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YY/T 1781-2021 English PDF

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YY/T 1781-2021: (Test method for mechanical properties of metal U-shaped nails)
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Basic data

Standard ID YY/T 1781-2021 (YY/T1781-2021)
Description (Translated English) (Test method for mechanical properties of metal U-shaped nails)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Word Count Estimation 22,223
Issuing agency(ies) State Drug Administration

YY/T 1781-2021: (Test method for mechanical properties of metal U-shaped nails)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Test method for mechanical properties of metal U-shaped nails) ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Test method for mechanical properties of metal staples Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Test method 2 Appendix A (Normative Appendix) Constant Amplitude Bending Fatigue Test Method for Metal Staples 3 Appendix B (normative appendix) Test method for pull-out strength of metal staples 8 Appendix C (Normative Appendix) Test Method for Soft Tissue Fixation Strength of Metal Staples 11 Appendix D (Normative Appendix) Static Bending Test Method for Metal Staples 14 Reference 18

foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Orthopedic Implants Sub-Technical Committee (SAC/TC110/ SC1) focal point. This standard was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, State Drug Administration Medical Device Technical Review Heart, Beijing Natong Technology Group Co., Ltd., Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. The main drafters of this standard. Li Wenjiao, Wang Tao, Zhang Shu, Sun Jiayi, Li Xiaoyun, Li Renyao, Zhao Wenwen, Wang Rongfei, Yang Shihao. Test method for mechanical properties of metal staples

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 article pieces. 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 staple 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 bonesubstitute 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.

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