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YY/T 1426.2-2016: Implants for surgery. Wear of total knee-joint prostheses. Part 2: Methods of measurement
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1426.2-2016 | English | 114 |
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Implants for surgery. Wear of total knee-joint prostheses. Part 2: Methods of measurement
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YY/T 1426.2-2016
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Basic data | Standard ID | YY/T 1426.2-2016 (YY/T1426.2-2016) | | Description (Translated English) | Implants for surgery. Wear of total knee-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 | 6,654 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | ISO 14243-1 | | Adopted Standard | ISO 14243-2-2009, IDT | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the method of assessing the tibial component wear of the general knee joint by weight analysis after total knee prosthesis wear test in accordance with Part 1. | YY/T 1426.2-2016: Implants for surgery. Wear of total knee-joint prostheses. Part 2: Methods of measurement
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Implants for surgery.Wear of total knee-joint prostheses.Part 2. Methods of measurement
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Peripheral prosthesis wear in surgical implants
Part 2. Methods of measurement
Part 2. Methodsofmeasurement
(ISO 14243-2..2009, IDT)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 gravimetric method
5 Test Report 3
Foreword
YY/T 1426 "Surgical implants per knee prosthesis wear" is divided into three parts.
- Part 1. Load and displacement parameters of load control wear testing machines and associated test environmental conditions;
- Part 2. Methods of measurement;
Part 3. Load and displacement parameters of displacement control wear testing machines and associated test environmental conditions.
This part is part 2 of YY/T 1426.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part uses the translation method equivalent to ISO 14243-2..2009 "Surgical implants of the knee joint prosthesis wear Part 2.
Quantity method ".
In this part of the normative reference to the international documents have a consistent correspondence between the following documents.
- YY/T 1426.1-2016 Surgical implants for wear of total knee prostheses Part 1. Wear test for wear control
Load and displacement parameters of the machine and associated test environmental conditions (ISO 14243-1..2009, IDT).
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This section is organized by the National Committee for the Standardization of Surgical Implants and Orthopedic Instruments Orthopedic Implants Subcommittee (SAC/TC110 /
SC1).
This part of the drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, Xi'an Jiaotong University.
This part of the main drafters. Jiao Yongzhe, Dong Shuangpeng, Wang Ling, Hou Yinhui.
Peripheral prosthesis wear in surgical implants
Part 2. Methods of measurement
1 Scope
This part of YY/T 1426 specifies the use of weight analysis to evaluate the total knee after total knee prosthesis wear test in accordance with Part 1
The method of wear of tibial parts of joint prosthesis.
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 14243-1 Surgical implants - Wear of the general knee prosthesis - Part 1. Load and wear of the load - controlled wear test machine.
Shift parameters and associated environmental conditions (Implantsforsurgery-Wearoftotalknee-jointprostheses-Part 1.
Loadinganddisplacementparametersforwear-testingmachineswithloadcontrolandcorresponding
environmentalconditionsfortests
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Wear wear
Due to the relative movement between the prosthetic component components and the load caused by the loss of component material.
4 weight analysis
4.1 Principles
The test sample is soaked in the lubricating fluid and repeatedly removed from the lubricating fluid, washed, dried and weighed until the liquid absorption rate reaches
Stability value. The test sample was mounted on a knee joint simulator for a wear test to measure the quality loss of the test sample due to wear.
The control samples were soaked in the same lubricating medium medium with no or no load and no relative motion, so that the control sample was drawn
And the same treatment procedure is used to achieve the purpose of the control.
4.2 Reagents and materials
4.2.1 Liquid test media, according to ISO 14243-1.
4.2.2 Control samples according to ISO 14243-1.
4.2.3 isopropanol.
4.3 Instruments
4.3.1 Balance. The range meets the mass range of the test sample with an accuracy of ± 0.1 mg.
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