YY/T 0858-2011Standard guide for three-point bending of balloon expandable vascular stents and stent systems (English PDF)

Foreword

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

The standard reference method using redrafted ASTM F2606-2008 "balloon-expandable stent and stent system three-point bending test side Law "prepared. Technical differences between this standard and ASTM F2606-2008 follows.

--- Deleted the Chapter 10, "keyword";

--- In Appendix X1 to Appendix A, remains unchanged.

1 Scope

The standard three-point bending test quantitative characterization compliant balloon-expandable stent and stent system to provide guidance. The standard for table Zheng has eluting stent flexibility and unreleased supple stent system stent and the balloon region.

This standard does not apply to diameter ratio of the sample holder and the span of less than 4 to 1, use other methods to assess such sample.

This standard does not provide for the characterization of self-expanding stents, self-expanding stent system stent implantation (stent - graft) or built-in stand system Bending compliance steps. However, the standard may provide some useful content to help develop these products to characterize three-point bending method.

Although this standard is based on vascular stents and stent systems, but for non-vascular stents and balloon-expandable stent bending flexibility of the system Characterization, this standard may also provide a reference.

This standard uses the International System of Units. Values in parentheses is the inch - pound units under the corresponding value for reference purposes only.

2 Terms and definitions

The following terms and definitions apply to this document.