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YY/T 0651.3-2020: Implants 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
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Implants 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
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YY/T 0651.3-2020
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Basic data | Standard ID | YY/T 0651.3-2020 (YY/T0651.3-2020) | | Description (Translated English) | Implants 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 | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,173 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 0651.3-2020: Implants 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
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(Surgical implants:Wear of total hip joint prostheses:Part 3: Load and displacement parameters of orbital bearing type wear testers and related test environmental conditions)
ICS 11:040:40
C35
People's Republic of China Pharmaceutical Industry Standard
Wear and tear of surgical implant total hip prosthesis
Part 3: Loads of Orbital Bearing Type Wear Tester
And displacement parameters and related test environmental conditions
(ISO 14242-3:2009,MOD)
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Principle 2
5 Reagents and samples 2
6 Equipment 2
7 Test procedure 6
8 Test report 6
9 Sample processing 7
Reference 8
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:
This part was proposed by the State Drug Administration:
This part is organized by the Orthopedic Implant Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110/
SC1) Centralized:
Drafting organizations of this section: Tianjin Medical Device Quality Supervision and Inspection Center, School of Mechanical and Electrical Engineering and Automation, Shanghai University, Xi'an Communications
University of Mechanical Engineering, Suzhou MicroPort Joint Medical Technology Co:, Ltd:
The main drafters of this section: Zhang Lu, Dong Shuangpeng, Hua Zikai, Chen Xinye, Wang Ling, Shan Cunqing, Yu Tianbai, Xu Min:
Wear and tear of surgical implant total hip prosthesis
Part 3: Loads of Orbital Bearing Type Wear Tester
And displacement parameters and related test environmental conditions
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 article
Pieces: 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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