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YY/T 0652-2016: Wear of implant materials. Polymer and metal wear particles. Isolation and characterization
Status: Valid YY/T 0652: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0652-2016 | English | 324 |
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Wear of implant materials. Polymer and metal wear particles. Isolation and characterization
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YY/T 0652-2016
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| YY/T 0652-2008 | English | 359 |
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Wear of implant materials. Polymer and metal wear particles. Isolation, characterization and quantification
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YY/T 0652-2008
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PDF similar to YY/T 0652-2016
Standard similar to YY/T 0652-2016 YY/T 0647 YY/T 0752 YY/T 0695 YY/T 0651.2 Basic data | Standard ID | YY/T 0652-2016 (YY/T0652-2016) | | Description (Translated English) | Wear of implant materials. Polymer and metal wear particles. Isolation and characterization | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 17,139 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY/T 0652-2008 | | Adopted Standard | ISO 17853-2011, IDT | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016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 sampling methods for debris produced by implantation of the implant in the human body and in the simulator. This standard specifies the instruments, reagents and test methods for the separation and characterization of polymer and metal debris (debris from the tissue or joint simulator fluid that resects around the articular replacement of the joint during the revision surgery or autopsy). Some of these steps can be applied to the separation and characterization of debris in human body fluids (eg, synovial fluid). This standard does not quantify the degree of wear generated by the implant; nor does it specify the amount of wear on any particular surface. This standard does not include the biological reactions of debris, nor does it include methods for assessing biosafety. | YY/T 0652-2016: Wear of implant materials. Polymer and metal wear particles. Isolation and characterization
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Wear of implant materials.Polymer and metal wear particles .Isolation and characterization
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0652-2008
Wear of implant material
Separation and characterization of polymer and metal materials
(ISO 17853..2011, IDT)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope 1
2 terms and definitions
Principle, reagents and instruments
Sampling and analysis of polymer debris and metal debris in tissue samples 4
5 Joint simulator Sampling and analysis of polymer and metal abrasive in lubricating fluid
6 Test Report 12
Reference 13
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0652-2008 "Wear of polymer materials and metal materials Debris separation, characterization and quantification
Analysis method ", compared with YY/T 0652-2008, the main technical changes are as follows.
--- increase the processing steps of 5.4 ceramic debris;
--- removed the original standard 3.9 control test and 3.10 particle number calculation.
This standard uses the translation method equivalent to ISO 17853..2011 "Wearing materials for wear materials and metal materials.
And characterization ". For ease of use, this standard has been modified as follows.
--- the standard concentration of the unit M with mol/L instead, M does not belong to GB 3101 and GB 3102 parts given by the unit.
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 standard is proposed by the State Food and Drug Administration.
This standard by the National Surgical Implantation and Orthopedic Equipment Standardization Technical Committee Materials and Orthopedic Implants Sub-Technical Committee
(SAC/TC110/SC1).
The drafting of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, China Food and Drug Administration Research Institute, the State Food and Drug Administration
Administration of Medical Devices Technical Review Center, China University of Mining and Technology.
The main drafters of this standard. Zhang Chen, An Junbo, Song Duo, Liu Li, Wang Shuo, Tang Jinglong, Wang Chunren, Guo Xiaolei, Sun Jiayi, Liu Hongtao,
Zhang Dekun.
This standard replaced the previous version of the standard release.
--- YY/T 0652-2008.
Introduction
The biological reaction of the debris can lead to bone resorption and prosthesis loosening, resulting in failure of the joint implant. To characterize the debris,
There must be a uniform method of extracting debris from the tissue to ensure a uniform standard for evaluating the impact of debris. On the implant simulator
The resulting debris speculation also provides valuable information for the wear properties and performance of the implant under study.
In this standard, the first method of separating and characterizing debris in the tissue or in the simulator lubricating fluid is to filter or embed the resin
(LC) or transmission electron microscopy (TEM) were used to analyze the debris. The results were analyzed by scanning electron microscopy (SEM) or transmission electron microscopy (TEM). Correct
Another method of separation and characterization of the implanted metal debris in the simulator has recently been developed in which debris can be deposited on the wafer
SEM analysis, without filtering or mosaic [1]. At the time of publication of this standard, the second method has not been used to separate and characterize debris in the tissue,
The results obtained by the two methods are not directly compared. Therefore, the latter is not listed in detail.
Wear of implant material
Separation and characterization of polymer and metal materials
1 Scope
This standard specifies the sampling methods for debris produced by implantation of the implant in the human body and in the simulator. This standard specifies separation
And characterization of polymer and metal debris (debris from the revision surgery or autopsy of the joint replacement of the implant around the excision of the tissue or joint simulation
Lubricating fluid), reagents and test methods. Some of these steps can be applied to the separation and characterization of debris in human body fluids (eg joints
Synovial fluid).
There is no quantification of the degree of wear generated by the implant in this standard; nor does it specify the amount of wear required for any particular surface. This standard does not
Including the biological reactions of debris, and the methods used to assess biosafety.
2 terms and definitions
The following terms and definitions apply to this document.
2.1
Polymer wear
The polymer parts of the implant are worn out by the particles.
2.2
Metal scraping metalwearparticle
The metal parts of the implant are worn out by particles and granular corrosion products.
2.3
Ceramic wear
The ceramic parts of the implant are worn out by the particles.
3 principle, reagents and instruments
3.1 Principles
Polymer debris and metal debris by digestion tissue samples and simulator lubricating fluid separation, and then by removing other organic debris
Purified to get.
Note. The method of separating polymer debris and metal debris is different and will be described separately in 4.2 and 4.3.
The debris was collected and characterized and counted by scanning electron microscopy (SEM) or transmission electron microscopy (TEM) (if applicable).
3.2 Reagents
During the analysis, unless otherwise stated, only approved analytical reagents, distilled water or water of the same purity grade are used.
To avoid contamination of the sample with foreign particles, all reagent solutions should be filtered using a filter with a pore size of 0.2 μm or less before use.
3.2.1 anhydrous ethanol
3.2.2 Acetone
100% or diluted with distilled water to 80%.
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