YY/T 0119.3-2014Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 3: Metallic spinal plates (English PDF)

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 ASTM F2193-07 "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.

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 ASTM E122 using specific tolerances, the sample size to assess the production batch or process characteristics mean calculation specifications (Practicefor CalculatingSampleSizetoEstimate, withSpecifiedPrecision, theAverageforaCharacteristicofaLot orProcess) Standards ASTM F382 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