naSRPS EN 13795-1:2022

Single use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 1: Information to be supplied, manufacturing and processing requirements and general guidance

Scope

EN DRAPE-1 specifies information to be supplied in addition to the usual labelling of medical devices (see EN 980 and EN 1041) and manufacturing and processing requirements and gives general guidance for single-use and reusable coverings (i.e. surgical gowns, surgical drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.