Field Of Medical Devices Research Articles

Preparation and characterisation of IPMC brakes modified with composite electrodes performance

Ionic Polymer Metal Composite (IPMC) can be used as flexible actuators and sensors in the fields of bionic machinery and medical devices. However, IPMC still suffer from poor actuation performance and high cost of electrode preparation in practical applications. Optimisation of electrodes and use of novel assembly processes are expected to solve these problems. In this paper, low-dimensional nanocarbon materials were used to modify the Nafion membrane. Appropriate amounts of carbon nanotubes and carbon black were weighed and dispersed in chitosan and acetic acid to form a stable electrolyte. A new IPMC was prepared by bonding carbon nanotube and carbon black films on the Nafion membrane using the hot pressing method. Scanning electron microscope images showed that the hybrid films composed of carbon nanotubes and carbon black were successfully hot pressed onto the surface of the Nafion membrane and the hybrid electrode layer composed of carbon nanotubes and carbon black was more homogeneous and densely packed. The results of driving performance tests show that the hybrid electrode-modified IPMC has excellent driving performance, with a maximum output displacement of 9.2 mm and a maximum output force of 9.9 mN at a voltage of 5.0 V. These results are 1.07 and 1.14 times higher than those of the carbon nanotube IPMC and 1.74 and 1.70 times higher than those of the carbon black IPMC under the same conditions, respectively.

Smart Antibacterial Coatings with On‐Demand Drug Release and Real‐Time Monitoring

AbstractSmart antibacterial coatings with surface‐independent methods, on‐demand antibiotic release, and real‐time drug loading monitoring capabilities have attracted increasing interest in the fields of medical devices, antibiotics delivery platforms, and implantable devices. Addressing the complexity inherent in existing methods, this work innovates by simplifying the synthesis process and integrating aminoglycosides with metallosupramolecules to develop versatile and effective coatings. These coatings not only exhibit exceptional biological activity and efficient antibacterial properties both in vitro and in vivo, but also enable high drug loading and controlled release. Significantly, their application across various devices has demonstrated profound therapeutic effects in treating implant infections and promoting bacterial wound healing. A key advancement of these coatings is the integration of color‐changing indicators for real‐time monitoring of drug levels, enhancing the precision of wound care, and facilitating timely clinical interventions. This research marks a significant stride in the development of more accessible, bioactive, and smart antibacterial materials, opening new avenues in the field of smart medical coatings.

Limitations of NHIC claim code-based surveillance and the necessity of UDI implementation in Korea

The E-Health Big Data Evidence Innovation Network (FeederNet) in Korea, based on the observational medical outcomes partnership (OMOP) common data model (CDM), had 72.3% participation from tertiary hospitals handling severe diseases as of October 2022. While this contributes to the activation of multi-institutional research, concerns about the comprehensiveness of device data persist due to the adoption of national health insurance corporation (NHIC) claim codes as device identifiers in the medical device field. This study critically evaluated the effectiveness and compatibility of NHIC claim codes and unique device identifier (UDI) within FeederNet to identify the optimal identifier for efficient Post-market surveillance (PMS). Specifically, this study addressed three main questions: (1) the number of UDIs classified as NHIC-covered items, (2) the number of UDIs included in each NHIC claim code, and (3) the number of NHIC claim codes each UDI covers. Among the 1,979,655 UDIs registered domestically, only 36.02% (712,983) were classified as covered by National Health Insurance. NHIC-covered medical devices were limited to categories (A) medical devices, (B) medical supplies, and (C) dental materials, excluding most software and in vitro diagnostics (IVD). Multiple UDIs could be registered under a single NHIC claim code, and a single UDI could be registered under multiple NHIC claim codes. Only 32.62% (13,756/42,171) of NHIC claim codes had registered UDIs, with an average of 53 UDIs per claim code. Of the UDIs listed as NHIC covered, 92.39% (659,046/713,341) had one claim code, while 7.25% (51,652) had multiple claim codes. Additionally, 2643 UDIs were listed as NHIC covered but had no registered claim codes. Due to this complex relationship, NHIC claim code-based PMS may pool safe and unsafe models or disperse problematic models across multiple claim codes, leading to a lower problem rate or insignificant differences between claim codes, thus reducing signal detection sensitivity compared to UDI-based PMS. In conclusion, NHIC claim code-based PMS has limitations in granularity and signal detection sensitivity, necessitating the adoption of UDI-based PMS to address these issues. The UDI system can enhance the accuracy of medical device identification and tracking, playing a crucial role in generating real-world evidence (RWE) by integrating data from various sources. Future research should explore specific strategies for integrating and utilizing UDI with NHIC claim codes, contributing to the implementation of a more reliable and comprehensive PMS in Korea’s healthcare system.

