ISO 12891-2:2020
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants
This document specifies methods for the analysis of retrieved surgical implants.
This document describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive.
This document can also be applied to other materials, e.g. animal tissue implants.
NOTE National regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material can also apply to specific topics covered in this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures for retrieval, handling and packaging
5 Analysis of the implant interfaces
5.1 Implant/tissue interface
5.2 Implant/implant interfaces
6 Analysis of the implant
6.1 General
6.2 Forms for recording the results of the analyses
6.3 Stage I investigation (macroscopic examination — non-destructive)
6.3.1 General
6.3.2 Identification/photography
6.3.3 Visual examination
6.3.4 Low-power optical examination
6.3.5 Further evaluation
6.4 Stage II investigation (microscopic examination — mostly non-destructive)
6.4.1 General
6.4.2 Microscopic examination
6.4.3 Fractographic examination
6.4.4 Surface topography
6.5 Stage III investigation (material investigation — mostly destructive)
6.5.1 General
6.5.2 Material composition
6.5.3 Microstructure
6.5.4 Mechanical properties
6.6 Surface-treated or coated implants
6.7 Biodegradable implants
7 Implant performance
Annex A (normative) Standard forms for the analysis of retrieved surgical implants
Annex B (informative) ISO documents applicable for the evaluation of materials
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures for retrieval, handling and packaging
5 Analysis of the implant interfaces
5.1 Implant/tissue interface
5.2 Implant/implant interfaces
6 Analysis of the implant
6.1 General
6.2 Forms for recording the results of the analyses
6.3 Stage I investigation (macroscopic examination — non-destructive)
6.3.1 General
6.3.2 Identification/photography
6.3.3 Visual examination
6.3.4 Low-power optical examination
6.3.5 Further evaluation
6.4 Stage II investigation (microscopic examination — mostly non-destructive)
6.4.1 General
6.4.2 Microscopic examination
6.4.3 Fractographic examination
6.4.4 Surface topography
6.5 Stage III investigation (material investigation — mostly destructive)
6.5.1 General
6.5.2 Material composition
6.5.3 Microstructure
6.5.4 Mechanical properties
6.6 Surface-treated or coated implants
6.7 Biodegradable implants
7 Implant performance
Annex A (normative) Standard forms for the analysis of retrieved surgical implants
Annex B (informative) ISO documents applicable for the evaluation of materials
Bibliography