By Mieczyslaw Pokorski (eds.)
The winning prophylaxis and remedy of ubiquitous breathing infections is key for the enhancement of public health and wellbeing. The chapters supply new insights into the biology of causative pathogens, take on the epidemiological facets, and current an replace on diagnostics, prevention and treatment of infections. The rising new pathogens and antibiotic resistance of the outdated ones are mentioned. Novel markers of the severity of group got pneumonia, which bears excessive morbidity and mortality, are also presented.
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Example text
12. 2012. From these, 169 affected culture media, reagents, kits and control materials, and culture-based analyzers and their general consumables for infection diagnostics. The number of annual reports regarding IVD and the corresponding FSCA strongly increased within this time (Table 2). 2 Fulfilment of MEDDEV Criteria German and English FSN were found in 157 and 154 cases, respectively. FSN were clearly characterized as FSN in 110 and 134 cases and the names of the affected products were provided in 157 German and 154 English cases.
Lot numbers and other information for product identification were also provided by most FSN, but the number of FSN complying with the MEDDEV criteria was smaller, even though distinct product identification is essential in cases of FSCA. Manufacturers, in the majority of FSN, provided sufficient information regarding FSCA and product malfunction. However, deviations from the MEDDEV requirements were observed and should be avoided, as clear descriptions serve as a basis for an understanding the FSCA and measures to be performed by users.
Wiener Klinische Wochenschrift 125:651 Medical devices post market surveillance (2009) National Competent Authority report exchange criteria and report form. (GHTF/SG2/N79R11:2009)/http://www. pdf. Accessed 6 Jan 2014 J. Hannig and R. Siekmeier Medizinproduktegesetz in der Fassung der Bekanntmachung vom 7 August 2002 (BGBl. I S. 3146), gea¨ndert durch Artikel 1 des Gesetzes vom 14 Juni 2007 (BGBl. I S. 1066), zuletzt gea¨ndert durch Artikel 6 des Gesetzes vom 29 Juli 2009 (BGBl. I S. 2326). gesetze-im-internet.