37 results match your criteria: "Beijing Institute of Medical Device Testing[Affiliation]"

Wnt/β-catenin is a signaling pathway associated with embryonic development, organ formation, cancer, and fibrosis. Its activation can repair kidney damage during acute kidney injury (AKI) and accelerate the occurrence of renal fibrosis after chronic kidney disease (CKD). Interestingly, p53 has also been found as a key modulator in AKI and CKD in recent years.

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Background: The fracture of bone plate can cause considerable pain for the patient and increase the burden on the public finances. This study aims to explore the failure mechanism of 49 plates retrieved from revision surgery and introduce pure magnesium (Mg) block to improve the biomechanical performance of the plate via decreasing the stiffness and to stimulate the biological response of the plate potentially by the degradation of Mg block.

Methods: The morphological analysis and component analysis of the plates were conducted to determine the fracture reason of the plates combining the clinical data.

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Objective: The purpose of this study is to compare the wear properties of UHMWPE acetabular liners after undergoing 3 million (3 Mc) and 5 million (5 Mc) cycles of wear testing. The results will serve as a reference for the design of testing for hip prostheses and as a control for clinical revision removals.

Methods: Wear tests were conducted on three different sizes of acetabular liners (28 mm, 32 mm, and 36 mm internal diameters) using a hip simulator to determine the amount of wear after 3 and 5 million cycles.

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[Application of Digital Galvanometer Scanner System for CO Fractional Laser Safety Improvement].

Zhongguo Yi Liao Qi Xie Za Zhi

May 2024

Beijing Hanhua Universal Technology Development Co., Ltd., Beijing, 101399.

An analog PID controller-based galvanometer scanner is widely used by fractional laser medical equipment (FLME) to scan lasers across tissue surfaces, achieving the desired therapeutic effect. This type of driver, primarily composed of passive components and operational amplifiers, can only accept commands from the central controller of the FLME, with a simple hardware circuit-based fault diagnosis; thus, the safety of the FLME is compromised. To address these issues, the failure mechanisms of galvanometers and their impact on the safety of FLME are thoroughly analyzed first.

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This article briefly describes the imaging performance standards of the kilovolt X-ray image guidance system used in radiotherapy, analyzes the main aspects that should be considered in the image quality of X-IGRT system, and focuses on parameters that should be considered in the imaging performance evaluation criteria of the CBCT X-IGRT. The purpose is to sort out the imaging performance evaluation standards of kilovolt X-IGRT system, clarify the image quality requirements of X-IGRT equipment, and reach a consensus when evaluating the imaging performance of X-IGRT system.

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In order to evaluate the reliability of the ID ICP-MS method for the measurement of magnesium, zinc, and copper in human serum, we investigated the traceability, precision, trueness, and uncertainty of the method. This method traces the contents of magnesium, zinc, and copper in human serum to the standard materials NIST SRM3131a, SRM3168a, and SRM3114 respectively, thus completing the traceability to SI unit. The repeatability of this method for measuring magnesium, zinc, and copper in the human serum reference material GBW09152 was found to be 0.

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Nickel nanoparticles (NiNPs) have wide applications in industry and biomedicine due to their unique characteristics. The liver is the major organ responsible for nutrient metabolism, exogenous substance detoxification and biotransformation of medicines containing nanoparticles. Hence, it is urgent to further understand the principles and potential mechanisms of hepatic effects on NiNPs administration.

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Biomechanical effects of the medial meniscus horizontal tear and the resection strategy on the rabbit knee joint under resting state: finite element analysis.

Front Bioeng Biotechnol

June 2023

Key Laboratory for Biomechanics and Mechanobiology of Ministry of Education, Beijing Advanced Innovation Center for Biomedical Engineering, School of Biological Science and Medical Engineering, Beihang University, Beijing, China.

The biomechanical changes following meniscal tears and surgery could lead to or accelerate the occurrence of osteoarthritis. The aim of this study was to investigate the biomechanical effects of horizontal meniscal tears and different resection strategies on a rabbit knee joint by finite element analysis and to provide reference for animal experiments and clinical research. Magnetic resonance images of a male rabbit knee joint were used to establish a finite element model with intact menisci under resting state.

