JIS T 3268:2018规定了一次性使用无菌血管内导管(以下简称导管),其设计用于插入或植入血管(包括房室分流术和血管移植物),用于诊断或治疗目的,或将医疗设备运送至所选位置。然而,本标准不适用于具有抗血栓形成特性、涂有肝素和尿激酶等生物材料的导管、具有抗菌效果、涂有抗菌剂的导管和可水合导管。
JIS T 3268:2018 specifies sterile, single-use intravascular cathetars (hereafter referred to as catheters) which are designed to be inserted or implanted into vessels (including AV shunts and vascular grafts) for diagnostic or therapeutic purposes, or to deliver medical devices to the chosen location. However, this Standard does not apply to catheters with anti-thrombogenic property, coated with biological materials such as heparin and urokinase, catheters with antibacterial effect, coated with antimicrobial agents, and hydratable catheters.