中国医疗器械杂志最新文献

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[Determination of Acetate Content in Hemodialysis Solutions and Dialysis Concentrates by HPLC]. [HPLC法测定血液透析液和透析浓缩液中醋酸盐含量]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240718
Huadong Wang, Yue Wang, Dong Liu, Xianghui Liu
{"title":"[Determination of Acetate Content in Hemodialysis Solutions and Dialysis Concentrates by HPLC].","authors":"Huadong Wang, Yue Wang, Dong Liu, Xianghui Liu","doi":"10.12455/j.issn.1671-7104.240718","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240718","url":null,"abstract":"<p><p>This study establishes a high-performance liquid chromatography (HPLC) method for the determination of acetate content in hemodialysis solutions and dialysis concentrates. In this study, Synergi Polar-RP column is utilized. Phosphate buffered saline (50 mmol/L, pH=2.5) is used as a mobile phase. The flow rate is 1.0 mL/min. The wavelength of detection is 212 nm. Results show that the linear relationship of acetate is good in the range of 0.1~20 mmol/L, <i>r</i> =0.999 9 and the spike recoveries are from 98.9%~99.5%, RSD<0.5% ( <i>n</i>=3). This method can easily and accurately determine the acetate content in hemodialysis solutions and dialysis concentrates, and can be applied to quality control in the production and use of such products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"350-354"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. [典型类Ⅱ伤口敷料产品全生命周期监管的研究与探讨]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240550
Lan Zhang, Ye Zeng, Xin Xie, Jiaohui Bao, Xiaohe Yang, Weiming Qi
{"title":"[Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products].","authors":"Lan Zhang, Ye Zeng, Xin Xie, Jiaohui Bao, Xiaohe Yang, Weiming Qi","doi":"10.12455/j.issn.1671-7104.240550","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240550","url":null,"abstract":"<p><p>In this study, the pre-market regulatory requirements for typical Class Ⅱ wound dressings, as well as the status of testing and post-market adverse events monitoring, were reviewed from the perspective of the whole lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on Class Ⅰ and Ⅱ liquid and paste dressing products. Furthermore, this study analyzed the issues in the registration and application of typical Class Ⅱ wound dressings and provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"344-349"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Review of Leachable Substances in Prefilled Syringes]. [预充式注射器中可浸出物质综述]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240353
Shuhan Wang, Senju Ma, Jun Peng, Linnan Ke, Yuanli Huang
{"title":"[Review of Leachable Substances in Prefilled Syringes].","authors":"Shuhan Wang, Senju Ma, Jun Peng, Linnan Ke, Yuanli Huang","doi":"10.12455/j.issn.1671-7104.240353","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240353","url":null,"abstract":"<p><p>As a new type of high-risk packaging container, prefilled syringes are more widely used, and concerns regarding their effectiveness, stability and safety in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to humans in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringe products, but also contributes to the healthy development of the industry.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"280-286"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Research Progress on Application of Intelligent Operation and Maintenance Models in Medical Equipment Management]. [智能运维模型在医疗设备管理中的应用研究进展]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240561
Jin Li, Xiu Xu, Jing Tong, Wei Jin, Chenge Wang, Ruiyao Jiang
{"title":"[Research Progress on Application of Intelligent Operation and Maintenance Models in Medical Equipment Management].","authors":"Jin Li, Xiu Xu, Jing Tong, Wei Jin, Chenge Wang, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.240561","DOIUrl":"10.12455/j.issn.1671-7104.240561","url":null,"abstract":"<p><p>Medical equipment management plays a crucial role in enhancing the quality and efficiency of healthcare services. However, traditional management approaches are increasingly inadequate to meet the growing demands of modern healthcare. As intelligent operation and maintenance (O&M) models based on big data, the Internet of Things (IoT), and artificial intelligence (AI) technologies develop, it is imperative to explore their application in medical equipment management. This paper reviews the technical overview of intelligent O&M and discusses the algorithms and challenges of intelligent O&M models based on different technologies. It also proposes issues that need improvement in intelligent O&M models, aiming to provide valuable references for the future development of medical equipment management.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"250-254"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Comparative Study of Seven New Dressings in Promoting Chronic Wound Healing in db/db Mice]. 7种新型敷料促进db/db小鼠慢性创面愈合的比较研究
