YY/T 1927-2024Implants for sports medicine - Suture buttons (English PDF)
运动医学植入器械 带袢固定板
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 7, 2024
Implementation date
March 1, 2025
Scope
YY/T 1927-2024 is the English-translated version of 运动医学植入器械 带袢固定板.
YY/T 1927-2024 is the Chinese standard "Implants for sports medicine - Suture buttons".
Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY/T 1927-2024
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 Requirement
- 5 Test methods
- 6 Manufacturing
- 7 Sterilization
- 8 Biosafety Assessment
- 9 Packaging
- 10 Information provided by the manufacturer
- References
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 11 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 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
- 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 0167-2020Non-absorbable surgical suture
- YY/T 0343Liquid penetrant inspection of metallic surgical implants
GB/T 16886
Similar standards
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Related Standards
GB/T 10610-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
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
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YY/T 1927-2024
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