DIN EN ISO 10993-11:2026-07
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2026); German and English version prEN ISO 10993-11:2026 / Note: Date of issue 2026-06-05*Intended as replacement for DIN EN ISO 10993-11 (2018-09).
| Fecha edición: |
2026-07-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. |
| Keywords: | Abbreviated description|Animal husbandry|Bioassay|Biological|Biological analysis and testing|Biological hazards|Biological tests|Conditions|Definitions|Dental equipment|Dental materials|Design|Determination|Dosage|Dose|Evaluations|Extraction|Health protection|Implants (surgical)|Information|Inhalation|Limits (mathematics)|Measurement|Measuring techniques|Medical devices|Medical equipment|Medical products|Methods|Methods of analysis|Preparation|Production|Quality assurance|Quality assurance systems|Recommendation|Residual content|Residue|Residues|Samples|Selection|Specification (approval)|Specimen preparation|Status|Sterilization (hygiene)|Surgical equipment|Surgical implants|Testing|Toxicity|Validation |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-11:2025-05 |
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