Clause / Test Requirement

5.1 Risk management 风险管理

5.2 Biocompatibility 生物相容性

5.3 Detectability 可检测性

5.4 Surface finish 表面光洁度

5.5 Size designation 尺寸设计

5.6 Connector 连接器

5.7 MRI compatibility MRI兼容性

5.8 Sterilization 无菌

6.1 Kink stability 扭结稳定性

6.2 Corrosion resistance 耐腐蚀性

6.3 Resistance to deformation 抗变形

6.4 Peak tensile force 峰值拉力

6.5 Impact resistance 耐冲击性

6.6 Flow rate 流量

6.7 Retension strength 固位力

6.8 Balloon safety 球囊安全性

6.9 Catheter inflation lumen integrity and volume maintenance 导管充气腔完整性和体积维持

6.10 Inflated balloon resistance to traction 充气球囊抗牵引力

6.11 Freedom from leakage during aspiration or vacuum 在抽吸或真空过程中无泄漏