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YY/T 0965-2025Implants for sports medicine - Particular requirements of artificial ligament (English PDF)

运动医学植入器械人工韧带专用要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 15, 2025

Implementation date

October 1, 2026

Scope

YY/T 0965-2025 is the English-translated version of 运动医学植入器械人工韧带专用要求.

YY/T 0965-2025 is the Chinese standard "Implants for sports medicine - Particular requirements of artificial ligament". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY/T 0965-2025

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45
Replacing: YY/T 0965-2014

Issued by: National Medical Products Administration

Preface
1.Scope
2 Normative References
3.Terms and Definitions
4.Expected Performance
5 Design Attributes
6.Materials
7 Design Evaluation
8.Preclinical evaluation
9.Test Methods
10 Post-IPO Follow-up
11 Manufacturing
12 Sterilization
13 Packaging
Appendix A (Normative) Dimensional Measurement Test Methods
Appendix B (Normative) Tensile Testing Methods
Appendix C (Normative) Tensile Fatigue Test Method
Appendix D (Normative) Torsional Fatigue Test Method

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).

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0962|YY/T 0663.2|YY 0948|YY/T 0954

Editions of YY/T 0965

Edition	Title	Revision	Status
YY/T 0965-2025	Implants for sports medicine - Particular requirements of artificial ligament	current edition	Current
YY/T 0965-2014	Implants for sports medicine - Particular requirements of artificial ligament	previous edition	In force until 2026-10-01

This page sells the current edition, YY/T 0965-2025. Earlier editions are listed for reference only.

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