“…Although there is a highly regulated environment, assessing the biological suitability of suits is a complex task associated with various factors, including mainly the chemical nature and physical properties of the material, the contact tissue and the duration of contact. International standards such as ISO 10993-1 are used to demonstrate compliance with regulatory requirements, but they may not provide sufficient guidance or hazard control capabilities [Zaborowski 2007, Mrkvica 2012, Michalik 2014, Baron 2016, Murcinkova 2017, Olejarova 2017, Bernard 2018, Chaus 2018, Straka 2018a,b, Modrak 2019, Panda 2019, Bozek 2021, Dyadyura 2021, Vagaska 2017. Therefore, the aim of the work is to create an integrated system for assessing and managing risks associated with the development, production and intended use of space suits from different biomaterials.…”