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YY/T 0859-2011: Standard guide for finite element analysis (FEA) of metallic vascular stents subjected to uniform radial loading
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0859-2011 | English | 329 |
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Standard guide for finite element analysis (FEA) of metallic vascular stents subjected to uniform radial loading
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YY/T 0859-2011
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Basic data | Standard ID | YY/T 0859-2011 (YY/T0859-2011) | | Description (Translated English) | Standard guide for finite element analysis (FEA) of metallic vascular stents subjected to uniform radial loading | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,144 | | 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 metal stent finite element modeling and analysis of the general requirements, this finite element analysis method for evaluating uniform radial load metal stent design performance. This standard specifies the assessment of metal stents subjected to a uniform radial load and pulse loads typical behavior of these recommended guidelines. This standard also proposed to confirm and validate the finite element model recommended procedures, which method can also be used to assess and analyze the results of the model itself. Finally, this standard lists that kind of mechanical simulation project report should contain specific content. This standard applies only to the following types of metal stents finite element structural analysis: plastic deformation of metal stents, self-expanding metal stents, stent grafts produced plastic deformation of the metal part of the self-expanding stent metal parts. The techniques described in this standard mainly for plastic materials (eg stainless steel) and super-elastic material (such as nickel titanium alloy). This standard does not involve the bracket shape memory performance for specific content. This standard does not address the conditions may change over time or with changes in load revascularization related conditions. This standard applies only to uniform radial load conditions. This standard does not provide in terms of fatigue life FEA guidance. This standard does not include the finite element method and its theoretical basis and a complete description of the formula. This standard adopts the international system of units, values ??in parentheses are for reference only. | YY/T 0859-2011: Standard guide for finite element analysis (FEA) of metallic vascular stents subjected to uniform radial loading
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Standard guide for finite element analysis (FEA) of metallic vascular stents subjected to uniform radial loading
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Uniform radial loads metal stent
Finite Element Method Guide
Standardguideforfiniteelementanalysis (FEA) ofmetalicvascularstents
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 ASTMF2514-2008 "under uniform radial load metal stent finite element analysis
Guide "prepared.
This standard compared with ASTMF2514-2008, 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.
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. Fan platinum, Kai Tao, Sun Bing, Dongshuang Peng, Li Libin, Shi repetition frequency, Li Yong.
Uniform radial loads metal stent
Finite Element Method Guide
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 conceptualmodel
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 deliverysystem
A stent delivery to the target location and complete mechanical device expansion.
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