Determination of longitudinal tensile strength (endovascular device)

Test samples coupons or the entire length of a catheter are chosen so that each tubular portion, each junction between hub or connector and tubing, and each junction between tubular portions is tested. A tensile force is applied to each test piece until the tubing breaks or the junction separates.

Test Procedure

The test specimen is gripped by the jaws of the tensile testing apparatus with its intended test region between the jaws. When required, appropriate fixture can be used to avoid deforming the hub or connector.
Placement of the test sample is inspected (no stretch or twist, or damage by the jaws, and slack to a minimum…).
Test specimen length between the jaws (gauge length) is measured and recorded.

If preloading is needed, the specimen is stretched with a uniform rate (sponsor defined) until an initial tensile force (sponsor defined) is reached.
The test specimen is stretched with a uniform rate as stated in the test protocol until the break point is reached (a tensile strain at a unit strain rate of 20 (mm/min)/mm of gauge length is recommended).

The load (T) and the rate of extension are continuously recorded.
The longitudinal tensile strength (the load at break Tmax) is recorded (in N).
At the end of the tests, depending on the protocol, the mean and standard deviation (SD) of the longitudinal tensile strength for tested samples could be calculated.

Equipment

  • Tensile testing machine: ZWICK 500N (measurement accuracy ±0.5%) having a constant rate of traverse (range 0.0005 to 3000 mm/min) and with appropriately sized round pins and suitable holders
  • A caliper (measurement accuracy ±0.03mm or measurement accuracy ±0.05mm)
  • Apparatus to measure the relaxed internal diameter: conical gauge
  • Calibrated thermometer (measurement accuracy ±0.1°C)
  • Calibrated Chronometer (measurement accuracy ±9s/24h)

Measured Parameters

Force –
• ±0.06N for forces between 0N and 20N
• ±0.30N for forces between 21N and 100N
• ±1.96N for forces between 101N and 500N

Displacement –
• ±0.02mm

Scope

  • PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
  • TAVI and TMVR delivery systems – functional performance during simulated use
  • Thrombectomy devices — functional performance during simulated use
  • Guidewires testing – functional performance during simulated use
  • Endoscopic devices – functional performance during simulated use
  • RF ablation catheters testing – functional performance during simulated use
  • Any interventional delivery systems – functional performance during simulated use

Service Levels

Applicable Standards

  • ISO 10555-1:2023
    Intravascular catheters — Sterile and single-use catheters
    Part 1: General requirements

  • FDA-16007
    FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

Related Tests

OLE2203


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