ISO 10993-1 Biological Evaluation of Medical Devices
Designed for medical device engineers, toxicologists, regulatory professionals, and quality staff who need to apply ISO 10993-1 within a risk management process. By the end, learners will be able to plan biological evaluations, select and justify evidence and testing across the ISO 10993 series, assess biological risks, and prepare a defensible Biological Evaluation Report.
5.000,00 LE
5000.0
EGP
5.000,00 LE
| Responsable | Rehaf Foula |
|---|---|
| Última actualización | 18/10/2026 |
| Miembros | 1 |
Health
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1. Evaluation Foundations1Lecciones ·
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1.1 WelcomeNuevo
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2. Planning the Evaluation2Lecciones ·
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2.1 Purpose of the Biological Evaluation PlanNuevo
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2.2 Building a Device Evidence StrategyNuevo
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3. Contact Categorization4Lecciones ·
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3.1 Defining Body ContactNuevo
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3.2 Classifying Contact DurationNuevo
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3.3 Accounting for Exposure ChangesNuevo
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3.4 Applying Contact CategoriesNuevo
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4. Biological Endpoints3Lecciones ·
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4.1 Mapping Relevant EndpointsNuevo
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4.2 Endpoint Evidence and HazardsNuevo
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4.3 When Endpoints Need TestingNuevo
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5. Chemical Characterization2Lecciones ·
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5.1 Role of Chemical CharacterizationNuevo
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5.2 Defining Materials and ConstituentsNuevo
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