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YY/T 0119.3-2014

Chinese Standard: 'YY/T 0119.3-2014'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0119.3-2014English159 Add to Cart Days<=3 Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 3: Metallic spinal plates Valid YY/T 0119.3-2014
YY/T 0119.3-2014Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY/T 0119.3-2014; YY/T0119.3-2014
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: 8,856
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: YY/T 0119.1-2014; YY/T 0857; ASTM E122; ASTM F382
Adopted Standard: ASTM F2193-2007, NEQ
Drafting Organization: Tianjin Medical Devices Inspection Center
Administrative Organization: National Surgical implants and orthopedic instruments 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 the spinal fixation implants longitudinal component metal spine board. This Standard specifies the classification of metal spine board, materials and performance requirements.


YY/T 0119.3-2014
Spinal implants.Components used in the surgical fixation of the spinal skeletal system.Part 3: Metallic spinal plates
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Spinal implants come within the spine system components
Part 3: Metal spine board
Spinalimplants-Componentsusedinthesurgicalfixationofthespinalskeletal
system-Part 3: Metalicspinalplates
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 30119 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
A2 and X3 recorded 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 added metal spine screws, metal plates and metal spine spine-related performance tests rods.
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, Zhang Lu, Dongshuang Peng, Wang Guohui, Shen Sheng strong.
Spinal implants come within the spine system components
Part 3: Metal spine board
1 Scope
YY/T 0119 provisions of this part of the classification of spine metal plate material and performance requirements.
This section applies to the spinal fixation implants longitudinal member.
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 0857 corpectomy model test method for spinal implant
ASTME122 using specific tolerances, the sample size to assess the production batch or process characteristics mean calculation specifications (Practicefor
CalculatingSampleSizetoEstimate, withSpecifiedPrecision, theAverageforaCharacteristicofaLot
orProcess)
Standards ASTMF382 metal bone plate and test methods (SpecificationandTestMethodforMetalicBone
Plates)
Category 3
Chiropractic spinal board with the following characteristics can be classified:
a) anatomical location: By area (such as spina board treatment: cervical, thoracic, lumbar and sacral vertebrae) and position (front and rear) to distinguish;
b) Type of surgery: According to the type of surgical spine board (for example: reconstruction, trauma, deformity, degeneration) distinction.
4 Materials
In accordance with YY/T 0119.1-2014 requirements in Chapter 5 and recommended choice spine board material.
5 requirements, performance and test methods
5.1 geometric properties
The recommended size of the metal plate can be found in the spine ASTMF382.
5.2 static test and fatigue test
5.2.1 Test requirements
Determination of the bending stiffness of the spine board structure according ASTMF382 the test method, the yield moment, ultimate moment, fatigue terminate moment
And 2.5 million times the median moment of fatigue cycles (if applicable), test methods shall comply with the requirements of 5.2.2.
Related standard:   YY/T 0119.1-2014  YY/T 0119.2-2014
   
 
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