Component Specifications for Medical Products
ثبت نشده
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.
منابع مشابه
Study of Vibration Specifications of a Three-axle Truck Using Lagrange Method
In this research, Ride quality of a three-axle truck is investigated to understand its vibration specifications and influence of it on special load. The truck is Benz 2624, and the load is rather sensitive to vibrations. The system is considered for an off-road duty. Hence, the vehicle is modeled as a nineteen-degree of freedom system and its equations of motion are derived by employing Lagrang...
متن کاملA Novel Method for Measuring, Regardless of Image Distortion and Lens Varying Specifications in Endoscopic Treatment of Vesicoureteral Reflux
متن کامل
Study of Vibration Specifications of a Three-axle Truck Using Lagrange Method
In this research, Ride quality of a three-axle truck is investigated to understand its vibration specifications and influence of it on special load. The truck is Benz 2624, and the load is rather sensitive to vibrations. The system is considered for an off-road duty. Hence, the vehicle is modeled as a nineteen-degree of freedom system and its equations of motion are derived by employing Lagrang...
متن کاملPattern of blood component utilization in Arak, Iran
Abstract Background and Objectives Blood transfusion in medical care is one of the main treatments. However, blood transfusion is not without risk. Investigating the patterns of blood products utilization can help improve blood products usage and predict future blood products demand. Therefore, in this study, the pattern of blood product utilization in Arak hospitals has been investigated. ...
متن کاملCatalyst-Free One-Pot Four-Component Synthesis of 3-(Imino)-pyrrolo[2,1-a]isoquinolines in Glycerol: Two Different Products through Two Different Purification Methods
The one-pot four component synthesis of 3-(Imino)-2,3-dihydropyrrolo[2,1-a]isoquinoline-1,1(10bH)-dicarbonitrile derivatives via a catalyst-free reaction between aryl aldehydes, malononitrile, isoquinoline and isocyanides was successfully conducted in glycerol as a benign, nontoxic and biodegradable promoting reaction medium. The progress of the reaction with two different common purification m...
متن کامل