Designing medical devices requires a wide range of verification steps for estimation of the performance and safety. Designing the research program needs a rational selection of appropriate testing methods (in preclinical and clinical studies) for determination of the risk of potential incompatibilities resulting in adverse events. The significance of the appropriate selection of the testing method is increased in advanced medical devices. The presented research considers the verification of the functional properties of recently developed topical haemostatic agents with the use of the chitosan/alginate fibrids, based on the previously elaborated risk analysis made according to the guidelines of the PN-EN-ISO 14971:2012 and PN-EN ISO 22442-1:2008 standards. The aim of this research was to verify the stability of the performance of the newly developed haemostatic agents during storage. The defined aim of the study arose from the thesis that the appropriate selection of raw materials and a new manner of reprocessing them enabled keeping the usability of the final product for at least two years.
This paper focused on analysing actual state-of-the-art personal protective equipment (PPE) used in humanitarian demining for the determination of potential gaps to provide improvements to increase the safety and, simultaneously, performance of PPE. The essential requirements and technical standards for PPEs used in humanitarian demining operations were analysed as a basis for gap identification. Furthermore based on the defined gap and risk analysis, the effect of accelerated ageing and simulation of the use of soft ballistic inserts designed with p-aramid woven fabrics was performed. The research provided new inputs for improvements in the standardisation of PPE with respect to performance and safety validation in a laboratory environment. Moreover the gap analysis resulted in strictly identified gap areas for PPE improvement in usability, functionality and safety.
Para-aramid materials such as Twaron® and Kevlar® are commonly used for ballistic-resistant body armor, which are designed to protect human life and health. For this reason, the materials from which body armor are made should be thoroughly investigated in the area of long-term reliability, particularly with regard to exposure to UV light, humidity and temperature, as these are known causes of degradation in commonly used ballistic materials. This research presents the durability of soft and hard ballistic inserts designed using para-aramid (Twaron®) materials. Para-aramid ballistic inserts not subjected to accelerated aging processes and also ones subjected to laboratory aging for 63, 129 and 194 days, which corresponded to 2, 4 and 6 years of aging in real conditions, were tested. The selected para-aramid inserts were verified in terms of ballistic and physico-mechanical properties as well as changes in chemical structure of the ballistic materials. Ballistic tests were carried out with the use of a 1.1 g FSP.22 fragment according to STANAG 2920. Changes in the microstructure of the para-aramid materials were evaluated using infrared spectroscopy and scanning electron microscopy. The obtained results indicate that despite the changes which took place at the molecular level in the Twaron® materials, accelerated aging processes do not affect the fragmentation resistance properties of ballistic inserts made of para-aramid materials.
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