YY/T 0651.3-2020Implants for surgery—Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test (English PDF)
外科植入物 全髋关节假体的磨损 第3部分：轨道轴承型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
June 30, 2020
Implementation date
June 1, 2021
Scope
YY/T 0651.3-2020 is the English-translated version of 外科植入物 全髋关节假体的磨损 第3部分：轨道轴承型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 0651.3-2020 is the Chinese pharmaceutical industry standard that fixes how a total hip prosthesis is run in an orbital bearing type wear simulator: the relative angular motion between the components, the loading pattern, the test speed and duration, the mounting of the specimens and the test environment.
It is the third part of the YY/T 0651 series, the companion to part 1 for the other machine type, and its parameters are what allow wear results from different laboratories to be compared. Issued on 30 June 2020, it has applied since 1 June 2021.
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Document preview — YY/T 0651.3-2020
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
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Principle
- 5 Reagents and samples
- 6 Equipment
- 7 Test procedure
- 8 Test report
- 9 Sample processing
- Reference
Foreword
YY/T 0651 "Abrasion of Total Hip Joint Prosthesis of Surgical Implants" is divided into the following 3 parts.
---Part 1. Load and displacement parameters of the wear tester and related test environmental conditions;
---Part 2. Measurement methods;
---Part 3. Load and displacement parameters of track bearing type wear testing machine and related test environment conditions. This part is part 3 of YY/T 0651.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part uses the redrafting method to amend and adopt ISO 14242-3:2009 "Surgical implants and total hip prosthesis wear part 3 Points. Load and displacement parameters of orbital bearing type wear tester and related test environmental conditions". This part and ISO 14242-3:2009 In comparison, there are the following technical differences.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows:
- Replace ISO 14242-2 with YY/T 0651.2 modified to adopt international standards.
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 part of YY/T 0651 specifies the wear test of total hip joint prosthesis. The relative angular motion between the joint components, the test loading mode, Test speed and duration, sample assembly and test environment for wear test of track bearing type for total hip joint prosthesis. This section applies to total hip prostheses.
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 0651.2 Surgical implants. Wear of total hip prostheses. Part 2. Measurement methods (YY/T 0651.2-2020,
ISO 14242-2:2016, MOD)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Abduction/adduction
Abduction and adduction movement around an axis that passes through the hip joint in the anterior-posterior direction.
Note 1. The movement of the femur away from the midline of the trunk is called abduction. The movement of the femur toward the midline of the trunk is called adduction.
Note 2. The angular movement is shown in Figure 1a).
3.2 Flexion/extension
Flexion and extension movements that occur around the transverse axis passing through the hip joint.
Note 1. Movement at the joints, reducing the angle between the trunk and the femur is called flexion. The opposite action is called stretching, where the angle between the trunk and femur increase.
Note 2. The angular movement is shown in Figure 1b).
3.3 Inward/outwardrotation
The inward/outward rotation component of the inward/outward movement.
Note 1. Orbital bearing type wear testing machine (OBM) hip simulator does not apply independent "inward/outward" movement to the hip (ie, the long axis of the femur). however, Saikko et al. pointed out that the anti-rotation rod connected to each test chamber of the OBM machine caused the internal-external rotation component of the motion path, effectively Convert OBM to a three-axis machine. The mechanism of the OBM simulator results in a cross-path component of the relative motion of the bearing surface. Therefore, Wang et al. proved in detail that during the load part of the gait cycle, the magnitude of the shear stress and the change in the direction of the stress are comparable to those in hip replacement. The same as the technique.
Note 2. The angular movement is shown in Figure 1c).
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 14242-2:2016
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Related Standards
YY/T 0651.2-2008 — Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
YY/T 0651.2-2020 — Implants for surgery—Wear of total hip-joint prostheses - Part 2: Methods of measurement
YY/T 0651.4-2025 — Joint replacements - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
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