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YY/T 0960-2014 English PDF

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YY/T 0960-2014: Spinal implants. Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression
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YY/T 0960-2014English259 Add to Cart 3 days [Need to translate] Spinal implants. Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression Valid YY/T 0960-2014

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Standard similar to YY/T 0960-2014

YY/T 0962   YY/T 0987.2   YY/T 0987.3   YY/T 0953   YY/T 0957.1   YY/T 0956   

Basic data

Standard ID YY/T 0960-2014 (YY/T0960-2014)
Description (Translated English) Spinal implants. Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 11,187
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard GB/T 16825.1; YY/T 0959; ASTM F1582; ASTM F1839
Adopted Standard ASTM F2267-2004, NEQ
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 interbody fusion. This Standard specifies the materials and methods used to promote abiotic interbody fusion in a particular axial compression of the spinal fusion segment subsidence test used.

YY/T 0960-2014: Spinal implants. Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression


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Spinal implants.Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Interbody fusion spinal implant Static Axial Compression Test Method for Subsidence Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Summary of Test Method 4 5 meaning and application 4 6 Equipment 4 Selection and preparation of samples 5 7 8 static axial compression test Step 5 9 6 Report Appendix A (informative) Basic principles 7

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard reference method using redrafted using "Standard Test Method for interbody fusion static axial compression subsidence" ASTMF2267-04 prepared by. Technical differences between this standard and ASTMF2267-04 follows. --- On normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, the adjusted situation Focus is reflected in the status of Chapter 2, "Normative references", the specific adjustments are as follows. • with GB/T 16825.1 instead ASTME4; --- Deleted the Chapter 10, "Precision and Bias"; --- Deleted the Chapter 11 "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. Zhang Lu, Jiaoyong Zhe, Dongshuang Peng, Wang Guohui, your Haven. Interbody fusion spinal implant Static Axial Compression Test Method for Subsidence

1 Scope

The standard provides for the promotion of non-biological fusion cage axially a specific spinal segment fusion compression subsidence test material used Materials and methods. This standard is used to compare the mechanical properties of intervertebral fusion cage Interbody Fusion rather than provide performance standards designed to contrast abiotic vertebral Fusion between the mechanical properties of the establishment of basic principles. This standard specifies a static test method specifies the type of loading and loading methods. This test method can be used for interbody fusion Comparative evaluation of the clutch. This standard has been established test pieces measuring deformation and determine interbody fusion cage subsidence guidelines. 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). Some require the use of additional interbody fusion implants to improve the stability, and therefore may not be in accordance with the manufacturer's recommended method to test Such implants. 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. Appendix A of this standard gives the basic principles.

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. 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) Interbody fusion material mechanical properties test methods YY/T 0959 spinal implant ASTMF1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants) ASTMF1839 orthopedic instruments and tools for testing standard material rigid polyurethane foam (Specificationforrigidpolyu- rethanefoamforuseasastandardmaterialfortestingorthopaedicdevicesandinstruments)

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Coordinates/axis coordinatesystem/axes Based ASTMF1582 defines three orthogonal axes, as shown in Figure 1. Coordinate origin located interbody fusion device geometry Heart, X-axis along the longitudinal axis of the implant, the forward positive, Y-axis a transverse axis, Z axis indicates a vertical axis.

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