Full Description

BS EN 13795-1:2019 specifies information to be supplied to users and third party verifiers in addition to theusual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing andprocessing requirements. This document gives information on the characteristics of single-use andreusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff andequipment, intended to prevent the transmission of infective agents between clinical staff and patientsduring surgical and other invasive procedures. This document specifies test methods for evaluating theidentified characteristics of surgical drapes and gowns and sets performance requirements for theseproducts.

Cross References:
EN ISO 22612:2005
EN 29073-3:1992
EN ISO 13938-1:1999
ISO 9073-10:2003
ISO 139:2005/AMD 1:2011
EN ISO 9073-10:2004
ISO 11737-1:2018
EN ISO 10993-1:2009
ISO 22610:2006 Ed 1
EN ISO 811:2018
EN ISO 139:2005
ISO 10993-1:2009
EN ISO 11737-1:2018
ISO 22612:2005
ISO 811:2018
EN ISO 22610:2006
ISO 13938-1:1999
ISO 139:2005
ISO 9073-6
EN ISO 11607-1
ISO 15223-1
EN ISO 9237
EN 62366
ISO 13485
EN ISO 11092
ISO 9237
EN ISO 10993-10
ISO 9073-11
ISO 11092
EN ISO 9073-12
EN 1041
EN ISO 15223-1
EN 14065
ISO 11607-2
EN ISO 11607-2
EN ISO 9073-11
ISO 11607-1
ISO 10993-10
ISO 10993-5
EN ISO 13485
EN ISO 10993-5
EN ISO 11810
EN ISO 15797
ISO 15797
ISO 9073-12
ISO 11810
EN ISO 9073-6


Replaces BS EN 13795:2011+A1:2013 which remains current

All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 04/12/2019 ISBN(s): 9780580980831 Number of Pages: 36 File Size: 1 file , 810 KB Product Code(s): 30358659, 30358659, 30358659 Note: This product is unavailable in United Kingdom