Analysis of implementation of GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed
10.19745/j.1003-8868.2025165
- VernacularTitle:GB 8369.1-2019《一次性使用输血器第1部分:重力输血式》实施情况分析
- Author:
Hong-jian CHEN
1
;
Wen-bo LU
1
;
Min WAN
1
;
Yu-xin BI
1
;
Li HOU
1
;
Bin LIU
1
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,济南 250101
- Publication Type:Journal Article
- Keywords:
GB 8369.1-2019;
infusion set;
gravity feed;
standard implementation;
compulsory standard
- From:
Chinese Medical Equipment Journal
2025;46(9):70-74
- CountryChina
- Language:Chinese
-
Abstract:
Questionnaire survey and symposium were carried out on the implementation of GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed,and then analyses were performed on its implementation by relative enterprises,inspection and testing organizations and regulatory authorities,applicability,coordination and implementation constraints accordingly.Some suggestions were put forward,and it was of great significance for comprehensively grasping the overall situation,efficacy and problems of the standard implementation,promoting the updating and upgrading of the standard and facilitating the implementation of compulsory standards.[Chinese Medical Equipment Journal,2025,46(9):70-74]
