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听诊器技术要求和测试方法研究

Study on Technical Requirement and Test Method of Stethoscope
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摘要 听诊器是一种声学听诊设备,是内科医疗设备不可或缺的设备,也是最好的家庭医疗设备,是家庭保健不可缺少的物品。听诊经常被用于听肺和心脏的声音,它也可以用来听肠和血流量在动脉和静脉的声音,再结合血压计,就可以用于测量血压,这是很常见的。在国内早些年已有电子听诊器上市,因此关于电子听诊器方面的技术也较为成熟,且至今尚未出现不良事件,故产品的安全有效性是符合要求的。在结合市场现状与需求量的情况下,国内多家企业研发的电子听诊器,顺应当代经济背景和当代市场需求,推动了听诊方面的医学进步和发展,在诊断患者过程中更加准确高效,且使用过程中简单易用。2022年随着听诊器新标准的实施,修改和增加了部分的性能和测试方法,在仪器在设计上结构合理,简洁实用,性能稳定可靠,满足医护人员使用需求基础上,最主要的也要满足听诊器标准要求。文章就YY/T 1035-2021听诊器的术语和定义、要求、测试方法和听诊器原理进行解析研究。 Stethoscope is a kind of acoustic auscultation equipment,is the internal medicine equipment indispensable equipment,is also the best family medical equipment,is the family health care indispensable items.Auscultation is often used to listen to the lungs and the heart.It can also be used to listen to the intestines and blood flow in the arteries and veins.Combined with a sphygmanometer,it can be used to measure blood pressure,which is very common.The electronic stethoscope has been on the market in China in the early years,so the technology about the electronic stethoscope is relatively mature,and there have been no adverse events,so the safety and effectiveness of the product is in line with the requirements.In combination with the market status and demand,the electronic stethoscope developed by many domestic enterprises,in line with the contemporary economic background and contemporary market demand,has promoted the medical progress and development of auscultation.It is more accurate and efficient in the process of diagnosing patients,and easy to use in the process.In 2022,with the implementation of the new standard of stethoscope,some performance and test methods have been modified and added.On the basis of reasonable structure,simple and practical design,stable and reliable performance,and meeting the use needs of medical staff,the most important thing is to meet the standard requirements of stethoscope.In this paper,the terms and definitions,requirements,test methods and principles of YY/T 1035-2021 stethoscope are analyzed and studied.
作者 符师 陈卓强 吕以源 FU Shi;CHEN Zhuo-qiang;LV Yi-yuan(Guangdong Institute of Quality Supervision and Inspection of Medical Devices,Guangdong Guangzhou 510700)
出处 《中国医疗器械信息》 2022年第21期27-31,共5页 China Medical Device Information
关键词 听诊器 测试方法 the stethoscope the test method
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