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YY/T 0651.2-2020: Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
Status: Valid YY/T 0651.2: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0651.2-2020 | English | 129 |
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Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
| Valid |
YY/T 0651.2-2020
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| YY/T 0651.2-2008 | English | 279 |
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Implant for surgery. Wear of total hip-joint prostheses. Part 2: Methods of measurement
| Obsolete |
YY/T 0651.2-2008
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Basic data | Standard ID | YY/T 0651.2-2020 (YY/T0651.2-2020) | | Description (Translated English) | Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 7,772 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Older Standard (superseded by this standard) | YY/T 0651.2-2008 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 0651.2-2020: Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Surgical implants:Wear of total hip prostheses:Part 2: Measurement methods)
ICS 11:040:40
C35
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0651:2-2008
Wear and tear of surgical implant total hip prosthesis
Part 2: Measurement method
(ISO 14242-2:2016,MOD)
2020-09-27 release
2021-09-01 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 Quality method 1
5 Volume method 3
6 Test report 4
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 2 of YY/T 0651:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
This part replaces YY/T 0651:2-2008 "Surgical implants and total hip joint prosthesis wear Part 2: Measurement methods":
Compared with YY/T 0651:2-2008, the main technical changes in this part are as follows:
---The scope of application is increased by YY/T 0651:3 "Surgical implants and total hip joint prostheses wear track bearing type wear testing machine
Load and displacement parameters and related test environmental conditions":
This part uses the redrafting method to modify and adopt ISO 14242-2:2016 ``Surgical implants and total hip joint prosthesis wear and tear Part 2
Points: Measurement Methods: Compared with ISO 14242-2:2016, this standard has the following technical differences:
---The scope (Chapter 1) adds "This standard applies to total hip prostheses:"
--- Regarding normative references, this standard 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 14242-1 with YY/T 0651:1 which is equivalent to the international standard;
● Replace ISO 14242-3 with YY/T 0651:3 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 standard was proposed by the State Drug Administration:
This standard is organized by the Orthopedic Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110/
SC1) Centralized:
Drafting organizations of this standard: Tianjin Medical Device Quality Supervision and Inspection Center, School of Mechanical Engineering, Xi'an Jiaotong University, Shanghai University
School of Engineering and Automation, Suzhou MicroPort Joint Medical Technology Co:, Ltd:
The main drafters of this standard: Li Wenjiao, Li Nan, Wang Ling, Hua Zikai, Yu Tianbai, Dong Enchun, Jia Haili, Xu Min:
The previous editions of this part of YY/T 0651 are as follows:
---YY/T 0651:2-2008:
Wear and tear of surgical implant total hip prosthesis
Part 2: Measurement method
1 Scope
This part of YY/T 0651 specifies the use of total hip joint prosthesis wear test according to YY/T 0651:1 or YY/T 0651:3
The mass method and volume method are used to assess the wear of acetabular components: This standard applies to total hip prostheses:
Note: Some researchers have encountered the problem of organic matter deposition that obviously affects the results of this test, especially when the hard surface and the hard surface are combined, this problem is more serious: Headquarters
The points did not give specific preventive measures, but if the cleaning techniques listed in this section can be used, the impact of such impurities can be reduced:
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 0651:1 Surgical implants: Wear of total hip joint prostheses: Part 1: Load and displacement parameters of wear testing machine and
Relevant test environmental conditions (YY/T 0651:1-2016, ISO 14242-1:2012, IDT)
YY/T 0651:3 Surgical implants: Wear of total hip joint prostheses: Part 3: Load and load of orbital bearing type wear tester
Displacement parameters and related test environmental conditions (YY/T 0651:3-2020, ISO 14242-3:2009, MOD)
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
Wear
The component material loss caused by the joint action of the joint prosthesis component and the load:
4 Quality method
4:1 Principle
Dip the test sample in the lubricant, take it out after a period of time, clean, dry and weigh it: Repeat the above process until the sample
Liquid absorption reaches a steady state: The sample is then placed on the hip joint wear simulator for joint wear test:
The mass loss of the posterior prosthesis component is used to assess the amount of joint wear: At the same time, a control sample is required, which carries the same load as the test sample but
There is no relative movement: It is used as a reference for the sample's absorption rate of lubricating fluid during the test:
The process of moisturizing, cleaning and drying can achieve the purpose of comparison:
4:2 Reagents and materials
4:2:1 Liquid test medium: If applicable, in accordance with YY/T 0651:1 or YY/T 0651:3:
4:2:2 Control sample: if applicable, in accordance with YY/T 0651:1 or YY/T 0651:3:
4:2:3 Isopropanol:
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