DIN EN ISO 10993-15:2023-07
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
| Fecha edición: |
2023-07-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behaviour in the body. The described chemical methodologies are a means to generate degradation products for further assessments. |
| Keywords: | Alloys|Bioassay|Biological analysis and testing|Biological tests|CE marking|Decomposition|Decomposition products|Definitions|Degradation|Determination|Electrochemical methods|Evaluations|Guide books|Identification|Implants (surgical)|Medical devices|Medical products|Metals|Quantification|Reagents|Specimen preparation|Testing|Toxicological testing|Verification |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-15:2023 Idéntica ISO 10993-15:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-15:2009-10 Reemplaza a DIN EN ISO 10993-15:2018-05 |
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