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prEN 13795-1 Edition 03/2002

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

Abstract

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.

Status

Draft - Superseded

Origin

Technical Committee :

CEN/TC 205 : Non-active medical devices

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project	16/12/1999	date of ratification (dor)	17/01/2002
end of the vote on the project	16/06/2000	date of anouncement (doa)	18/06/2002
start of the vote on the final project	17/10/2001	date of publication (dop)	18/09/2002
end of the vote on the final project	17/12/2001	date of withdrawal (dow)	18/09/2002