DIN EN ISO 7405:2025-12
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025); German version EN ISO 7405:2025
| Fecha edición: |
2025-12-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body. |
| Keywords: | Bioassay|Biocompatibility|Biological|Biological analysis and testing|Biological tests|Clinical investigations|Compatibility|Compatibility tests|Definitions|Dental equipment|Dental instruments|Dental materials|Dentistry|Evaluations|Materials|Medical devices|Medical products|Pharmacology|Test reports|Testing |
| ICS: | 11.100.99 - Otras normas relativas a medicina de laboratorio, 11.100.20 - Evaluación biológica de productos sanitarios, 11.060.10 - Productos y materiales dentales |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 7405:2025 Idéntica ISO 7405:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 7405:2019-03 Reemplaza a DIN EN ISO 7405:2024-04 |
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