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YY/T 1426.1-2016Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test (English PDF)

外科植入物 全膝关节假体的磨损 第1部分:载荷控制的磨损试验机的载荷和位移参数及相关的试验环境条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1426.1-2016 is the English-translated version of 外科植入物 全膝关节假体的磨损 第1部分:载荷控制的磨损试验机的载荷和位移参数及相关的试验环境条件.

YY/T 1426.1-2016 is the Chinese standard "Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test".

Its scope clause reads: This part of the YY/T 1426 specifies the flexion/extension angle between the joint parts under the total knee prosthesis wear test under load control Movement, loading method, test speed and duration, specimen assembly and test environment requirements. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY/T 1426.1-2016

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 reference document
  • 3 Terms and definitions
  • 4 Principle
  • 5 samples and lubricants
  • 7 Test procedure
  • 8 Test Report
  • 9 Test sample handling

1 Scope

This part of the YY/T 1426 specifies the flexion/extension angle between the joint parts under the total knee prosthesis wear test under load control

Movement, loading method, test speed and duration, specimen assembly and test environment requirements.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

ISO 7207-1 surgical implants and total knee prostheses - Part 1. Classification, definition and dimensioning (Implantsforsurgery-Componentsforpartialandtotalknee-jointprostheses-Part 1. Classification, definitionsanddesignationofdimensions

ISO 14243-2 Peripheral prosthesis for surgical implants - Part 2. Methods of measurement (Implantsforsurgery-

Wearoftotalknee-jointprostheses-Part 2. Methodsofmeasurement)

3 terms and definitions

The following terms and definitions apply to this document.

3.1 Before and after displacement APdisplacement

The offset of the axial force axis relative to the buckling/extension axis measured in the direction perpendicular to the axial force axis and the buckling/extension axis.

Note 1. A is the abbreviation of "anterior"; P is the abbreviation of "posterior".

Note 2. When the total knee joint is at the reference position (3.7), the displacement is set to zero, and when the axial force axis is relative to the reference position of the total knee joint

Defined as a positive value (3.7), see Figure 1.

3.2 Before and after force APforce

Perpendicular to the tibial axis and the flexion/extension axis, the force acting on the tibial plateau component, the force acting through the axial force axis.

Note. When the direction of action of the force along the tibial component from the forward, the definition is positive, see Figure 1.

3.3 Axial force axisforce

The force applied to the tibial component of the knee prosthesis parallel to the tibial axis.

Note. When the direction of force from the bottom up when the provisions of the force is positive (see Figure 1 and Figure 2).

3.4 Axial force axis

Axial force of the line, the line through the knee prosthesis tibial component from the tibial axis to the tibial lateral displacement of 0.07w ±

0.01 w, where w is the total width of the tibial component, see ISO 7207-1.

Note 1. See Figure 2.

Note 2. For an average width (i.e., 74 mm) tibial component, the 0.07 w value is approximately equal to 5 mm.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 27 pages — is available in the English PDF.

Referenced standards

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