GB/T 25440.4-2010Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants (English PDF)

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.

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.

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.