Application of Medical Implants for Public Health Monitoring and Treatment

The World Health Organisation (WHO) reports that diabetes affects roughly 180 million people worldwide and that cardiovascular illnesses account for nearly 30% of all fatalities worldwide. Applications involving radio frequency (RF) or microwave technology are crucial to medical diagnosis and illness prevention. The most recent developments in the field of implantable medical devices (IMDs), such as biomedical telemetry, allow biosignals to be monitored remotely via wireless communication technology. Providing correct information to the external monitoring station is the primary function of the health maintenance monitoring scheme. Because wireless communication lessens the invasiveness of electromagnetic (EM) medical equipment, it is extremely helpful in improving patient comfort during treatment. The first swallowable pills with sensing capabilities and the introduction of pacemakers in the early 1960s both demonstrated the significance of implantable medical devices (IMDs), which enable disease monitoring and therapy. Using IMDs with wireless connection has allowed for the monitoring of both system performance and patient status. IMDs have been widely employed in healthcare systems to gather real-time signals from biosensors or preprocessed physiological bio-signals for early disease identification, improving treatment quality and promoting healthy living.

Polyvinyl alcohol-silk fibroin composite stents: A comprehensive investigation into biocompatibility and mechanical performance

Bioresorbable stents (BRS) are manufactured using biodegradable materials. As an alternative to those commonly used in commercial stents, this study explored the development of BRS using polyvinyl alcohol (PVA) and silk fibroin (SF). PVA is a promising material for the fabrication of BRS due to its biocompatibility and mechanical attributes, closely resembling those of aortic vessels. However, its application presents challenges in terms of cell adhesion and proliferation. SF has been extensively studied for its potential to enhance cell adhesion and proliferation, making it a promising biomaterial in the field of medical devices. SF was introduced by dissolving it in a PVA solution or by coating the hydrogel surface with a layer of SF. Initial tests revealed that overnight incubation of fetal bovine serum significantly increased cell viability in hydrogels. Viability assays confirmed that SF substantially improved cell viability compared to PVA alone. The method was extended to fabricate SF-coated stents, which demonstrated robust cell proliferation and improved performance compared to electrospun polycaprolactone scaffolds. In addition, the SF-coated stents displayed an increase in compressive strength, demonstrating improved biocompatibility and mechanical performance. Dynamic mechanical analysis evaluated the positive impact of SF on stent properties at physiological temperatures. The study revealed that PVA-SF stents offer a compromise between biocompatibility, mechanical strength, and elastic recovery, positioning them as a valuable alternative for cardiovascular stent applications. The dual benefits of enhanced biocompatibility and improved mechanical performance make SF-coated stents promising candidates for bioresorbable stent design.  

Removal mechanism of double-diamond-abrasive-grinding GaN single crystals under graphene lubrication

Gallium nitride (GaN) is an advanced material used to manufacture chip wafers and high-power devices. Recently, grinding processing, has been applied in the fields of machinery manufacturing, aerospace, and medical devices as a highly efficient machining method. An in-depth understanding of the material removal mechanism produced by the double-grinding processes can provide guidance for the design of GaN-based nanodevices. Herein, molecular dynamics simulations were used to investigate the mechanism of removal of double-diamond-abrasive-grinding gallium nitride crystals under graphene lubrication, and a systematic study was performed to investigate the involved surface morphology, grinding force, stress distribution, and subsurface damage behavior. Results reveal that graphene can substantially enhance the wear resistance of GaN substrates by reducing surface wear, atomic displacement., potential energy, and subsurface damage, thereby playing a protective role toward the substrate. As the grinding depth increases, the grinding force and subsurface damage depth also increase. Furthermore, the effects of abrasive grain spacing on subsurface damage depth and phase change atoms were analyzed and found to have limited influence on material removal efficiency. These results deepen our understanding of material removal and protection mechanisms relative to substrates resulting from double-grinding processes as well as offer valuable insights for the rational design of abrasive wheels.

