| Evaluation of MEMS materials of construction for implantable medical devices. | |
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MedLine Citation:
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PMID: 12059024 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Medical devices based on microelectro-mechanical systems (MEMS) platforms are currently being proposed for a wide variety of implantable applications. However, biocompatibility data for typical MEMS materials of construction and processing, obtained from standard tests currently recognized by regulatory agencies, has not been published. Likewise, the effects of common sterilization techniques on MEMS material properties have not been reported. Medical device regulatory requirements dictate that materials that are biocompatibility tested be processed and sterilized in a manner equivalent to the final production device. Material, processing, and sterilization method can impact the final result. Six candidate materials for implantable MEMS devices, and one encapsulating material, were fabricated using typical MEMS processing techniques and sterilized. All seven materials were evaluated using a baseline battery of ISO 10993 physicochemical and biocompatibility tests. In addition, samples of these materials were evaluated using a scanning electron microscope (SEM) pre- and post-sterilization. While not addressing all facets of ISO 10993 testing, the biocompatibility and SEM data indicate few concerns about use of these materials in implant applications. |
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Authors:
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Geoffrey Kotzar; Mark Freas; Phillip Abel; Aaron Fleischman; Shuvo Roy; Christian Zorman; James M Moran; Jeff Melzak |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Biomaterials Volume: 23 ISSN: 0142-9612 ISO Abbreviation: Biomaterials Publication Date: 2002 Jul |
Date Detail:
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Created Date: 2002-06-12 Completed Date: 2002-12-06 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8100316 Medline TA: Biomaterials Country: England |
Other Details:
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Languages: eng Pagination: 2737-50 Citation Subset: IM |
Affiliation:
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BIOMEC, Inc., Cleveland, OH 44114, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biocompatible Materials*
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standards Bone Substitutes* / standards Carbon Compounds, Inorganic Materials Testing / methods* Microscopy, Electron, Scanning Silicon Silicon Compounds Silicon Dioxide Time Factors Titanium Water |
| Chemical | |
Reg. No./Substance:
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0/Biocompatible Materials; 0/Bone Substitutes; 0/Carbon Compounds, Inorganic; 0/Silicon Compounds; 12033-89-5/silicon nitride; 409-21-2/silicon carbide; 7440-21-3/Silicon; 7440-32-6/Titanium; 7631-86-9/Silicon Dioxide; 7732-18-5/Water |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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