大型医用氧舱性能与质量评价方法的现状与趋势OA
Current Status and Trends in Performance and Quality Evaluation Methods for Large Medical Hyperbaric Oxygen Chambers
大型医用氧舱作为在高压环境下提供富氧或纯氧的关键医疗设备,在临床医学中应用日益广泛,主要用于治疗缺氧性疾病、促进创伤愈合及改善多种慢性病的症状.其性能与质量直接关系到治疗效果和患者安全.本文综述了大型医用氧舱的关键性能指标及其影响因素,系统分析了国内外氧舱性能与质量的评价方法,重点探讨了舱体结构、密封性能、氧浓度控制、环境稳定性及安全性测试等方面的研究进展与技术规范.同时,结合行业发展趋势,分析了性能评价中存在的不足,展望了智能化检测、标准化体系建设及全生命周期质量管理等未来研究方向与技术突破,以期为医用氧舱的研发、生产及标准化提供参考.
As a key medical device that provides oxygen-enriched or pure oxygen in a hyperbaric environment,large-scale medical oxygen chambers have been increasingly widely used in clinical medicine.They are mainly used for treating hypoxic diseases,promoting wound healing,and alleviating symptoms of various chronic diseases.Their performance and quality are directly related to treatment efficacy and patient safety.This paper reviewed the key performance indicators of large-scale medical oxygen chambers and their influencing factors,systematically analyzed domestic and international methods for evaluating the performance and quality of oxygen chambers,and focused on discussing the research progress and technical specifications in aspects such as chamber structure,sealing performance,oxygen concentration control,environmental stability,and safety testing.Additionally,combined with industry development trends,it analyzed the deficiencies in performance evaluation and prospected for future research directions and technical breakthroughs,including intelligent detection,standardization system construction,and full-life-cycle quality management,aiming to provide references for the research and development,production,and standardization of medical oxygen chambers.
于哲;张克;陈甜甜;张在爱;宋阳阳;牟鹏涛
山东省医疗器械和药品包装检验研究院/国家药品监督管理局药品包装材料质量控制重点实验室/济南市高端诊疗装备质量评价重点实验室,山东 济南 250101山东省医疗器械和药品包装检验研究院/国家药品监督管理局药品包装材料质量控制重点实验室/济南市高端诊疗装备质量评价重点实验室,山东 济南 250101山东省医疗器械和药品包装检验研究院/国家药品监督管理局药品包装材料质量控制重点实验室/济南市高端诊疗装备质量评价重点实验室,山东 济南 250101山东省医疗器械和药品包装检验研究院/国家药品监督管理局药品包装材料质量控制重点实验室/济南市高端诊疗装备质量评价重点实验室,山东 济南 250101山东省医疗器械和药品包装检验研究院/国家药品监督管理局药品包装材料质量控制重点实验室/济南市高端诊疗装备质量评价重点实验室,山东 济南 250101山东省医疗器械和药品包装检验研究院/国家药品监督管理局药品包装材料质量控制重点实验室/济南市高端诊疗装备质量评价重点实验室,山东 济南 250101
医药卫生
医用氧舱质量评价性能检验标准体系全生命周期智能化检测
medical oxygen chamberquality evaluationperformance inspectionstandard systemfull life cycleintelligent detection
《中国医疗设备》 2025 (9)
161-167,7
山东省科学技术厅高端智能医用氧舱研发与产业化示范(2022CXGC020509).
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