YY/T 1764-2021Standard guide for in vitro axial, bending, and torsional durability testing of vascular stents (English PDF)

Foreword

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

1 Scope

This standard specifies three independent cyclic deformation durability tests related to vascular stents. axial, bending and torsional. The three tests Both model the effect of non-radial arterial motion on stent durability that may originate from musculoskeletal activities, including walking and breathing, to and cardiac exercise.

This standard applies to balloon-expandable and self-expanding stents made of metal or alloys, including coated stents (e.g., with superficial stents), single polymer stents or absorbable stents, as well as stents for the treatment of aneurysmal disease, peripheral vascular injury, or to provide vascular access Endovascular prostheses (stent grafts), and this standard applies to the testing of the above-mentioned stents (or a representative part of the stents).

This standard does not apply to the testing of alternatives, although durability testing of alternatives (such as scaled-up partial support structures) may Provide useful information.

Note 1.This standard does not cover flat, local extrusion durability or multi-mode testing. Although this standard does not cover multimodal testing, the information described in the text can Help build multimodal tests.

Note 2.For the treatment of aneurysm disease, peripheral vascular injury, or other tubular products to provide vascular access can refer to this standard.

Note 3.This standard does not provide in vivo physiological deformation conditions for vascular stents. In these durability tests, develop and justify these boundary conditions (e.g. such as literature studies, in vivo studies, cadaveric studies or modeling of stent-vascular interactions) is the responsibility of the standard user. Other than that, it may be necessary to consider Conditions include vascular calcification, vascular taper, eccentric lesions, loading offsets (eg, motion), and vascular remodeling.

Note 4.This standard does not specify the specific properties of the test product.

2 Normative references

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

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.