Crossing Profile

A measurement of the maximum diameter over the length of the delivery system, from the proximal end of the mounted stent to the distal tip.

Test Procedure

With the stent pre-mounted or hand crimped on the delivery system in accordance with the instructions for use, and the sheath (if any) in place, measure the maximum diameter over the length from the proximal end of the mounted stent to the distal tip of the delivery system.

Equipment

The measurement instrument is a non-contacting calibrated optical system.

Measured Parameters

Diameter of the length of the device.

Service Levels

Applicable Standards

  • ASTM F2081 – 06(2017) 
    Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

  • ISO 10555-5:2013
    Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters

  • ISO 25539-2:2020
    Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

OLE1208, OLE1209


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