YY/T 1559-2017 (YY/T1559-2017, YYT 1559-2017, YYT1559-2017)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1559-2017 | English | 359 |
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Spinal implants—Standard test methods for static and dynamic characterization of spinal artificial discs
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YY/T 1559-2017
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Standards related to: YY/T 1559-2017
| 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 | 18,139 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Medtronic (Shanghai) Management Co., Ltd., Changzhou Osmanthus Medical Devices Co., Ltd., Shandong Weigao Orthopedic Materials Co., Ltd. | | Administrative Organization | National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (SAC/TC 110/SC 1) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | 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
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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