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EVS-EN 13544-3:2002+A1:2009

Respiratory therapy equipment - Part 3: Air entrainment devices CONSOLIDATED TEXT

General information

Withdrawn from 01.06.2022
Base Documents
EN 13544-3:2001+A1:2009
ICS Groups
11.040.10 Anaesthetic, respiratory and reanimation equipment
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
01.06.2022
Main
EVS-EN ISO 23372:2022
06.11.2009
Main + amendment
EVS-EN 13544-3:2002+A1:2009
Main
EVS-EN 13544-3:2002
This part of this European Standard specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device. It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration. This standard does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.

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Standard monitoring
English (PDF 228 KB)

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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