YY/T 0119.4-2014Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 4: Metallic spinal rods (English PDF)
脊柱植入物 脊柱内固定系统部件 第4部分：金属脊柱棒
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0119.4-2014 is the English-translated version of 脊柱植入物 脊柱内固定系统部件 第4部分：金属脊柱棒.
YY/T 0119.4-2014 is the Chinese pharmaceutical industry standard for the metallic spinal rod, the longitudinal member on which a posterior spinal construct is built.
It is the fourth part of the YY/T 0119 series and sets the classification, the material and the performance requirements for such rods, covering the diameter and the length and their tolerances, the mechanical properties and the behaviour when the rod is contoured, the surface finish and the corrosion resistance. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 0119.4-2014
National Standard of the People's Republic of China
- Replacing
- YY 0119-2002
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope5
- 2 Normative references5
- 3 Classification5
- 4 Materials6
- 5 Requirements, performance and test methods6
- 6 Information provided by manufacturer8
- Annex A (informative) Basic principle10
- Bibliography11
1 Scope
This Part of YY/T 0119 specifies classification, material and performance requirements for metallic spinal rods.
This Part is applicable to the longitudinal elements in spinal fixation implants.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY/T 0119.1-2014, Spinal implants - Components used in the surgical fixation of the spinal skeletal system - Part 1: General requirements
ASTM E122, Practice for Calculating Sample Size to Estimate, with Specified Precision, the Average for a Characteristic of a Lot or Process ASTM F382, Specification and Test Method for Metallic Bone Plates
3 Classification
For the purposes of this document, the following terms and definitions apply.
Spinal rods for spinal treatment can be classified according to the following characteristics:
a) Anatomical position: According to the area (for example: cervical spine, thoracic spine, lumbar spine and sacral spine) and position (front and back) treated by spinal rods.
b) Type of operation: According to the type of surgical operation of the spinal rod (for example: reconstruction, trauma, deformity, degenerative disease).
4 Materials
According to the requirements and recommendations in Chapter 5 of YY/T 0119.1-2014, select the spinal rod material.
5 Requirements, performance and test methods
5.1 Geometric characteristics
The recommended size of the metal spinal rod can be found in YY/T 0119.1.
5.2 Static test and fatigue test
5.2.1 Test requirements
Determine the bending structure stiffness, yield bending moment, ultimate bending moment, fatigue end bending moment and median fatigue bending moment of 2.5 million cycles of the spinal rod according to the test method in ASTM F382 (if applicable). The test method shall meet the requirements of 5.2.2.
5.2.2 Test method
5.2.2.1 Installation method and requirements
5.2.2.1.1 Install a 90°V-groove roller shaft on the test device. The shape of the roller allows a single set of rollers to test a range of sizes of spinal rods. These rollers also prevent the application of loads on the maximum stress points on the circumference of the spinal rod.
5.2.2.1.2 Install four-point bending test device to make the loading roller (the inner roller placed on both sides of "a") be placed according to the requirements of Table 1 (see Figure 1).
5.2.2.1.3 Place the support roller in the test device according to the recommended size in Table 1 (the outer roller shaft is placed at a distance "h" from the nearest roller shaft).
Annex A (informative) Basic principle
A.1 This Part aims to provide practical and uniform information related to spinal rods.
A.2 Because the spinal rod is the main way to stabilize the active segment, the bending performance is an important performance characteristic of the spinal rod. In addition, the bending stiffness of the spinal rod may directly affect the healing rate and fusion ability.
A.3 A four-point bending load is specified for the spinal rod. The loading structure of this test can simulate the principal stress state after the spinal rod is implanted.
A.4 Since the cross-section of the spinal rod is uniform along the length of the spinal rod, and it is considered that there is no design feature of stress concentration points along the length, therefore, the user is allowed to freely choose the test fixture device (roller contact point) for the spinal rod test.
Therefore, choosing any part of the spinal rod for test has the representativeness of its mechanical properties. […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
ASTM E122
Similar standards
Editions of YY/T 0119.4
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0119.4-2014 | Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 4: Metallic spinal rods | current edition | Current |
| YY 0119-2002 | Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 4: Metallic spinal rods | previous edition | Superseded |
This page sells the current edition, YY/T 0119.4-2014. Earlier editions are listed for reference only.
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Related Standards
YY/T 0119.1-2014 — Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 1: General requirements
YY/T 0119.5-2014 — Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 5: Test method for measure the static and fatigue bending strength of metallic screws
YY/T 0119.3-2014 — Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 3: Metallic spinal plates
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