Determining carrier frequency for implantable human body communication based on transmission efficiency–electromagnetic interference trade-off

This study proposes a novel methodology for determining the optimal carrier frequency for implantable human body communication (HBC) by focusing on the trade-off between transmission efficiency and electromagnetic interference (EMI) robustness. Traditional radio communication technologies use high-frequency bands, which pose some challenges, such as increased power consumption, EMI with other devices, and security risks. Implantable HBC is a promising alternative, wherein the human body is used as a transmission medium. Through phantom experiments simulating the human abdomen, we assess the transmission characteristics of implantable HBC between an abdominal neurostimulator and an external controller across a frequency range of 1–100 MHz. Results revealed that maximum transmission gain was achieved at 37.2 MHz. Moreover, rapid signal attenuation occurred beyond a minimal distance from the skin, indicating enhanced communication efficiency, reduced EMI, and enhanced information security. An evaluation index (EI) was also proposed to quantitatively assess the balance between transmission efficiency and EMI and determine an appropriate carrier frequency for specific implantable HBC applications. This study advances the field of implantable medical devices by optimizing communication performance while addressing key challenges in EMI and security.

Medical devices based on natural substances: Applications and perspectives

The growing interest in natural and biocompatible solutions has led to the development of medical devices based on natural bioactive substances offering safe and effective alternatives to synthetic products. This review examines the current state of research and technological advances in the field of medical devices based on plants and natural bioactive substances, focusing on their applications in wound healing and transdermal drug delivery. Wound-healing devices using plant extracts such as Centella asiatica and Curcuma longa are showing promising results in accelerating the repair of damaged tissue. In addition, transdermal delivery systems based on natural compounds enable controlled and targeted administration of active ingredients, increasing therapeutic efficacy while reducing side effects. The advantages of these devices include enhanced biocompatibility and biodegradability, as well as improved therapeutic efficacy. However, challenges remain, not least the regulatory aspect, especially with regard to the variability of natural compounds and the difficulties of standardisation. Ongoing research and rigorous clinical trials are needed to overcome these obstacles and maximise the clinical benefits of medical devices based on natural bioactive substances.

Research of upper limb tremor reduction with a vibrational medical device for Parkinson’s disease

Parkinson’s disease (PD) is a common neurodegenerative disease that manifests as a various movement disorders: tremor, rigidity and postural instability. These dysfunctions can significantly impact the individual’s quality of life, leading to a decline in overall well-being. However, recent innovations in medical devices field promise additional methods to alleviate PD symptoms. The VILIM Ball is a local hand-arm stimulation device that generates mechanical vibrations within the frequency range of 8–18 Hz. It was shown in this study that Parkinson’s disease patients (PD) may experience enhanced upper limb functionality and reduction in tremor power through physiotherapy in conjunction to therapy with VILIM Ball device. A total of 24 participants were recruited and divided into two groups: the control group (N= 12) underwent physiotherapy alone, while the experimental group (N= 12) received physiotherapy in combination with the VILIM Ball. Hand coordination, tremor power, and the right-hand grip strength before and after interventions were assessed to quantify the effects of the interventions. The right-hand tremor power decreased by an average of 7.38% for the control group and by an average of 48.11% for the experimental group. The left-hand tremor power increased by 3.89% for the control group and decreased by the 30.23% for the experimental group. There were no significant changes in the right-hand grip strength after the interventions. These findings indicate that the local hand-arm vibration provided by the VILIM Ball in conjunction to physiotherapy can benefit patients more than the physiotherapy alone.

Highly transparent and stretchable multi-layered capacitive film sensor with flexible dot and micro-pillar array for small pressure sensing

The research aim is to develop multilayered capacitive film pressure sensors with dot and micro-pillar array, having high transparency, sensitivity, and flexibility by utilizing polydimethylsiloxane (PDMS) and the conductive polymer, poly(3,4-ethylenedioxythiophene): poly (styrene sulfonate) (PEDOT: PSS)" as the primary components. The results reveal that the transmittance values of the multilayered capacitive film sensors with dot array vary with their thickness, achieving values of 76.39 %, 72.06 %, and 65.39 % at a center wavelength of 550 nm and demonstrating the effective capacitive sensing response in the pressure range of 0–750 kPa. Notably, the micro-pillar array multilayered capacitive film sensor shows high sensitivity of 0.025 kPa−1 in the pressure range of 0–100 kPa and a clear trend of capacitance change around 60 kPa. It achieves the highest sensitivity of 0.05 kPa−1 within the 0–10 kPa pressure range. The stability of the multilayered capacitive film sensor is examined by applying compressive forces of 0.5 N, 1.0 N, and 1.5 N in a suspended state, resulting in a maximum rate of change reaching 104.7 % compared to the initial capacitance value. Additionally, the multilayered capacitive film sensors demonstrate good stability under cyclic pressures of 0.5 N, 1.0 N, and 1.5 N. The novel multilayered capacitive film sensor offers specific promising potentials for various applications in the fields of wearable, medical devices, and human-machine interfaces.

