YY/T 1503-2016Implants for surgery—Test method for determining the bending fatigue properties of metallic bone plates (English PDF)
外科植入物金属接骨板弯曲疲劳性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1503-2016 is the English-translated version of 外科植入物金属接骨板弯曲疲劳性能试验方法.
YY/T 1503-2016 is the Chinese pharmaceutical industry standard that gives the test method for determining the bending fatigue properties of a metallic bone plate.
It provides an evaluation of bending fatigue for plates of different designs, setting out the specimen and its support, the loading mode and the frequency, the number of cycles and the runout level, the examination of the plate afterwards and the way the fatigue result is reported. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1503-2016
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
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 ASTM F382-2008 "metal plate standard specification and test method" preparation.
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 document. 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 JJG 139 Rally, pressure and universal testing machine
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Fatigue life
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. Minimum bending moment Maximum bending moment
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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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