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240693
Qiuyun Feng, Jia Ke, Danning Qi, Lei Zhou, Haiguang Chai
{"title":"[Comparative Study of Seven New Dressings in Promoting Chronic Wound Healing in db/db Mice].","authors":"Qiuyun Feng, Jia Ke, Danning Qi, Lei Zhou, Haiguang Chai","doi":"10.12455/j.issn.1671-7104.240693","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240693","url":null,"abstract":"<p><p>This study evaluated the healing-promoting effect and applicability of seven new dressings in chronic wounds. A chronic wound model was established using 48 db/db diabetic mice, which were randomly divided into 8 groups (control, polymer film, alginate, foam, hydrocolloid, hydrogel, carbon fiber, and silver dressing groups). Regular monitoring was conducted on the 5, 10, 15, and 20 days after surgery, and a comprehensive evaluation was performed based on healing rate, characteristic of histopathology, and semi-quantitative scoring. The results showed that, except for the polymer film dressing group, all other dressing groups had significantly better healing-promoting effect than the control group ( <i>P</i><0.05), with the hydrocolloid, carbon fiber, and silver dressing groups demonstrated particularly outstanding efficacy. This study systematically compared the efficacy differences of seven dressings, and combined them with the adhesion, exudate volume and infection risks to provide a scientific basis for clinical dressing selection.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"295-301"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Research on MRI Gradient Coil Magnetic Field Induced Eddy Current Method]. 磁共振梯度线圈磁场感应涡流法的研究
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240596
Xiaotao Zhang, Yicheng Li, Zhanping Zheng, Mingke Wang, Like Feng, Congbo Li
{"title":"[Research on MRI Gradient Coil Magnetic Field Induced Eddy Current Method].","authors":"Xiaotao Zhang, Yicheng Li, Zhanping Zheng, Mingke Wang, Like Feng, Congbo Li","doi":"10.12455/j.issn.1671-7104.240596","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240596","url":null,"abstract":"<p><p>After the production of the gradient coil of the magnetic resonance imaging system, electromagnetic field testing is required to verify whether the assembly accuracy meets the electromagnetic field requirements. Since the passive magnetic field <i><b>B</b> <sub>z</sub></i> satisfies the Laplace <sup>,</sup>s equation and is a harmonic function, and according to the extreme value principle of harmonic function, the maximum or minimum values of <i><b>B</b> <sub>z</sub></i> can only appear on the boundaries, so the observation points of the magnetic field are generally selected on the surface of the spherical imaging area. For superconducting magnets used for human body magnetic resonance imaging, a spherical area with a center diameter of 40~50 cm is generally selected as the shimming target area. Only the field value of the target area needs to be measured, and the spherical harmonic coefficients obtained after data processing are used to determine the magnetic field performance of the gradient coil. There are many testing principles and methods for electromagnetic fields, so there is no unified way and method in the field of commercial applications. This article is based on the Gauss-Legendre numerical integration, measures and analyzes the magnetic field performance of gradient coils by building a data acquisition system, and this article applies numerical analysis methods to calculate the spherical harmonic coefficients of the magnetic field using discrete test data, providing a feasible method for the production and testing of gradient coils.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"263-268"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument]. [液滴数字PCR仪性能评价关键方面]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240426
Wen Bao
