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| YY/T 0858-2011 | English | 259 |
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Standard guide for three-point bending of balloon expandable vascular stents and stent systems
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YY/T 0858-2011
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Basic data
| Standard ID | YY/T 0858-2011 (YY/T0858-2011) |
| Description (Translated English) | Standard guide for three-point bending of balloon expandable vascular stents and stent systems |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C35 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 11,160 |
| Date of Issue | 2011-12-31 |
| Date of Implementation | 2013-06-01 |
| Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies the balloon-expandable stent and stent system flexibility. This standard has been released for the characterization of the stent flexibility and does not release the stent and balloon stent system regional flexibility. This standard does not apply to stent diameter ratio of less than 4: 1 and the span of the sample, use other methods to assess such samples. |
YY/T 0858-2011: Standard guide for three-point bending of balloon expandable vascular stents and stent systems
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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).
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