21 resultaten gevonden voor 'in vitro diagnostic medical device'

in vitro diagnostic medical device

device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles

in vitro diagnostic instrument

equipment or apparatus intended by a manufacturer to be used as an IVD medical device

medical device

instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,

investigation, replacement, modification or support of the anatomy or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information for medical purposes by means of in vitro examination of specimens derived from the human body,

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which can be assisted in its intended function by such means

in vitro diagnostic reagent

chemical, biological or immunological components, solutions or preparations intended by the manufacturer to be used as an IVD medical device

IVD medical device

device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles

in-use condition

any circumstance that contributes to or causes the degradation (3.1.17) of a building (ISO 6707-1:2014, 3.1.3)(3.1.10)/ constructed assets (3.1.15) or a part of it under normal use

specimen collection device

apparatus specifically intended by an IVD manufacturer to obtain, contain and preserve a body fluid or tissue for in vitro diagnostic examination

in-use condition

any circumstance that can impact on the performance (3.1.78.1)(3.1.78.2) of a building (ISO 6707-1:2014, 3.1.3)(3.1.10) or a constructed asset (3.1.15), or a part thereof, under normal use

in-use condition

any circumstance that can impact the performance (3.1.78.1)(3.1.78.2) of a building (ISO 6707-1:2014, 3.1.3)(3.1.10) or a constructed asset (3.1.15), or a part thereof under normal use

feed-in tariff

tariff for surplus energy exported to the grid, applied by an energy supplier to someone who installs an electricity generating technology from a renewable or low energy carbon source