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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 ...
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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.
The measurement is partly subjective, since some of its measurement rules have to be suitably interpreted by the person who performs the measurement. The diffusion of the method in the software development community is quite limited. To overcome at least some of these problems, the SFP method was defined to provide the following characteristics:
The Joint Committee for Guides in Metrology (JCGM) is a committee which created and maintains two metrology guides: Guide to the expression of uncertainty in measurement (GUM) [55] and International vocabulary of metrology – basic and general concepts and associated terms (VIM). [34] The JCGM is a collaboration of eight partner organisations ...
The measure f ∗ (λ) might also be called "arc length measure" or "angle measure", since the f ∗ (λ)-measure of an arc in S 1 is precisely its arc length (or, equivalently, the angle that it subtends at the centre of the circle.) The previous example extends nicely to give a natural "Lebesgue measure" on the n-dimensional torus T n.
The term clinical engineering was first used in a 1969 paper by Landoll and Caceres. [2] Caceres, a cardiologist, is generally credited with coining the term.. The broader field of biomedical engineering also has a relatively recent history, with the first inter-society engineering meeting focused on engineering in medicine probably held in 1948.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.