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YY/T 0857-2011: Standard test methods for spinal implant constructs in a vertebrectomy model
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Standard test methods for spinal implant constructs in a vertebrectomy model
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YY/T 0857-2011
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Basic data | Standard ID | YY/T 0857-2011 (YY/T0857-2011) | | Description (Translated English) | Standard test methods for spinal implant constructs in a vertebrectomy model | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 25,269 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 10623; GB/T 19701.2; JJG 139; ASTM E739; ASTM F1582; ??ASTM F2077 | | 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 pushing body resection of spinal implant component model static and fatigue testing materials and methods. Most spinal implants test material combination of components depending on the desired spinal implant site and application methods. The test method is designed to past, present and future spinal implant components provide the basis for comparing the mechanical properties, allowing for the intended use and application of the different parts of the spinal implant structure compare these test method is not intended to define performance levels, Because there is not enough information to predict the result of using some implants. These test methods are loading type and loading method provides guidance for spinal implants comparative evaluation component provides for three static test method and a fatigue test methods. The test method for measuring the displacement of the load to determine the yield and to assess spinal implant component established principles of stiffness and strength. Some structures may not in all tested in experimental models. | YY/T 0857-2011: Standard test methods for spinal implant constructs in a vertebrectomy model---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 test methods for spinal implant constructs in a vertebrectomy model
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
The spinal implant model test method corpectomy
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Summary of Test Method 12
5 meaning and application 12
6 Equipment 13
Selection and preparation of samples 14 7
8 Step 15
9 of the report 16
10 Precision and Bias 18
Appendix A (informative) Fundamentals 19
Annex B (informative) Optional Test Method 20
References 21
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference method using redrafted ASTMF1717-10 "corpectomy spinal implant model test method" establishment.
Technical differences between this standard and ASTMF1717-10 follows.
--- On normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, the adjusted situation
Focus is reflected in the status of Chapter 2, "Normative references", the specific adjustments are as follows.
● with the GB/T 19701.2 instead ASTMD638;
● GB/T 10623 instead ASTME6 and ASTME1150;
● replaced with JJG139 ASTME4;
● delete ASTME177 and ASTME691 references.
--- Deleted the Chapter 11 "Keyword."
--- Removed Tables 1 to 10 and the criteria in relevant inter-laboratory comparison content.
--- In Appendix X1 to Appendix A, remains unchanged.
--- The Appendix X2 to Appendix B, 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 surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC /
TC110/SC1) 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. Dongshuang Peng Tao Kai, Song Duo, Jiaoyong Zhe, Wang Guohui.
The spinal implant model test method corpectomy
1 Scope
This standard specifies the vertebral body resection model spinal implant assembly materials and methods were static and fatigue tests. Most spinal implant
Test material components in combination depending on the intended site of spinal implants and application methods. These test methods are designed to past, present and future
Mechanical properties of spinal implant components provide the basis for comparison, it is expected to allow for the application site and application of different methods of spinal implant structure
Compare. These test methods is not intended to define the level of performance, because there is not enough information to predict some of the implant using a junction
fruit. These test methods provide guidance for the type of load and the load method, spinal implant assembly provides for three static comparative evaluation
Test method and a fatigue test methods. These test methods to measure the displacement, and the assessment of yield load determined spinal implant component
Stiffness and strength to establish a principle. Some structures may not be tested in all experimental models.
This standard uses the International System of Units.
This standard does not attempt to all the security issues involved elaborate, even those safety issues associated with their use. establish
Appropriate safety and health practices and suitability before applying clear administrative limit, this is the standard user's own responsibility.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 10623 test the mechanical properties of metallic materials term
GB/T 19701.2 surgical implants ultrahigh molecular weight polyethylene - Part 2. molded plastic (ISO 5834-2)
JJG139 tension, pressure, and universal testing machine
Statistical analysis lifetime (ε-N) Fatigue Data - ASTM E739 linear or linearized stress - life (SN) and strain
(Practiceforstatisticalanalysisoflinearorlinearizedstress-life (SN) andstrain-life (ε-N) fatiguedata)
ASTMF1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants)
ASTMF2077 interbody fusion test methods (Testmethodsforintervertebralbodyfusiondevices)
3 Terms and Definitions
ASTMF1582, GB/T 10623 and as defined in the following terms and definitions apply to this document.
3.1
Working length activelengthofthelongitudinalelement longitudinal member
The upper end of the connecting pin is connected with the lower end of the straight line distance between the centerline of the pin.
3.2
2% residual angular displacement angular displacement corresponding angulardisplacementat2% offsetyield (degrees)
Angular displacement (see Fig. 1 when the residual angular displacement of structure measured by the loader in the XY plane produced 0.020 times the torsional coefficient
Point A).
Unit (°)
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