11.1ptca球囊扩张导管技术要求英文翻译

Technical requirements for medical device product registration number：Disposable Sterile PTCA balloon catheter

1、Model / Specifications and divide instructions

1、1 Model

PTCA-XX-XX

Balloon nominal Diameter mm

Product Name Code

Model mark example：PTCA——10 represents balloon nominal outer diameter is and working length is 10mm of disposable Sterile PTCA balloon catheter

1、2 Specifications

1、3 Divide instructions

Disposable Sterile PTCA balloon catheter consists of balloon, connecting catheter, tip, support catheter and Handle.According to different balloon diameter to divide the balloon into different specifications and sizes. According to medical device classification rules 6877, the balloon catheter belonging to Class Ⅲ interventional equipment intravascular catheter.

2、Performance

2、1 Appearance

As with normal vision or corrected vision at a magnification of times the conditions of inspection, the effective length of the outer catheter should be clean and free of impurities.There should be no processing defects and surface defects on the surface of catheter effective length and end.

The inner and outer surface of the distal end components of the catheter should have silicone oil (polydimethylsiloxane) lubricant coating. With normal vision or corrected vision inspection,the outer surface of the catheter should not see the convergence of lubricant droplets.

Note：The inner and outer surface of the distal end components of the catheter is the out surface from the tip (figure 1) to the transition weld (figure 7),and the inner surface from guide wire lumen (from the tip (Figure 1 below) to quickly switch ports (figure 5)).

2、2 Size requirements

Balloon catheter size requirements reference table1, specification list reference table 2.

1、Tip

2、Balloon

3、Radiopaque ring

4、Out catheter

5、Quickly switch ports

6、Guide wire

7、Transition weld

8、Hypo Tube（FEP Coated）

9、Bending resistant tube 10、Handle 11 Balloon effective length（ L） 12、catheter effective length

Pic 1. PTCA balloon catheter schematic

Pic 2. Tip schematic

Table 1 disposable Sterile PTCA balloon catheter size and tolerance requirements

Connector of balloon catheter must be tapered connector.Size should be consistent with GB / T requirements.

Physical properties

Breaking force

Breaking strength of each test section shall comply with the requirements of Table 3.

Leakage

a) There should no liquid leakage at catheter hub,connection assembly part and other parts of catheter.There should be no leak or signs of damage for catheter or balloon. If prominent or burst,this requirement adapt before hydrated and after hydrated.