STUDIES ON THE USABLE PROPERTIES OF INNOVATIVE WOUND DRESSINGS
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The new implemented wound dressings should meet several requirements connected with the clinical safety and performance. The series of PN-EN 13726 Standards describes the tests methods for the verification the most important parameters related to mentioned performance and safety of a new designed wound dressing being the base for the risk analysis (according to PN-EN ISO 14971:2009 Standard). The aim of the research was to evaluate the behavior of several types of new designed prototypes of innovative wound dressings made of various form of chitosan (such as: foams, films, etc.). The behavior of studied chitosan wound dressings was evaluated before and after of accelerated aging according to ASTM F 1980-07:2002 to establish the effect of the wound dressings storing conditions. The presented study is a continuation of earlier research.
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- Institute of Biopolymers and Chemical Fibres ul. M. Skłodowskiej-Curie 19/27, 90-570 Łódź, Poland
- Institute of Security Technologies ‘MORATEX’, email@example.com
- Institute of Security Technologies ‘MORATEX’
- Institute of Biopolymer and Chemical Fibres
- Kucharska M., Struszczyk M.H., Cichecka M., Brzoza-Malczewska K., PRELIMINARY STUDIES ON THE USABLE PROPERTIES OF INNOVATIVE WOUND DRESSINGS, Progress in the Chemistry and Application of Chitin and its Derivatives, vol. 16, 2011, 131-137.
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:pl:PDF [2011-10- 20].
- Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market, http://eur-lex.europa.eu/LexUriServ LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF [2011-10-20].
- ASTM F 1980-07:2002 Standard Guide for Accelerated Ageing of Sterile Barrier Systems for Medical Devices.
- Kucharska M., Niekraszewicz A., Ciechańska D., Gruchała B., Brzoza-Malczewska K., Wiśniewska-Wrona M., Method of producing fibrids containing chitosan, Patent Applications No. P-385031.
- Kucharska M., Niekraszewicz A., Ciechańska D., Gruchała B., Brzoza-Malczewska K.,. Wiśniewska-Wrona M, Method of producing fibrids containing chitosan, Patent Applications No. P-385032.
- PN-EN 13726-1:2005 „Test methods for primary wound dressings - Part 1: Aspects of absorbency”.
- PN-EN 13726-2:2005 „Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings”.
- Kucharska M., Struszczyk M.H., Niekraszewicz A., et. al., TROMBOGUARD® - FIRST AID WOUND DRESSING, Progress in the Chemistry and Application of Chitin and its Derivatives, vol. 16, 2011, 121-130.
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