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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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.
Das's modification to the long curved delivery forceps (shorter in length) with axis traction devices in place, seen from the right side (left blade in front: with respect to the mother's vaginal wall).
The function point is a "unit of measurement" to express the amount of business functionality an information system (as a product) provides to a user. Function points are used to compute a functional size measurement (FSM) of software. The cost (in dollars or hours) of a single unit is calculated from past projects. [1]
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
during the 10 minute period of measurement 3 contractions occurred; subtract the resting tone from the peak intensity of the contraction; add the 3 contractions together to get the MVUs; Montevideo units are calculated by obtaining the peak uterine pressure amplitude and subtracting the resting tone.
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 ...
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 ...