GB/T 25440.4-2010 Retrieval and analysis of surgical implants—Part 4:Analysis of retrieved ceramic surgical implants

Scope

The various parts of GB/T 25440 provide guidance on the removal, processing, and analysis of surgical implants and related samples from patients undergoing routine removal, surgical repair, or autopsy. The purpose of formulating this standard is to provide guidelines for the removal and analysis of implants to avoid affecting the investigation results due to sample damage, and to provide guidance for collecting data at appropriate times and in appropriate environments. Part 1 of GB/T 25440 provides guidance on the removal and processing of implants, and Parts 2 to 4 specify the analysis methods for implants made of specific materials, including the protocols used for data collection. For special research projects, additional more detailed protocols are required. If special analysis techniques are used, it is advisable to specify appropriate procedures.
This part provides guidance on the analysis of ceramic surgical implants removed. For general information on ceramics, see the references. Based on the increasing degree of implant damage, the research can be divided into three stages. The selection of research stages and types depends on the type of implant and the research purpose.
This part deals with "dense" and "stable" ceramics, such as alumina and tetragonal zirconia. However, when appropriate, this part can also be used for less stable ceramics (such as hydroxyapatite) and bioactive ceramics (such as tricalcium phosphate). Some provisions in Chapter 6 are used for analyzing these types of ceramics.
The removal of implants, tissues, and related biological materials, as well as their processing and analysis, comply with national laws and regulations.

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