ISO 12891-4:2000 PDF

The various parts of ISO 12891 give recommendations for the retrieval, handling and analysis of surgical implants and associated specimens which are removed from patients routinely, during revision surgery or post-mortem. The aim is to provide guidance in preventing damage to the specimens which could obscure the investigation results, and in gathering data at the proper time and under the proper circumstances to validate the study. Part 1 deals with retrieval and handling. Parts 2 to 4 concern the analysis of implants of specific materials, including protocols for reporting the data collected. For particular investigation programmes, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate procedures should be specified.

This part of ISO 12891 provides guidance on the analysis of retrieved ceramic surgical implants. For general information on ceramics, see the bibliography. The investigation is divided into three stages that are increasingly destructive. The stage and type of investigation should be chosen as a function of the type of implant and the purpose of the investigation.

This part of ISO 12891 concerns "dense", "stable" ceramics such as alumina and tetragonal zirconia. However, where suitable, sections of this part of ISO 12891 may be also applied to less stable ceramics like hydroxyapatite or bio-accessible ceramics like tricalcium phosphate. In clause 6, some provisions are made for analyses of such types of ceramic.

This part of ISO 12891 should be used in accordance with national regulations or legal requirements concerning the handling and analysis of retrieved implants and tissues and associated biological material.