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YY/T 0119.2-2014

Search Result of Chinese Standard: 'YY/T 0119.2-2014'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0119.2-2014English139 Add to Cart Days<=3 Spinal implants. Components uesd in the surgical fixation of the spinal skeletal system. Part 2: Metallic spinal screws Valid YY/T 0119.2-2014
YY/T 0119.2-2014Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY/T 0119.2-2014; YY/T0119.2-2014
Description (Translated English): Medical & Medicine
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 7,781
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Older Standard (superseded by this standard): YY 0119-2002
Quoted Standard: YY/T 0119.1-2014; YY/T 0119.5-2014; ASTM F543; ASTM F1839
Drafting Organization: Tianjin Medical Devices Inspection Center
Administrative Organization: National Surgical implants and Johnson shaped instrument Standardization Technical Committee materials and orthopedic implants Sub-Technical Committee
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to internal spinal fixation implant anchoring element metal spine screws. This Standard specifies the metal spine screws classification, material and performance requirements.

YY/T 0119.2-2014
. Spinal implants Components uesd in the surgical fixation of the spinal skeletal system Part 2: Metallic spinal screws
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Partially replaced YY 0119-2002
Spinal implants come within the spine system components
Part 2: Metal screws spine
Spinalimplants-Componentsusedinthesurgicalfixationofthespinalskeletal
system-Part 2: Metalicspinalscrews
Issued on: 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
YY/T 0119 "was within the spinal implant spinal fixation system components" is divided into five sections:
--- Part 1: General requirements;
--- Part 2: Metal screws spine;
--- Part 3: Metal spine board;
--- Part 4: Metal spinal rod;
--- Part 5: Metal screw spinal static and fatigue bending strength Test method.
This section YY/T Section 20119 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Used in this section refer to redraft the law ASTMF2193-07 "standard spinal fixation system components and test methods" in the Annex
Record A1 and X2 preparation.
This standard and YY 0119-2002 "metal orthopedic implants osteosynthesis with nails", YY 0120-2002 "osteosynthesis implant metal
Orthopedic stick, "the main differences:
--- YY 0119-2002, YY 0120-2002 in materials including stainless steel, titanium, and the new standard also includes titanium, thus
YY/T 0119-2014 broader scope;
--- YY/T 0119-2014 has also increased the relative performance testing of metal spine screws, metal plates and metal spine spinal rods.
Since the implementation of this section, instead of YY 0119-2002 "metal orthopedic implants osteosynthesis staple" relating to pedicle screws, vertebral
Content sacrum nail body and nail. Generic companies can use passive metal surgical implant in accordance with this standard and reference YY 0341-2009 "osteosynthesis
Technical conditions "content development of enterprise standards.
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 part is proposed by the China Food and Drug Administration.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee
(SAC/TC110/SC1) centralized.
This section is drafted: Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Medical Technology Co., Ltd. minimally invasive orthopedics.
The main drafters of this section: Zhang Chen, Jiang Xi, said Zhang, Zhang Lu, Wang Guohui, MA Yunpeng.
Spinal implants come within the spine system components
Part 2: Metal screws spine
1 Scope
This section YY/T 0119 provisions of the spine metal screws classification, materials, requirements and performance.
This section applies to internal spinal fixation implants anchoring element.
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.
YY/T 0119.1-2014 come within the spinal implant spinal fixation system components - Part 1: General requirements
YY/T 0119.5-2014 spinal fixation system implanted in the spine was part Part 5: Metal screw spinal static and fatigue
Bending Strength Test Method
Standards ASTMF543 medical metal bone screws and test methods (Specificationandtestmethodsforme-
talicmedicalbonescrews)
ASTMF1839 orthopedic instruments and tools to test using standard materials - rigid polyurethane foam (Specificationforrigidpolyure-
thanefoamforuseasastandardmaterialfortestingorthopedicdevicesandinstruments)
Category 3
3.1 In accordance with the classification prescribed ASTMF543 spinal screws classification.
3.2 can also be in accordance with the capacity between the spinal screw fixation system and spinal other components interconnected their classification, such as the expansion head screw
Nail, locking screws and self-locking screws.
4 Materials
In accordance with YY/T 0119.1-2014 requirements in Chapter 5 and recommended choice spine screw material.
5 requirements, performance and test methods
5.1 geometric properties
Recommended metal spine screw size can be found ASTMF543.
5.2 rotating connection
Recommended spine screws in grooves can see ASTMF543 Appendix A6.
5.3 torsional performance
Determination of torsional strength properties of the screw in accordance with Test Method ASTMF543 of (yield torque, maximum torque and breaking twist angle).
Related standard:   YY/T 0119.1-2014  YY/T 0119.3-2014
   
 
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