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YY/T 1504-2016Implants for surgery—Test method for determining the axial pullout strength of metallic bone screws (English PDF)

外科植入物金属接骨螺钉轴向拔出力试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1504-2016 is the English-translated version of 外科植入物金属接骨螺钉轴向拔出力试验方法.

YY/T 1504-2016 is the Chinese pharmaceutical industry standard that gives the test method for measuring the axial force needed to pull a metallic bone screw out of a specified material or to make it fail.

It sets out the test block and the insertion of the screw, the rate of pulling and the measurement of the force, and it is meant only to confirm the consistency of a product or to compare the force values of different products, not to predict the force with which a screw is held in human bone. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1504-2016

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

Foreword
1 Scope
2 Normative reference documents
3 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 A3 "Test Method for Axial Pullout Force of Medical Bone Screws" prepared by.

1 Scope

This standard specifies the test for measuring the axial force required to remove or fail from the specified material by means of a metal screw (hereinafter referred to as "screw") method. This standard is only used to confirm the consistency of the tested product or to compare the force values of different products, not to predict the extraction of screws from the human body The value of the force.

This standard may not apply to certain special purpose screws. It is advisable to consider this standard from the point of view of the specific material of the screw and its intended use The applicability.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 16825.1 Tests for static uniaxial testing machines - Part 1. Tests for force measurement systems of tension and/or pressure testing machines calibration

YY 0018 Bone Graft Implant Metal Bone Screw Standard Test Method for Rotational Torque of Surgical Implant Metal Bone Screws YY/T 1506

3 Equipment

3.1 Test device

The means for determining the axial pull-out force of the screw shall comply with the requirements of GB/T 16825.1. The test device is shown in Fig. Test device Shall include. Test blocks made of materials conforming to ASTM F1839 and their jigs, bushings and drill sets described in YY/T 1506 Hold tooling. At the same time, the test block clamp and the bushing clamping tooling should have a sufficiently large rigidity so that the change under the required load conditions shape. The minimum tightening span of the test block fixture shall be 5 times the diameter of the screw and the screw shall be located at the center of the fastening end and shall be clamped during the test The distance should remain the same.

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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.

Referenced standards

Normative references

Cited by

YY/T 0346-2022Implants for osteosynthesis-Metallic fixation screw for femur neck

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