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GB/T 25440.4-2010: Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants
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| GB/T 25440.4-2010 | English | 594 |
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Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants
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GB/T 25440.4-2010
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Basic data | Standard 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
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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 Contents
Preface 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 2
6 analysis of the implant
7 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 10
Foreword
GB/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.
Introduction
Study 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 implants
1 Scope
GB/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 references
The 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 Definitions
The 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.
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