Current status of standards and national supervision and sampling inspection of disposable sterile urethral catheter
10.19745/j.1003-8868.2024014
- VernacularTitle:一次性使用无菌导尿管标准现状与国家监督抽检情况分析
- Author:
Chang-Bin WANG
1
;
Ke-Long YU
;
Kan-Yuan LI
;
Wen-Bo LU
Author Information
1. 山东省医疗器械和药品包装检验研究院,国家药品监督管理局生物材料器械安全性评价重点实验室,山东省医疗器械生物学评价重点实验室,济南 250101
- Keywords:
disposable sterile urethral catheter;
medical device;
YY/T 0325-2022;
national supervision and sampling inspection
- From:
Chinese Medical Equipment Journal
2024;45(1):84-88
- CountryChina
- Language:Chinese
-
Abstract:
The disposable sterile urethral catheter was described in terms of the current status of the standards of foreign countries and China and its regulation and registration.The national supervision and sampling inspection and exploratory research of the disposable sterile urethral catheter in 2018,2019 and 2021 were introduced,and the problems found and the causes were analyzed and then the countermeasures were proposed accordingly.References were provided for guiding and standardizing the development of catheter products industry.[Chinese Medical Equipment Journal,2024,45(1):84-88]
