YY/T 1560-2017 English PDF

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YY/T 1560-2017: Spinal implant - Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1560-2017	439	Add to Cart	5 days	Spinal implant - Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model	Valid

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Basic data

Standard ID: YY/T 1560-2017 (YY/T1560-2017)
Description (Translated English): Spinal implant - Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 22,269
Date of Issue: 2017-03-28
Date of Implementation: 2018-04-01
Issuing agency(ies): State Food and Drug Administration

YY/T 1560-2017: Spinal implant - Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model

---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.
Spinal implant-Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Spine implants in vertebral body excision models Pillow neck and occipito - cervical implant test methods Spinalimplant-Standardtestmethods foroccipital-cervicaland 2017-03-28 Posted 2018-04-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Surgical implants and orthopedic instruments Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (SAC/TC110 / SC1) centralized. This standard was drafted unit. Tianjin Medical Device Quality Supervision and Inspection Center, Changzhou Osmai Medical Devices Co., Ltd., Shandong Wei high bone Branch Materials Co., Ltd., Medtronic (Shanghai) Management Co., Ltd. The main drafters of this standard. Zhao Binghui, King Ming, Chen Changsheng, Wang Jian, Lu Chenglin, Gu Ying Song, Yang Haijun, Guo Yujia. Spine implants in vertebral body excision models Pillow neck and occipito - cervical implant test methods

1 Scope

This standard specifies the materials and methods of static and fatigue tests of the occipitocervix and occipito-cervical implant components in a vertebral body excision model. most The test material for the occipitoccipital and occipito-cervical implant components depends on the intended site of implantation and the method of application. This test method is intended to provide a basis for the comparison of the mechanical properties of occipitoccipital and occipito-cervical implant components in the past, present and future, The method can be used to compare the occipito-cervical and occipito-cervical thoracic implants that are expected for different application sites and methods of application. The purpose of these test methods It is not intended to define the performance level as there is not enough information to predict the outcome of an implant. This standard provides guidelines for loading types and loading methods and provides for the comparative evaluation of occipitoccipital and occipito-cervical implant components three Static test methods and two fatigue test methods. This test method is to measure the displacement, determine the yield load and evaluate the occipital or occipitocervix The rigidity and strength of the implant assembly establish the guiding principle. Some occipito-cervical or occipito-cervical implants may not be suitable for use in accordance with this standard Test configuration for testing. This standard is not intended to address all the safety issues involved, even those related to their use safety issues. establish Appropriate safety and health practices, as well as the applicability of a clear management limit before application, are the sole responsibility of the user of this standard.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16825.1 static uniaxial testing machine test Part 1. Tensile and (or) pressure testing machine testing system and force measurement calibration YY/T 0857 vertebral excision model of spinal implant test methods Spinal implant interbody fusion cage mechanical properties test method

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Longitudinal part of the working length activelengthofthelongitudinalelement The linear distance between the center of rotation of the test block. 3.2 Arm blockmomentarm Vertical line from the point where the screw is inserted to the hinge pin axis. 3.3 Compression or tensile bending stiffness compressiveortensilebendingstiffness Compression or tensile bending yield load divided by the elastic displacement (see Figure 1, the initial slope of BC). ......

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