YY/T 1560-2017 (YY/T1560-2017, YYT 1560-2017, YYT1560-2017)
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| YY/T 1560-2017 | English | 439 |
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Spinal implant—Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model
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YY/T 1560-2017
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Standards related to: YY/T 1560-2017
| 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 | 22,246 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Changzhou Osmanthus Medical Devices Co., Ltd., Shandong Weigao Orthopedic Materials Co., Ltd., Medtronic (Shanghai) Management Co., Ltd. | | Administrative Organization | National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (AC/TC 110/SC 1) | | Proposing organization | China Food and Drug Administration | | 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
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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