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YY/T 0119.5-2014: Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 5: Test method for measure the static and fatigue bending strength of metallic screws
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Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 5: Test method for measure the static and fatigue bending strength of metallic screws
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YY/T 0119.5-2014
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Basic data | Standard ID | YY/T 0119.5-2014 (YY/T0119.5-2014) | | Description (Translated English) | Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 5: Test method for measure the static and fatigue bending strength of metallic screws | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,184 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 16825.1; GB/T 19701.2; ASTM E122; ASTM E467; ASTM E1942; ASTM F1839 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to internal spinal fixation implant anchoring element metal spine screws. This Standard specifies the test method for the determination of metal spine screws static and dynamic bending properties. | YY/T 0119.5-2014: Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 5: Test method for measure the static and fatigue bending strength of metallic screws
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Spinal implants.Components used in the surgical fixation of the spinal skeletal system.Part 5. Test method for measure the static and fatigue bending strength of metallic screws
ICS 11.040.40
C35
Medical device industry standards People's Republic of China
Spinal implants come within the spine system components
Part 5. Metal screw spinal static and fatigue bending
Strength Test Method
system-Part 5. Testmethodformeasurethestaticandfatiguebendingstrength
ofmetalicscrews
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
YY/T 0119 "was within the spinal implant spinal fixation system components" is divided into five sections.
--- Part 1. General requirements;
--- Part 2. Metal screws spine;
--- Part 3. Metal spine board;
--- Part 4. Metal spinal rod;
--- Part 5. Metal screw spinal static and fatigue bending strength Test method.
This section YY/T Section 50119 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Used in this section refer to redraft the law ASTMF2193-07 "standard spinal fixation system components and test methods" in Appendix A4
And X5 establishment.
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 part is proposed by the China Food and Drug Administration.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC /
TC110/SC1) centralized.
This section is drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Medical Technology Co., Ltd. minimally invasive orthopedics.
The main drafters of this section. Zhang said, Jiang Xi, Zhang Chen, Zhang Lu, Wang Guohui, Xuezong Yu.
Spinal implants come within the spine system components
Part 5. Metal screw spinal static and fatigue bending
Strength Test Method
1 Scope
YY/T 0119 provisions of this part of the test method for the determination of metal screws spine static and dynamic bending properties.
This section applies to the spinal fixation implants in the spine metal screws.
This section is intended to provide a means for different types of spinal screw the mechanical characterization methods. There is currently not enough pre-knowledge
Use screws to know the results of specific design, it is not the purpose of this test method is used to define the level of performance of spinal screw.
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.
Inspection and GB/T 16825.1 of static uniaxial testing machines - Part 1 Rally and (or) pressure testing machine force measuring system
calibration
GB/T 19701.2 ultra-high molecular weight polyethylene - Part 2. plastic molding
ASTME122 using specific tolerances, the sample size to assess the production batch or process characteristics mean calculation specifications (Practicefor
calculatingsamplesizetoestimate, withaspecifiedtolerableerror, theaverageforacharacteristicofa
lotorprocess)
ASTME467 Axial Fatigue Test System for constant amplitude dynamic loads calibration specification (Standardpracticeforverification
ofconstantamplitudedynamicforcesinanaxialfatiguetestingsystem)
ASTME1942 cycle fatigue and fracture mechanics test data acquisition system evaluation guidelines (Guideforevaluatingdataac-
quisitionsystemsusedincyclicfatigueandfracturemechanicstesting)
ASTMF1839 orthopedic instruments and tools to test using standard materials - rigid polyurethane foam (Specificaionforrigidpolyure-
thanefoamforuseasastandardmaterialfortestingorthopedicdevicesandinstruments)
3 Summary of Test Method
3.1 pairs of spinal screw quasi-static cantilever bending load is applied, so that the recording member in response to applied mechanical load corresponding. By Loads -
Deflection curves were used to determine the data for deriving the spinal screw flexural properties.
3.2 pairs of sinusoidal cantilever sample is applied to a given predetermined frequency spinal screw bending loads. Until one of the following three conditions Fatigue test. samples
Product failure, limit or terminate the trial reaches a predetermined number of cycles (termination limit). The test results information is used to draw the moment - cycle times
Curve to characterize a given moment in the spinal screw type range applied general fatigue properties. Further, in the case where the result of the appropriate
Information can be used to determine the spinal screw N at a predetermined number of cycles in the value of fatigue moment.
4 significance and application
4.1 part of the establishment of a unified method for static and dynamic bending test, and thus different types of spinal screw static and fatigue bending properties
Properties were characterized and compared. This test method is used to determine the maximum bending moment in the spinal screw range conditions fatigue life, in addition, it may also be
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