T/ZAMEI 0003-2023 紫杉醇药物涂层球囊扩张导管

ICS11.040

C48

ZAMEI

团体标准

T/ZAMEI0003—2023

紫杉醇药物涂层球囊扩张导管

Paclitaxel-coatedBalloonCatheter

2023-12-06发布2023-12-08实施

浙江省医疗器械行业协会发布

T/ZAMEI0003—2023

目次

前言..................................................................................III

1范围...................................................................................1

2规范性引用文件.........................................................................1

3术语和定义.............................................................................1

4要求...................................................................................2

4.1外观...............................................................................2

4.2尺寸...............................................................................2

4.3导管座.............................................................................3

4.4耐腐蚀性...........................................................................3

4.5峰值拉力...........................................................................3

4.6球囊额定爆破压（RBP）..............................................................3

4.7球囊疲劳：充起时无泄漏和损坏.......................................................3

4.8球囊卸压时间.......................................................................3

4.9球囊直径与充盈压力的关系...........................................................4

4.10无泄漏............................................................................4

4.11兼容性............................................................................4

4.12紫杉醇药物涂层性能................................................................4

4.13化学性能..........................................................................4

4.14环氧乙烷残留量....................................................................5

4.15无菌..............................................................................5

4.16细菌内毒素........................................................................5

5试验方法...............................................................................5

5.1外观...............................................................................5

5.2尺寸...............................................................................5

5.3导管座.............................................................................5

5.4耐腐蚀性...........................................................................5

5.5峰值拉力...........................................................................5

5.6球囊额定爆破压（RBP）..............................................................5

5.7球囊疲劳：充起时无泄漏和损坏.......................................................5

5.8球囊卸压时间.......................................................................6

5.9球囊直径与充盈压力的关系...........................................................6

5.10无泄漏............................................................................6

I

T/ZAMEI0003—2023

5.11兼容性............................................................................6

5.12紫杉醇涂层........................................................................6

5.13化学性能..........................................................................7

5.14环氧乙烷残留量....................................................................7

5.15无菌..............................................................................7

5.16细菌内毒素........................................................................7

附录A....................................................................................8

附录B....................................................................................9

II

T/ZAMEI0003—2023

前言

本文件按照GB/T