PTCA球囊扩张导管关键技术要求英文翻译.doc

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 represents 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 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
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%
Assembly integrated tolerances±10%，
Reference pic 1.
Radiopacity Length（Platinum ring spacing）
mm
(L-1)mm（L is balloon effective length）
±10%
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
2.2.2 Tapered connector
Connector of balloon catheter must be tapered connector. Size should be consistent with GB / T 1962.1- requirements.
2.3 Physical properties
2.3.1 Breaking force
Breaking strength of each test section shall comply with the requirements of Table 3.
Table 3 Catheter test section breaking force
Min OD of catheter test section /mm
Minimum breaking force /N
<0.55
≥0.55~<0.75
≥0.75~<1.15
≥1.15~<1.85
≥1.85
1.38
3
5
10
15
Note：YY0285.1- did not make provisions for the breaking force which catheter OD is less than 0.55mm.

2.3.2 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.
b)In the continuous process of the suction，air should not enter into the assembly part of catheter. This requirement adapt before hydrated and after hydrated.
2.3.3 Ray detectability
Radiopaque ring should be visible under proven imaging technology which in the clinical use.
2.3.4 Tip configuration
In order to reduce damage to blood vessels during the use process，the end of tip should be smooth and have a taper or there is a certain process or via similar finishing.
2.3.5 Particulate pollution
Balloon catheter production should under the min particulate pollution conditions，inner and out surface of catheter should be clean and pollution index shall comply with the requirements of GB 8368- in Chapter 6.1.
2.3.6 Non-hydratable
Changes of effective before and after hydration should not exceed 4mm or 1% higher than before hydration（Take min）；and max OD changes before and after hydration should not exceed 10%of max OD.
2.4 Chemical properties
2.4.1 Corrosion resistance
Shall comply with the requirements 4.4 of YY 0285.1-.
2.4.2 Reducing substance（Readily oxidizable substance）
The volume difference between test liquid and blank liquid consume potassium permanganate solution [c (KmnO4) = 0.002mol / l] shall not exceed 2.0ml.
2.4.3 c
The total content of barium，chromium，copper，lead，tin in the test liquid should not exceed 1μg / ml,Cadmium content should not exceed 0.1μg / ml.
2.4.4 PH
The difference between test pH value and the control of pH value should be less than 1.5.
2.4.5 Residual ethylene oxide
Residual ethylene oxide of balloon catheter should not more than 10ug/g.
2.4.6 Balloon catheter should be sterile.
2.4.7 Balloon catheter endotoxin content should not exceed 2.15EU each.

3. Test Method
3.1 Appearance
With normal or corrected vision at 2.5 times magnification inspection，It should meet the requirements of 2.1.
3.2 Size and color
With general gauge for testing，color with visual. It should meet the requirements of 2.2.
3.3 Physical properties
3.3.1 Breaking force
The method according to YY 0285.1- / given in Appendix B，and it shall comply with the requirements of 2.3.1.
3.3.2 Leakage
a) The method according to YY 0285.1- given in Appendix C，and it shall comply with the requirements of 2.3.2 a.
b) The method according to YY 0285.1- given in Appendix D，and it shall comply with the requirements of 2.3.2 b.
3.3.3 Ray detectability
Using hospital conventional method to perform film.
3.3.4 Tip configuration
With normal or corrected vision at 2.5 times magnification inspection.
3.3.5 Particulate pollution
The method according to GB 8368- given in Appendix A.1 chapter，the results should meet the requirements of 2.3.5.
3.3.6 Non-hydratable
According to YY 0285.1- specified in 3.9，immerse balloon catheter into（37℃±1℃） two hours and then measure the size，it shall comply with the requirements of 2.3.6.
3.4 Chemical properties
Preparation of test solution according to GB / T14233.1- Chapter 4.3，paragraph 6 a table in the provisions。
3.4.1 Corrosion resistance
Carried out according to the method given in Appendix A of YY 0285.1-,it should meet the requirements of 2.4.1。
3.4.2 Reducing substance（Readily oxidizable substance）
Test in accordance with GB / T14233.1- provisions of Chapter 5.2.2 ,it shall comply with the requirements of 2.4.2.。
3.4.3 Metal ion
Test in accordance with GB / T14233.1- provisions of Chapter 5.9.1,it shall comply with the requirements of 2.4.3.
3.4.4 PH
Test in accordance with GB / T14233.1- provisions of Chapter 5.4.1,it shall comply with the requirements of 2.4.4.
3.4.5 Residual ethylene oxide
Test in accordance with GB / T14233.1- provisions of Chapter 9，it shall comply with the requirements of 2.4.5.
3.4.6 Sterile
Test in accordance with GB / T14233.2- provisions of Chapter 3，it shall comply with the requirements of 2.4.6.
3.4.7 Bacterial endotoxin
Experiments conducted in accordance with Part IV 14233.2- recommended test methods ,it shall comply with the requirements of 2.4.7.

