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YY/T 0858-2011: Standard guide for three-point bending of balloon expandable vascular stents and stent systems
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YY/T 0858-2011	English	259	Add to Cart	3 days [Need to translate]	Standard guide for three-point bending of balloon expandable vascular stents and stent systems

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

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Standard guide for three-point bending of balloon expandable vascular stents and stent systems ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Balloon dilatation of vascular stents and stent systems Three-point bending test method Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard reference method using redrafted ASTMF2606-2008 "balloon-expandable stent and stent system three-point bending test side Law "prepared. Technical differences between this standard and ASTMF2606-2008 follows. --- Deleted the Chapter 10, "keyword"; --- In Appendix X1 to Appendix A, remains unchanged. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the State Food and Drug Administration. This standard by the national orthopedic implants and surgical instruments cardiovascular implants Standardization Technical Committee Technical Committee (SAC/TC110/SC2) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, minimally invasive medical devices (Shanghai) Limited. The main drafters of this standard. Jiaoyong Zhe, Fan platinum, Qibao Fen Song Duo, Li Libin, Sun Bing, Shi repetition frequency, Li Yong. Balloon dilatation of vascular stents and stent systems Three-point bending test method

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. 2.1 Bending flexibility bendingflexibility Flexural properties of the sample. 2.2 Bending stiffness bendingstiffness Bending resistance of the test sample. 2.3 Adaptability conformability The degree of stent or stent systems for vascular system with natural curvature. 2.4 Deflection deflection Test any time dynamically loaded displacement member (load element). 2.5 Delivery system deliverysystem The stent delivery catheter target location and release the stent. Balloon-expandable stent delivery system can be used in similar revascularization Balloon dilatation catheter. 2.6 Span moment midspanbendingmoment Span moment intermediate position (see 8.5). 2.7 Cross curvature midspancurvature Span the middle of curvature (see 8.5). ...