YY/T 1927-2024 English PDF

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YY/T 1927-2024: Implants for sports medicine - Suture button
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1927-2024	219	Add to Cart	3 days	Implants for sports medicine - Suture button	Valid

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Basic data

Standard ID: YY/T 1927-2024 (YY/T1927-2024)
Description (Translated English): Implants for sports medicine - Suture button
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 10,112
Date of Issue: 2024-02-07
Date of Implementation: 2025-03-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the performance requirements for sports medicine implantable device loop fixation plates (hereinafter referred to as loop fixation plates), describes the corresponding test methods, and specifies the manufacturing, sterilization, biological safety evaluation, packaging and manufacturer information provided, etc. This document is applicable to the testing and evaluation of loop fixation plates used for fixation of soft tissue and bone or bone and bone.

YY/T 1927-2024: Implants for sports medicine - Suture button

---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 Implant Device with Loop Fixation Plate Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Table of Contents

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 2 5 Test methods 4 6 Manufacturing 6 7 Sterilization 6 8 Biosafety Assessment 6 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. Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review Center Center, National Medical Products Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Yunyi (Beijing) Medical Device Co., Ltd., Beijing De Yidamei Medical Technology Co., Ltd., Beijing Tianxing Bomaidi Medical Equipment Co., Ltd., Beijing Medical Equipment Inspection Institute (Beijing Medical Equipment Inspection Institute Biological Protection Equipment Inspection and Research Center), Dabao Medical Technology Co., Ltd., Beijing Fule Technology Development Co., Ltd., Beijing Natong Technology Group Co., Ltd., Shanghai Ligetai Biotechnology Co., Ltd., Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., Smith & Nephew Medical Products Pin International Trading (Shanghai) Co., Ltd. and Beijing Aikang Yicheng Medical Equipment Co., Ltd. The main drafters of this document are. Li Wenjiao, Jing Ming, Wang Ying, Guo Xiaolei, Zhai Bao, Zhang Yidan, Peng Pu, Liu Jimei, Zhao Xuedong, Kong Qingjun, Wei Ning, Hou Suhua, Dong Wenxing, Han Qizhi, Wang Lixia, Zeng Da, Ye Yanjie, Bai Yanli, Zhao Wenwen, Chen Dandan, Chen Ruikai, He Xueqin, Wang Caimei. Sports Medicine Implants with Loop Fixation Plates

1 Scope

This document specifies the performance requirements for sports medicine implants with loop fixation plates (hereinafter referred to as "loop fixation plates") and describes the corresponding The standard specifies test methods, manufacturing, sterilization, biological safety evaluation, packaging and information provided by the manufacturer. This document applies to the testing and evaluation of fixation plates with loops for fixation of soft tissue to bone or bone to bone.

2 Normative references

The contents of the following documents constitute the 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 4340.1 Vickers hardness test for metallic materials Part 1.Test method GB/T 10610 Geometrical Product Specification (GPS) Rules and methods for evaluating surface structure using the surface structure profile method GB/T 14233.1-2022 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 0167-2020 Non-absorbable surgical sutures YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants YY/T 0640 General requirements for passive surgical implants YY/T 1074 Pitting Potential of Stainless Steel Products for Surgical Implants YY/T 1832 Tensile test method for sutures of sports medicine implants Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Suturebutton with loop fixing plate Medical devices used to connect and fix ligaments or tendons to bones, or bones to bones in orthopedic reconstruction surgery. See Figure 1 for a schematic diagram. ......

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