Controlling the lifetime of biodegradable electronics: from dissolution kinetics to trigger acceleration

Biodegradable electronics have revolutionized the field of medical devices by offering inherent advantages such as natural disintegration after a useful functional period, thereby eliminating the need for removal surgery. This paradigm shift addresses challenges with long-term implantation, the risks of secondary surgeries, and potential complications, offering a safer and more patient-friendly approach to temporary implantable devices. This review delves into the dissolution kinetics of materials and strategies for lifetime control providing a comprehensive overview of recent advancements in biodegradable electronics. Understanding the kinetics is crucial for meeting the required functional lifetime for implantable medical applications, which varies based on application scope and target diseases. The dissolution kinetics of silicon and biodegradable metals form the core of the discussion, focusing on recent studies aimed at controlling the dissolution rate and enhancing properties. The exploration extends to ideas for accelerating material degradation or initiating on-demand degradation in biodegradable electronics after stable function. Additionally, the compilation of encapsulation layer materials and strategies enhances understanding of how to improve the stable operation time of devices. Emphasis is placed on efforts to adjust the lifetime of biodegradable electronics, particularly in medical applications.

Exploration of Application of Reliability Standard YY/T 1837-2022 in Development of Active Implantable Medical Devices

In the field of medical devices, there has been a long-term lack of a general technical requirements framework for reliability that can be applied in the development of high-risk active implantable medical devices. This study combines the requirements of YY/T 1837-2022 to comprehensively explain and explore the requirements for reliability work that can be performed at each stage of development of active implantable medical device products, and provides a reference for product reliability work in the industry.

A Novel Low-Cost Capacitance Sensor Solution for Real-Time Bubble Monitoring in Medical Infusion Devices

In the present day, IoT technology is widely applied in the field of medical devices to facilitate real-time monitoring and management by medical staff, thereby better-ensuring patient safety. In IoT intravenous infusion monitoring sensors, it is particularly important to ensure that air bubbles are not infused into the patient’s body. The most common method for bubble detection during intravenous infusions is the use of infrared or laser sensors, which can usually meet design requirements at a relatively low cost. Another method is the use of ultrasonic detection of bubbles, which achieves high accuracy but has not been widely promoted in the market due to higher costs. This proposed work introduces a new type of sensor that detects bubbles by monitoring changes in capacitance between two electrodes installed at the surface of the infusion pipe. If this sensor is deployed on the ESP32 platform, which is widely used in embedded IoT devices, it can achieve 35 μL bubble detection precision with an average power consumption of 5.18 mW and a mass production cost of $0.022. Although the precision of this sensor is significantly lower than the low-cost IR bubble sensor, it still satisfies the design requirement of the IV infusion IoT sensor.

Nanotechnology in development of next generation of stent and related medical devices: Current and future aspects.

Coronary stents have saved millions of lives in the last three decades by treating atherosclerosis especially, by preventing plaque protrusion and subsequent aneurysms. They attenuate the vascular SMC proliferation and promote reconstruction of the endothelial bed to ensure superior revascularization. With the evolution of modern stent types, nanotechnology has become an integral part of stent technology. Nanocoating and nanosurface fabrication on metallic and polymeric stents have improved their drug loading capacity as well as other mechanical, physico-chemical, and biological properties. Nanofeatures can mimic the natural nanofeatures of vascular tissue and control drug-delivery. This review will highlight the role of nanotechnology in addressing the challenges of coronary stents and the recent advancements in the field of related medical devices. Different generations of stents carrying nanoparticle-based formulations like liposomes, lipid-polymer hybrid NPs, polymeric micelles, and dendrimers are discussed highlighting their roles in local drug delivery and anti-restenotic properties. Drug nanoparticles like Paclitaxel embedded in metal stents are discussed as a feature of first-generation drug-eluting stents. Customized precision stents ensure safe delivery of nanoparticle-mediated genes or concerted transfer of gene, drug, and/or bioactive molecules like antibodies, gene mimics via nanofabricated stents. Nanotechnology can aid such therapies for drug delivery successfully due to its easy scale-up possibilities. However, limitations of this technology such as their potential cytotoxic effects associated with nanoparticle delivery that can trigger hypersensitivity reactions have also been discussed in this review. This article is categorized under: Implantable Materials and Surgical Technologies > Nanotechnology in Tissue Repair and Replacement Therapeutic Approaches and Drug Discovery > Nanomedicine for Cardiovascular Disease Therapeutic Approaches and Drug Discovery > Emerging Technologies.

