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11.1 PTCA球囊扩张导管技术要求英文翻译

11.1 PTCA球囊扩张导管技术要求英文翻译
11.1 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 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 8368-2005 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, 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 YY0285.1-2004、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

2.英文翻译格式和要求

英文 小四号字,单倍行距,首行缩进2个字符,不能定义文档网格。约3千英文单词。 MCU Description SCM is also known as micro-controller (Microcontroller Unit), commonly used letters of the acronym MCU MCU that it was first used in industrial control. Only a single chip by the CPU chip developed from a dedicated processor. The first design is by a large number of peripherals and CPU on a chip in the computer system, smaller, more easily integrated into a complex and demanding on the volume control device which. INTEL's Z80 is the first designed in accordance with this idea processor, then on the development of microcontroller and dedicated processors have parted ways. 一、SCM history SCM was born in the late 20th century, 70, experienced SCM, MCU, SoC three stages. SCM the single chip microcomputer (Single Chip Microcomputer) stage, mainly seeking the best of the best single form of embedded systems architecture. "Innovation model" success, laying the SCM and general computer completely different path of development. In the open road of independent development of embedded systems, Intel Corporation contributed. MCU the micro-controller (Micro Controller Unit) stage, the main direction of technology development: expanding to meet the embedded applications, the target system requirements for the various peripheral circuits and interface circuits, highlight the object of intelligent control.It involves the areas associated with the object system, therefore,the development of MCU's responsibility inevitably falls on electrical, electronics manufacturers. From this point of view, Intel faded MCU development has its objective factors. In the development of MCU, the most famous manufacturers as the number of Philips Corporation. Philips company in embedded applications, its great advantage, the MCS-51 single-chip micro-computer from the rapid development of the micro-controller. Therefore, when we look back at the path of development of embedded systems, do not forget Intel and Philips in History. 二、Embedded Systems Embedded system microcontroller is an independent development path, the MCU important factor in the development stage, is seeking applications to maximize the solution on the chip; Therefore, the development of dedicated single chip SoC trend of the natural form. As the microelectronics, IC design, EDA tools development, application system based on MCU SoC design have greater development. Therefore, the understanding of the microcontroller chip microcomputer can be, extended to the single-chip micro-controller applications. 三、MCU applications SCM now permeate all areas of our lives, which is almost difficult to find traces of the field without SCM. Missile navigation equipment, aircraft, all types of instrument control, computer network communications and data transmission, industrial automation, real-time process control and data processing, extensive use of various smart IC card, civilian luxury car security system, video recorder, camera, fully automatic washing machine control, and program-controlled toys, electronic pet, etc., which are inseparable from the microcontroller. Not to mention the area of robot control, intelligent instruments, medical equipment was. Therefore, the MCU learning, development and application of the large number of computer applications and

办公室各部门英文翻译

办公室各部门英文翻译 关于办公部门英文翻译: 管理高层:.总公司:Head Office 董事室: Director's Office董事长室Chairman's Office 执行董事助理: The assistant of the executive director 总经理室:General Manager Office (总经理室:GM)财务总监CFO=chief finanical officer 开发部 Development Dept. 财务部Finance Dept. 财务部经理Finance Dept. Manager, 人事行政部: The Personnel Administratio Department人事行政部Personnel & Admin Dept. 秘书室Secretary Room 策划部Planning Dept. 预算部Budget Dept. 市场部Marketing Dept. 工程设计部Construction & Design Dept. 样品室 Sample Room 会议室Meeting Room 保卫室Safe-Guarder Room /Guard Room 策划部主管Supervisor/Director of Planning Department 传达室reception room 食堂工作间 Canteen workshop值班室Room on-duty 质量安全部 Quality Safety Department 部门经理办公室:Section manager's office 质量和安全部Quality & Safety Department 商务接待室:Business anteroom 会客室——Meeting Room 发行部——Publish Dept. 技术部——Technology Dept. 行政部——Administration 项目部——Project Dept. 设计部——Design Dept. 餐厅——Cafeteria 保安室——Guard Room 储藏室——Store Room 技术质量部 Technical quality department, 市场运行部market movement department, 设计开发部design development department VIP贵宾室 --VIP room 副总经理 ---Office of the general assistant manager 助理室---the office of the assistant 经理室---the office of the manager 会议室---the conference room 档案室 ---the file room 签约室一---Reception Room one 签约室二 ---Reception Room Two 签约室三--- Reception Room Three 更衣室---Dressing Room 办公室---office 储藏室---closet 财务部---accounting department 策划部---strategy department(division) 副总室 ---the office of vice president 营销部---the sales department 工程部--- engineering department 总师室--the office the general engineer 经理室---office of the manager 物业管理 ---property management 促销部 sales promotion Dept. 总务部 Gernal affairs Dept. 策划部,启化部.drafting barracks 营业部 Business Offices

