Back

EVS-EN 13544-1:2007+A1:2009

Respiratory therapy equipment - Part 1: Nebulizing systems and their components CONSOLIDATED TEXT

General information

Withdrawn from 01.10.2019
Base Documents
EN 13544-1:2007+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Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard.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
01.10.2019
Main
EVS-EN ISO 27427:2019
06.11.2009
Main + amendment
EVS-EN 13544-1:2007+A1:2009
Main
EVS-EN 13544-1:2007
This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system. This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic and membrane devices) or manually-powered nebulizers.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 256 KB)

Related products

Main

EVS-EN ISO 27427:2019

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)
Withdrawn from 15.08.2023
Main

EVS-EN ISO 18562-1:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)
Newest version Valid from 02.03.2020
Main

EVS-EN ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
Newest version Valid from 03.12.2018
Main

EVS-EN ISO 80601-2-12:2020

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
Withdrawn from 01.12.2023

Customers who bought this item also bought

Main + amendment

EVS-EN 13544-2:2002+A1:2010

Respiratory therapy equipment - Part 2: Tubing and connectors CONSOLIDATE TEXT
Newest version Valid from 06.05.2010
Main

EVS-EN ISO 8185:2009

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
Newest version Withdrawn from 02.03.2020
Main

EVS-EN ISO 17510-1:2009

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
Withdrawn from 15.12.2020
Main

EVS-EN 15154-3:2009

Emergency safety showers - Part 3: Non plumbed-in body showers
Newest version Valid from 07.05.2009

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