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A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Sequential function chart (SFC) is a visual programming language used for programmable logic controllers (PLCs). It is one of the five languages defined by IEC 61131-3 standard. The SFC standard is defined as Preparation of function charts for control systems , and was based on GRAFCET [ fr ] (itself based on binary Petri nets [ 1 ] [ 2 ] ).
The need to measure automatic diagnostic effectiveness was recognized in the late 1980s. [7] Functional safety failure modes were added and first documented in the book Evaluating Control System Reliability . [ 8 ]
Medical devices are apparati used for diagnostics, treatment, or prevention of disease and injury. [10] [11] Most of the time these devices affect the structure or function of the body. The easiest way to tell the difference is that biomedical instruments measure, sense, and output data while medical devices do not. Examples of medical devices:
Modalities applied to measurement of ejection fraction is an emerging field of medical mathematics and subsequent computational applications. The first common measurement method is echocardiography, [7] [8] although cardiac magnetic resonance imaging (MRI), [8] [9] cardiac computed tomography, [8] [9] ventriculography and nuclear medicine (gated SPECT and radionuclide angiography) [8] [10 ...
Lux meter for measuring illuminance, i.e. incident luminous flux per unit area; Luminance meter for measuring luminance, i.e. luminous flux per unit area and unit solid angle; Light meter, an instrument used to set photographic exposures. It can be either a lux meter (incident-light meter) or a luminance meter (reflected-light meter), and is ...
Function block: Each function on an FFBD should be separate and be represented by single box (solid line). Each function needs to stand for definite, finite, discrete action to be accomplished by system elements. Function numbering: Each level should have a consistent number scheme and provide information concerning function origin. These ...