Abstract
One of the leading places among medical products in terms of application is occupied by surgical and protective, disposable masks, designed for protection and prevention of diseases that are transmitted by air. Aim. Conduct an analysis of samples of protective and surgical masks to determine the possibility of their use as intended. Materials and Мethods. Examination of medical and surgical masks of various manufacturers in accordance with the requirements of the Technical Regulations on medical products (Cabinet Resolution No. 753 dated 02.10.2013). Results. Modern methodological approaches to assessing the degree of potential risk of medical products are based on the study of toxicological characteristics and sanitary-chemical indicators in accordance with the requirements of DSTU ISO 10993-1:2015, namely: determination of the spectrum of potential biological risk factors (cytotoxicity, skin-irritating and sensitizing effects), bactericidal filtration; determination of the qualitative and quantitative composition of chemicals (phenol, formaldehyde, acetaldehyde) in accordance with the requirements of DSTU EN ISO 10993-12:2015 and DSTU EN ISO 10993-13:2015; determination of breathability, durability against splashes, in accordance with the requirements (DSTU EN 14683:2014 "Surgical masks. Requirements and test methods"). The specified indicators make it possible to determine the possibilities of using medical products ‒ medical masks, are mandatory and are measured by the institutions of the Derzhspozhivstandard of Ukraine. Conclusions. Modern methods of sanitary and chemical research make it possible to study the processes of migration of components and degradation products from the materials of medical masks into simulated environments, to identify the composition of migrating chemical compounds, to study the degradation products of polymers, and to determine the scope of further toxicological studies. Keywords: biological safety, means of individual protection of respiratory organs, surgical and protective masks.
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