YY/T 1736-2020Standard test method for evaluating tibial insert endurance and deformation under high flexion (English PDF)
评价高屈曲条件下膝关节胫骨衬垫耐久性和变形试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
June 1, 2021
Scope
YY/T 1736-2020 is the English-translated version of 评价高屈曲条件下膝关节胫骨衬垫耐久性和变形试验方法.
YY/T 1736-2020 is the Chinese pharmaceutical industry standard that gives the test method for the durability and the deformation of the ultra-high molecular weight polyethylene tibial insert of a bicompartmental or tricompartmental knee prosthesis, under defined laboratory conditions.
It sets out the specimens, their mounting in the metal components, the cyclic loading and its magnitude and duration, and the examination and measurement of the insert afterwards, so that designs and materials can be compared.
It applies to inserts made of UHMWPE. Issued on 30 June 2020, it has applied since 1 June 2021.
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Document preview — YY/T 1736-2020
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
1 Scope
This standard specifies the ultra-high molecular weight polyethylene (UHMWPE) tibial pad components in the design of double-compartment or three-compartment knee joint prostheses Test method for determining durability and deformation under specified laboratory conditions.
This standard applies to gasket parts made of ultra-high molecular weight polyethylene.
Note. The single-compartment total knee replacement system (TKR) can also be tested with reference to this standard, provided that the single-compartment system has sufficient constraints to be able to use this test This standard does not apply to testing two single-compartment knee systems as a double-compartment system.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.
YY/T 0772.3 Surgical implants Ultra-high molecular weight polyethylene Part 3: Accelerated aging method
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Femoral anatomical (mechanical) axis
The straight line from the center of the femoral head to the center of the femoral condyle of the knee joint.
3.2 Liner
The mirror image of the femoral joint surface in the anteroposterior direction.
Note. For tibial pads of asymmetrical design, the appropriate tibial pad centerline is determined according to the positioning principle.
3.3 Pad restraint mechanism
A mechanical method to prevent separation of the tibial tray from the tibial pad.
3.4 Femoral component centerline
A straight line located between the femoral condyles in the anteroposterior direction and parallel to the femoral condyles.
Note. The straight line is equidistant from the two condyles. For asymmetric or non-parallel condyle designs, determine the appropriate centerline.
3.5 Pad fixed system
Including a knee joint prosthesis system composed of femoral components and tibial components, in which the tibial articular surface and tibial tray are not expected to move.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
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Related Standards
YY/T 0772.3-2009 — Implants for surgery Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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