With the revision to the ISO 10993-1 standard, it is stated that in the risk assessment process, the definition of chemical components of direct and indirect contact medical devices and material characterisation, including chemical characterisation, should be performed.
Hygienic adequacy of production facilities and devices, microbiological tests on products before and after sterilisation and screening for contaminants that may be left behind from the sterilisation process (Endotoxins, Ethylene Oxide).
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