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YY/T 1781-2021Test methods for mechanical property of metallic bone staples (English PDF)

金属U型钉力学性能试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

September 1, 2022

Scope

YY/T 1781-2021 is the English-translated version of 金属U型钉力学性能试验方法.

YY/T 1781-2021 is the Chinese pharmaceutical industry standard that gives the test methods for the mechanical properties of metallic bone staples, the staples used for internal fixation in the musculoskeletal system.

It sets out the specimens and their mounting, the loads applied and the way the results are derived, so that the design and the mechanical function of a staple can be characterised and different designs compared.

It does not describe or prescribe any particular staple design. Issued on 6 September 2021, it has applied since 1 September 2022.

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Document preview — YY/T 1781-2021

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

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Test method
Appendix A (Normative Appendix) Constant Amplitude Bending Fatigue Test Method for Metal Staples
Appendix B (normative appendix) Test method for pull-out strength of metal staples
Appendix C (Normative Appendix) Test Method for Soft Tissue Fixation Strength of Metal Staples
Appendix D (Normative Appendix) Static Bending Test Method for Metal Staples
Reference

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies test methods for the determination of the mechanical properties of metal staples.

This standard applies to metal staples.

Note 1.This standard test method can be used for the design and mechanical function characterization of metal staples for internal fixation in the musculoskeletal system.

This standard does not apply to describe or designate specific designs for metal staples.

Note 2.This standard includes a variety of test methods, but the user does not necessarily use all methods for testing, and can choose a suitable one according to the design of a specific device experiment method.

2 Normative references

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

GB/T 16825.1 Inspection of Static Uniaxial Testing Machines Part 1: Inspection and Calibration of Force Measuring Systems of Tensile and/or Compressive Testing Machines

GB/T 25917.1 Uniaxial Fatigue Test System Part 1: Dynamic Force Calibration

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Staples

Usually made of metal material, in a U-shaped configuration, with at least two legs, which can be driven into the bone surface to fix or stabilize adjacent bone fragments, or Fix soft tissue or other material to the bone.

3.2 Stapleleg

Parallel or near-parallel extensions for penetrating bone tissue.

NOTE. The cross-section may be round, square, or polygonal, and may have serrations or barbs to increase fixation or tightening strength within the bone.

3.3 Staplebridge

Connect the beams to the legs of the nails.

NOTE. Nail bridges may be smooth or have dentate protrusions on the underside to allow fixation of soft tissue or other materials.

3.4 Bone

Fresh, freshly frozen or preserved bone whose material properties can represent the site of staple implantation; cadaveric or animal bone is applicable.

3.5 Bone substitute

A material with known and stable properties that is similar in strength, density or stiffness to fresh, freshly frozen or preserved bone.

NOTE. Depending on its type, material properties and construction, alternatives such as natural wood, solid plastics, composites or rigid foam may be suitable.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY 0017-2026|YY 0018-2026|GB/T 44003-2024|NB/T 47016-2023|NB/T 47016-2011|GB/T 46592-2025

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