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CEN

EN ISO 27427:2019

(Main)

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)

ISO 27427:2013 specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
ISO 27427:2013 includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO 27427:2013)

*Diese Internationale Norm legt Anforderungen für die Prüfung der Sicherheit und Leistung von Mehrzweck-Verneblersystemen fest, die für die kontinuierliche oder atmungsaktivierte Abgabe von Flüssigkeiten in Form von Aerosolen an Menschen über das Atmungssystem vorgesehen sind.
Diese Internationale Norm schließt gasbetriebene Vernebler, die z. B. mit Kompressoren, Rohrleitungs-systemen, Gasflaschen usw. betrieben werden können, und elektrisch betriebene Vernebler [z. B. Drehscheibe, Ultraschall, vibrierende Mesh-Vernebler (aktiv und passiv) und Kapillargeräte] oder von Hand betriebene Vernebler ein.
Diese Internationale Norm legt keine Mindestangaben für die Leistung von Verneblersystemen fest.
*Diese Internationale Norm gilt nicht für Geräte, die für die nasale Ablagerung vorgesehen sind.
Diese Internationale Norm gilt nicht für Geräte, die ausschließlich für die Erzeugung von Feuchtigkeit oder für die Hydration durch Bereitstellung von Wasser in Form von Aerosolen vorgesehen sind.
ANMERKUNG   Dies wird von ISO 8185 abgedeckt [3].
*Diese Internationale Norm gilt nicht für medikamentenspezifische Vernebler oder ihre Bauteile (z. B. Dosierinhalatoren, Flüssigkeits-Dosierinhalatoren, Trockenpulver-Inhalatoren).

Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et ses composants (ISO 27427:2013)

L'ISO 27427:2013 spécifie les exigences relatives à la sécurité, aux performances et aux essais des systèmes de nébulisation à usage général destinés à l'administration continue ou déclenchée par la respiration, sous forme d'un aérosol, de liquides aux personnes, via le système respiratoire.
L'ISO 27427:2013 inclut les nébuliseurs pneumatiques qui peuvent être alimentés, par exemple par compresseurs, par réseau de gaz médicaux, par bouteilles, etc. ainsi que les nébuliseurs à énergie électrique [par exemple les dispositifs à disque rotatif, ultrasoniques, à tamis vibrant (actif et passif) et à capillaire] ou les nébuliseurs manuels.

Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO 27427:2013)

Standard ISO 27427:2013 določa zahteve glede varnosti in preskušanje učinkovitosti razprševalnih sistemov za splošno uporabo, ki so namenjeni stalnemu ali z vdihavanjem aktiviranemu dovajanju tekočin v aerosoli obliki prek dihalnega sistema.
Standard ISO 27427:2013 vključuje nebulatorje s potisnim plinom, ki se lahko napajajo npr. prek kompresorjev, cevovodov, jeklenk itd., ter električne nebulatorje (npr. z vrtečim diskom, ultrazvočni, z vibrirajočo mrežico (aktivno ali pasivno) in kapilarne naprave) ali ročne nebulatorje.

General Information

Status
Withdrawn
Publication Date
17-Sep-2019
Withdrawal Date
25-Jul-2023
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
Ref Project
SIST EN ISO 27427:2019 - Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)

Relations

Replaces
EN 13544-1:2007+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Effective Date
26-Dec-2018
Replaced By
EN ISO 27427:2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
Effective Date
19-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 27427:2019
01-november-2019
Nadomešča:
SIST EN 13544-1:2007+A1:2009
Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO
27427:2013)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO
27427:2013)
Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO 27427:2013)
Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et ses
composants (ISO 27427:2013)
Ta slovenski standard je istoveten z: EN ISO 27427:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 27427:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 27427:2019

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SIST EN ISO 27427:2019


EN ISO 27427
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 13544-1:2007+A1:2009
English Version

Anaesthetic and respiratory equipment - Nebulizing
systems and components (ISO 27427:2013)
Matériel d'anesthésie et de réanimation respiratoire - Atemtherapiegeräte - Verneblersysteme und deren
Systèmes de nébulisation et ses composants (ISO Bauteile (ISO 27427:2013)
27427:2013)
This European Standard was approved by CEN on 28 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27427:2019 E
worldwide for CEN national Members.

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SIST EN ISO 27427:2019
EN ISO 27427:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 27427:2019
EN ISO 27427:2019 (E)
European foreword
The text of ISO 27427:2013 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 27427:2019 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2020, and conflicting national standards shall
be withdrawn at the latest by March 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13544-1:2007+A1:2009.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 27427:2013 has been approved by CEN as EN ISO 27427:2019 without any modification.


3

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SIST EN ISO 27427:2019

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SIST EN ISO 27427:2019
INTERNATIONAL ISO
STANDARD 27427
Third edition
2013-12-15
Anaest
...

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