Component Specifications for Medical Products

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چکیده

The need for component-level specifications for medical applications has been long identified; the existing process today is inconsistent. There are no medical industry specifications for the qualification of components or their suppliers. Thus every component that is purchased for highreliability medical products today must be individually qualified. Component suppliers have no industry standard to which they can turn, but instead, must develop their own suites of tests, some of which may not be relevant to medical applications. For an industry standard, both a clear understanding of the failure mechanisms of critical components is required, and the reliability and performance requirements of the critical components in medical devices must be considered. This report summarizes the work conducted by the iNEMI project team to identify relevant critical components and then, using a case study of a specific critical component, to assess the level of understanding and technical knowledge needed to develop a relevant specification for that component that would be appropriate for medical devices.

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تاریخ انتشار 2014