Screen LibraryIntegrated safety and risk assessment for medical devices and combination products /
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| Main Authors: | |
|---|---|
| Published: |
Springer,
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| Publisher Address: | Cham, Switzerland : |
| Publication Dates: | [2019] |
| Literature type: | Book |
| Language: | English |
| Subjects: | |
| Carrier Form: | xiii, 490 pages : illustrations (some color) ; 24 cm |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9783030352400 3030352404 |
| Index Number: | R856 |
| CLC: | R197.39 |
| Call Number: | R197.39/G123 |
| 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. |