ZigBee技术外文翻译

ZigBee:无线技术,低功耗传感器网络 加里莱格 美国东部时间2004年5月6日上午12:00 技师(工程师)们在发掘无线传感器的潜在应用方面从未感到任何困难。例如,在家庭安全系统方面,无线传感器相对于有线传感器更易安装。而在有线传感器的装置通常占无线传感器安装的费用80%的工业环境方面同样正确(适用)。而且相比于有线传感器的不切实际甚至是不肯能而言,无线传感器更具应用性。虽然,无线传感器需要消耗更多能量,也就是说所需电池的数量会随之增加或改变过于频繁。再加上对无线传感器由空气传送的数据可靠性的怀疑论,所以无线传感器看起来并不是那么吸引人。 一个低功率无线技术被称为ZigBee,它是无线传感器方程重写,但是。一个安全的网络技术,对最近通过的IEEE 802.15.4无线标准(图1)的顶部游戏机,ZigBee的承诺,把无线传感器的一切从工厂自动化系统到家庭安全系统,消费电子产品。与802.15.4的合作下,ZigBee提供具有电池寿命可比普通小型电池的长几年。ZigBee设备预计也便宜,有人估计销售价格最终不到3美元每节点,。由于价格低,他们应该是一个自然适应于在光线如无线交换机,无线自动调温器,烟雾探测器和家用产品。 (图1)

虽然还没有正式的规范的ZigBee存在(由ZigBee联盟是一个贸易集团,批准应该在今年年底),但ZigBee的前景似乎一片光明。技术研究公司 In-Stat/MDR在它所谓的“谨慎进取”的预测中预测,802.15.4节点和芯片销售将从今天基本上为零,增加到2010年的165万台。不是所有这些单位都将与ZigBee结合,但大多数可能会。世界研究公司预测的到2010年射频模块无线传感器出货量4.65亿美量,其中77%是ZigBee的相关。 从某种意义上说,ZigBee的光明前途在很大程度上是由于其较低的数据速率20 kbps到250 kbps的,用于取决于频段频率(图2),比标称1 Mbps的蓝牙和54的802.11g Mbps的Wi - Fi的技术。但ZigBee的不能发送电子邮件和大型文件,如Wi - Fi功能,或文件和音频,蓝牙一样。对于发送传感器的读数,这是典型的数万字节数,高带宽是没有必要,ZigBee的低带宽有助于它实现其目标和鲁棒性的低功耗,低成本。 由于ZigBee应用的是低带宽要求,ZigBee节点大部分时间可以睡眠模式,从而节省电池电源,然后醒来,快速发送数据,回去睡眠模式。而且,由于ZigBee 可以从睡眠模式过渡到15毫秒或更少主动模式下,即使是睡眠节点也可以达到适当的低延迟。有人扳动支持ZigBee的无线光开关,例如,将不会是一个唤醒延迟知道前灯亮起。与此相反,支持蓝牙唤醒延迟通常大约三秒钟。 一个ZigBee的功耗节省很大一部分来自802.15.4无线电技术,它本身是为低功耗设计的。 802.15.4采用DSSS(直接序列扩频)技术,例如,因为(跳频扩频)另类医疗及社会科学院将在保持一样使用它的频率过大的权力同步。 ZigBee节点,使用802.15.4,是几个不同的沟通方式之一,然而,某些方面比别人拥有更多的使用权力。因此,ZigBee的用户不一定能够实现传感器网络上的任何方式选择和他们仍然期望多年的电池寿命是ZigBee的标志。事实

信息技术英文缩写与解释

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数量。众所周知共析钢(T80)在超过723℃形成的是奥氏体,在此温度下形成的是珠光体。为了形成珠光体碳原子应该分散形成渗碳体。扩散是一个过程需要足够的时间来完成奥氏体向珠光体的转变。我们可以注意到在不同的样本内在任何的温度下数量都在发生变化。这些点被绘制在以时间和温度为轴的坐标内。通过这些点共析钢的变换曲线如图1所示。曲线的左极端代表在任何给定的温度下奥氏体向珠光体的转变。同样的右极端代表完成所需要的时间。这两个曲线之间转换的点代表部分转换。水平线条s M和f M发代表开始和完成的马氏体转变。 热处理工艺的分类 在某些情况下,热处理在技术和使用程序上是分开的。而在其他情况下,,描述或简单的解释是不够的,因为相同的技术常常可以获得不同的目标。例如,应力消除和回火需要相同的设备和利用相同时间和温度循环。然而这是两个不同的过程。 图8.1 T80钢在等温间隔下的热处理图 以下对热处理的描述主要是根据他们之间的关系来安排的。正火指加热铁合金到高于它转变温度上的一个合适温度(通常是50°F到100°F或28℃到56℃)。接下来是在精致空气至少是在低于其转变温度范围下冷却。由此产生的结构和性能和通过完全退火是一样的。对大多数铁合金来说正火和退火是不一样的。 正火通常被用作调节处理,尤其是没有经过高温锻造或其他热加工的精炼粒钢。正火的成功通常由另一个热处理来完成如奥氏体化的淬火、退火或回火。 退火是一个通用术语,它表示一个热处理,包括加热和保持在一个合适的温度后以一个合适的冷却速度冷却。它主要用来软化金属材料,但它同时也会产生其他属性或期望的微观结构。

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