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Implants for sports medicine - Particular requirements of artificial ligaments
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Implants for surgery. Artificial ligaments
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Basic data
| Standard ID | YY/T 0965-2025 (YY/T0965-2025) |
| Description (Translated English) | Implants for sports medicine - Particular requirements of artificial ligaments |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C45 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 26,264 |
| Date of Issue | 2025-09-15 |
| Date of Implementation | 2026-10-01 |
| Older Standard (superseded by this standard) | YY/T 0965-2014 |
| Issuing agency(ies) | National Medical Products Administration |
YY/T 0965-2025: Implants for sports medicine - Particular requirements of artificial ligaments
---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
CCSC45
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0965-2014
Special requirements for artificial ligaments in sports medicine implants
Published on 2025-09-15
Implemented on October 1, 2026
National Medical Products Administration issued
Table of contents
Preface III
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.Expected Performance 2
5 Design Attributes 2
6.Materials 2
7 Design Evaluation 3
8.Preclinical evaluation 3
9.Test Methods 4
10 Post-IPO Follow-up 6
11 Manufacturing 6
12 Sterilization 6
13 Packaging 6
Appendix A (Normative) Dimensional Measurement Test Methods 7
Appendix B (Normative) Tensile Testing Methods 8
Appendix C (Normative) Tensile Fatigue Test Method 13
Appendix D (Normative) Torsional Fatigue Test Method 16
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
This document supersedes YY/T 0965-2014 "Specific Requirements for Artificial Ligaments in Passive Surgical Implants" and is consistent with YY/T 0965-2014.
Compared to previous versions, aside from structural adjustments and editorial changes, the main technical changes are as follows.
---The scope of application has been changed (see Chapter 1, Chapter 1 of the.2014 edition);
---The normative references have been changed (see Chapter 2, Chapter 2 of the.2014 edition);
---Some terms and definitions have been changed (see Chapter 3, Chapter 3 of the.2014 edition);
---The dimensional requirements and test methods have been changed (see 8.2 and Appendix A,.2014 edition of 8.2 and Appendix A);
---The requirements and test methods for tensile properties have been changed (see 8.3.1, 9.2.1 and Appendix B, 8.3, 9.2 and Appendix B in the.2014 edition);
---The requirements and test methods for fatigue testing have been revised (see 8.3.2, 9.2.2, Appendix C and Appendix D, 8.4.1 and 9.3 in the.2014 edition).
Appendix C and Appendix D);
---The requirements and test methods for chemical properties have been changed (see 8.4, 9.3; 8.5, 9.4 in the.2014 edition);
---Added requirements for coating performance (see 8.5);
---The requirements for biological assessment have been changed (see 8.8, 8.6.3 in the.2014 edition).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This document was drafted by. China National Institutes for Food and Drug Control, Shanghai Ligtech Biotechnology Co., Ltd., and Hebei Provincial Drug and Medical Institutions.
Medical Device Testing Institute, Huashan Hospital Affiliated to Fudan University, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Donghua University, South China University of Technology
University, Rascare Medical Technology (Shanghai) Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Yunkang Hengye Biotechnology Co., Ltd.
company.
The main drafters of this document are. Fu Bufang, Li Chongchong, Wang Yuanqiang, Shao Wenliang, Chen Shiyi, Zhao Jinzhong, Wang Lu, Du Chang, Xiao Xiang, Zhang Shu, and Huang Yuanli.
Liu Li, Guo Wenxin, Guo Caini, Chen Dandan, Liu Ruojin, Chen Jun, Wei Xiaojuan, Lin Jing, Hao Lijing, Liu Qingyou, Zhang Haocheng, Qiu Wanyu.
The release history of this document and the document it replaces is as follows.
---First published in.2014 as YY/T 0965-2014 "Specific Requirements for Passive Surgical Implants and Artificial Ligaments";
---This is the first revision.
Special requirements for artificial ligaments in sports medicine implants
1 Scope
This document specifies the expected performance, design attributes, materials, design evaluation, and clinical application of artificial ligaments used in clinical sports medicine implants.
Requirements for pre-clinical evaluation, post-marketing follow-up, manufacturing, sterilization, and packaging are described, along with corresponding test methods.
This document applies to textile-type artificial ligaments; other types of artificial ligaments can refer to this document for further information.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 3923.1-2013 Textiles - Tensile properties of fabrics - Part 1.Determination of breaking strength and elongation at break (strip method)
GB/T 14233.1-2022 Medical infusion, transfusion and injection equipment test methods - Part 1.Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices – Part 1.Evaluation and testing in the risk management process
YY/T 0640-2016 General Requirements for Passive Surgical Implants
Pharmacopoeia of the People's Republic of China, 2020 Edition, Part IV
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
artificial ligaments
Made from artificial materials, it possesses the biomechanical strength and function of ligaments, is biocompatible, and can be used to replace human ligament tissue.
A structure that facilitates surgical implantation into the human body and allows for fixation.
A schematic diagram of an artificial ligament (taking the anterior cruciate ligament as an example) is shown in Figure 1.
Index number explanation.
1---Traction line;
2---end;
3---Knitting section;
4---Free filaments.
In clinical use, the traction suture is used to pull the artificial ligament into the bone tunnel; depending on the depth of the patient's bone tunnel, part of the braided portion is fixed within the bone tunnel, while the excess...
The braided portion, ends, and traction threads are cut off; the free thread portion is located within the joint cavity.
Figure 1.Schematic diagram of artificial ligaments (taking anterior cruciate ligament as an example).
...
