YY/T 1660-2019Guide for radial loading of balloon expandable and self expanding vascular stents (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

This standard provides an in vitro laboratory test method for the radial load of balloon-expanded and self-expanding vascular stents. In vivo conditions may be different.

This standard does not recommend any specific method or measuring device for testing radial strength, collapse pressure or chronic abduction force, but provides Using the test method and equipment examples, the expression format of the test results is also recommended.

The basis for evaluating the radial strength of the balloon-expandable stent using the unloading line is given in Appendix A of this standard. The self-expanding branch is given in Appendix B. Example of a pulsation offset test for the rack.

This standard does not attempt to address all of the security issues involved, if any. It should be used in combination even if needed. Establish appropriate Safe and healthy operating practices, as well as explicit management of restricted permissions before application. This is the responsibility of the users of this standard. This standard adopts the International System of Units. Balloon expansion and self-expanding vascular stent Radial load test method

1 Scope

This standard specifies the development of a body that measures the radial strength or collapse pressure of a balloon-expandable vascular stent and the chronic extensor of a self-expanding vascular stent. Guidelines for external test methods.

This standard applies to balloon-expanded and self-expanding stents in tubular structures.

This standard applies to bare stents and stent grafts, but not for Bifurcated brackets and non-circular cross-section brackets or tapered brackets.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 10623-2008 Metallic material mechanical properties test terminology

GB/T 16825.1-2008 Inspection of static single-axis testing machines - Part 1. s. Inspection and calibration

YY/T 0694-2008 Standard test method for elastic retraction of balloon-expandable stents

YY/T 0808-2010 Standard test method for in vitro pulsation durability of vascular stents

3 Terms and definitions

The following terms and definitions apply to this document.