title: Evaluation of MEMS materials of construction for implantable medical devices.
abstract: 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.
authors.affiliation: BIOMEC, Inc., Cleveland, OH 44114, USA.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Kotzar
authors.forename: Mark
authors.initials: M
authors.lastname: Freas
authors.forename: Phillip
authors.initials: P
authors.lastname: Abel
authors.forename: Aaron
authors.initials: A
authors.lastname: Fleischman
authors.forename: Shuvo
authors.initials: S
authors.lastname: Roy
authors.forename: Christian
authors.initials: C
authors.lastname: Zorman
authors.forename: James M
authors.initials: JM
authors.lastname: Moran
authors.forename: Jeff
authors.initials: J
authors.lastname: Melzak
mesh_terms: D001672:Biocompatible Materials / Q000592:standards; D018786:Bone Substitutes / Q000592:standards; D017554:Carbon Compounds, Inorganic; D008422:Materials Testing / Q000379:methods*; D008855:Microscopy, Electron, Scanning; D012825:Silicon; D017655:Silicon Compounds; D012822:Silicon Dioxide; D013997:Time Factors; D014025:Titanium; D014867:Water
chemical_list: D001672:Biocompatible Materials; D018786:Bone Substitutes; D017554:Carbon Compounds, Inorganic; D017655:Silicon Compounds; D014867:Water; D012822:Silicon Dioxide; D014025:Titanium; C032734:silicon nitride; C022088:silicon carbide; D012825:Silicon