DIN EN ISO 10993-1:2026-03
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025); German version EN ISO 10993-1:2025
| Fecha edición: |
2026-03-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | The most important concern of this document is the protection of humans from possible biological risks arising from the use of medical devices. The document has been compiled from numerous international and national standards and guidelines relating to the biological evaluation of medical devices. It is intended as a description of the biological evaluation of medical devices within a risk management process, as part of the comprehensive evaluation and development of medical devices. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, allowing a complete assessment to be made of the biological response to each medical device according to its safety in use. |
| Keywords: | Bioassay|Biocompatibility|Biological|Biological analysis and testing|Biological hazards|Biological tests|Categories|Classification|Compatibility|Definitions|Evaluations|Fine mechanics|Fitness for purpose|Human body|Implants (surgical)|Management systems|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Principles|Risk management|Safety|Selection|Specification (approval)|Surgical equipment|Testing|Use |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-1:2025 Idéntica ISO 10993-1:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-1:2021-05 Reemplaza a DIN EN ISO 10993-1:2024-07 |
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