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YY/T 1504-2016 English PDF

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YY/T 1504-2016: Implants for surgery--Test method for determining the axial pullout strength of metallic bone screws
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1504-2016119 Add to Cart 3 days Implants for surgery--Test method for determining the axial pullout strength of metallic bone screws Valid

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Basic data

Standard ID: YY/T 1504-2016 (YY/T1504-2016)
Description (Translated English): Implants for surgery--Test method for determining the axial pullout strength of metallic bone screws
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Word Count Estimation: 6,669
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Quoted Standard: GB/T 16825.1; YY 0018; YY/T 1506
Adopted Standard: ASTM F 543-2013, NEQ
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the test method for measuring the axial force required to remove or fail from the specified material by means of a metal screw (hereinafter referred to as "screw"). This standard is only used to confirm the consistency of the tested product or to compare the force values ??of different products and not to predict the force of the screw pulled out of the human bone. This standard may not apply to certain special purpose screws. It is advisable to consider the applicability of this standard from the specific material of the screw and its intended use.

YY/T 1504-2016: Implants for surgery--Test method for determining the axial pullout strength of metallic bone screws


---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 axial pullout strength of metallic bone screws ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical Implants Metal Bone Screws Test method for axial pull - out force 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. Reference ASTM F543-2013 Appendix A3 "Test Method for Axial Pullout Force of Medical Bone Screws" prepared by. 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, Shandong Weigao orthopedic materials Limited. The main drafters of this standard. Zhang Lu, Gao Jintao, Wang Shicheng, Gu Yingsong, Lu Chenglin. Surgical Implants Metal Bone Screws Test method for axial pull - out force

1 Scope

This standard specifies the test for measuring the axial force required to remove or fail from the specified material by means of a metal screw (hereinafter referred to as "screw") method. This standard is only used to confirm the consistency of the tested product or to compare the force values of different products, not to predict the extraction of screws from the human body The value of the force. This standard may not apply to certain special purpose screws. It is advisable to consider this standard from the point of view of the specific material of the screw and its intended use The applicability.

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. GB/T 16825.1 Tests for static uniaxial testing machines - Part 1. Tests for force measurement systems of tension and/or pressure testing machines calibration YY 0018 Bone Graft Implant Metal Bone Screw Standard Test Method for Rotational Torque of Surgical Implant Metal Bone Screws YY/T 1506

3 equipment

3.1 Test device The means for determining the axial pull-out force of the screw shall comply with the requirements of GB/T 16825.1. The test device is shown in Fig. Test device Shall include. Test blocks made of materials conforming to ASTM F1839 and their jigs, bushings and drill sets described in YY/T 1506 Hold tooling. At the same time, the test block clamp and the bushing clamping tooling should have a sufficiently large rigidity so that the change under the required load conditions shape. The minimum tightening span of the test block fixture shall be 5 times the diameter of the screw and the screw shall be located at the center of the fastening end and shall be clamped during the test The distance should remain the same.
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