Integrated Safety and Risk Assessment for Medical Devices and Combination Products
• Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devi...
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| Format: | eBook |
| Language: | English |
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Cham
Springer International Publishing
2019, 2019
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| Edition: | 1st ed. 2019 |
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| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 1. Introduction – History and Where We are Headed
- 2. Regulatory Guidance
- 3. Sample Preparation and Biocompatibility Testing
- 4. Testing for Leachables and Extractables
- 5. Where the Data is – And What is It?
- 6. Bridging Issues of Route
- 7. Risk Assessments for Medical Devices
- 8. (Q)SAR
- 9. Histopathology in Medical Device Studies
- 10. Assessment of Nanomaterial Devices
- 11. Integrated Safety Assessments for Devices
- 12. Toxicity of Common Extractables and Leachables