一次性使用无菌导尿管中流量测定的影响因素考察  

Influencing factors of flow measurement in disposable sterile catheter

作　　者：喻亮宇 朱武莲 颜敏 YU Liang-yu;ZHU Wu-lian;YAN Min(Hunan Drug Inspection Center,Changsha 410001,Hunan,China;Hunan Institute for Drug Control,Changsha 410001,Hunan,China)

机构地区：[1]湖南省药品审核查验中心,湖南长沙410001 [2]湖南省药品检验检测研究院,湖南长沙410001

出　　处：《生物医学工程与临床》2023年第2期138-142,共5页Biomedical Engineering and Clinical Medicine

摘　　要：目的对一次性使用无菌导尿管中流量测定的影响因素进行分析,并对行业标准YY 0325—2016提出修订建议。方法收集16批双腔导尿管,其中一次性使用无菌导尿管6批,一次性使用无菌导尿包10批。根据外径分为4.0 mm(2批)、4.7 mm(1批)、5.3 mm(12批)、6.7 mm(1批)4种规格。通过导尿管流量实验,从导尿管的内径、未接导尿管时水箱流量(以下简称:原始流量)、导尿管排泄孔眼大小三个方面进行考察,并对导尿管内径与导尿管流量关系、原始流量与导尿管流量关系、排泄孔眼与导尿管流量关系进行分析。结果在一定的原始流量下,大致为导尿管内径越大,流量越大。内径较小的导尿管,加大原始流量,对流量结果影响不大。而内径越大的样品,则原始流量对其的影响幅度也越大,流量偏差为58%。内径接近的导尿管,在相同原始流量下,流量与排泄孔眼的面积大小无正相关。结论行业标准YY 0325—2016中所引用的导尿管流量实验方法未考虑原始流量对结果的影响,未规定原始流量上限值。建议行业管理部门针对原始流量对结果的影响进行实验、细化和论证,必要时对原始流量进行区间范围的规定。Objective To investigate and analyze the influencing factors of flow measurement in disposable sterile catheter, and propose revisions for the industry standard YY 0325-2016. Methods A total of 16 batches of dual-lumen catheter were collected, which included 6 batches disposable sterile catheter and 10 batches disposable sterile catheter package. According to outer diameter, the catheters were divided into 4 specifications: 4.0 mm(2 batches), 4.7 mm(1 batch), 5.3 mm(12 batches),6.7 mm(1 batch). The catheter’s inner diameter, flow rate of unconnected catheter water tank(original flow rate), and size of catheter excretory orifice were investigated by catheter flow experiment. The relationship between catheter ’s inner diameter and catheter flow, relationship between original flow and catheter flow, and relationship between excretory orifice and catheter flow were analyzed. Results Under the certain original flow, the larger the catheter’s inner diameter, the greater the flow.For catheters with smaller inner diameter, the increased original flow had little effect on flow results. The larger the inner diameter,the greater the influence of original flow on flow results, and the deviation was 58 %. For catheters with similar inner diameters, there was no positive correlation between flow and size of excretory orifice under the same original flow. Conclusion It is demonstrated that there is no relationship between original flow and result, and no original flow upper limit in industry standard YY 0325-2016. It is suggested that the industry management department experiment, refine and demonstrate the influence of original flow on results,and stipulate the range of original flow if necessary.

关 键 词：一次性使用无菌导尿管 原始流量 影响因素 行业标准YY 0325—2016 

分 类 号：R318.08[医药卫生—生物医学工程]