ISO 10555 Catheter Testing

ISO 10555 Catheter Testing

MSI Lab Product Workshops

Want to see the Machine Solutions testing equipment in action? You can book an in person or virtual Lab Day where the MSI Labs testing team works with you to identify a procedure and perform device-catheter testing. These Lab Days provide raw data same day, which is some of the fastest turn around available.

What is a balloon catheter?

Catheters or balloon catheters are devices used during minimally invasive interventional procedures to navigate the vasculature to target clinical sites for diagnosis or treatment procedures. Intravascular catheters have become essential to the practice of modern medicine by improving treatment methods, patient care, and quality of life. While catheter designs evolve and improve so to must the testing of these devices. Balloon catheters require rigorous functional and failure testing to ensure efficacy, safety, and performance.

Listed below are a variety of standard test methods our experienced team offers to evaluate the performance of Catheters, Balloon catheters, or accessory devices (guidewires, guide catheters, endoscopes, stents…). These test methods were designed following the outlined general requirements in the ISO 10555 and ISO 11070 standards, as well as the FDA 824 guidance document. All of MSI Labs contract testing follows Good Lab Practices and requires customer approval of study plans and protocols prior to performing testing.

Catheter & balloon test methods

There are a variety of methods used to evaluate the properties of catheters and balloons. ISO 10555 outlines general requirements for testing intravascular sterile use catheters. We offer comprehensive testing services for catheters according to FDA guidance document recommendations and ISO standards.

Simulated Use Testing

Utilizing MSI’s simulated use testing equipment, the IDTE, following stepped parameters that control and record insertion/withdraw- distance, speed, and delay MSI Labs quantitatively collect forces required to track a catheter or device through a tortuous path that mimics challenging in vivo physiologic/anatomic conditions.

Standard test methods include:

  • Simulated use
  • Lesion cross-ability force
  • Push efficiency
  • Catheter-guide wire compatibility
  • Flexibility/kink force
  • Bifurcation “kissing” stent force
  • Insertion force measurement
  • Preconditioning cycles

Related Standards and Guides:

  • ISO 10555
  • ISO 25539
  • ISO/TS15539
  • ASTM F2394

Torque Characteristics

Utilizing MSI’s simulated use testing equipment, the IDTE, following stepped parameters that control and record proximal rotational direction and speed MSI Labs quantitatively collect proximal forces and rotations while also recording distal forces or rotations.

Standard test methods include:

  • Torque strength
  • Rotational response
  • Torque to failure
  • Rotational Bond strength

Related Standards and Guides:

  • ISO 10555
  • ISO 25539
  • ISO/TS15539
  • ASTM F2394

Dimensional Analysis/ Verification

Utilizing calibrated measurement equipment, MSI Labs will analysis and record product measurements at specified locations as a standalone dimensional verification or pre and/or post simulated use or other testing method.

Related Standards and Guides:

  • ISO Standard 25539
  • ASTM F2081

Motorized Push/ Pull Tester

Utilizing our in-house Motorized push/ pull tester with data collection, MSI labs can control to move speed and distance while collecting force distance and speed data. This method of testing is for all ASTM and ISO linear tension and compression testing.

  • 3 point bend
  • Tension/ Compression
  • Tip stiffness
  • Packaging

Related Standards and Guides:

  • ISO Standard 25539
  • ASTM F2081
  • ASTM F2606

Stent Retention Testing

Utilizing MSI’s Stent Retention equipment, the SR1000, following stepped parameters that control and record retention diameter, distance, and speed MSI Labs quantitatively collect forces required dislodge a balloon expandable stent from the balloon catheter.

Standard test methods include:

  • Stent Securement

Related Standards and Guides:

  • ISO Standard 25539
  • ASTM F2394

Radial Expansion Testing

Utilizing MSI’s Radial expansion testing equipment, the RX650, following stepped parameters that control and record the Iris diameter and speed MSI Labs quantitatively collect the radial resistive forces and the Chronic outward forces that a stent experiences during a run process.

 

Standard test methods include:

  • Radial compression/expansion cycle testing
  • Stent deployment forces

Related Standards and Guides:

  • ISO 25539
  • ISO/TS15539
  • FDA guidance 1545

Balloon Burst, Leak, Compliance (HBLT) Testing

Our knowledge of Standards, Documents, and Guidelines is ever growing. Should you have need to test to something outside of the list below our expert team will be happy to work with you to develop a Study Plan and Protocol to meet your needs.

  • ISO 10555-1 Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements
  • ISO 10555-3 Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters
  • ISO 10555-4 Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters
  • ISO 10555-5 Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters
  • ISO 11070 Intravascular introducers – Sterile single-use, dilators and guidewires
  • ISO Standard 25539-1 Cardiovascular Implants – Endovascular Devices
  • ISO/TS15539 Cardiovascular Implants Endovascular Prostheses
  • ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing
  • ASTM F623 Standard Performance Specification for Foley Catheter
  • ASTM F2081 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
  • ASTM F2394 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
  • ASTM standard F3067 – 14 Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
  • ASTM F2606 – 08 Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
  • Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
  • Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices
  • Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
  • Title 21–Food and Drugs, Chapter I–Food and Drug Administration, Department of Health and Human Services, Subchapter A–General, Part 58–Good Labratory Practice for Conclinical Labratory Studies

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