股市加杠杆如何操作 导管导丝破裂测试夹具工装（Catheter Guide Wire Rupture Testing Fixture）

发布日期：2025-01-04 00:04    点击次数：164

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医疗器械类（Medical Device Category）

导管导丝破裂测试夹具工装（Catheter Guide Wire Rupture Testing Fixture）

执行标准：

YY0450.1-2020 一次性使用无菌血管内导管辅件

第1部分:导引器械

Execution Standards:

YY0450.1-2020 Disposable sterile intravascular catheter accessories

Part 1: Guiding Instruments

技术参数：

1.圆柱体,其直径是导丝最大外径D(见82)的10倍。可用适当的基于风险的临床论证(见图F1中1)使用不同直径的圆柱体。

2.支撑架用于支撑圆柱体的两端(见图F1中3)。

3.固定点,圆柱体上的孔(见图F1中4)用于固定导丝(见图F1中2)。

4.将圆柱体(F21)装入支撑架(F22)内

5.将导丝末端插入圆柱体(F23)的孔中固定导丝。转第一圈时握持住。

6.通过转动手柄并握紧导丝将导丝紧紧地缠绕在圆柱体上。至少缠绕完整的八圈，有适当的基于风险的临床论证也可减少编绕圈数。

7.展开导丝并检查由此引起的破裂。在固定处和第一圈上产生的破裂不计；

8.夹具规格：外径2.54/9.65/4.06/5.33/3.56/4.57/8.89/6.36/3.05不锈钢制造;

Technical Parameters:

1. A cylinder with a diameter 10 times the maximum outer diameter D (see 82) of the guide wire. Appropriate risk-based clinical evidence (as shown in Figure F1, 1) can be used to demonstrate the use of cylinders of different diameters.

2. The support frame is used to support the two ends of the cylinder (see Figure 3 in F1).

3. Fixed point, the hole on the cylinder (see Figure 4 in F1) is used to fix the guide wire (see Figure 2 in F1).

4. Install the cylinder (F21) into the support frame (F22)

5. Insert the end of the guide wire into the hole of the cylinder (F23) to fix the guide wire. Hold onto it during the first lap.

6. Tightly wrap the guide wire around the cylinder by turning the handle and gripping it tightly. At least eight complete loops should be wrapped, and appropriate risk-based clinical evidence can also reduce the number of loops.

7. Unfold the guide wire and check for any rupture caused by it. Breaks occurring at the fixed location and the first circle are not considered;

8. Fixture specifications: outer diameter 2.54/9.65/4.06/5.33/3.56/4.57/8.89/6.36/3.05 made of stainless steel;

原理：

将导丝缠绕在一圆柱形模型上，然后展开并检查破裂情况，完全符合YY0450.1-2020标准中相关条款设计制造。

Principle:

Wrap the guide wire around a cylindrical model, then unfold and inspect for breakage, fully complying with the relevant provisions of YY0450.1-2020 standard for design and manufacturing.

应用领域：

医疗器械领域：在医疗器械行业中，导管导丝破裂测试夹具工装主要用于测试导引管导丝在手术器械和植入器械中的破裂性能。通过模拟导引管导丝在实际使用中受到的拉伸、弯曲、扭曲等外力，评估其在手术过程中能否承受这些外力而不破裂，从而确保其在手术过程中的安全性和可靠性‌。

工业制造领域：在工业制造领域，导管导丝破裂测试夹具工装同样发挥着重要作用。它用于测试导引管导丝在工业设备和机械中的破裂性能，确保其在工业应用中的稳定性和可靠性‌。

科研和教学领域：此外，导管导丝破裂测试夹具工装还广泛应用于科研和教学领域。科研人员可以利用该工装进行实验研究，获取直观的实验数据和测试结果，而学生则可以通过实际操作了解导引管导丝的破裂测试过程，增强对相关知识的理解和掌握‌。

Application Areas:

In the field of medical devices: In the medical device industry, the Catheter Guide Wire Rupture Testing Fixture is mainly used to test the rupture performance of guide catheter guide wires in surgical instruments and implant instruments. By simulating the external forces such as tension, bending, and twisting experienced by the guide tube guide wire during actual use, evaluate whether it can withstand these external forces without breaking during the surgical process, thereby ensuring its safety and reliability during the surgery.

In the field of industrial manufacturing, the Fixture For Testing Catheter Guide Wire Rupture also plays an important role. It is used to test the rupture performance of guide tubes and wires in industrial equipment and machinery, ensuring their stability and reliability in industrial applications.

Research and teaching fields: In addition, the Fixture For Testing Catheter Guide Wire Rupture is widely used in research and teaching fields. Researchers can use this tool for experimental research, obtaining intuitive experimental data and test results, while students can understand the rupture testing process of guide tubes and wires through practical operation, enhancing their understanding and mastery of relevant knowledge.

功能：

‌导管导丝破裂测试夹具工装的主要功能是检测导丝在特定条件下的破裂情况，确保其在使用过程中能够承受预期的机械应力，从而保证其安全性和可靠性。

Function:

The main function of the Catheter Guide Wire Rupture Testing Fixture is to detect the rupture of the guide wire under specific conditions, ensuring that it can withstand the expected mechanical stress during use, thereby ensuring its safety and reliability.

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夹具规格：外径2.54/9.65/4.06/5.33/3.56/4.57/8.89/6.36/3.05不锈钢制造数量各1件

Auxiliary Tools:

Fixture specifications: Outer diameter 2.54/9.65/4.06/5.33/3.56/4.57/8.89/6.36/3.05 Stainless steel manufacturing quantity: 1 piece each股市加杠杆如何操作

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