摘要
医用冷藏箱是需要低温保存的医用材料运输的重要手段,能最大程度保障存品的质量。但在临床使用中部分产品存在温度不均匀、温度波动度大、温度显示误差大等问题,给临床应用带来较大的安全隐患。文章基于产品安全、有效的基本要求,围绕产品主要性能指标如温度均匀性、温度波动度、温度监控,并结合产品审评及监管常见问题、产品使用安全隐患等方面对医用冷藏箱的质量控制要点进行分析研究,以期对产品的设计研发、生产质量、注册审批、日常监管提供参考。
Medical refrigerated containers are an important means of transporting medical materials that require low-temperature preservation,which can maximize the quality of stored products.However,in clinical use,some products have problems such as uneven temperature,large temperature fluctuations,and large temperature display errors,which pose significant safety hazards to clinical applications.This article is based on the basic requirements of product safety and effectiveness,focusing on the main performance indicators of the product such as temperature uniformity,temperature fluctuation,temperature monitoring,and combining with common problems in product evaluation and supervision,as well as safety hazards in product use,to analyze and study the quality control points of medical refrigerators,in order to provide reference for product design and development,production quality,registration and approval,and daily supervision.
作者
孙靓
徐琨
耿友军
任希力
闫芳
李国勇
SUN Liang;XU Kun;GENG You-jun;REN Xi-li;YAN Fang;LI Guo-yong(Shandong Provincial Food and Drug Evaluation and Inspection Center,Shandong Jinan 250014)
出处
《中国医疗器械信息》
2024年第11期21-24,共4页
China Medical Device Information
关键词
医用冷藏箱
性能指标
质量控制
温度
medical refrigerated box
performance indicators
quality control
temperature
