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Prototypes of Primary Wound Dressing of Fibrous and Quasi-Fibrous Structure in Terms of Safety of Their Usage

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Abstract:

The subject of this paper is the evaluation of the critical usability parameters and the parameters characterising the safety of selected prototypes of dressing materials on featuring fibrous, quasi-fibre and hybrid structures, developed at the Institute of Biopolymers and Chemical Fibres (IBWCh). Primary sterile dressing materials were evaluated for usability, which determines the user’s safety and physiological comfort according to a series of PN-EN 13726 standards, harmonised with the EU Directive on medical devices, before and after the accelerated ageing process. The scope of the research was developed based on identifying potential threats arising from the expected clinical application of the medical devices being designed. It allowed for the determination of the impact of selected physical and mechanical parameters, needed from a utility point of view, on the properties of the final medical devices, and the elaboration of the documentation of risk analysis, according to the guide described in Standard PN-EN ISO 14971:2011.

Tags:

wound dressings, fibrous structure, biopolymers, preclinical studies, risk assessment

Citation:

Kucharska M, Struszczyk MH, Cichecka M, Brzoza-Malczewska K, Wiśniewska-Wrona M. Prototypes of Primary Wound Dressing of Fibrous
and Quasi-Fibrous Structure in Terms of Safety of Their Usage. FIBRES & TEXTILES in Eastern Europe 2012; 20, 6B (96): 142-148.

Published in issue no 6B (96) / 2012, pages 142–148.

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