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Medical Guidewire Flexibility Test System Manufacturer | ISO Standard Compliant

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Whats/App: +86 156 1874 6768

Web: standard-groups.com

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 ParameterSpecification
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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