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YY/T 1832-2022 English PDF

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YY/T 1832-2022: Implants for sports medicine - Tensile testing method for suture
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Standard similar to YY/T 1832-2022

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Basic data

Standard ID YY/T 1832-2022 (YY/T1832-2022)
Description (Translated English) Implants for sports medicine - Tensile testing method for suture
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Word Count Estimation 11,170
Issuing agency(ies) State Drug Administration

YY/T 1832-2022: Implants for sports medicine - Tensile testing method for suture

---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.
Implants for sports medicine - Tensile testing method for suture ICS 11.040.40 CCSC35 People's Republic of China Pharmaceutical Industry Standard Sports Medicine Implants Suture Tensile Test Method Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration directory Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Test principle 2 5 Instruments 2 6 Test sample 3 7 Test Step 3 8 Test report 4 Appendix A (Informative) Fundamentals of Tensile Fatigue Testing of Sports Medicine Sutures 5

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document is drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Yunyi (Beijing) Medical Device Co., Ltd., State Drug Administration Supervision Administration Medical Device Technology Review Center, Beijing Natong Technology Group Co., Ltd., Shandong Weigao Orthopaedic Materials Co., Ltd., Shanghai Jingwei Fusheng Medical Technology Co., Ltd., Dabo Medical Technology Co., Ltd., Stryker (Beijing) Medical Equipment Co., Ltd., Beijing Fusheng Medical Technology Co., Ltd. Music Technology Development Co., Ltd., Shanghai Ligetai Biotechnology Co., Ltd. The main drafters of this document. Li Wenjiao, Zhang Shu, Jiang Xi, Dong Shuangpeng, Zhao Xuedong, Jiang Yao, Gao Jintao, Zhen Zhen, Li Renyao, Zhao Wenwen, Wang Zhongli, Qin Dan, Zeng Da, Zhang Songwei, Li Hongyan, Ji Jie.

Introduction

Static tensile tests can be used to measure the breaking force of sutures and compare the tensile properties of different types of sutures. Dynamic tensile testing was used to characterize and compare the fatigue properties of different sutures. Can be used to determine the fatigue life of sutures under specified loads, It can also be used to determine the fatigue strength of sutures at a specified number of cycles. The suture fatigue strength measured using this method is the Fatigue strength of the formula. The data obtained in this test method can be used to study the effect of suture material, design, wire diameter, surface treatment, etc. on tensile properties, and can also be used in Product quality control. The results obtained by this test method cannot be used directly to predict clinical manifestations. Manufacturers can conduct tests that simulate clinical use as much as possible on the basis of this test method according to the design characteristics of the product. Sports Medicine Implants Suture Tensile Test Method

1 Scope

This document specifies a static tensile test method and a dynamic tensile test method for sports medicine sutures at room temperature, which are used for Determination of breaking force and fatigue properties of sports medicine sutures. This document applies to sports medicine sutures (hereafter referred to as sutures).

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date 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 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 sports medicine suture sportsmedicinesuture Used alone or in combination with anchors, staples or fixation plates and other fixation devices implanted in the human body in sports medicine surgery, for shoulder, elbow, Soft tissue reconstruction and repair of wrists, hands, hips, knees, feet, ankles, etc., or sutures to fix muscle ligaments or implants to bones. Note. Sports medicine surgery refers to surgery to deal with muscle ligament or soft tissue injury or tear or rupture caused by sports-related trauma and disease treat. 3.2 breaking force tensilestrength Fm Tie the suture in a simple knot (see Figure 3) and stretch to the maximum force at break. 3.3 Sc The maximum force at which the wire loop will not be damaged after the specified number of cycles. 3.4 Ss Half of the fatigue strength of the wire loop.

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