswamy exponential distribution for applications to quality control reliability. This study includes a detailed analysis of the operating characteristic function values, producer risk, and minimum required group size for the acceptance number, which are determined by three shape parameters. To determine the quality index, we used the median and tested various parametric values to obtain the optimized values. These optimized values are presented in the tables and graphically for a better understanding. In addition, we explain the results of our study using two real-life datasets and an example. Comparison has been also made between GASP and OSP.
在这项研究中,我们提出了一个群体接受抽样计划的情况下,一个项目的寿命遵循一个灵活的新Kumaraswamy指数分布的应用质量控制可靠性。本研究详细分析了由三个形状参数决定的运行特征函数值、生产者风险和验收数量所需的最小群体规模。为了确定质量指标,我们使用中位数,并对各种参数值进行检验,得到最优值。为了更好地理解,这些优化值以表格和图形形式呈现。此外,我们用两个真实的数据集和一个例子来解释我们的研究结果。并对GASP和OSP进行了比较。
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引用次数: 1
Soft computing for sustainable drilling of AISI 316L stainless steel under formulated neem oil minimum quantity lubrication condition 配方印楝油最少量润滑条件下aisi316l不锈钢可持续钻井的软计算
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-09-28 DOI: 10.1080/23311916.2023.2261231
C.P. Natesh, Y.M. Shashidhara, H.J. Amarendra, Raviraj Shetty, Rajesh Nayak, S. V. UdayKumar Shetty, Madhukara Nayak, Adithya Hegde
This paper discusses about process input optimization to obtain desired output characteristics such as Surface Roughness (microns), Thrust Force (N) and Torque (N-m) during drilling of AISI 316 L Stainless Steel under minimum quantity formulated neem oil lubrication condition based on Taguchi Design of Experiments (TDOE), Response Surface Methodology (RSM) and Desirability Functional Analysis (DFA) by varying flow rate (ml.min−1), stand-off distance (mm), flow pressure (Bar) and nozzle exit diameter (mm). Formulated Neem Oil possesses natural lubricating properties that reduce friction and heat generation, thus prolonging the tool life and improving surface finish. Additionally, it is biodegradable and environmentally friendly, making it a sustainable choice for machining operations. From the experimental investigation using TDOE, it was observed that there was considerable improvement in thrust force, surface roughness and torque with modified neem oil as a lubricant. Further, plot for main effects and Analysis of Variance (ANOVA) are successfully used to identify the optimum process input parameters and their percentage of contribution (P%) on output parameters. RSM is successfully used to generate a second order mathematical model which can be effectively used to analyze the process parameters. Further, from Desirability Functional Analysis (DFA), minimum surface roughness (0.34 microns), thrust force (1292.37 N) and torque (14.71 N-m) value were predicted. Finally, Back Propagation Artificial Neural Network (BPANN) analysis has been adopted to predict the surface roughness, thrust force and torque with a minimal error of 1.46%, 0.017% & 0.17%, respectively. The adoption of Neem oil formulations has been successful in improving machining characteristics. Its versatility across an array of machining processes and materials, in tandem with the global momentum toward greener manufacturing paradigms, positions it as a promising lubricant for various machining practices.
