YY/T 1764-2021 Active Industry standards-Medicine

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

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1764-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2021-09-06

Implement Date: 2022-09-01

Pages: 28 pages

Scope

This standard specifies three independent cyclic deformation durability tests related to vascular stents: axial, bending, and torsion. These three tests simulate the effects of non-radial arterial motion on stent durability, which may arise from musculoskeletal activities, including walking and breathing, as well as cardiac motion.
This standard applies to balloon-expandable and self-expandable stents made of metal or alloys, including coated stents (e.g., stents with a surface layer of added materials), single-polymer stents, or absorbable stents, as well as intravascular prostheses (covered stents) used to treat aneurysm diseases, peripheral vascular injuries, or provide vascular access, and these stents (or a representative part of the stents) are subject to testing.
This standard does not apply to the testing of substitutes, although durability tests of substitutes (e.g., scaled-down partial stent structures) can provide useful information.
Note 1: This standard does not address flat-panel, localized compression durability, or multimodal testing. Although this standard does not include multimodal testing, the information described herein can assist in establishing multimodal testing.
Note 2: Other tubular products used to treat aneurysm diseases, peripheral vascular injuries, or provide vascular access may refer to this standard.
Note 3: This standard does not provide in vivo physiological deformation conditions for vascular stents. In these durability tests, it is the responsibility of the standard users to develop and justify the reasonableness of these boundary conditions (e.g., literature research, in vivo studies, cadaver studies, or modeling of stent-vessel interactions). Other conditions that may need to be considered include vascular calcification, vascular taper, eccentric lesions, loading offsets (such as movement), and vascular remodeling.
Note 4: This standard does not specify the specific properties of the tested