中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
9期
921-925
,共5页
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
醫療器械%一次性使用無菌導尿管%質量標準%國際標準%行業標準%註冊標準%關鍵參數%扭結度%閥門標記%流量%脩訂建議
의료기계%일차성사용무균도뇨관%질량표준%국제표준%행업표준%주책표준%관건삼수%뉴결도%벌문표기%류량%수정건의
medical device%the sterile urethral catheter%quality standards%international standards%industry standards%registration standards%key parameters%kink degrees%valve marker%rate of lfow%revised proposal
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。
目的：對一次性使用無菌導尿管進行產品質量調研和檢驗，探討影響產品質量的因素，併對行業標準應增加的內容提齣建議。方法：通過檢驗對數據進行統計比對，分析研究該產品的現行國際標準、行業標準、企業註冊標準的不同之處。結果與結論：我國行業標準對該產品關鍵參數的要求是全麵的，對產品的安全性和有效性均作瞭要求。但對扭結度、閥門標記、流量等，建議增加或脩訂必要的檢驗項目，將會對該產品的質量要求更為全麵。
목적：대일차성사용무균도뇨관진행산품질량조연화검험，탐토영향산품질량적인소，병대행업표준응증가적내용제출건의。방법：통과검험대수거진행통계비대，분석연구해산품적현행국제표준、행업표준、기업주책표준적불동지처。결과여결론：아국행업표준대해산품관건삼수적요구시전면적，대산품적안전성화유효성균작료요구。단대뉴결도、벌문표기、류량등，건의증가혹수정필요적검험항목，장회대해산품적질량요구경위전면。
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 lfow be added to make the standard more comprehensive.