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Article Synopsis
  • - The study examines the requirements for clinical trials specifically related to SARS-CoV-2 antigen testing, aiming to assess the scientific validity of these trials.
  • - A comparison of guidelines for listing these tests was conducted across China, the USA, and Europe, highlighting both similarities and differences in their clinical trial requirements.
  • - While methods for clinical trials were consistent across the regions, variations were noted in protocol design due to differing regulations and local conditions, with a common goal of ensuring the reliability of clinical product performance.
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PEG-GNPs aggravate MCD-induced steatohepatitic injury and liver fibrosis in mice through excessive lipid accumulation-mediated hepatic inflammatory damage.

NanoImpact

July 2023

CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, Institute of High Energy Physics, Chinese Academy of Sciences (CAS), Beijing 100049, China. Electronic address:

Rapid development of gold nanoparticles (GNPs) in delivering pharmaceutics and therapeutics approaches still linger the concerns of their toxic effects. Nonalcoholic steatohepatitis (NASH) is characterized by excessive lipid accumulation and overt hepatic inflammatory damage, and is the leading cause of chronic liver disease worldwide. This study aimed to assess the potential hepatic effects of GNPs on NASH phenotype and progression in mice.

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Mass spectrometry technology is becoming an important tool for clinical analysis due to its high specificity, high sensitivity and high multi-component detection capability. The current applications of this technology are mainly in liquid chromatography-tandem mass spectrometry (LC-MS/MS), matrix-assisted laser desorptionionization time-of-flight mass spectrometry (MALDI-TOF-MS), inductively coupled plasma mass spectrometry (ICP-MS), gas chromatography-mass spectrometry (GC-MS) and the related in vitro diagnostic kits. At present, the number of medical device (MD) based on mass spectrometry technology is growing rapidly, especially the number of LC-MS/MS and MALDI-TOF-MS registered MD products, and the standardization of relevant product quality requirements is also being effectively carried out.

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The wear of the tibial insert is one of the primary factors leading to the failure of total knee arthroplasty. As materials age, their wear performance often degrades. Supplementing highly cross-linked polyethylene (HXLPE) with dodecyl gallate (DG) can improve the oxidation stability of tibial inserts for use in total knee arthroplasty (TKA).

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Objective: The debate on the superiority of single- or double-bundle for anterior cruciate ligament reconstruction has not ceased. The comparative studies on intra-articular biomechanics after different surgical reconstructions are rare. This study is to evaluate the biomechanical stress distribution intra-knee after single- and double-bundle anterior cruciate ligament reconstruction by three-dimensional finite element analysis, and to observe the change of stress concentration under the condition of vertical gradient loads.

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This study introduced the current testing content and standards of ECG medical electronic instruments, combined with actual clinical needs, and discussed the comprehensive verification and evaluation protocol for ECG medical electronic instruments. The protocol mainly includes hardware performance testing, automatic diagnostic function testing and clinical application evaluation. The protocol emphasizes the clinical practicality and importance of the comprehensive verification and evaluation program, and provides a reference for the institutions involved in the program.

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Objective: Myofiber necrosis is a significant pathologic characteristic of idiopathic inflammatory myopathies (IIMs), and its molecular mechanism is largely unknown. Necroptosis is a recently identified form of regulated necrotic cell death, and its activation might have crucial biologic consequences. The aim of the present study was to investigate the role of necroptosis in IIM muscle damage.

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Comparative study of plasma clearance of iohexol at different injection doses.

Clin Chim Acta

January 2022

Department of Clinical Laboratory, Civil Aviation General Hospital, Beijing, China; Peking University Civil Aviation School of Clinical Medicine, Beijing, China. Electronic address:

Background: Our goal was to compare the metabolic curves of plasma clearance of iohexol (Cl) at standard dose (5 ml) and contrast-level dose (50 ml).

Methods: The concentration of iohexol was measured at fasting state and at nine different time periods after a single bolus of iohexol injection. The interval between the injection of the two doses was longer than 24 hrs.

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High-Accuracy Determination of Potassium and Selenium in Human Serum by Two-Step Isotope Dilution ICPMS.

