YY/T 0119.3-2014 English PDF

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YY/T 0119.3-2014: Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 3: Metallic spinal plates
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0119.3-2014	189	Add to Cart	3 days	Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 3: Metallic spinal plates	Valid

Similar standards

YY 0118   YY/T 0119.4   YY/T 0119.1   YY 0117.1   YY 0117.2   YY/T 0119.2   

Basic data

Standard ID: YY/T 0119.3-2014 (YY/T0119.3-2014)
Description (Translated English): Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 3: Metallic spinal plates
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 8,834
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
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 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

---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.
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 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. ......

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