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
| 负责人 | Rehaf Foula |
|---|---|
| 最后更新 | 2026/10/18 |
| 成员 | 1 |
Health
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1. Evaluation Foundations1课程 。
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1.1 Welcome新建
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2. Planning the Evaluation2课程 。
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2.1 Purpose of the Biological Evaluation Plan新建
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2.2 Building a Device Evidence Strategy新建
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3. Contact Categorization4课程 。
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3.1 Defining Body Contact新建
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3.2 Classifying Contact Duration新建
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3.3 Accounting for Exposure Changes新建
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3.4 Applying Contact Categories新建
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4. Biological Endpoints3课程 。
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4.1 Mapping Relevant Endpoints新建
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4.2 Endpoint Evidence and Hazards新建
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4.3 When Endpoints Need Testing新建
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5. Chemical Characterization2课程 。
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5.1 Role of Chemical Characterization新建
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5.2 Defining Materials and Constituents新建
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