3D porous structure imaging of membranes for medical devices using scanning probe microscopy and electron microscopy: from membrane science points of view.

The evolution of hemodialysis membranes (dialyzer, artificial kidney) was remarkable, since Dow Chemical began manufacturing hollow fiber hemodialyzers in 1968, especially because it involved industrial chemistry, including polymer synthesis and membrane manufacturing process. The development of hemodialysis membranes has brought about the field of medical devices as a major industry. In addition to conventional electron microscopy, scanning probe microscopy (SPM), represented by atomic force microscopy (AFM), has been used in membrane science research on porous membranes for hemodialysis, and membrane science contributes greatly to the hemodialyzer industry. Practical studies of membrane porous structure-function relationship have evolved, and methods for analyzing membrane cross-sectional morphology were developed, such as the ion milling method, which was capable of cutting membrane cross sections on the order of molecular size to obtain smooth surface structures. Recently, following the global pandemic of SARS-CoV-2 infection, many studies on new membranes for extracorporeal membrane oxygenator have been promptly reported, which also utilize membrane science researches. Membrane science is playing a prominent role in membrane-based technologies such as separation and fabrication, for hemodialysis, membrane oxygenator, lithium ion battery separators, lithium recycling, and seawater desalination. These practical studies contribute to the global medical devices industry.

Formation of a Controllable Diffusion Barrier Layer on the Surface of Polydimethylsiloxane Films by Infrared Laser Irradiation.

Developing a diffusion barrier layer on material interfaces has potential applications in various fields such as in packaging materials, pharmaceuticals, chemical filtration, microelectronics, and medical devices. Although numerous physical and chemical methods have been proposed to generate the diffusion barrier layer, the complexity of fabrication techniques and the high manufacturing costs limit their practical utility. Here, we propose an innovative approach to fabricate the diffusion barrier layer by irradiating poly(dimethylsiloxane) (PDMS) with a mid-infrared (λ = 10.6 μm) CO2 laser. This process directly creates a diffusion barrier layer on the PDMS surface by forming a heavily cross-linked network in the polymer matrix. The optimal irradiation conditions were investigated by modulating the defocusing distance, laser power, and number of scanning passes. The barrier thickness can reach up to 70 μm as observed by the scanning electron microscope (SEM). The attenuated total reflectance (ATR), electron dispersive X-ray (EDX), and X-ray photoelectron spectroscopy (XPS) analyses collectively confirmed the formation of the SiOx structure on the modified surface based on the decreased methyl group signal and the increased oxygen/silicon ratio. The diffusion test with the model drugs (rhodamine B and donepezil) demonstrated that the modified surface exhibits effective diffusion barrier properties and the rate of drug diffusion through the modified barrier layer can be controlled by the optimization of the irradiation parameters. This novel approach provides the possibility to develop a controllable diffusion barrier layer in a biocompatible polymer with prospective applications in the fields of pharmaceuticals, packing materials, and medical devices.

Hydrogel coatings on universal medical devices with water-responsive Janus adhesion and acidity-triggered transformation for adaptive antibacterial treatment and fluorescence diagnosis

Hydrogel coatings of catheters have attracted extensive attention in the field of medical devices due to its hydrophilicity and softness, while scarcities of Janus adhesion, adaptive antibacterial property, and real-time disease monitoring restricted their clinical translational applications. Herein, a novel hydrogel coating with water-responsive Janus adhesion and acidity-triggered transformation was fabricated for antibacterial treatment and fluorescence diagnosis of catheters-associated infections. First, a sufficient adhesion strength of 44.6 ± 1.9 kPa effectively prevented shedding of the hydrogel coating during catheterization, and meanwhile a super-lubricated layer with an extremely-low coefficient of friction of about 0.03 was formed to reduce friction pain in an aqueous microenvironment. Furthermore, size and fluorescence intensity of chitosan/bovine serum albumin-gold nanoparticles within the hydrogel were varied with pH due to acidity-triggered transformation, where an adaptive release of antibacterial nanoparticles was achieved to reduce biofilms formation and alleviate inflammation degree synergistically. More importantly, such antibacterial treatment was monitored in real-time dependent on an on–off variation of fluorescence intensity. Overall, amounts of in-vitro and in-vivo results performed in rabbit urinary tract infection model and porcine tracheal intubation model fully suggested our newly-synthesized hydrogel coating on universal medical devices showed a promising potential for integrated diagnosis and treatment of catheters-associated infections.

