YY 0109-2013《医用超声雾化器》部分项目的检验方法
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摘要
目前,医用超声雾化器在临床上的使用越来越广泛。国家药品监督管理局加大了对超声雾化器的监管力度,将其列为国家监督抽验的品种。吉林省医疗器械检验所近年承担了医用超声雾化器的国家监督抽检和省内监督抽检任务,根据实际检验经验,现主要探讨超声振荡频率偏差、最大雾化率、电源适应能力项目的检验方法,以及雾化罐预充水量对雾化率的影响。
In recent years, medical ultrasonic nebulizers are widely used in the clinical application. Therefore, National Medical Products Administration(NMPA) has enhanced the supervision of ultrasonic nebulizers and added it in the list of government surveillance projects. In the past few years, Jilin Medical Device Test Institute had conducted some national and provincial supervision and sampling inspection of medical ultrasonic nebulizers. Based on the practical experience, this paper mainly discusses the methods for measuring the deviation of the ultrasonic oscillator frequency, the maximum nebulization rate and the adaptability of the power supply unit. Furthermore, the influence of the pre-charged water volume in the tank on the nebulization rate is also studied in this paper.
In recent years, medical ultrasonic nebulizers are widely used in the clinical application. Therefore, National Medical Products Administration(NMPA) has enhanced the supervision of ultrasonic nebulizers and added it in the list of government surveillance projects. In the past few years, Jilin Medical Device Test Institute had conducted some national and provincial supervision and sampling inspection of medical ultrasonic nebulizers. Based on the practical experience, this paper mainly discusses the methods for measuring the deviation of the ultrasonic oscillator frequency, the maximum nebulization rate and the adaptability of the power supply unit. Furthermore, the influence of the pre-charged water volume in the tank on the nebulization rate is also studied in this paper.
引文
[1]陈聪,郝素丽.医用雾化器的工作原理及主要技术要求[J].中国医疗器械信息,2016,22(7):57-61.
[2]国家食品药品监督管理总局.YY 0109-2013医用超声雾化器[S/OL].[2013-10-21].http://www.csres.com/detail/236551.html.
[2]国家食品药品监督管理总局.YY 0109-2013医用超声雾化器[S/OL].[2013-10-21].http://www.csres.com/detail/236551.html.