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YY/T 0859-2011Standard guide for finite element analysis(FEA) of metallic vascular stents subjected to uniform radial loading (English PDF)

均匀径向载荷下金属血管支架有限元分析方法指南

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY/T 0859-2011 is the English-translated version of 均匀径向载荷下金属血管支架有限元分析方法指南.

YY/T 0859-2011 is the Chinese pharmaceutical industry standard that sets the general requirements for the finite element modelling and analysis of a metallic vascular stent subjected to uniform radial loading, the method by which the performance of a stent design under such a load is assessed.

It provides the way that assessment is made for a uniform radial load and for a pulsatile load, covering the model and its mesh, the material properties, the boundary conditions, the validation of the model and the reporting of the results. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY/T 0859-2011

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C 35

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Terms and definitions

Foreword

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

The standard reference method using redrafted ASTM F2514-2008 "under uniform radial load metal stent finite element analysis Guide "prepared.

This standard compared with ASTM F2514-2008, technical content unchanged, the main differences are as follows.

--- According to Chinese customs for some formatting has been modified;

--- Some will apply to US standards formulation to apply our standard formulation;

Chapter 11 --- delete "key words." 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.

1 Scope

This standard specifies the metal stent finite element modeling and analysis of the general requirements, the finite element analysis method used to assess the uniform Radial load performance under the metal stent design. This standard provides an assessment of metal stent subjected to a uniform radial load and pulse load Recommended guidelines for these typical behavior. This standard also proposed for validation and verification procedures recommended finite element model, these programs side The same method can be used to assess and analyze the results of the model itself. Finally, this standard lists the simulation of such mechanical engineering report should include specific content.

This standard only applies to the following types of metal stents finite element structural analysis. plastic deformation of metal stents, self-expanding metal stents, coated Generation stent plastically deformed metal parts, the metal part of the self-expanding stent graft.

The standard technique described mainly for elastic-plastic material (such as stainless steel) and super-elastic material (such as Nitinol). This standard does not address Specific content and shape memory properties of the stent-related.

This standard does not address may change over time or conditions associated with revascularization load conditions change.

This standard applies only to uniform radial loading conditions.

This standard does not provide guidance in terms of the fatigue life of the finite element analysis.

This standard does not include a complete description of the finite element method and its theoretical basis and calculation formulas.

This standard is used in the international system of units, the value in parentheses is for reference only.

2 Terms and definitions

The following terms and definitions apply to this document.

2.1 Balloon-expandable stent baloonexpandablestent

A progressive expansion of the stent at the treatment site by a balloon catheter. The role of the stent balloon is plastically deformed, so that the bracket After the balloon relief can still maintain expansion.

2.2 Conceptual Model

In order to study and analyze a physical description of the system and the establishment of mathematical models and formulas of this system.

2.3 Model computationalmodel

Conceptual model of software running.

2.4 Pressure grip crimp

The bracket in the delivery system (catheter) in the expansion of the delivery device (such as a balloon) on or fixed by radial compression.

2.5 Delivery system

A stent delivery to the target location and complete mechanical device expansion.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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