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1

Managing the results of Quality Management System implementation in medical devices companies

100%
Feliczek P.
Towaroznawcze Problemy Jakości. Polskie Towarzystwo Towaroznawcze
|
2017
|
nr 1
2
Artykuł dostępny w postaci pełnego tekstu - kliknij by otworzyć plik
Content available

Operational reliability model of the production line

86%
Bartnik G., Marciniak A. W.
Teka Komisji Motoryzacji i Energetyki Rolnictwa
|
2011
|
tom 11C
3
Artykuł dostępny w postaci pełnego tekstu - kliknij by otworzyć plik
Content available

Environmental impact of the use of radiofrequency electromagnetic fields in physiotherapeutic treatment

72%
Gryz K., Krapowicz J.
Roczniki Państwowego Zakładu Higieny
|
2014
|
tom 65
|
nr 1
Background. Electromagnetic fields used in physiotherapeutic treatment affect not only patients, but also physiotherapists, patients not undergoing treatment and electronic medical equipment. Objective. The aim of the work was to study the parameters of the electromagnetic fields of physiotherapeutic devices with respect to requirements regarding the protection of electronic devices, including medical implants, against electromagnetic interference, and the protection of the general public (patients not undergoing treatment and bystanders), as well as medical personnel, against the health hazards caused by electromagnetic exposure. Material and methods. The spatial distribution of electric and magnetic field strength was investigated near 3 capacitive short-wave and 3 long-wave diathermies and 3 ultrasound therapy units, as along with the capacitive electric currents caused by electromagnetic field interaction in the upper limbs of the physiotherapists operating these devices. Results. The physiotherapists’ exposure to electromagnetic fields depends on the spatial organisation of the workspace and their location during treatment. Electric fields able to interfere with the function of electronic medical implants and in which anyone not undergoing treatment should not be present were measured up to 150-200 cm away from active applicators of short-wave diathermy, and up to 40-45 cm away from long-wave diathermy ones. Electric fields in which workers should not be present were measured up to 30-40 cm away from the applicators and cables of active short-wave diathermy devices. A capacitive electric current with a strength exceeding many times the international recommendations regarding workers protection was measured in the wrist while touching applicators and cables of active short-wave diathermy devices. Conclusions. The strongest environmental electromagnetic hazards occur near short-wave diathermy devices, and to a lesser degree near long-wave diathermy devices, but were not found near ultrasound therapy units.
4

Supplier management in medical device industry

72%
Feliczek P.
Towaroznawcze Problemy Jakości. Polskie Towarzystwo Towaroznawcze
|
2013
|
nr 2
5

Application of the operational reliability model to the risk analysis in medical device production

72%
Bartnik G., Kalbarczyk G., Marciniak A. W.
Teka Komisji Motoryzacji i Energetyki Rolnictwa
|
2011
|
tom 11C
6

FDA role in quality assurance of medical devices distributed on the US market

58%
Feliczek P.
Towaroznawcze Problemy Jakości. Polskie Towarzystwo Towaroznawcze
|
2013
|
nr 1
7

Evaluation of quantitative PCR measurement of bacterial colonization of epithelial cells

58%
Schmidt M. T., Olejnik-Schmidt A. K., Myszka K., Borkowska M., Grajek W.
Polish Journal of Microbiology
|
2010
|
tom 59
|
nr 2
89-93
Microbial colonization is an important step in establishing pathogenic or probiotic relations to host cells and in biofilm formation on industrial or medical devices. The aim of this work was to verify the applicability of quantitative PCR (Real-Time PCR) to measure bacterial colonization of epithelial cells. Salmonella enterica and Caco-2 intestinal epithelial cell line was used as a model. To verify sensitivity of the assay a competition of the pathogen cells to probiotic microorganism was tested. The qPCR method was compared to plate count and radiolabel approach, which are well established techniques in this area of research. The three methods returned similar results. The best quantification accuracy had radiolabel method, followed by qPCR. The plate count results showed coefficient of variation two-times higher than this of qPCR. The quantitative PCR proved to be a reliable method for enumeration of microbes in colonization assay. It has several advantages that make it very useful in case of analyzing mixed populations, where several different species or even strains can be monitored at the same time.
8

Nadzór rynku UE - system zgłaszania i oceny incydentów medycznych

44%
Wyroba A., Tkaczyk J.
Problemy Jakości
|
2012
|
tom 44
|
nr 04
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