ISO 12891-2:2014
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants
ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants.
ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive.
ISO 12891-2:2014 can also be applied to other materials, e.g. animal tissue implants.
ISO 12891-2:2014 can be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Section sec_6.4
Section sec_6.4.1
Section sec_6.4.2
Section sec_6.4.3
Section sec_6.4.4
Section sec_6.5
Section sec_6.5.1
Section sec_6.5.2
Section sec_6.5.2.1
Section sec_6.5.2.2
Section sec_6.5.2.3
Section sec_6.5.2.4
Section sec_6.5.3
Section sec_6.5.4
Section sec_6.6
Section sec_6.7
Section sec_7
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex sec_B
Annex sec_B.1
Annex sec_B.1.1
Annex sec_B.1.2
Annex sec_B.1.3
Annex sec_B.2
Annex sec_B.2.1
Annex sec_B.2.2
Annex sec_B.2.3
Annex sec_B.3
Annex sec_B.3.1
Annex sec_B.3.2
Annex sec_B.3.3
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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)
6.4 Stage II investigation (microscopic examination — mostly non-destructive)
6.5 Stage III investigation (material investigation — mostly destructive)
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 Standards applicable for the evaluation of materials
Bibliography
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Section sec_6.4
Section sec_6.4.1
Section sec_6.4.2
Section sec_6.4.3
Section sec_6.4.4
Section sec_6.5
Section sec_6.5.1
Section sec_6.5.2
Section sec_6.5.2.1
Section sec_6.5.2.2
Section sec_6.5.2.3
Section sec_6.5.2.4
Section sec_6.5.3
Section sec_6.5.4
Section sec_6.6
Section sec_6.7
Section sec_7
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex sec_B
Annex sec_B.1
Annex sec_B.1.1
Annex sec_B.1.2
Annex sec_B.1.3
Annex sec_B.2
Annex sec_B.2.1
Annex sec_B.2.2
Annex sec_B.2.3
Annex sec_B.3
Annex sec_B.3.1
Annex sec_B.3.2
Annex sec_B.3.3
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Reference ref_63
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)
6.4 Stage II investigation (microscopic examination — mostly non-destructive)
6.5 Stage III investigation (material investigation — mostly destructive)
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 Standards applicable for the evaluation of materials
Bibliography