YY/T 1988-2025Implants for sports medicine - Meniscus repair system (English PDF)
运动医学植入器械 半月板缝合系统
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 30, 2025
Implementation date
November 1, 2026
Scope
YY/T 1988-2025 is the English-translated version of 运动医学植入器械 半月板缝合系统.
YY/T 1988-2025 is the Chinese standard "Implants for sports medicine - Meniscus repair system". Its scope clause reads: This document specifies the requirements, manufacturing, sterilization, biological evaluation, packaging, and manufacturer specifications for meniscus suture systems used in sports medicine implants.
The information provided describes the corresponding experimental methods. This document applies to the testing and evaluation of meniscus suture systems (hereinafter referred to as meniscus suture systems) used in sports medicine implants.
Full suture Refer to parts of this document for information on meniscus suture systems. Note. The basic principles are explained in Appendix A. Its clauses include terms and definitions.
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Document preview — YY/T 1988-2025
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C35
Issued by: National Medical Products Administration
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4 Requirements
- 5.Test Methods
- 6 Manufacturing
- 7.Sterilization 6.
- 8.Biological Evaluation 6.
- 9 Packaging
- 10.Information provided by the manufacturer
- Appendix A (Informative) Basic Principles
- References
1 Scope
This document specifies the requirements, manufacturing, sterilization, biological evaluation, packaging, and manufacturer specifications for meniscus suture systems used in sports medicine implants.
The information provided describes the corresponding experimental methods.
This document applies to the testing and evaluation of meniscus suture systems (hereinafter referred to as meniscus suture systems) used in sports medicine implants. Full suture
Refer to parts of this document for information on meniscus suture systems.
Note. The basic principles are explained in Appendix A.
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 4340.1 Metallic materials - Vickers hardness test - Part 1.Test method
GB/T 14233.1-2022 Medical infusion, transfusion and injection equipment test methods - Part 1.Chemical analysis methods
GB/T 14233.2 Test methods for medical infusion, transfusion and injection equipment - Part 2.Biological test methods
GB/T 16886 (all parts) Biological evaluation of medical devices
YY/T 0149-2006 Test Method for Corrosion Resistance of Stainless Steel Medical Devices
YY 0167 Non-absorbable surgical sutures
YY/T 0640 General Requirements for Passive Surgical Implants
YY 1116 Absorbable Surgical Sutures
YY/T 1832 Tensile testing method for sutures used in sports medicine implants
Pharmacopoeia of the People's Republic of China (Volume IV)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 meniscus repair system
Surgical instruments used for percutaneous or arthroscopic meniscus repair of the knee joint.
Note. It typically consists of an implant and assistive devices. The implant usually includes fixation devices and sutures, while the assistive devices usually include inserters, etc.
3.2 puncture force
During the process of fully inserting the inserter with the fixation device into the meniscus simulator, the maximum amount of time required for the inserter needle tip to pierce the meniscus simulator.
Force value.
Note. The unit is Newton (N).
3.3 Fixed strength
The stitched meniscus simulator was stretched to the maximum force required to fail.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 4340.1Metallic materials - Vickers hardness test - Part 1: Test method
- GB/T 14233.1-2022Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- YY/T 0149-2006Medical instruments of stainless steel - Test methods of corrosion resistance
- YY 0167Non-absorbable surgical suture
- YY/T 0640Non-active surgical implants - General requirements
GB/T 16886
Similar standards
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Related Standards
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 14233.2-2025 — Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
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