Medical Guidewire Flexibility Test System Manufacturer | ISO Standard Compliant
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The Guidewires Tip Flexibility Tester is designed and manufactured in accordance with the relevant clauses of YY/T 1554-2017 and YY 0450.1-2003. It is specifically designed for testing the flexibility of interventional guidewires and catheters, and is suitable for determining the tip flexibility of various interventional guidewires and catheters.
Standards
FDA-16007 FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires –Performance Tests and Recommended Labeling
ISO 11070:Cardiovascular implants and extracorporeal systems — Balloon dilatation catheters
YY 0450.1-2003:Disposable sterile intravascular catheters — Part 1: General requirements
YY/T 1554-2017:Medical devices — Surface lubricious coatings — Test method for coefficient of friction
Features
1. Intelligent Operation: A large LCD screen displays the testing process in real time. Built-in standard testing programs enable one-click operation and automatic completion of the experiment.
2. High-Precision Sensors: Utilizes advanced displacement sensors to ensure accurate speed and displacement transmission, making testing more scientific and reliable.
3. Secure and Compliant Design: Supports hierarchical access control and password protection to prevent unauthorized operations and ensure data traceability.
4. Complete Data Output: Equipped with a mini printer, it can directly print information on test personnel, testing time, and results, ensuring complete retention of experimental records.
5. Personalized Upgrades: The system program supports ISP online upgrades and can provide customized services based on user needs.
Technical Parameters
| Technical Parameter | Specification |
|---|---|
| Testing Speed | It can be adjusted within a certain range, such as 3mm/min or 8mm/min. Some testers can reach 100mm/s and can be set arbitrarily with stepless speed regulation, and the speed accuracy can reach 0.01mm/s. |
| Displacement Range and Resolution | The displacement range is generally 0.001 - 40.000mm, and the displacement resolution is 0.001mm. |
| Force - measuring Mechanism | Mostly built - in, using high - precision force sensors. |
| Control System | Commonly, there is a PLC (Programmable Logic Controller). The operation interface is generally a color touch screen, which can be switched between Chinese and English. |
| Clamping Device | It is used to fix the guidewire tip to ensure the stable position of the guidewire during the testing process. It is generally made of high - quality materials such as 304 stainless steel. |
Accessoriess
The package includes: 1 main unit, 1 set of fixtures, 1 set of testing software, 1 set of sensors, 1 power cord, 1 instruction manual, 1 operation video, and 1 certificate of conformity.
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