Corrosion of silicon integrated circuits and lifetime predictions in implantable electronic devices

Corrosion is a prime concern for active implantable devices. In this paper we review the principles underlying the concepts of hermetic packages and encapsulation, used to protect implanted electronics, some of which remain widely overlooked. We discuss how technological advances have created a need to update the way we evaluate the suitability of both protection methods. We demonstrate how lifetime predictability is lost for very small hermetic packages and introduce a single parameter to compare different packages, with an equation to calculate the minimum sensitivity required from a test method to guarantee a given lifetime. In the second part of this paper, we review the literature on the corrosion of encapsulated integrated circuits (ICs) and, following a new analysis of published data, we propose an equation for the pre-corrosion lifetime of implanted ICs, and discuss the influence of the temperature, relative humidity, encapsulation and field-strength. As any new protection will be tested under accelerated conditions, we demonstrate the sensitivity of acceleration factors to some inaccurately known parameters. These results are relevant for any application of electronics working in a moist environment. Our comparison of encapsulation and hermetic packages suggests that both concepts may be suitable for future implants

National Aeronautics and Space Administration (NASA)/American Society for Engineering Education (ASEE) Summer Faculty Fellowship Program, 1989, volume 1

The 1989 Johnson Space Center (JSC) National Aeronautics and Space Administration (NASA)/American Society for Engineering Education (ASEE) Summer Faculty Fellowship Program was conducted by Texas A and M University and JSC. The 10-week program was operated under the auspices of the ASEE. The program at JSC, as well as the programs at other NASA Centers, was funded by the Office of University Affairs, NASA Headquarters, Washington, D.C. The objectives of the program, which began nationally in 1964 and at JSC in 1965, are: (1) to further the professional knowledge of qualified engineering and science faculty members; (2) to stimulate an exchange of ideas between participants and NASA; (3) to enrich and refresh the research and teaching activities of participants' institutions; and (4) to contribute to the research objective of the NASA Centers

Diagnostic and prognostic analysis tools for monitoring degradation in aged structures

This research addresses the problem of prolonging the life of aged structures of historical value that have already outlived their original designed lives many times. While a lot of research has been carried out in the field of structural monitoring, diagnostics and prognostics for high tech industries, this is not the case for historical aged structures. Currently most maintenance projects for aged structures have focused on the instrumentation and diagnostic techniques required to detect any damage with a certain degree of success. This research project involved the development of diagnostic and prognostic tools to be used for monitoring and predicting the ‘health’ of aged structures. The diagnostic and prognostic tools have been developed for the monitoring of Cutty Sark iron structures as a first application. The concept of canary and parrot sensor devices are developed where canary devices are small, accelerated devices, which will fail according to similar failure mechanisms occurring in an aged structures and parrot devices are designed to fail at the same rate as the structure, thus mimicking the structure. The model-driven prognostic tool uses a Physics-of-Failure (PoF) model to predict remaining life of a structure. It uses a corrosion model based on the decrease in corrosion rate over time to predict remaining life of an aged iron structures. The data-driven diagnostic tool developed uses Mahalanobis Distance analysis to detect anomalies in the behaviour of a structure. Bayesian Network models are then used as a fusion method, integrating remaining life predictions from the model-driven prognostic tool with information of possible anomalies from data-driven diagnostic tool to provide a probability distribution of predicted remaining life. The diagnostics and prognostic tools are validated and tested through demonstration example and experimental tests. This research primarily looks at applying diagnostic and prognostic technologies used in high-tech industries to aged iron structures. In order to achieve this, the model-driven and data-driven techniques commonly used had to be adapted taking into consideration the particular constraints of monitoring and maintaining aged structures. The fusion technique developed is a novel approach for prognostics for aged structures and provides the flexibility often needed for diagnostic and prognostic tools

Space biology initiative program definition review. Trade study 2: Prototype utilization in the development of space biology hardware