{"title":"[Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument].","authors":"Wen Bao","doi":"10.12455/j.issn.1671-7104.240426","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240426","url":null,"abstract":"<p><p>From the perspective of performance evaluation, this paper describes briefly the concerns of study on each component module and the entire instrument, clinical items, software, and product testing on droplet digital PCR instruments, including the study methods and quality control requirements. The increase of the research and development efficiency of products and contribute to the promotion of application of digital PCR instruments in clinical laboratories are expected.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"340-343"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Research on Classification of Medical Devices with Nanomaterials]. 纳米材料医疗器械分类研究
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240600
Qian Dong, Li Yi, Liyin Wen, Rui Liu, Jinglong Tang, Jiong Zhu
{"title":"[Research on Classification of Medical Devices with Nanomaterials].","authors":"Qian Dong, Li Yi, Liyin Wen, Rui Liu, Jinglong Tang, Jiong Zhu","doi":"10.12455/j.issn.1671-7104.240600","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240600","url":null,"abstract":"<p><p>The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"336-339"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Review on Applications of Deep Learning in Digital Pathological Images]. [深度学习在数字病理图像中的应用综述]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240499
Chaoyi Lyu, Yuan Xie, Lu Qiu, Lu Zhao, Jun Zhao
{"title":"[Review on Applications of Deep Learning in Digital Pathological Images].","authors":"Chaoyi Lyu, Yuan Xie, Lu Qiu, Lu Zhao, Jun Zhao","doi":"10.12455/j.issn.1671-7104.240499","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240499","url":null,"abstract":"<p><p>Computer-assisted methods for pathological image analysis can improve doctor's efficiency of image reading and diagnostic accuracy, effectively addressing the shortage of pathology diagnostic manpower. With the rapid development of artificial intelligence and digital pathology, deep learning technology has spurred a wealth of research in the field of histopathology. This article reviews the various applications of deep learning in digital pathological image analysis, such as pathological image segmentation, cancer auxiliary diagnosis, and cancer prognosis prediction, and discusses the challenges and solutions in its application. Furthermore, it predicts future trends in deep learning for pathological image analysis and proposes potential research directions.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"237-243"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Quantitative Study on Morphological Parameters of Healthy Cervical Spinal Cord Based on SCT]. 基于SCT的健康颈脊髓形态学参数定量研究
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240337
Wei Jin, Hao Liu, Ruiyao Jiang, Guangqi Liu
{"title":"[Quantitative Study on Morphological Parameters of Healthy Cervical Spinal Cord Based on SCT].","authors":"Wei Jin, Hao Liu, Ruiyao Jiang, Guangqi Liu","doi":"10.12455/j.issn.1671-7104.240337","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240337","url":null,"abstract":"<p><strong>Objective: </strong>To utilize Spinal Cord Toolbox (SCT) to measure the morphological parameters of healthy cervical spinal cords and explore the impact of gender, age and vertebral levels on them.</p><p><strong>Methods: </strong>A retrospective study was conducted, collecting cervical spinal cord magnetic resonance images of 184 healthy adults. Then, cross-sectional area (CSA), eccentricity, antero-posterior diameter (AP) and right-left diameter (RL) were each computed for every subject. Then, impacts of gender, age and vertebral level on CSA and eccentricity were explored. Moreover, linear correlation analysis was conducted among CSA, AP and RL.</p><p><strong>Results: </strong>The CSA of the cervical spinal cord in males was significantly larger than that in females at C2~C7 segments (<i>P</i><0.05) . For C2~C6 segments, there was no statistically significant difference in CSA between the young and middle-aged groups, but both were significantly larger than that of the elderly group. CSA of C4 was the largest whereas CSA of C7 was the smallest. Eccentricity values of C4 and C5 were significantly larger than those of other vertebral levels (<i>P</i><0.05). Linear correlation was established between CSA, AP and RL at C2~C7 segments.</p><p><strong>Conclusion: </strong>The results allow for minimizing inter-subject variability using normalization, and thereby highlighting the importance of morphological parameters as biomarkers in the research of cervical spinal lesions.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"141-147"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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