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YY/T 1505-2016: Implant for surgery--Test method for determining the self-tapping performance of metallic bone screws
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1505-2016	English	139	Add to Cart	3 days [Need to translate]	Implant for surgery--Test method for determining the self-tapping performance of metallic bone screws

YY/T 1505-2016: Implant for surgery--Test method for determining the self-tapping performance of metallic bone screws

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Implant for surgery - Test method for determining the self-tapping performance of metallic bone screws ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical Implants Metal Bone Screws Self - attack performance test 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. Reference ASTM F543-2013 Appendix A4 "Medical Bone Screw Self-tapping Performance Test Method" 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. The main drafters of this standard. Gao Jintao, Li Nan, Duan Qingjiao. Surgical Implants Metal Bone Screws Self - attack performance test method

1 Scope

This standard is used to measure the axial compression required for screwing the standard material with a self-tapping metal screw (hereinafter referred to as "screw") force. The results obtained using this standard test method are not directly related to the axial pressure required for the screw to be inserted into the human bone. This standard is only used To confirm the consistency of the product under test, or to compare the similarity of different products with similar performance. This standard does not apply to the formation of self-extrusion with the human bone during the attack with the thread, without prefabricated guide hole "self-drilling" or "self-drilling / Form of metal screw.

2 equipment

2.1 Test device The test device used to measure the axial self-attack force is shown in Fig. The test device should include a variable speed motor that can be continuously used Drive the spindle. The spindle is axially movable while continuously rotating to provide a variable axial force. The test device and the spindle should be sufficient Stiffness, so as to ensure that under the conditions of the test load will not occur without deflection or deformation. In addition, the test apparatus shall include a test The block clamps are fixed to the test block and are capable of continuously monitoring and recording the force, torque and axial displacement generated during the screw test, The range of force, torque and axial displacement is calibrated during the process. Figure 1 self-tapping performance test device 2.2 Axial pressure sensor The converter that converts the applied axial pressure into an electrical signal suitable for continuous recording is carried out within the range of the range used in the test ...