Abstract
The results of testing sterile surgical gowns made of domestically produced SMS nonwoven material are presented. For each standardized quality parameter, a quality safety margin coefficient was calculated, which made it possible to identify the indicators requiring priority control. It was shown that sterility testing of 84 samples can only rule out contamination levels above 3.5%; therefore, sterility assurance must be provided through validation of the sterilization process. Based on data from 36 months of storage, it was established that shelf life is limited by the strength of the package heat-sealed seam.
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