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ILNAS-EN 13795-1:2019 Edition 04/2019
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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Abstract

This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products. EN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. EN 13795-1 does not cover requirements for incise drapes or films. EN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    08/06/2017   date of ratification (dor)    24/10/2018
end of the vote on the project    31/08/2017   date of anouncement (doa)    31/07/2019
start of the vote on the final project    29/03/2018   date of publication (dop)    31/10/2019
end of the vote on the final project    24/05/2018   date of withdrawal (dow)    31/10/2019


Publication Official Journal
of the Grand-Duchy of Luxembourg
24/05/2019
Reference Mémorial A N° 347

Relations

Relations to older standards
ILNAS-EN 13795:2011+A1:2013
ILNAS-EN 13795:2011

International Classification for Standards (ICS codes) :

11.140 : Hospital equipment
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