医疗器械实质性一致比拟说明范本(国外英文资料).docVIP

医疗器械实质性等同对比说明范本(国外英文资料) The actual equivalent of the medical instrument is the comparison An overview of This product is a kind of according to the medical devices category 2 kinds of medical polymer materials and products (6866), according to the registered product standard YY0325-2002 the disposable use asepsis catheter design. The product is a one-time aseptic silicone rubber multi-cavity catheter, manufactured in the 100, 000 grade purification workshop and sterilized by epoxy ethane, and the test is finished. Select the comparison object Choose * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Its registration number: * drug tube (quasi) character 20 * * * * * * * The comparison that 1 the product material: In the course of clinical use, both products are made from imported medical silicone rubber materials besides exposed air valves. Good biosolubility can meet clinical requirements. Working principle of the 2 Urethral catheterization is a commonly used the basic operation of urology, its basic principle is to put the catheter through the urethra into the bladder, by adsorption, negative pressure and siphon effect, make the urine of bladder drainage in vitro. Silicone rubber material disposable aseptic catheter, the surface is smooth, the bacteria are not easy to adhere to, the texture is soft, the urethra damage is small. The catheters head is about 3.5 cm and is designed for a small airbag that can be injected into 10ML ~ 30ML of air or injected water to ensure a fixed and prevent urinary outflow. At the end there are two openings, an open catheter and an open airbag. Tube body has two cavity, one for air cavity, through a one-way valve to balloons into the air or water for injection, another way for urine discharge cavity, through this cavity to the urine bladder in vitro. Some scholars think the urethral catheter, dont do bladder douche, 72 h bacteriuri