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
| Sorumlu | Rehaf Foula |
|---|---|
| Son Güncelleme | 18.10.2026 |
| Üyeler | 1 |
Health
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1. Evaluation Foundations1Dersler ·
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1.1 WelcomeYeni
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2. Planning the Evaluation2Dersler ·
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2.1 Purpose of the Biological Evaluation PlanYeni
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2.2 Building a Device Evidence StrategyYeni
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3. Contact Categorization4Dersler ·
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3.1 Defining Body ContactYeni
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3.2 Classifying Contact DurationYeni
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3.3 Accounting for Exposure ChangesYeni
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3.4 Applying Contact CategoriesYeni
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4. Biological Endpoints3Dersler ·
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4.1 Mapping Relevant EndpointsYeni
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4.2 Endpoint Evidence and HazardsYeni
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4.3 When Endpoints Need TestingYeni
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5. Chemical Characterization2Dersler ·
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5.1 Role of Chemical CharacterizationYeni
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5.2 Defining Materials and ConstituentsYeni
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