The objective was to define the factors which space flight hardware developers and planners should consider when determining: (1) the number of hardware units required to support program; (2) design level of the units; and (3) most efficient means of utilization of the units. The analysis considered technology risk, maintainability, reliability, and safety design requirements for achieving the delivery of highest quality flight hardware. Relative cost impacts of the utilization of prototyping were identified. The development of Space Biology Initiative research hardware will involve intertwined hardware/software activities. Experience has shown that software development can be an expensive portion of a system design program. While software prototyping could imply the development of a significantly different end item, an operational system prototype must be considered to be a combination of software and hardware. Hundreds of factors were identified that could be considered in determining the quantity and types of prototypes that should be constructed. In developing the decision models, these factors were combined and reduced by approximately ten-to-one in order to develop a manageable structure based on the major determining factors. The Baseline SBI hardware list of Appendix D was examined and reviewed in detail; however, from the facts available it was impossible to identify the exact types and quantities of prototypes required for each of these items. Although the factors that must be considered could be enumerated for each of these pieces of equipment, the exact status and state of development of the equipment is variable and uncertain at this time

THE EFFECT OF RELATIVE HUMIDITY ON THE MICROBIAL BARRIER PROPERTIES OF POROUS PACKAGING MATERIALS USED IN THE MEDICAL DEVICE INDUSTRY

Porous packaging materials, such as medical-grade paper and Tyvek¨, are used often by the medical device industry for packaging sterile devices when the products are sterilized post packaging. Their use can be attributed to the fact that multiple sterilization methods require the ability for vapors to enter and/or exit the package efficiently, while simultaneously reducing the amount of microbes entering the package. Much research as been done to study the effects of multiple material and environmental factors, such as material structure and dispersion concentration, on the microbial barrier properties of these materials, however no research had been conducted to examine the impact of relative humidity. This research was aimed at identifying the effect relative humidity levels can have on the microbial barriers of four porous packaging materials: coated and uncoated Tyvek¨ 1073B, dot coated Ovantex¨, and coated medical-grade paper. Research was conducted with slight adjustments to the ASTM F2638-07 test standard method for using aerosol filtration for measuring the performance of porous packaging materials as a surrogate microbial barrier. The adjustments included preconditioning samples at 15%, 50%, and 90% relative humidity levels and switching samples after each tested flow rate. Results from testing show that the microbial barrier properties of medical-grade paper were significantly impacted by fluctuations in relative humidity. Microbial barrier properties of the medical-grade paper and Ovantex¨ were also significantly impacted by the dispersion flow rate through the material sample, while uncoated Tyvek¨ 1073B was found to only be slightly impacted. Interestingly, when analyzing the coated and uncoated Tyvek¨, a data analysis suggests that the addition of the heat seal coating may significantly decrease the impact flow rate has on microbial penetration

Fuzzy FMECA Process Analysis for Managing the Risks in the Lifecycle of a CBCT Scanner

The Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the risk analysis techniques proposed by the ISO 14971 Standard. This analysis allows to identify and assess the consequences of faults that affect each component of a complex system. The FMECA is a forward-type technique used for highlighting critical points and classifying them by priority. It also makes it possible to evaluate the extent of failures by means of numerical indices. It can be applied to a product or to a work process. In the latter case we talk about Process-FMECA. The application of the Process-FMECA to bioengineering is of particular interest because this procedure provides an analysis related to risk management during all the different phases of the medical device life cycle. However, practical applications of this method have revealed some shortcomings that can lead to inaccuracies and inconsistencies regarding the risk analysis and consequent risk prioritization. This paper presents an example of application of a Fuzzy Process-FMECA, an improved Process-FMECA based on fuzzy logic, to a small computerized tomography (CT) device prototype designed for studying the extremities of the human body. This prototype is a CT device that uses the Cone Beam CT (CBCT) technology. The Fuzzy Process-FMECA analysis has made it possible to produce a table of risks, that are quantified according to the specifications of the method. The analysis has shown that each phase or activity is fundamental to guarantee a correct functioning of the device. The methodology applied to this specific device can be paradigmatic for analyzing the process risks for any other medical device

JPL spacecraft sterilization technology program - A status report

Facility description and procedures for heat and ethylene oxide sterilization of spacecraft instrumentation, components, and material