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Implants for surgery--Test method for determining the bending fatigue properties of metallic bone plates
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Basic data
| Standard ID | YY/T 1503-2016 (YY/T1503-2016) |
| Description (Translated English) | Implants for surgery--Test method for determining the bending fatigue properties of metallic bone plates |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C35 |
| Word Count Estimation | 7,75 |
| Date of Issue | 2016-07-29 |
| Date of Implementation | 2017-06-01 |
| Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) |
| Issuing agency(ies) | State Food and Drug Administration |
YY/T 1503-2016: Implants for surgery--Test method for determining the bending fatigue properties of metallic bone plates
---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.
Implants for surgery - Test method for determining the bending fatigue properties of metallic bone plates
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical Implants - Metal Bending Plate Bending Fatigue Performance
experiment method
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the re-drafting method to refer to ASTMF382-2008 "metal plate standard specification and test method" preparation.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Surgical Implantation and Orthopedic Equipment Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (SAC/TC110 /
SC1).
The standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, a medical device China (limited) company.
The main drafters of this standard. Dong Shuangpeng, Zhang Shi, Zhao Binghui, Chen Changsheng, Yu Qingren.
Surgical Implants - Metal Bending Plate Bending Fatigue Performance
experiment method
1 Scope
This standard specifies the method of bending fatigue performance of metal plate (hereinafter referred to as "bone plate"). This standard is intended for different designs
The bending plate provides the evaluation method of bending fatigue performance.
This standard applies to orthopedic internal fixation plate.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
Guide for the maintenance and operation of orthopedic implants for surgical implants GB/T 24629
Surgical implants - Determination of flexural strength and rigidity of bone plate YY/T 0342-2002
JJG139 Rally, pressure and universal testing machine
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Fatigue life fatiguelife
The number of cycles (n) that a given sample can withstand before its specified characteristics fail.
3.2
Maximum bending moment
The maximum algebraic value of the bending moment applied in the load cycle. So that the bending moment on the surface of the plate which is in contact with the outer support roll is considered to be a bending moment
Positive value. Correspondingly, the pressure is generated as a negative value.
3.3
Minimum bending moment
The minimum algebraic value of the bending moment applied in the load cycle. So that the bending moment on the surface of the plate which is in contact with the outer support roll is considered to be a bending moment
Positive value. Correspondingly, the pressure is generated as a negative value.
3.4
MN Figure M-Ndiagram
Maximum Moment - The coordinate plot of the number of cycles that specify the fatigue failure point.
3.5
R ratio R-ratio
Algebraic ratio of the minimum and maximum values of the load parameters in the fatigue cycle.
Note. In this test method, the R ratio is defined as.
R ratio =
Minimum bending moment
Maximum bending moment
...