YY/T 1559-2017 English PDF

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YY/T 1559-2017: Spinal implants - Standard test methods for static and dynamic characterization of spinal artificial discs
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Basic data

Standard ID: YY/T 1559-2017 (YY/T1559-2017)
Description (Translated English): Spinal implants - Standard test methods for static and dynamic characterization of spinal artificial discs
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 18,113
Date of Issue: 2017-03-28
Date of Implementation: 2018-04-01
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 38
Issuing agency(ies): State Food and Drug Administration

YY/T 1559-2017: Spinal implants - Standard test methods for static and dynamic characterization of spinal artificial discs

---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 implants-Standard test methods for static and dynamic characterization of spinal artificial discs ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Spine implants disc prosthesis static and dynamic properties experiment method 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, Medtronic (Shanghai) Management Co., Ltd., Changzhou Osmai medicine Medical Devices Co., Ltd., Shandong Weigao Orthopedic Materials Co., Ltd. The main drafters of this standard. Gao Jintao, Li Wenjiao, Song Duo, Yang Haijun, Guo Yujia, Chen Changsheng, Cao Haipeng, Lu Chenglin, Gu Ying Song. Spine implants disc prosthesis static and dynamic properties experiment method

1 Scope

This standard specifies the materials and methods for static and dynamic testing of disc prosthesis, specifying the type of loading and loading method. The purpose of this standard is to establish the basic principles for the comparison of the mechanical properties of non-living disc prostheses of the past, present and future. this The test method allows for the comparison of intervertebral disc prostheses with different application sites (cervical, thoracic and lumbar) and different methods of application. This standard can be For comparison of the mechanical properties of disc prostheses but without providing performance criteria. This standard is not intended to address all clinical failure modes associated with disc prosthetics, as some failure modes are device specific. For example, this test method does not address the anti-saliency of the prosthesis or the wear performance of the prosthesis in the desired in vivo load and exercise modes. In addition, this Test methods do not address the biological response to wear debris. This standard established a measure of displacement, to determine the yield load or torque, disc stiffness evaluation criteria. Some disc prostheses may not be suitable for testing according to all test configurations in this standard. 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 regulatory 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 Spinal implant interbody fusion cage mechanical properties test method YY/T 1428 spinal implants related terms

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Disc prosthesis artificialintervertebraldisc An artificial structure that can be permanently implanted between two adjacent vertebral bodies, providing spinal support and allowing movement between the vertebral bodies. 3.2 Coordinate system/axis coordinates system/axes According to YY/T 1428 defines three orthogonal axes, the coordinate system to the geometric center of the disc prosthesis as the origin (if the reasons are sufficient, too Other coordinate systems can be used). The XY plane will divide the upper and lower halves in order to simulate two adjacent vertebral endplates. Z axis On the positive and perpendicular to the intervertebral space bisector, the X-axis anterior forward and parallel to the intervertebral space, Y-axis to the left is positive and parallel with the intervertebral space. The shear load is a component of force parallel to the XY plane. The axial compressive force is negative along the Z axis and the torque is the moment parallel to the Z axis. ......

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