Legal Requirements Concerning Textile Medical Products

Czech version

Authors: J. Bříza; Z. Krška; J. Pavlíková
Authors‘ workplace: 1. chirurgická klinika VFN a LF UK Praha, Odbor kvality VFN
Published in: Rozhl. Chir., 2011, roč. 90, č. 9, s. 517-518.
Category: Monothematic special - Original

Overview

Presently, more and more often the medical public is concerned with questions regarding use of textile products intended for multiple application at operating theatres. Such questions have been evoked especially by spreading information on restrictions regarding purchase and us of health care products or medical means made from cotton of intended for multiple application. Based on this information preference is fiven to significantly more expensive products intended for single-use only. This decision is being reasoned by conditions given by European standard EN 13795 reportedly prohibiting the application of cotton within health care. Since this piece of information is not precise, we would like to sum-up legislative situation within this area.

Key words:
health care products – clean areas – operation overcoats – operation masks – legislation – means for multiple application

Sources

1. http.//www.tribune.cz/clanek/12459

2. Pešek, J., Pavlíková, J. Naše zdravotnictví a lékárenství v EU. Grada, Praha, 2005, ISBN: 80-247-1392-6.

3. Bříza, J., Pavlíková, J., Hotmar, J., Pařík, J. Zdravotník v Evropské unii, příručka otázek a odpovědí. Eurolex Bohemia, Praha, 2007. ISBN 80-7379-004.

4. Bříza, J., Pavlíková, J., Hotmar, J., Pařík, J. Věda, výzkum a jeho podpora z EU zejména z pohledu zdravotnictví. Nová Forma, České Budějovice, 2009, ISBN: 978-80-87313-48-0.

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Article was published in

Perspectives in Surgery

2011 Issue 9