本文基于田口实验设计(TDOE)、响应面法(RSM)和期望功能分析(DFA),通过改变流量(ml.min−1)、间隔距离(mm)、流量(ml.min−1),对aisi316l不锈钢在最少量配方印草油润滑条件下的钻孔过程进行工艺输入优化,以获得所需的输出特性,如表面粗糙度(微米)、推力(N)和扭矩(N-m)。流量压力(Bar)和喷嘴出口直径(mm)。配方印楝油具有天然的润滑性能,减少摩擦和热量的产生,从而延长工具寿命和改善表面光洁度。此外,它是可生物降解和环保的,使其成为加工操作的可持续选择。从TDOE的实验研究中可以看出,改性印楝油作为润滑剂对推力、表面粗糙度和扭矩都有很大的改善。此外,主效应图和方差分析(ANOVA)成功地用于确定最佳过程输入参数及其对输出参数的贡献百分比(P%)。利用RSM成功地建立了二阶数学模型,该模型可有效地用于工艺参数分析。此外,通过理想泛函分析(Desirability Functional Analysis, DFA),预测了最小表面粗糙度(0.34微米)、推力(1292.37 N)和扭矩(14.71 N-m)值。最后,采用反向传播人工神经网络(BPANN)对表面粗糙度、推力和扭矩进行预测,误差最小,分别为1.46%、0.017%和0.17%。采用印度楝油配方已成功地改善了加工特性。它在一系列加工工艺和材料中的多功能性,与全球向绿色制造范式的发展势头相结合,使其成为各种加工实践的有前途的润滑剂。
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引用次数: 0
Compression after impact & vibrational analysis of aramid-basalt/epoxy interply composites under hygrothermal conditions 冲击后压缩&湿热条件下芳纶-玄武岩/环氧复合材料的振动分析
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-09-27 DOI: 10.1080/23311916.2023.2262812
Anuj Deshmukh, Yogeesha Pai
With the application of composites in various industries viz. aerospace, automobile, defence and marine, it becomes essential to carry out the Compression After Impact (CAI) and vibration tests to study their behavior in different environmental conditions. This study investigates the significance of CAI and damping characteristics of the aramid-basalt/epoxy interply composites under different hygrothermal conditions. In this examination, laminates were exposed to three different ageing conditions, namely, ambient (ageing in distilled water at 25°C), sub-zero (ageing in distilled water at −10°C), and humid (ageing in an environmental chamber maintained at 40°C and 60% relative humidity) for a duration of 180 days. Moisture saturated specimens were subjected to low velocity impacts (LVI) of 10 J and 15 J energy levels using drop weight impact method. CAI test was carried out on post impact specimens to analyze the residual compressive strengths. Furthermore, impact hammer and impedance tube tests were also conducted to compute the damping properties and sound transmission loss (dB) of the specimens. The results were compared with the pristine samples to analyze the effect of hygrothermal conditions on the CAI and vibrational properties. The results indicated that the moisture has a detrimental effect on the compressive residual strength, natural frequency, and sound transmission loss of the specimens. The Scanning Electron Microscopy (SEM) of fractured CAI specimens displayed the occurrence of various types of damages such as fiber fractures, delamination, matrix fractures, etc as the primary reason for failure of the specimens.
随着复合材料在航空航天、汽车、国防、船舶等领域的广泛应用,开展冲击后压缩试验和振动试验研究复合材料在不同环境条件下的性能变得十分必要。研究了不同湿热条件下芳纶-玄武岩/环氧树脂夹层复合材料的CAI和阻尼特性的意义。在这项研究中,层压板暴露在三种不同的老化条件下,即环境(在25°C的蒸馏水中老化)、零下(在- 10°C的蒸馏水中老化)和潮湿(在保持40°C和60%相对湿度的环境室中老化),持续180天。采用落锤冲击法对湿饱和试样进行了10 J和15 J能级的低速冲击。对冲击后试样进行CAI试验,分析残余抗压强度。此外,还进行了冲击锤和阻抗管试验,计算了试件的阻尼特性和传声损失(dB)。将实验结果与原始样品进行了比较,分析了湿热条件对CAI和振动性能的影响。结果表明,水分对试件的残余抗压强度、固有频率和透声损失均有不利影响。断裂CAI试件的扫描电镜(SEM)显示,纤维断裂、分层、基体断裂等多种损伤的发生是试件破坏的主要原因。
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引用次数: 0
Managing supply chain performance using a real time Microsoft Power BI dashboard by action design research (ADR) method 通过行动设计研究(ADR)方法,使用实时Microsoft Power BI仪表板管理供应链绩效
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-09-27 DOI: 10.1080/23311916.2023.2257924
Dewan Hafiz Nabil, Md. Habibur Rahman, Altaf Hussain Chowdhury, Brenno Castrillon Menezes
Supply chain (SC) performance is being advanced through digitalization, automation, and real-time visibility, leading to improved operational efficiency, optimized inventory management, and proactive solutions for problems. This study focuses on managing SC performance by developing a real-time Microsoft Power BI dashboard using the ADR method. The aim is to help small business owners effectively and affordably manage their supply chains. The research analyzed data from Ly Foods Ltd. and utilized Microsoft Power BI to create the dashboard. The study highlights how this state-of-the-art dashboard enhances the measurement of operational and decision-making processes by providing efficient, visible, accessible, and shareable information. The findings demonstrate the potential benefits of leveraging advanced technologies to enhance supply chain management (SCM) practices. This research makes a significant contribution to the field of SCM by illustrating how SC performance can be managed using the ADR method and the SC key performance indicators (KPIs). The results of this study have important implications for businesses of all sizes, as they enhance SC efficiency and profitability.
