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ILNAS-EN 13795:2011+A1:2013 Edition 02/2013
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
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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 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.

Status

Standard - Superseded

Origin

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

Implementation

start of the vote on the project      date of ratification (dor)    08/01/2013
end of the vote on the project      date of anouncement (doa)    31/05/2013
start of the vote on the final project      date of publication (dop)    31/08/2013
end of the vote on the final project      date of withdrawal (dow)    31/08/2013


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/06/2013
Reference

Relations

Evolutions
ILNAS-EN 13795-1:2019
ILNAS-EN 13795-2:2019

Relations to older standards
ILNAS-EN 13795:2011

International Classification for Standards (ICS codes) :

11.140 : Hospital equipment

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