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1、Technical requirements for medical device product registration number：Disposable Sterile PTCA balloon catheter1、Model / Specifications and divide instructions1、1 Model PTCA-XX-XXBalloon Working Length mmBalloon nominal Diameter mmProduct Name CodeModel mark example：PTCA2.010 represents balloon nomin
2、al outer diameter is 2.0mm and working length is 10mm of disposable Sterile PTCA balloon catheter1、2 Specifications PTCA balloon catheter specification listSpecifications OD LengthThe effective length of the catheterMax guide wire diameter Nominal pressure RBPDK-PTCA-1.5-10 1.50mm 10mm 142cm 0.014in
3、 8ATM 16ATMDK-PTCA-1.5-20 1.50mm 20mm 142cm 0.014in 8ATM 16ATMDK-PTCA-1.5-30 1.50mm 30mm 142cm 0.014in 8ATM 16ATMDK-PTCA-1.75-10 1.75mm 10mm 142cm 0.014in 8ATM 16ATMDK-PTCA-1.75-20 1.75mm 20mm 142cm 0.014in 8ATM 16ATMDK-PTCA-1.75-30 1.75mm 30mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.0-10 2.00mm 10mm 142c
4、m 0.014in 8ATM 16ATMDK-PTCA-2.0-20 2.00mm 20mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.0-30 2.00mm 30mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.5-10 2.50mm 10mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.5-20 2.50mm 20mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.5-30 2.50mm 30mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.75-10 2.75mm 10
5、mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.75-20 2.75mm 20mm 142cm 0.014in 8ATM 16ATMDK-PTCA-2.75-30 2.75mm 30mm 142cm 0.014in 8ATM 16ATMDK-PTCA-3.0-10 3.00mm 10mm 142cm 0.014in 8ATM 16ATMDK-PTCA-3.0-20 3.00mm 20mm 142cm 0.014in 8ATM 16ATMSpecifications OD LengthThe effective length of the catheterMax gui
6、de wire diameter Nominal pressure RBPDK-PTCA-3.0-30 3.00mm 30mm 142cm 0.014in 8ATM 16ATMDK-PTCA-3.5-10 3.50mm 10mm 142cm 0.014in 6ATM 16ATMDK-PTCA-3.5-20 3.50mm 20mm 142cm 0.014in 6ATM 16ATMDK-PTCA-3.5-30 3.50mm 30mm 142cm 0.014in 6ATM 16ATMDK-PTCA-4.0-10 4.00mm 10mm 142cm 0.014in 6ATM 16ATMDK-PTCA-
7、4.0-20 4.00mm 20mm 142cm 0.014in 6ATM 16ATMDK-PTCA-4.0-30 4.00mm 30mm 142cm 0.014in 6ATM 16ATM1、3 Divide instructionsDisposable Sterile PTCA balloon catheter consists of balloon, connecting catheter, tip, support catheter and Handle. According to different balloon diameter to divide the balloon into
8、 different specifications and sizes. According to medical device classification rules 6877, the balloon catheter belonging to Class interventional equipment intravascular catheter.2、Performance2、1 AppearanceAs with normal vision or corrected vision at a magnification of 2.5 times the conditions of i
9、nspection, 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 oi
10、l (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
11、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 requirements2.2.1 Balloon catheter size requirements reference table1, specification list reference table 2.1、Tip 2、Balloon 3、Radiopaque ring 4、
12、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 lengthPic 1. PTCA balloon catheter schematicPic 2. Tip schematicTable 1 disposable Sterile PTCA balloon catheter size an
13、d tolerance requirementsName Unit Standard Tolerance RemarkBalloon diameter under nominal pressuremm D 0.125Balloon effective length mm L 10%Radiopacity Length（Platinum ring spacing）mm (L-1)mm（L is balloon effective length）10% Assembly integrated tolerances10%，Reference pic 1.Adapted to the maximum
14、diameter of the guide wireInch 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 componentsmm 1.0 0.1 Proximal welding pointCatheter effective length cm 142 2 Reference pic 1.Tip size mm 2 0.5 Reference pic 2.
15、 outside of crater2.2.2 Tapered connectorConnector of balloon catheter must be tapered connector. Size should be consistent with GB / T 1962.1-2001 requirements.2.3 Physical properties2.3.1 Breaking forceBreaking strength of each test section shall comply with the requirements of Table 3.Table 3 Cat
16、heter test section breaking forceMin OD of catheter test section /mmMinimum breaking force /N0.550.550.750.751.151.151.851.851.38351015Note: YY0285.1-2004 did not make provisions for the breaking force which catheter OD is less than 0.55mm.2.3.2 Leakagea) 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 b
