YY/T 1922-2024Implants for sports medicine - Interference screw (English PDF)
运动医学植入器械 肌腱韧带固定螺钉
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 8, 2024
Implementation date
July 20, 2025
Scope
YY/T 1922-2024 is the English-translated version of 运动医学植入器械 肌腱韧带固定螺钉.
YY/T 1922-2024 is the Chinese standard "Implants for sports medicine - Interference screw".
Its scope clause reads: This document specifies the performance requirements for tendon and ligament fixation screws for sports medicine implants, describes the corresponding test methods, and specifies the content of manufacture, sterilization, biological safety evaluation, packaging and information provided by the manufacturer.
This document applies to sports medicine implants tendon ligament fixation screws (hereinafter referred to as "tendon ligament fixation screws"), which are available for Tendon-ligament grafts are fixed in bone tunnels for use in sports medicine surgery. Its clauses include terms and definitions.
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Document preview — YY/T 1922-2024
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 tendon and ligament fixation screws for sports medicine implants, describes the corresponding test methods, and specifies the content of manufacture, sterilization, biological safety evaluation, packaging and information provided by the manufacturer.
This document applies to sports medicine implants tendon ligament fixation screws (hereinafter referred to as "tendon ligament fixation screws"), which are available for
Tendon-ligament grafts are fixed in bone tunnels for use in sports medicine surgery.
2 Normative references
The contents of the following documents constitute 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 10610 Geometric Product Specification (GPS) Rules and methods for evaluating surface structure by surface structure profile method
GB/T 14233.1 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/T 0343 Liquid Penetrant Testing of Surgical Metal Implants
YY/T 0474 In vitro degradation test of poly (L-lactide) resin and its products for surgical implants
YY/T 0640 General requirements for passive surgical implants
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Tendon ligament interference screw
A medical device for fixing soft tissue grafts or bone-tendon-bone grafts by compression, which may consist of a screw or a screw and a sheath.
3.2 Insertion force
The maximum pressure required to fully insert a knock-in sheath into a test block.
Note 1.Applicable to tendon and ligament fixation screws consisting of a screw and a sheath.
Note 2.The unit is Newton (N).
3.3 Fixation strength
After fixing the tendon-ligament fixing screw and the ligament simulation (or bone-tendon-bone simulation) on the test block,
The maximum force required to pull a tendon-bone mimic out of a test block.
Note. The unit is Newton (N).
......
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 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
- GB/T 14233.1Test 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 0343Liquid penetrant inspection of metallic surgical implants
- YY/T 0474Surgical Implants - Polylactide Homopolymers, Copolymers, and Blends - In Vitro Degradation Tests
- YY/T 0640Non-active surgical implants - General requirements
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 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
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