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BS ISO 12891-2:2020:2024 Edition

BS ISO 12891-2:2020:2024 Edition

$167.15

Retrieval and analysis of surgical implants – Analysis of retrieved surgical implants

Published By Publication Date Number of Pages
BSI 2024 34
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
4 Procedures for retrieval, handling and packaging
10 5 Analysis of the implant interfaces
5.1 Implant/tissue interface
5.2 Implant/implant interfaces
6 Analysis of the implant
6.1 General
11 6.2 Forms for recording the results of the analyses
6.3 Stage I investigation (macroscopic examination ā€” 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 ā€” mostly non-destructive)
6.4.1 General
12 6.4.2 Microscopic examination
6.4.3 Fractographic examination
6.4.4 Surface topography
6.5 Stage III investigation (material investigation ā€” mostly destructive)
6.5.1 General
6.5.2 Material composition
13 6.5.3 Microstructure
14 6.5.4 Mechanical properties
6.6 Surface-treated or coated implants
6.7 Biodegradable implants
15 7 Implant performance
16 Annex A (normative) Standard forms for the analysis of retrieved surgical implants
27 Annex B (informative) ISO documents applicable for the evaluation of materials
31 Bibliography

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BS ISO 12891-2:2020
$167.15