{"title":"医用伤口敷料质量评价研究策略","authors":"Yanhui Xu, Xiang Li, Jinsheng Xie, Fang Lin, Jingfeng Zheng","doi":"10.12455/j.issn.1671-7104.250058","DOIUrl":null,"url":null,"abstract":"<p><p>Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has certain significance in standardizing and improving their quality level, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices..</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"453-459"},"PeriodicalIF":0.0000,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Research Strategies for Quality Evaluation of Medical Wound Dressings].\",\"authors\":\"Yanhui Xu, Xiang Li, Jinsheng Xie, Fang Lin, Jingfeng Zheng\",\"doi\":\"10.12455/j.issn.1671-7104.250058\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has certain significance in standardizing and improving their quality level, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices..</p>\",\"PeriodicalId\":52535,\"journal\":{\"name\":\"中国医疗器械杂志\",\"volume\":\"49 4\",\"pages\":\"453-459\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-07-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国医疗器械杂志\",\"FirstCategoryId\":\"1087\",\"ListUrlMain\":\"https://doi.org/10.12455/j.issn.1671-7104.250058\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.12455/j.issn.1671-7104.250058","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[Research Strategies for Quality Evaluation of Medical Wound Dressings].
Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has certain significance in standardizing and improving their quality level, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices..
期刊介绍:
Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.