摘要
目的分析医用可穿戴柔性电子设备临床使用风险,研究对应的质量评价方法,以加强对医用柔性电子设备进行质量评价及风险控制。方法分析医用柔性电子产品的风险点,结合实际检验检测中关心的问题,对此类设备的对应风险点开展质量评价方法分析。结果针对使用柔性电子器件的医用电气设备,其机械特性、电学特性是质控评价的难点和关键点,通过分析归纳以及列举实际检测示例,总结可穿戴柔性电子产品机械和电学的评价要点,指出可穿戴柔性设备在实验设计中,结合产品的临床风险和临床条件确定实验条件是十分重要的。结论通过对柔性电子产品进行风险分析,同时分析了实际使用中如何开展风险控制和质量评价,可为今后此类产品的检测和监管提出思路。
Objective To analyze the risk of medical wearable flexible electronics,and to study the corresponding quality evaluation methods,so as to strengthen the quality evaluation and risk control of medical flexible electronic devices.Methods This paper analyzed the risk points of mechcal flexible electronic products,and carried out quality evaluation method analysis on the corresponding risk points of such devices combined with the problems concerned in the actual inspection and testing.Results For medical electrical equipment using flexible electronics,its mechanical and electrical characteristics were the difficulties and key points of quality control evaluation.Through analysis,induction and listing actual detection examples,this paper summarized the main points of mechanical and electrical evaluation of wearable flexible electronic products,and pointed out that in the experimental design of wearable flexible equipment,it was very important to determine the experimental conditions based on the clinical risks and clinical conditions of the product.Conclusion Through the risk analysis of flexible electronic products,this paper also analyzes how to carry out risk control and quality evaluation in practical use,and can put forward ideas for the detection and supervision of such products in the future.
作者
王权
李佳戈
郝烨
WANG Quan;LI Jiage;HAO Ye(Department of Active Medical Device and Medical Optics,National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国医疗设备》
2023年第2期63-67,共5页
China Medical Devices
基金
国家重点研发计划(2020YFC2007102)。
关键词
柔性电子
风险分析
质量评价
医用可穿戴
质控
flexible electronics
risk analysis
quality evaluation
medical wearable
quality control
