YY/T 0961-2014 English PDFUS$329.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0961-2014: Standard guide for evaluation the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants Status: Valid
Basic dataStandard ID: YY/T 0961-2014 (YY/T0961-2014)Description (Translated English): Standard guide for evaluation the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 14,199 Date of Issue: 6/17/2014 Date of Implementation: 7/1/2015 Quoted Standard: GB/T 16825.1; 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 the spinal fixation system. This Standard specifies test methods loosening of spinal fixation system uniaxial static and fatigue strength as well as the components connected device reactance. YY/T 0961-2014: Standard guide for evaluation the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants---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. Standard guide for evaluation the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Spinal implant components come within the spinal fixation system And static and fatigue performance evaluation method of connecting device Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released Table of ContentsPreface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Summary of Test Method 3 5. Significance and Application 3 6 Equipment 4 Selection and preparation of samples 7 7 8 static mechanical properties test step 7 9 Fatigue strength test Step 8 10 8 Report Appendix A (normative) Fundamentals 10ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard uses redrafted fixed system components and connections within the law Reference ASTMF1798-2008 "spinal implant spinal device Static and Fatigue Evaluation Method opposed to "establishment. Technical differences between this standard and ASTMF1798-2008 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; • ASTMF382 delete references; --- Deleted the Chapter 11 "precision and bias"; --- Chapter 12 will be adjusted as Appendix A; --- Deleted the Chapter 13 "key words." 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 Jiaotong University. The main drafters of this standard. Dongshuang Peng, Zhang said, Jiaoyong Zhe, Zhang Lu, Li Chao. Spinal implant components come within the spinal fixation system And static and fatigue performance evaluation method of connecting device1 ScopeThis standard specifies the test method for loosening of spinal fixation system uniaxial static and fatigue strength as well as anti-assembly connecting means. The standard Evaluation criteria are intended to provide a method for the mechanical properties of different designs of the spinal implant connection device. Different components and connecting devices shall be combined into a ridge Column implant static and fatigue test structure. The purpose of these test methods is not to analyze overall and local structure spinal implants, nor is it Define its performance level, because there is not enough information to predict the results of the use of a design of the implant. This standard lists the test spine The implant assembly connection definition means strength, reporting a possible test methods and results. In addition to measuring angles in degrees or radians units, the standard SI units. 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 administrative limit, this is the standard user's own responsibility.2 Normative referencesThe 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) ASTMF1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants)3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Longitudinal member working length activelengthofthelongitudinalelement The distance between the rigid support. For example. 1, 2, 3, 4 of the working length of 50mm. 3.2 Global coordinate system globalcoordinatesystem There are six degrees of freedom of motion of the spine, along the three axes of translation and rotation around the three axes. Front and rear axles for the X axis, the left-right axis The Y-axis, the vertical axis is the Z-axis. Coordinate system consistent with the right-hand rule, the forward X direction, toward the left in the body is the Y direction, up to Z-direction. Also by the forward rotation of the right-hand rule to define [see Figure 5a)]. 3.3 Clamping capacity grippingcapacity When generating initial residual displacement of 1.5mm or residual angular displacement of 5 ° between the connecting member, or the maximum force exerted by the connecting device Torque. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0961-2014_English be delivered?Answer: Upon your order, we will start to translate YY/T 0961-2014_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0961-2014_English with my colleagues?Answer: Yes. 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