YY/T 1505-2016Implant for surgery—Test method for determining the self-tapping performance of metallic bone screws (English PDF)
外科植入物金属接骨螺钉自攻性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1505-2016 is the English-translated version of 外科植入物金属接骨螺钉自攻性能试验方法.
YY/T 1505-2016 is the Chinese pharmaceutical industry standard that gives the test method for measuring the axial compressive force needed to drive a self-tapping metallic bone screw into a standard material, which is how its self-tapping performance is judged.
The values it yields are not directly related to the force needed to insert the screw into human bone, and the method serves to confirm the consistency of a product and to compare products with one another. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1505-2016
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Equipment
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the re-drafting method. Reference ASTM F543-2013 Appendix A4 "Medical Bone Screw Self-tapping Performance Test Method" prepared by.
1 Scope
This standard is used to measure the axial compression required for screwing the standard material with a self-tapping metal screw (hereinafter referred to as "screw") force. The results obtained using this standard test method are not directly related to the axial pressure required for the screw to be inserted into the human bone. This standard is only used To confirm the consistency of the product under test, or to compare the similarity of different products with similar performance.
This standard does not apply to the formation of self-extrusion with the human bone during the attack with the thread, without prefabricated guide hole "self-drilling" or "self-drilling / Form of metal screw.
2 Equipment
2.1 Test device
The test device used to measure the axial self-attack force is shown in Fig. The test device should include a variable speed motor that can be continuously used Drive the spindle. The spindle is axially movable while continuously rotating to provide a variable axial force. The test device and the spindle should be sufficient Stiffness, so as to ensure that under the conditions of the test load will not occur without deflection or deformation. In addition, the test apparatus shall include a test The block clamps are fixed to the test block and are capable of continuously monitoring and recording the force, torque and axial displacement generated during the screw test, The range of force, torque and axial displacement is calibrated during the process.
2.2 Axial pressure sensor
The converter that converts the applied axial pressure into an electrical signal suitable for continuous recording is carried out within the range of the range used in the test
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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