Biobased, self-healing, and recyclable polyurethane derived hydrogel-elastomer hybrids for efficient lubrication

Developing biobased hydrogel-elastomer hybrids with stable lubrication derived from self-healing and recyclable polymer matrix poses a key challenge in the field of medical devices. Herein, we reported a novel hydrogel-elastomer hybrid incorporating a tung oil (TO)-based, self-healing, and recyclable polyurethane (PU) substrate that exhibits exceptional hydrophilic and lubricating properties. Initially, a series of UV-curable PU elastomers containing dynamic hindered urea bonds (HUBs) derived from renewable TO were prepared. By adjusting the ratios of the cross-linking agent TO-based polyol and the chain-extending agent polytetramethyleneglycol, the mechanical and thermal properties of these elastomers could be tuned well. The as-prepared PU elastomers demonstrated remarkable dynamic properties, attributed to the dissociation and recombination of HUBs, enabling efficient self-healing and effective recycling through solvent or hot-pressing methods while preserving their mechanical properties. Furthermore, functional hydrogel-elastomer hybrids were obtained by applying UV-initiated polymerization method to generate hydrogel coatings onto the optimized PU elastomer surface. Compared to the pristine PU material, the resulting hydrogel-elastomer hybrids exhibited excellent lubricity in aqueous environments, resulting from the formation of a robust hydration layer facilitated by electrostatic forces. Overall, our current research work provides key design inspiration for developing next-generation medical devices from sustainable and recyclable functional biomaterials.

Feasibility and mechanism of atmospheric pressure cold plasma jet (APCPJ) assisted micro-milling of bulk metallic glasses (BMGs)

The unique microstructures of bulk metallic glasses (BMGs) provide them with excellent mechanical, physical, and chemical properties, having important applications in the fields of medical devices, military equipment, aerospace, etc. However, the superb mechanical properties also contribute to poor machinability of the BMGs. Currently, researchers have proposed to improve the machinability by single-point diamond turning, laser-assisted machining and ultrasonic vibration-assisted machining, but their plasticity and viscous flow remain unchanged, thus restraining further enhancement of surface quality. Atmospheric pressure cold plasma jet (APCPJ), which is rich in active particles, can effectively ameliorate material machinability by modulating material properties. In this paper, we propose to use the APCPJ to regulate the properties of BMGs, and carry out nanoindentation, nanoscratching, and micro-milling experiments to investigate the influence mechanisms of APCPJ on the material properties and cutting process. The results demonstrate that after modified by APCPJ, plastic deformability of the BMGs is improved due to the increase of free volume content; meanwhile, the viscous flow is inhibited. The micro-milling experiments indicate that under the conditions of feed rate Vf = 500 μm/s, spindle speed n = 30,000 rpm, and cutting depth ap = 5 μm, the improvement effect of APCPJ on the cutting process is relatively optimum. The surface roughness Ra of the Zr-based BMG and Ti-based BMG obtained by APCPJ are respectively 0.076 μm and 0.081 μm, which can be reduced by 37.7 % and 38.2 % compared with dry micro-milling. The cutting forces Fz in the direction of cutting depth are also reduced by 30.9 % and 23.3 %, respectively. The APCPJ-assisted micro-milling method proposed in this work may ameliorate the machining quality of BMGs and promote the application of BMGs and APCPJ-assisted machining technology in aerospace and precision machining.

Оценка биологической безопасности медицинских изделий (аналитический обзор)

The main goal of the article is to familiarize specialists working in the field of medical devices (MD) with existing approaches to the study of their biocompatibility, set out in the standards of the GOST ISO 10993 series. The concept of the GOST ISO 10993 series of standards is to establish the biological safety and functional effectiveness of MD in the terms of biological risk, as necessary and sufficient conditions for biocompatibility of MD in the clinical application. The main attention in the general scheme of assessing the biological safety of MD is paid to the program of toxicological studies (tests), consisting of a set of methods that take into account the category, purpose and duration of MD functioning.