EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective

2007 ◽  
Vol 24 (5) ◽  
pp. 385-405 ◽  
Author(s):  
Christa Altenstetter ◽  
Govin Permanand
Keyword(s):  
Medical Devices ◽  
Comparative Perspective ◽  
Eu Regulation

scholarly journals The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories

HemaSphere ◽  
2021 ◽  
Vol 5 (5) ◽  
pp. e568
Author(s):  
Bart R. Lubbers ◽  
Anke Schilhabel ◽  
Christa M. Cobbaert ◽  
David Gonzalez ◽  
Isabel Dombrink ◽  
...  
Keyword(s):  
Medical Devices ◽  
Eu Regulation ◽  
In Vitro Diagnostic

The rise of rules: Will the new EU regulation of medical devices make us safer?

2020 ◽  
Vol 80 ◽  
pp. 117-120 ◽  
Author(s):  
R. Tarricone ◽  
O. Ciani ◽  
S. D'Acunto ◽  
S. Scalzo
Keyword(s):  
Medical Devices ◽  
Eu Regulation

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

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