NA 176

DIN Standards Committee Health Technologies

Project

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits; German version FprEN 13795-2:2024

Abstract

This document 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 document 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 document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

Begin

2022-02-08

WI

00205383

Planned document number

DIN EN 13795-2

Project number

06302137

Responsible national committee

NA 176-04-07 AA - Surgical textiles  

Responsible european committee

CEN/TC 205/WG 14 - Surgical clothing and drapes, and medical face masks  

draft standard

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits; German and English version prEN 13795-2:2023
2023-10
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previous edition(s)

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits; German version EN 13795-2:2019
2019-06

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Contact

M.Sc.

Maximilian Rasser

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2572
Fax: +49 30 2601-42572

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