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DIN EN ISO 10993-3:2025-05

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025 / Note: Date of issue 2025-03-28*Intended as replacement for DIN EN ISO 10993-3 (2015-02).

Fecha edición: 2025-05-01
En Vigor
Idiomas disponibles: Alemán, Inglés
Resumen: This document specifies strategies for risk estimation and selection of biological harms identification tests with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: — genotoxicity; — carcinogenicity; — reproductive and developmental toxicity. This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity has been established.

Keywords: Bioassay|Biological|Biological hazards|Biological tests|Carcinogenic materials|Carcinogens|Definitions|Dental equipment|Dental instruments|Dental materials|Evaluations|Fine mechanics|Genes|Genetics|Genotoxicity|Implants (surgical)|In vitro|In vivo|Materials|Medical devices|Medical equipment|Medical sciences|Methods|Preparation|Reproductions|Reproductive system|Sample preparation|Samples|Surgical equipment|Surgical implants|Testing|Toxicity
ICS: 11.100.20 - Evaluación biológica de productos sanitarios
CTN:

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