YY/T 0652-2016 English PDFUS$324.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0652-2016: Wear of implant materials. Polymer and metal wear particles. Isolation and characterization Status: Valid YY/T 0652: Historical versions
Basic dataStandard 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11.040.40 Word Count Estimation: 17,139 Date of Issue: 2016-01-26 Date of Implementation: 2017-01-01 Older Standard (superseded by this standard): YY/T 0652-2008 Adopted Standard: ISO 17853-2011, IDT Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25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---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. 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 definitionsPrinciple, reagents and instruments Sampling and analysis of polymer debris and metal debris in tissue samples 45 Joint simulator Sampling and analysis of polymer and metal abrasive in lubricating fluid6 Test Report 12 Reference 13ForewordThis 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.IntroductionThe 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 materials1 ScopeThis 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 definitionsThe 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%. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0652-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 0652-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0652-2016?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0652-2016 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