4、Term
During the using process of disposable Sterile PTCA balloon catheter，First，transport the guide wire to the lesion location，then penetrate the end of guide wire from the tip and pierce out from guide wire lumen. Then under the X-ray image to observe the radiopaque ring which along the guide wire delivery the catheter to the lesion. The catheter tip connect to the pressure pump and give the pressure to the catheter. Thereby filling the balloon under the folded state，Prop up the lesion，after repeated evacuation filling，observe that the effect is suitable，then withdrawal the catheter and guide wire. To achieve the purpose of clear the blood vessels.
Disposable Sterile PTCA balloon catheter consists of stainless steel support rods，balloon，Balloon connecting catheter，balloon tip，guide wire lumen，taper connector. Disposable sterile PTCA balloon catheter made of medical polymer materials，the main raw material for is medical nylon，PC particles pellets and stainless steel. Raw materials for its products have been widely used. Such as single-use medical equipment，its safety has been demonstrated.
According to the provisions of "People's Republic of China Standardization Law"，"People's Republic of China Product Quality Law" ,"Supervision and Regulation of Medical Devices" and YY0285.1-、YY0285.4-1999，in order to standardize the technical characteristics of the product，to ensure product safety and effective，Formulated registered product standards as its basis in the production，testing and marketing. Criteria are as follows：
GB 191- Packing and storage diagram
GB/T 1962.1- Syringes，needles and other medical equipment - 6% (Luer) taper fittings - Part 1：General requirements
GB/T 2828.1- Sampling procedures for inspection - Part 1：by acceptance quality limit (AQL) retrieval batch inspection sampling plan
GB/T 2829- Periodic inspection Sampling procedures and tables (suitable for process stability test)
GB/T 8368 - Disposable infusion Gravity infusion formula
GB/T 14233.1- Infusion，transfusion，injection equipment part I：Chemical analysis methods
GB/T 14233.2- Infusion，transfusion，injection equipment testing methods Part II：Bioanalytical Method
GB/T 16886.1- Biological evaluation of medical devices - Part 1：Evaluation of the risk management process and Test
GB/T 16886.4- Biological evaluation of medical devices - Part 4：Selection of tests for interactions with blood
GB/T 16886.5- Biological evaluation of medical devices - Part 5：vitro cytotoxicity tests
GB/T 16886.7-1998 Biological evaluation of medical devices - Part 7：Ethylene oxide sterilization residuals
GB/T 16886.10- Biological evaluation of medical devices - Part 10：stimulation and delay hypersensitivity test
GB/T 16886.11-1997 Biological evaluation of medical devices - Part 11：Tests for systemic toxicity
GB/T 16886.12- Biological evaluation of medical devices - Part 10：Sample preparation and reference sample
GB 19335- Trail use disposable products General technical requirements
YY 0285.1- Sterile single-use intravascular catheters - Part 1：General requirements
YY 0285.4-1999 Sterile single-use intravascular catheters - Part 4：Balloon catheters
YY/T 0313-1998 Packaging，labeling，transportation and storage for Medical Polymer products
YY/T 0663- Active surgical implants Particular requirements for cardiac and vascular implants Requirements for arterial stents
YY/T 0698.5- Terminally sterilized medical devices packaging materials - Part 5：Requirements and test methods for sealable bags and coil combination which consist of breathable material and plastic film

Preparation instructions

According to "Supervision and Regulation of Medical Devices"，"Medical Devices standard management approach" formulate the "technical requirements"，regard its as the basis for the production，testing and marketing
The preparation format of "technical requirements" implement the GB / T 1.1- "Standardization Guide Part 1 standard structure and writing rules" and "registered medical equipment product standards the preparation of specifications."
The "technical requirements" is reference the industry-standard YY0285.1- "Sterile single-use intravascular catheters - Part 1：General requirements" and YY0285.4-1999 "sterile single-use intravascular catheters - Part 4：Ball refinement prepared on the basis of balloon catheter "to be made.
The "technical requirements" as the quality basis for the production，testing，and marketing of disposable sterile PTCA balloon catheter.

Intuit Medical，LLC
Sep,18th,