摘要
目的:对一次性使用无菌导尿管进行产品质量调研和检验,探讨影响产品质量的因素,并对行业标准应增加的内容提出建议。方法:通过检验对数据进行统计比对,分析研究该产品的现行国际标准、行业标准、企业注册标准的不同之处。结果与结论:我国行业标准对该产品关键参数的要求是全面的,对产品的安全性和有效性均作了要求。但对扭结度、阀门标记、流量等,建议增加或修订必要的检验项目,将会对该产品的质量要求更为全面。
Objective: To make a survey on the quality standard of the Sterile Urethral Catheter, so as to probe into the factors which affect the quality of products and to suggest the industry standard that needs to be replenished. Methods: Data analysis was carried out, and a comparison study was performed. Then, the difference among the current international standard, industry standard and enterprise registration standard was discussed. Results and Conclusion: The current standard of our country is basically comprehensive, which covered the security as well as validity of the products. However, it is suggested that other inspection items for kink degree, valve marking and rate of fl ow be added to make the standard more comprehensive.
出处
《中国药事》
CAS
2015年第9期921-925,共5页
Chinese Pharmaceutical Affairs
关键词
医疗器械
一次性使用无菌导尿管
质量标准
国际标准
行业标准
注册标准
关键参数
扭结度
阀门标记
流量
修订建议
medical device
the sterile urethral catheter
quality standards
international standards
industry standards
registration standards
key parameters
kink degrees
valve marker
rate of fl ow
revised proposal