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EVS-EN 13795-2:2025

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

General information

Valid from 17.02.2025
Base Documents
EN 13795-2:2025
ICS Groups
11.140 Hospital equipment
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
17.02.2025
Main
EVS-EN 13795-2:2025
15.04.2019
Main
EVS-EN 13795-2:2019
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 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.

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Standard monitoring
English (PDF 470 KB)

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Amendment

EVS-EN 60601-2-52:2010/A1:2015

Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
Newest version Valid from 08.06.2015
Main + corrigendum

EVS-EN 14683:2019

Medical face masks - Requirements and test methods (corrected version 07.2019)
Withdrawn from 17.02.2025
Main

EVS-EN 13795-1:2019

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Withdrawn from 17.02.2025
Main

EVS-EN IEC 60601-2-46:2019

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
Withdrawn from 01.10.2024

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EVS-EN 13795-1:2025

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EVS-EN 868-5:2018

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English