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Medical Device Testing Equipment - Guidewire Fracture Fixture

Guidewire Fracture Fixture

Manual Test Fixture for Evaluating the Structural Integrity of Medical Guidewires

ToronMed-GFF01 Guidewire Fracture Fixture is designed to evaluate the fracture resistance and durability of intravascular guidewires. The test simulates clinical conditions where the guidewire is wound around a cylindrical former, then unwound and visually inspected for signs of fracture or structural failure.

This compact, precision-machined fixture is ideal for R&D labs, quality control departments, and medical device testing facilities focused on compliance with international performance standards.

Applications

Application Area Test Objective
Intravascular Guidewires Fracture resistance evaluation
Catheter Guidewires Structural durability under mechanical stress
Manufacturing QA Verification of guidewire performance
Guidewire Fracture Fixture

Test Method

The guidewire is manually wound around a cylindrical former with a diameter defined by ISO 11070 (10× the wire’s outer diameter). After winding, the guidewire is carefully unwound and examined visually or under magnification to assess fracture points or material fatigue. This method ensures compliance with guidewire integrity requirements for safe clinical use.

Standards Compliance

The ToronMed-GFF01 complies with relevant international standards for medical guidewire testing, including:

  • ISO 11070 – Sterile, single-use intravascular catheter introducers, dilators, and guidewires – Test methods and requirements
  • Designed in reference to the principles of YY0450.1-2020

Materials & Construction

  • Made from high-grade 304 stainless steel
  • Non-corrosive, precision-machined components
  • Easy-to-clean and designed for long-term durability in lab environments

How Can We Help You?

Contact our sales team for a quotation.

Key Features

  • Cylindrical Former: The diameter of the cylinder is equal to 10× the outer diameter of the guidewire under test
  • Adjustable Bracket System: Rigid support structure holds both ends of the cylinder securely during testing
  • Guidewire Clamping Fixture: Securely clamps the head end of the guidewire for stable winding and unwinding
  • Standardized Test Range: Supports common guidewire sizes including:
  • 0.30 mm, 0.35 mm, 0.46 mm, 0.53 mm, 0.64 mm, 0.69 mm, 0.71 mm, 0.81 mm, 0.89 mm, 0.97 mm, 1.14 mm, 1.19 mm, 1.27 mm
  • Constructed from 304 Stainless Steel: Corrosion-resistant and easy to clean
Quote Form
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