J Anal Methods Chem

November 2021

Beijing Institute of Medical Device Testing, Beijing Key Laboratory of Medical Device Testing and Safety Evaluation, Beijing 101111, China.

A high-accuracy measurement technique for determining potassium and selenium in human serum was developed by using two-step Isotope Dilution Inductively Coupled Plasma-Mass Spectrometry (ICPMS) in this research. A more accessible method of the quadrupole ICPMS was employed in this research to achieve an equally high accuracy which had been achieved by a much more expensive method, namely, high-resolution sector field ICPMS (SF-ICPMS), with a comparatively easy and simple operation. In addition, we have evaluated the uncertainty of this method.

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The coronavirus disease 2019 (COVID-19) pandemic has caused a surge in demand for face masks, with the massive consumption of masks leading to an increase in resource-related and environmental concerns. In this work, we fabricated meltblown polypropylene (mb-PP)-based high-performance planar face masks and investigated the effects of six commonly used disinfection methods and various mask-wearing periods on the reusability of these masks. The results show that, after three cycles of treatment using hot water at 70 °C for 30 min, which is one of the most scalable, user-friendly methods for viral disinfection, the particle filtration efficiency (PFE) of the mask remained almost unchanged.

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In this research, the anti-cancer activity of the Populus euphratica extract was evaluated with Cell Counting Kit-8 (CCK-8) assay. The inhibitory activity of the Populus euphratica extract on the activation levels of VEGF signaling pathway in the cancer cells was measured with real time RT-PCR. Next, the high-throughput Illumina pair-end sequencing was performed to detect the chloroplast (cp) genome of Populus euphratica for genome evolution assessment.

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In Vitro Analysis of Wearing of Hip Joint Prostheses Composed of Different Contact Materials.

Materials (Basel)

July 2021

School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China.

Cobalt-chromium-molybdenum alloy (CoCrMo) and ceramic are the two most common materials for the femoral head in hip joint prostheses, and the acetabular liner is typically made from ultra-high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (XLPE), or highly cross-linked polyethylene blended with Vitamin E (VEXLPE). The selection of suitable materials should consider both wear performance and cost-effectiveness. This study compared the wear rate between different friction pairs using a hip joint simulator and then recommended a suitable prosthesis based on the corresponding processing technology and cost.

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Wear Assessment of Tibial Inserts Made of Highly Cross-Linked Polyethylene Supplemented with Dodecyl Gallate in the Total Knee Arthroplasty.

Polymers (Basel)

June 2021

Beijing Advanced Innovation Centre for Biomedical Engineering, School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China.

Background: the wear of tibial insert is still one of primary factors leading to failure of total knee arthroplasty (TKA). Dodecyl gallate (DG) has shown improvements in the oxidation stability of highly cross-linked polyethylene (HXLPE). This study aimed to assess the application of HXLPE supplemented with DG (HXLPE-DG) on the tibial insert in TKA concerning the wear resistance and the potential impact on implant fixation; Methods: tibial inserts made of HXLPE-DG were subjected to a 3 million loading-cycle wear test following ISO 14243-1:2009.

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Background: Tumor mutational burden (TMB) is a promising biomarker for stratifying patient subpopulation who would benefit from immune checkpoint blockade (ICB) therapies. Although great efforts have been made for standardizing TMB measurement, mutation calling and TMB quantification can be challenging in samples with low tumor content including liquid biopsies. The effect of varying tumor content on TMB estimation by different assay methods has never been systematically investigated.

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High-quality interpretation of variants plays a critical role in the clinical practice of precision medicine. However, a comprehensive system to evaluate the quality and accuracy of variant interpretation has yet to be established. This study investigates the performance of an interpretation system in evaluating the capacities of interpretation among distinct laboratories in China.

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The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.

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Masks have become one of the most indispensable pieces of personal protective equipment and are important strategic products during the coronavirus disease 2019 (COVID-19) pandemic. Due to the huge mask demand-supply gap all over the world, the development of user-friendly technologies and methods is urgently needed to effectively extend the service time of masks. In this article, we report a very simple approach for the decontamination of masks for multiple reuse during the COVID-19 pandemic.

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