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11.1-PTCA球囊扩张导管技术要求英文翻译

更新时间:2023-05-08 17:54:38 阅读：评论：0

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 Working Length mm

Balloon nominal Diameter mm

Product Name Code

Model mark example：PTCA—2.0—10 reprents balloon nominal outer diameter is 2.0mm and working length is 10mm of disposable Sterile PTCA balloon catheter

1、2 Specifications

PTCA balloon catheter specification list

Specifications	OD	Length	The effective length of the catheter	Max guide wire diameter	Nominal pressure	RBP
DK-PTCA-1.5-10	1.50mm	10mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-1.5-20	1.50mm	20mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-1.5-30	1.50mm	30mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-1.75-10	1.75mm	10mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-1.75-20	1.75mm	20mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-1.75-30	1.75mm	30mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.0-10	2.00mm	10mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.0-20	2.00mm	20mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.0-30	2.00mm	30mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.5-10	2.50mm	10mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.5-20	2.50mm	20mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.5-30	2.50mm	30mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.75-10	2.75mm	10mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.75-20	2.75mm	20mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-2.75-30	2.75mm	30mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-3.0-10	3.00mm	10mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-3.0-20	3.00mm	20mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-3.0-30	3.00mm	30mm	142cm	≦0.014in	8ATM	16ATM
DK-PTCA-3.5-10	3.50mm	10mm	142cm	≦0.014in	6ATM	16ATM

DK-PTCA-3.5-20	3.50mm	20mm	142cm	≦0.014in	6ATM	16ATM
DK-PTCA-3.5-30	3.50mm	30mm	142cm	≦0.014in	6ATM	16ATM
DK-PTCA-4.0-10	4.00mm	10mm	142cm	≦0.014in	6ATM	16ATM
DK-PTCA-4.0-20	4.00mm	20mm	142cm	≦0.014in	6ATM	16ATM
DK-PTCA-4.0-30	4.00mm	30mm	142cm	≦0.014in	6ATM	16ATM

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 2.5 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 e 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

2.2.1 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

Name	Unit	Standard	Tolerance	Remark
Balloon diameter under nominal pressure	mm	D	±0.125
Balloon effective length	mm	L	±10%	Asmbly integrated tolerances±10%， Reference pic 1.
Radiopacity Length（Platinum ring spacing）	mm	(L-1)mm（L is balloon effective length）	±10%	Asmbly integrated tolerances±10%， Reference pic 1.
Adapted to the maximum diameter of the guide wire	Inch	NA	NA	0.014in Guide wire pass through guide wire lumen smoothly（Wear into the tip，piercing out from fast switching port 5）
Max catheter OD in components	mm	1.0	±0.1	Proximal welding point
Catheter effective length	cm	142	±2	Reference pic 1.
Tip size	mm	2	±0.5	Reference pic 2. outside of crater