GB/T 4506-1984
Abolished
YY/T 1898-2024
Active
Industry standards-Medicine
YY/T 1898-2024 Intravascular catheter and guidewire—Testing method for fastness of the hydrophilic coating
YY/T 1898-2024 Intravascular catheter and guidewire—Testing method for fastness of the hydrophilic coating
Basic Information
Standard Code:
YY/T 1898-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2024-02-07
Implement Date:
2025-03-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
15 pages
Scope
本文件描述了血管内使用的带亲水润滑涂层医用导管导丝的涂层牢固度试验方法，包括外观检查法、摩擦力测试法、微粒测试法、化学性能测试法4种方法。本文件涉及的亲水润滑涂层仅指利用聚合物制备的与基材表面化学结合的亲水润滑涂层，不包括其他类型的涂层，如载药涂层、可降解涂层等。本文件适用于带亲水润滑涂层的血管内导管、导丝。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、江苏百赛飞生物科技有限公司、苏州苏大卫生与环境技术研究所有限公司、乐普(北京)医疗器械股份有限公司、波科国际医疗贸易(上海)有限公司、鼎科医疗技术(苏州)有限公司、健适医疗器械(无锡)有限公司、美敦力(上海)管理有限公司
Drafting Persons:
陈红、万敏、艾冲冲、方菁嶷、杨婷茹、崔永平、翁玉麟、王蕊、孔凡志、聂佳祺、刘叶、韩磊
Referenced Standards
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced