Biomaterials in the design and reliability of medical devices:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Georgetown, Tex.
Landes Bioscience / Eurekah.Com [u.a.]
2003
|
| Schriftenreihe: | Tissue engineering intelligence unit
5 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | 226 S. graph. Darst. |
| ISBN: | 0306476908 |
Internformat
MARC
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| 245 | 1 | 0 | |a Biomaterials in the design and reliability of medical devices |c Michael N. Helmus |
| 264 | 1 | |a Georgetown, Tex. |b Landes Bioscience / Eurekah.Com [u.a.] |c 2003 | |
| 300 | |a 226 S. |b graph. Darst. | ||
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| 490 | 1 | |a Tissue engineering intelligence unit |v 5 | |
| 650 | 4 | |a Biocompatible Materials | |
| 650 | 4 | |a Biomedical engineering | |
| 650 | 4 | |a Biomedical materials | |
| 650 | 4 | |a Equipment Design | |
| 650 | 4 | |a Equipment and Supplies | |
| 650 | 4 | |a Materials Testing | |
| 650 | 4 | |a Materials testing | |
| 650 | 4 | |a Medical instruments and apparatus | |
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| 999 | |a oai:aleph.bib-bvb.de:BVB01-010731794 | ||
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Datensatz im Suchindex
| _version_ | 1804130557794189312 |
|---|---|
| adam_text | I CONTENTS T
Preface viii
1. Overview and Introduction: Unique Aspects of Biomaterials
in the Safety and Efficacy of Medical Implant Devices 1
Michael N. Helmus
Materials Selection 1
Functional Requirements 2
Biomaterials and Regulatory Guidelines 53
2. Standards and Guidelines for Biocompatibility of Medical Devices 74
Sharon ]. Northup
Product Registration Requirements 74
Standards and Guidelines for Biocompatibility Testing 106
Chemical Characterization 107
Risk Assessment 113
Case Studies of Materials Toxicity Risk Assessment 117
Conclusion 125
3. Regulation of Medical Devices 127
Barry Sail
U.S. Food and Drug Administration Regulation
of Medical Devices 127
4. Nonclinical Medical Device Testing 144
Sharon J. Northup
Overview of Biocompatibility Procedures 144
Sample Preparation 146
Detailed Description of Biocompatibility Procedures 148
Cytotoxicity 149
Sensitization 150
Irritation Assays 152
Systemic Toxicity (Single and Repeated Dose Toxicity Including
Pyrogenicity) 152
Pyrogenicity 156
Genotoxicity 157
Implantation 160
Hemocompatibility 162
Chronic Toxicity and Carcinogeniciry 164
Reproductive and Developmental Toxicity 165
Biodegradation 165
Toxicokinetic Studies 166
Effectiveness Testing 167
Externally Communicating Devices 169
, Implanted Devices 169
Conclusion 170
5. Failure Analysis: Learning for the Future from the Past 172
Michael N. Helm us
6. Product Development in a Small Company Environment 178
Roger W. Snyder
Records and Record Keeping 179
Testing 181
Materials and Components 182
Prototyping 184
Vendor Relationships 185
Sterilization and Shelf Life 186
Production Facilities 187
Conclusion 189
7. Tissue Engineering Constructs and Commercialization 191
Kelvin G.M. Brock bank
Case Studies: Development of Effective Transport Solutions
and Devices to Enable Product Distribution 194
Development of Methods to Increase Product Shelf life 195
8. Testing of Biomaterials Modified
with Bioactive Molecules: A Case Study 198
Katherine S. Tweden
Characterization of the Nature and Uniformity
of the Modification 199
Quantitation of the Modification 202
Assessment of the Biological Activity In Vitro 202
In Vitro Challenges 204
Manufacturing Ruggedness 204
Assessment of the Biological Activity In Vivo 205
Immobilization of an RGD Containing Peptide: A Case Study 206
Materials 206
Results 209
Appendix: Selecting Contract Labs 223
Barry Sail
Index 224
|
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| isbn | 0306476908 |
| language | English |
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| spelling | Biomaterials in the design and reliability of medical devices Michael N. Helmus Georgetown, Tex. Landes Bioscience / Eurekah.Com [u.a.] 2003 226 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Tissue engineering intelligence unit 5 Biocompatible Materials Biomedical engineering Biomedical materials Equipment Design Equipment and Supplies Materials Testing Materials testing Medical instruments and apparatus Biomaterial (DE-588)4267769-5 gnd rswk-swf Test (DE-588)4059549-3 gnd rswk-swf Biomedizinische Technik (DE-588)4006882-1 gnd rswk-swf Biokompatibilität (DE-588)4221531-6 gnd rswk-swf Medizinisches Gerät (DE-588)4038281-3 gnd rswk-swf Biomaterial (DE-588)4267769-5 s Test (DE-588)4059549-3 s DE-604 Biomedizinische Technik (DE-588)4006882-1 s Medizinisches Gerät (DE-588)4038281-3 s Biokompatibilität (DE-588)4221531-6 s 1\p DE-604 Helmus, Michael N. Sonstige oth Tissue engineering intelligence unit 5 (DE-604)BV013099830 5 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010731794&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Biomaterials in the design and reliability of medical devices Tissue engineering intelligence unit Biocompatible Materials Biomedical engineering Biomedical materials Equipment Design Equipment and Supplies Materials Testing Materials testing Medical instruments and apparatus Biomaterial (DE-588)4267769-5 gnd Test (DE-588)4059549-3 gnd Biomedizinische Technik (DE-588)4006882-1 gnd Biokompatibilität (DE-588)4221531-6 gnd Medizinisches Gerät (DE-588)4038281-3 gnd |
| subject_GND | (DE-588)4267769-5 (DE-588)4059549-3 (DE-588)4006882-1 (DE-588)4221531-6 (DE-588)4038281-3 |
| title | Biomaterials in the design and reliability of medical devices |
| title_auth | Biomaterials in the design and reliability of medical devices |
| title_exact_search | Biomaterials in the design and reliability of medical devices |
| title_full | Biomaterials in the design and reliability of medical devices Michael N. Helmus |
| title_fullStr | Biomaterials in the design and reliability of medical devices Michael N. Helmus |
| title_full_unstemmed | Biomaterials in the design and reliability of medical devices Michael N. Helmus |
| title_short | Biomaterials in the design and reliability of medical devices |
| title_sort | biomaterials in the design and reliability of medical devices |
| topic | Biocompatible Materials Biomedical engineering Biomedical materials Equipment Design Equipment and Supplies Materials Testing Materials testing Medical instruments and apparatus Biomaterial (DE-588)4267769-5 gnd Test (DE-588)4059549-3 gnd Biomedizinische Technik (DE-588)4006882-1 gnd Biokompatibilität (DE-588)4221531-6 gnd Medizinisches Gerät (DE-588)4038281-3 gnd |
| topic_facet | Biocompatible Materials Biomedical engineering Biomedical materials Equipment Design Equipment and Supplies Materials Testing Materials testing Medical instruments and apparatus Biomaterial Test Biomedizinische Technik Biokompatibilität Medizinisches Gerät |
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