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
| Ответственный | Rehaf Foula |
|---|---|
| Последнее обновление | 18.10.2026 |
| Участники | 1 |
Health
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1. Evaluation Foundations1Уроки -
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1.1 WelcomeНовый
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2. Planning the Evaluation2Уроки -
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2.1 Purpose of the Biological Evaluation PlanНовый
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2.2 Building a Device Evidence StrategyНовый
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3. Contact Categorization4Уроки -
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3.1 Defining Body ContactНовый
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3.2 Classifying Contact DurationНовый
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3.3 Accounting for Exposure ChangesНовый
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3.4 Applying Contact CategoriesНовый
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4. Biological Endpoints3Уроки -
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4.1 Mapping Relevant EndpointsНовый
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4.2 Endpoint Evidence and HazardsНовый
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4.3 When Endpoints Need TestingНовый
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5. Chemical Characterization2Уроки -
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5.1 Role of Chemical CharacterizationНовый
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5.2 Defining Materials and ConstituentsНовый
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