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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.
Regulation; European Union regulation: Title: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
Measuring tape: for length, height, head circumference and girth measurements Medical halogen penlight: to see into the eye, natural orifices, etc. and to test for pupillary light reflex, etc. Medical ultrasound: to create an image of internal body structures Nasogastric tube: for nasogastric suction or the introduction of food or drugs into ...
Glass chart. A 1951 USAF resolution test chart is a microscopic optical resolution test device originally defined by the U.S. Air Force MIL-STD-150A standard of 1951. The design provides numerous small target shapes exhibiting a stepped assortment of precise spatial frequency specimens.
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.
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
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 ...
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.