DIN EN ISO 10993-23:2021-10
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
| Fecha edición: |
2026-03-01
Anulada
|
|---|---|
| Fecha cancelación: | 2026-03-01 |
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-12. |
| Keywords: | Alloys|Biological|Biological tests|CE marking|Checks|Chemical composition|Conditions|Cytotoxicity|Definitions|Dental equipment|Dental instruments|Evaluations|Extracts|Implants (surgical)|In vitro|In vivo|Interpretations|Irritant effect|Irritants|Irritation|Materials|Medical devices|Medical equipment|Medical products|Particles|Patterns|Polymers|Production|Selection|Skin (body)|Specification (approval)|Surfaces|Surgical equipment|Surgical implants|Surgical instruments|Testing |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-23:2021/A1:2025 Idéntica ISO 10993-23:2021/Amd 1:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-23:2019-08 Es reemplazada por DIN EN ISO 10993-23 (2026-03) |
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