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YY/T 1503-2016 English PDF

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YY/T 1503-2016: Implants for surgery--Test method for determining the bending fatigue properties of metallic bone plates
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1503-2016139 Add to Cart 3 days Implants for surgery--Test method for determining the bending fatigue properties of metallic bone plates Valid

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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: 7,727
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
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