通过数字化、自动化和实时可见性,供应链(SC)的性能得到了提升,从而提高了运营效率,优化了库存管理,并为问题提供了积极的解决方案。本研究的重点是通过使用ADR方法开发一个实时Microsoft Power BI仪表板来管理SC绩效。其目的是帮助小企业主有效和经济地管理他们的供应链。该研究分析了来自Ly Foods Ltd.的数据,并利用Microsoft Power BI创建了仪表板。该研究强调了这种最先进的仪表板如何通过提供高效、可见、可访问和可共享的信息来增强对运营和决策过程的测量。研究结果证明了利用先进技术来增强供应链管理(SCM)实践的潜在好处。本研究通过说明如何使用ADR方法和供应链关键绩效指标(kpi)来管理供应链绩效,对供应链管理领域做出了重大贡献。本研究的结果对各种规模的企业都有重要的意义,因为它们提高了供应链的效率和盈利能力。
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引用次数: 0
Challenges faced by manufacturers with clinical evaluation under the new European Medical Device Regulations 制造商在新的欧洲医疗器械法规下进行临床评估所面临的挑战
Q2 ENGINEERING, MULTIDISCIPLINARY Pub Date : 2023-09-26 DOI: 10.1080/23311916.2023.2261236
Breda Kearney, Olivia McDermott
This study seeks to investigate the impact of strengthened requirements for clinical evaluation for medical device manufacturers in Europe due to the new Medical Device Regulations. Qualitative interviews were conducted with eight clinical evaluation consultants from eight different European countries who review and approve clinical evaluation reports for manufacturers prior to their submission to notified bodies. The study describes the sources of device clinical evaluation evidence and describes the consultants’ recommendations and challenges encountered when reviewing Clinical Evaluation Reports. The findings from the study demonstrate that understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant Clinical Evaluation Report. Additionally, the study identified a knowledge and skills gap in the generation and assessment of acceptable regulatory and clinical data. Further, there is heterogeneity in the reviews of Clinical Evaluation Reports received by consultants and inadequate guidance to enable compliance by manufacturers. This study found that some manufacturers of certain CE-marked medical devices are planning to remove them from the EU market upon expiration of their certificate, and in the case of new innovative devices, some manufacturers may launch in other non-EU markets.
本研究旨在调查由于新的医疗器械法规而加强对欧洲医疗器械制造商临床评估要求的影响。对来自8个不同欧洲国家的8名临床评价顾问进行了定性访谈,这些顾问负责在制造商向公告机构提交临床评价报告之前对其进行审查和批准。该研究描述了器械临床评估证据的来源,并描述了在审查临床评估报告时顾问的建议和遇到的挑战。这项研究的结果表明,理解什么是充分的临床证据,是编写耐多药依从性临床评估报告的最大挑战。此外,该研究还发现,在可接受的监管和临床数据的生成和评估方面存在知识和技能差距。此外,咨询师收到的临床评估报告的审查存在异质性,并且没有足够的指导使制造商能够遵守。本研究发现,某些带有ce标志的医疗器械的一些制造商正计划在其证书到期后将其从欧盟市场移除,而对于新的创新器械,一些制造商可能会在其他非欧盟市场推出。
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引用次数: 0
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Cogent Engineering
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