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PTCA球囊扩张导管技术要求英文翻译

PTCA球囊扩张导管技术要求英文翻译
PTCA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—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

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

Connector of balloon catheter must be tapered connector.Size should be consistent with GB / T 1962.1-2001 requirements. 2.3 Physical properties 2.3.1 Breaking force

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

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 visibleunderproven 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 besmooth 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 8368-2005 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 0285.1-2004.

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.

2.4.7Balloon 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 0285.1-2004 / 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 0285.1-2004 given in Appendix C, and it shall comply with the requirements of 2.3.2 a.

b) The method according to YY 0285.1-2004 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 8368-2005 given in Appendix A.1 chapter, the results should meet the requirements of 2.3.5.

3.3.6 Non-hydratable

According to YY 0285.1-2004 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 / T14233.1-2008 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 0285.1-2004,it should meet the requirements of 2.4.1。

3.4.2 Reducing substance(Readily oxidizable substance)

Test in accordance with GB / T14233.1-2008 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 / T14233.1-2008 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 / T14233.1-2008 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 / T14233.1-2008 provisions of Chapter 9, it shall comply with the requirements of 2.4.5.

3.4.6 Sterile

Test in accordance with GB / T14233.2-2005 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 14233.2-2005 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, thenpenetrate 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 ofclear 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 YY0285.1-2004、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 191-2008 Packing and storage diagram

GB/T 1962.1-2001 Syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 1: General requirements

GB/T 2828.1-2003 Sampling procedures for inspection - Part 1: by acceptance quality limit (AQL) retrieval batch inspection sampling plan

GB/T 2829-2002 Periodic inspection Sampling procedures and tables (suitable for process stability test)

GB/T 8368 -2005 Disposable infusion Gravity infusion formula

GB/T 14233.1-2008 Infusion, transfusion, injection equipment part I: Chemical analysis methods

GB/T 14233.2-2005Infusion, transfusion, injection equipment testing methods Part II: Bioanalytical Method

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation of the risk management process and Test

GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

GB/T 16886.5-2003 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 16886.10-2005 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 16886.12-2005 Biological evaluation of medical devices - Part 10: Sample preparation and reference sample

GB 19335-2003 Trail use disposable products General technical requirements

YY 0285.1-2004 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 0663-2008 Active surgical implants Particular requirements for cardiac and vascular implants Requirements for arterial stents

YY/T 0698.5-2009 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 1.1-2009 "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 YY0285.1-2004 "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,2014

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翻译时间格式新要求(必看)

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中英文对照版合同翻译样本

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毕业论文外文文献翻译 院 年级专业: 2009 级XXXXXXXXXXX 姓 名:学 号:附 件: 备注:(注意:备注页这一整页的内容都不需要打印,看懂了即可)

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the theoretic framework, this paper takes WONG LO KAT and JIA DUO BAO herbal tea as an example, and researches the strategy on brand positioning and relevant marketing mix of it. Through analysis on the prevention sense of WONG LO KAT herbal tea, it was positioned the beverage that can prevent excessive internal heat in body, a new category divided from the beverage market. the process of brand positioning of it in Consumers brain was finished. Based on this positioning strategy, WONG LO KAT reasonably organized and arranged its product strategy, price strategy, distribution strategy and promotion strategy, which not only served for and further consolidated the position of preventing excessive internal heat in body, but also elevated the value of brand. The JDB and WONG LO KAT market competition brings us enlightenment. Reference the successful experience from the JDB and lessons from the failure of the WONG LO KAT.,Times New Roman. 【Key Words】Brand positioning; Marketing mix; Positioning Strategy; enlightenment, lessons;ABC (本页为英文文献摘要,关键词两项一起单独一页,字体为:Times New Roman,小四号,1.5倍行距)

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