Clause / Test Requirement

4.10 Corrosion resistance 耐腐蚀性能

5.1 General 总则

5.2 Inlet ports 进气口

5.3 Outlet ports 出口

5.4 Access ports 接入端口

5.5 Tensile strength 拉伸强度

5.6 Leakage 泄露

5.7 Additional information provided by the manufacturer 制造商提供的其他信息

6.1 General 总则

6.2 Outlet port 出口

6.3 Enteral syringe requirements 肠内注射器要求

6.4 Enteral Syringe dose accuracy requirement 肠内注射剂量准确性要求

6.5 Marking 标记

7.1 General 总则

7.2 Access ports 接入端口

7.3 Tensile properties 拉伸强度

7.4 Leakage properties 泄露

7.5 Flow rate 流速

7.6 Enteral feeding catheter designated size 肠内饲管指定尺寸

7.7.1 Balloon burst volume 球囊爆破体积

7.7.2 Balloon recommended inflation volume 球囊推荐充气体积

7.7.3 Balloon inflation system performance 球囊充气系统性能

7.7.4 Balloon concentricity 球囊同心度

7.7.5 Balloon integrity in simulated gastric fluid 模拟胃液中的球囊完整性

7.9 Marking 标记

8 Additional requirements for enteral accessories 肠内附件的附加要求