YY/T 1922-2024 English PDF

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YY/T 1922-2024: Implants for sports medicine - Interference screw
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1922-2024	289	Add to Cart	3 days	Implants for sports medicine - Interference screw	Valid

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Basic data

Standard ID: YY/T 1922-2024 (YY/T1922-2024)
Description (Translated English): Implants for sports medicine - Interference screw
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 14,144
Date of Issue: 2024-07-08
Date of Implementation: 2025-07-20
Issuing agency(ies): State Drug Administration

YY/T 1922-2024: Implants for sports medicine - Interference screw

---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.
ICS 11.040.40 CCSC35 Pharmaceutical Industry Standards of the People's Republic of China Sports Medicine Implants Tendon Ligament Fixation Screws Released on 2024-07-08 2025-07-20 Implementation The State Drug Administration issued

Table of Contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 2 5 Test methods 3 6 Manufacturing 5 7 Sterilization 5 8 Biosafety Assessment 5 9 Packaging 6 10 Information provided by the manufacturer 6 References 7

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 for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. Dabao Medical Technology Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, National Drug Administration Medical Device Technical Review Center of the State Food and Drug Administration, Greater Bay Area Center for Medical Device Technical Review and Inspection of the State Food and Drug Administration, Guangdong Medical Medical Device Quality Supervision and Inspection Institute, Beijing Deyi Damei Medical Technology Co., Ltd., Beijing Tianxing Bomaidi Medical Device Co., Ltd., Yunyi (Beijing) Medical Devices Co., Ltd., Beijing Fule Technology Development Co., Ltd., Beijing Natong Technology Group Co., Ltd., Smith & Nephew Medical Products Products International Trading (Shanghai) Co., Ltd., Stryker (Beijing) Medical Devices Co., Ltd. The main drafters of this document are. Zeng Da, Ye Yanjie, Zhao Binghui, Yao Li, Min Yue, Li Xiaoyun, Han Dan, Yuan Sheng, Xie Shengfen, Chen Xiaojun, Kong Qingjun, Wei Ning, Hou Suhua, Dong Wenxing, Liu Jimei, Zhao Xuedong, Miao Guoshuai, Zhao Wenwen, He Xueqin, Zhang Haiming. Sports Medicine Implants Tendon Ligament Fixation Screws

1 Scope

This document specifies the performance requirements for tendon and ligament fixation screws for sports medicine implants, describes the corresponding test methods, and specifies the content of manufacture, sterilization, biological safety evaluation, packaging and information provided by the manufacturer. This document applies to sports medicine implants tendon ligament fixation screws (hereinafter referred to as "tendon ligament fixation screws"), which are available for Tendon-ligament grafts are fixed in bone tunnels for use in sports medicine surgery.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 10610 Geometric Product Specification (GPS) Rules and methods for evaluating surface structure by surface structure profile method GB/T 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants YY/T 0474 In vitro degradation test of poly (L-lactide) resin and its products for surgical implants YY/T 0640 General requirements for passive surgical implants Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Tendon ligament interference screw A medical device for fixing soft tissue grafts or bone-tendon-bone grafts by compression, which may consist of a screw or a screw and a sheath. 3.2 Insertion force The maximum pressure required to fully insert a knock-in sheath into a test block. Note 1.Applicable to tendon and ligament fixation screws consisting of a screw and a sheath. Note 2.The unit is Newton (N). 3.3 Fixation strength After fixing the tendon-ligament fixing screw and the ligament simulation (or bone-tendon-bone simulation) on the test block, The maximum force required to pull a tendon-bone mimic out of a test block. Note. The unit is Newton (N). ......

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