GB/T 25440.4-2010 English PDFUS$594.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 25440.4-2010: Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants Status: Obsolete
Basic dataStandard ID: GB/T 25440.4-2010 (GB/T25440.4-2010)Description (Translated English): Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 15,150 Date of Issue: 2010-11-10 Date of Implementation: 2011-05-01 Quoted Standard: GB/T 25440.1-2010 Adopted Standard: ISO 12891-4-2000, IDT Regulation (derived from): National Standard Approval Announcement 2010 No.8 (Total No.163) Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This standard specifies the implants and related surgical removal of samples, processing and analysis. Implants and reports relevant samples taken from the patient's body, autopsy or surgical repair. Formulation of this standard are intended for implant removal and analysis to provide a guidance to avoid damage to the surface of the sample due to the impact of the findings, and provide guidance for the collection of data in the appropriate time and circumstance, GB/T 25440 first a part of the guidance implants removed and processed, the second part to the provisions of section 4 of the analytical methods specific implant materials, including used when reporting data collection program, for special research projects that require additional more detailed program, if you use special analytical techniques. It should specify appropriate procedures, This section when removing ceramic dental implant surgical analysis provides guidance, information about ceramic two dice, see reference, according to the degree of damage to the Tan figures increasing, research can be divided into three phase, the research stage and the choice depends on the type of the type of implants and research purposes, this section refers to a " compact", "stable" ceramics such as molybdenum oxide, cobalt oxide and tetragonal, but at the appropriate time, this section can also be used less stable ceramic (eg hydroxyapatite) and bioactive ceramics (such as tricalcium phosphate), certain provisions of Chapter 6 of these types of ceramics used in the analysis, the use of this part of the involved removal of the implant, processing and analysis of biological materials and related organizations to follow state laws and regulations. GB/T 25440.4-2010: Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants---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. Retrieval and analysis of surgical implants Part 4. Analysis of retrieved ceramic surgical implants ICS 11.040.40 C45 National Standards of People's Republic of China Surgical implants removed and Analysis Part 4. Remove Analysis ceramic surgical implants Part 4. Analysisofretrievedceramicsurgicalimplants (ISO 12891-4.2000, IDT) Issued on. 2010-11-10 2011-05-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released Table of ContentsPreface Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 out, handling and packaging procedures 1 5 implant interface analysis 26 analysis of the implant7 implant performance 4 Standard format Appendix A (informative) Remove ceramic surgical implants analysis 5 Detection Annex B (informative) Evaluation of the ceramic material 8 Reference 10ForewordGB/T 25440 "removal and analysis of surgical implants" is divided into four parts. --- Part 1. Remove and processing; --- Part 2. Remove the metal analysis of surgical implants; --- Part 3. Remove the analysis of polymer surgical implants; --- Part 4. Remove Analysis ceramic surgical implants. This section GB/T Part of 425,440. This part identical with ISO 12891-4.2000 "surgical implant removal and analysis - Part 4. Remove the ceramic surgical implants Analysis "(in English). Appendix A of this section and Appendix B is an informative annex. This part is proposed by the State Food and Drug Administration. This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized. This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Qibao Fen, Li Libin, Furui Zhi, Li Yuan.IntroductionStudy removed surgical implants and adjacent tissues of diagnostic value of clinical complications can deepen clinical implant performance and plant Into the matter with the understanding of the human interaction, providing an implant performance and security of information, so as to promote the development of a biocompatible implant material and Improve life. GB/T 25440 Part of the analysis taken into ceramic surgical implants provide guidance aimed at reducing the damage to the implant, indeed A typical set of research methods, findings from different sources were compared. This section also provides guidance for clinical research literature. This section It can also be used for animals removed and analyzed. Other parts of the GB/T 25440 describes the addition of a ceramic material made of other materials plant The detailed process was taken out and processed and analytical methods. GB/T 25440.1 provides removal and processing of general guidance, and applied to this section and other parts, which relate to different materials Analysis of materials. GB/T 25440.1 of Information Appendix B and Appendix C includes examples of clinical and removing data collection. These data Other parts of the GB/T 25440 will not be repeated; based on fetched surgical implants, may be attached to or associated with the removal and analysis of biological materials and The purpose, they can be cut and increased. Surgical implants removed and Analysis Part 4. Remove Analysis ceramic surgical implants1 ScopeGB/T 25440 for each part of surgical implants and related samples taken, processed and analyzed to provide guidance, implants and related Routine samples taken from the patient, surgical repair or autopsy. The development of this standard is intended to remove the implant and analysis provided A guidance, in order to avoid damage to the sample affect the findings and to provide guidance for the collection of data at the right time and the environment. GB/T removal and handling, 25440 Part 1 Guidance implant Part 2 to Part 4 provides an analysis of specific materials implant The method, including the collection of data used when reporting scheme. For special research projects, the need for additional more detailed plan. If you use special Special analysis techniques, are advised to indicate the appropriate procedures. This section analyzes the ceramic surgical implants removed to provide guidance. For general information about ceramics, see Ref. Based on plant The extent of damage was increasing, research can be divided into three stages. Research stage and the choice depends on the type of implant and the type of research purpose. This section refers to "compact", "stable" ceramics such as alumina and tetragonal zirconia. However, at the appropriate time, this section also It can be used in less stable ceramics (e.g., hydroxyapatite) and bioactive ceramics (e.g. tricalcium phosphate). Chapter 6 for certain provisions These types of ceramics were analyzed. Use this section relates to the removal of the implant, tissue processing and analysis and related biological material in accordance with national laws and regulations.2 Normative referencesThe following documents contain provisions which, through reference GB/T 25440 in this section constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section. GB/T 25440.1-2010 surgical implant removal and analysis - Part 1. Remove and handling (ISO 12891-1.1998, IDT)3 Terms and DefinitionsThe following terms and definitions apply to this part of the GB/T 25440 of. 3.1 Ceramic surgical implants ceramicsurgicalimplant In surgical technique to implant a ceramic material medical devices. Note 1. hereinafter referred to as "implant." Note 2. The compound can be used as part of the implant. 4 out, handling and packaging procedures Remove, handling, packaging and related personnel protection program should be consistent with the provisions of GB/T 25440.1 of. NOTE. As a precaution, remove the implant suitably appropriate method for sterilization, this method should not adversely impact on the implants and is expected to study the corresponding fine See section GB/T 25440.1-2010 Appendix A. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 25440.4-2010_English be delivered?Answer: Upon your order, we will start to translate GB/T 25440.4-2010_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 25440.4-2010_English with my colleagues?Answer: Yes. 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