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EVS-EN 13795-2:2019

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

General information
Valid from 15.04.2019
Base Documents
EN 13795-2:2019
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
Status
Date
Type
Name
15.04.2019
Main
05.03.2013
Main + amendment
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 clean air suits used as medical devices for clinical staff, 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 clean air suits and sets performance requirements for these products.
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