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YY/T 0959-2014: Spinal implants. Test methods for mechanical property of intervertebral body fusion devices
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0959-2014 | English | 369 |
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Spinal implants. Test methods for mechanical property of intervertebral body fusion devices
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YY/T 0959-2014
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Basic data | Standard ID | YY/T 0959-2014 (YY/T0959-2014) | | Description (Translated English) | Spinal implants. Test methods for mechanical property of intervertebral body fusion devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 16,184 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 10623; GB/T 16825.1; ASTM E 1823; ASTM F 1582 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to compare the mechanical properties of the fusion cage. This Standard specifies the static and dynamic tests for the promotion of a particular segment of the spinal fusion interbody fusion, including the materials and methods used i | YY/T 0959-2014: Spinal implants. Test methods for mechanical property of intervertebral body fusion devices
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Spinal implants.Test methods for mechanical property of intervertebral body fusion devices
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Spinal implant
Mechanical Properties Test Method for interbody fusion
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Summary of Test Method 7
5 meaning and application 8
6 Equipment 8
Selection and preparation of samples 7 9
8 static test procedure 9
9 dynamic test procedure 10
10 of the report 10
Appendix A (informative) Test Method justification for the 12
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference method using redrafted ASTMF2077-03 "interbody fusion test method" establishment.
Information on normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, adjust the set
As reflected in Chapter 2, "Normative references", the specific adjustments are as follows.
● with the GB/T 16825.1 instead ASTME4;
● with the GB/T 10623 instead ASTME6;
Technical differences between this standard and ASTMF2077-03 follows.
--- Deleted the Chapter 11 "precision and bias";
--- Deleted the Chapter 12, "keyword";
--- In Appendix X1 to Appendix A, remains unchanged.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC /
TC110/SC1) centralized.
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Medical Technology Co., Ltd. minimally invasive orthopedics.
The main drafters of this standard. Jiaoyong Zhe, Zhang Lu, Dongshuang Peng, Wang Guohui, your Haven.
Spinal implant
Mechanical Properties Test Method for interbody fusion
1 Scope
This standard specifies the static and dynamic test is used to promote a particular spinal segment fusion interbody fusion device, including the test timber
Materials and methods.
This standard is intended for non-mechanical properties of biological interbody fusion contrast to establish basic principles. This test method can be used to compare with
Mechanical properties in different locations and spine interbody fusion using different methods. This standard can be used in the mechanical properties of intervertebral fusion device
Contrast, but it does not provide performance standards.
This standard specifies the static and dynamic testing device, specifies the type of loading and loading methods. The test device may be used for intervertebral
Comparative evaluation of the fusion device.
This standard does not involve the fusion cage prolapse test.
This standard was established to measure the displacement, determine the yield strength or torque, evaluation interbody fusion stiffness and strength guidelines.
Some interbody fusion device may not be suitable for testing in this standard test methods in all.
The standard unit of angle measurement in addition to the possibility of using degrees or radians, the other measurements using the International System of Units (SI).
This standard does not attempt to all the security issues involved elaborate, even those safety issues associated with their use. establish
Appropriate safety and health practices and suitability before applying clear management restrictions, the user of this standard is its own responsibility.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 10623 test the mechanical properties of metallic materials terminology (GB/T 10623-2008, ISO 23718.2007, MOD)
Inspection and correction tension and (or) pressure testing machine force measuring system. GB/T 16825.1 of static uniaxial testing machines - Part 1
Associate (GB/T 16825.1-2008, ISO 7500-1.2004, IDT)
ASTME1823 standard terminology related to fatigue and crack test (Terminologyrelatingtofatigueandfracture
testing)
ASTMF1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Coordinate System/axis coordinatesystem/axes
Based ASTMF1582 defines three orthogonal axes of the coordinate system and interbody fusion geometric center of origin, XY plane to
Sagittal angle upper and lower ends line (surface) between the average divided into two parts, the purpose is to simulate two adjacent vertebral endplate. Z axis
On the positive. Component parallel to the XY plane shear loads, axial compressive force along the Z-axis negative direction, the torque of the Z-axis is parallel to the sub torque.
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