Analysis on national supervision and sample inspection of disposable sterile surgical drapes
10.19745/j.1003-8868.2025089
- VernacularTitle:一次性使用无菌手术膜国家监督抽检情况分析
- Author:
Yu-peng SUN
1
;
Qing-yu LI
1
;
Fan LI
1
;
Ze-chen LIN
1
;
Xue-chong LIU
1
;
Bo ZHANG
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医用卫生材料及生物防护器械质量评价重点实验室,济南 250101
- Publication Type:Journal Article
- Keywords:
disposable sterile surgical drape;
national supervision and sample inspection;
medical device
- From:
Chinese Medical Equipment Journal
2025;46(5):66-72
- CountryChina
- Language:Chinese
-
Abstract:
The existing relevant standards and registration of disposable sterile surgical drapes were introduced,and four times of national supervision and sample inspection of disposable sterile surgical drapes from 2017 to 2023 were described.The unqualified items found in the supervision and sample inspection were analyzed,the exploratory research projects carried out were summarized and other problems encountered during the sample inspection were pointed out.Relevant enterprises were suggested to strengthen the implementation of industry standards,take seriously the product material identification information,clearly limit the raw materials used and standardize the product registration name.References were provided for the industrial supervision and development of disposable sterile surgical drapes.[Chinese Medical Equipment Journal,2025,46(5):66-72]
