Interpretation of ISO 10555-1:2023 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements
10.19745/j.1003-8868.2025184
- VernacularTitle:一次性使用无菌血管内导管通用要求标准ISO 10555-1:2023更新解读
- Author:
Shan FENG
1
;
Zi-xiang HONG
1
;
Xi-yun DANG
1
;
Jun KE
1
;
Xue BAI
1
Author Information
1. 广东省医疗器械质量监督检验所,广州 510663
- Publication Type:Journal Article
- Keywords:
ISO 10555-1:2023;
YY 0285.1-2017;
intravascular catheter;
disposable sterile catheter;
standard interpretion
- From:
Chinese Medical Equipment Journal
2025;46(10):65-70
- CountryChina
- Language:Chinese
-
Abstract:
The overall revision of ISO 10555-1:2023 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements was introduced,which was compared with YY 0285.1-2017 Intravascular catheters—Sterile and sing-use catheters—Part 1:General requirements in terms of terminology definition,requirements and identification of nominal size.The new and changed contents of ISO 10555-1:2023 were interpreted,and references were provided for the develop-ment,inspection and testing and supervision of related products and for the future revision of YY 0285.1-2017 standard.[Chinese Medical Equipment Journal,2025,46(10):65-70]
