Law and references

     Pursuant to the MDD 93/42 EU directive, the provisions of which were introduced in Poland by the medical products act of 20th April 2004, the surgical aprons, surgical wrappings and surgical suite clothing were classified as medical products. 

The PN-EN 13795 norm specified the detailed requirements for operating room textiles.Part one of the PN-EN 13795-1 published in February 2006. Defines the general requirements for surgical wrappings, aprons and surgical suite clothing, indicates the names of parameters that these products should meet. Part two of the PN-EN 13795-2 norm published in July 2006. Defines the research methods for establishing the values of parameters defined in part one of the norm. Part three of the PN-EN 13795-3 norm published in September 2006. Indicates concrete values for particular parameters.

The parameters are:

·         microorganism impenetrability – in dry and wet conditions,

·         microbiological cleanness,

·         cleanness from particulate matters,

·         dusting,

·         fluid impenetrability,

·         ripping endurance in dry and wet conditions,

·         stretching endurance in dry and wet conditions