DIN EN ISO 10993-4:2025-09
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017 + Amd 1:2025, Corrected version 2025-04); German version EN ISO 10993-4:2017 + A1:2025
| Fecha edición: |
2025-09-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended. |
| Keywords: | Bioassay|Biological hazards|Biological tests|Blood|CE marking|Classification|Definitions|Dental equipment|Dental instruments|Dentistry|Evaluations|Guidelines|Haematology|Implants (surgical)|In vitro|Interaction|Materials|Medical devices|Medical equipment|Medical products|Medical sciences|Risk|Specification (approval)|Surgical equipment|Surgical implants|Testing |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-4:2017/A1:2025 Idéntica ISO 10993-4:2017/Amd 1:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-4:2017-12 Reemplaza a DIN EN ISO 10993-4/A1:2024-04 |
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