摘要
目的基于卡尔费休法测定可吸收性缝线的含水量,并对检测结果进行统计分析。方法首先用标准水校准仪器,然后将制好的样品置于卡氏炉中加热释放出水分,通过载气将水分导入卡尔费休吸收液中,依据卡尔费休法计算含水量。结果测定16批次样品,大部分可吸收性缝线的含水量符合行业标准要求,但仍有两批次产品的含水量高于行业标准要求。结论大部分可吸收性缝线的含水量测定结果符合行业标准要求,针对不合格产品,需要生产企业在原材料、加工工艺及产品包装等方面寻找原因,改进产品质量。
Objective The water content of absorbable sutures was measured by Karl Fischer method and the results were counted and analyzed.Methods Firstly,the instrument was calibrated with standard water,and then the prepared sample was heated in a Carlsberg furnace to release water,which was introduced into the Karl Fischer absorption solution through carrier gas,and the water content was calculated according to the Karl Fischer method.Results Sixteen batches of samples were tested,and the water content of most absorbable sutures could meet the requirements in the industry standard,but the water content of two batches of products were still higher than the requirements in the industry standard.Conclusion The water content of most absorbable sutures can meet the requirements in the industry standard,as for the unqualified products,manufacturers should seek reasons from aspects such as raw materials,processing technology and product packaging to improve product quality.
作者
朱进清
马金竹
姜熙
李沅
景明
董双鹏
Zhu Jinqing;Ma Jinzhu;Jiang Xi;Li Yuan;Jing Ming;Dong Shuangpeng(Tianjin Medical Devices Quality Supervision And Testing Center of National Medical Products Administration,Tianjin 300384,China)
出处
《医疗装备》
2022年第15期22-24,共3页
Medical Equipment
基金
国家重点研发计划课题(2018YFC1106700)。
