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English: This psychrometric chart represents the acceptable combination of air temperature and humidity values, according to the PMV/PPD method in the ASHRAE 55-2010 Standard. The comfort zone in blue represents the 90% of acceptability, which means the conditions between -0.5 and +0.5 PMV, or PPD < 10%.
The Simple Function Point (SFP) method [1] is a lightweight Functional Measurement Method.. The Simple Function Point method was designed by Roberto Meli in 2010 to be compliant with the ISO14143-1 standard and compatible with the International Function Points User Group (IFPUG) Function Point Analysis (FPA) method.
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
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 ...
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.
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 ...
The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials. [3] The third regulatory pathway for new medical devices is the Premarket Approval process (PMA), described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are ...
The "Measurement Manual" defines the principles, rules and a process for measuring a standard functional size of a piece of software. Functional size is a measure of the amount of functionality provided by the software, completely independent of any technical or quality considerations. [ 1 ]