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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
INTERNATIONAL ISO
STANDARD 27427
Third edition
2013-12-15
Anaesthetic and respiratory
equipment — Nebulizing systems and
components
Matériel d’anesthésie et de réanimation respiratoire — Systèmes de
nébulisation et ses composants
Reference number
ISO 27427:2013(E)
©
ISO 2013
ISO 27427:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2013 – All rights reserved
ISO 27427:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements and requirements for test . 4
4.1 Risk management . 4
4.2 Test methods and alternatives . 5
4.3 Electrical safety . 5
4.4 Mechanical safety. 5
4.5 Pneumatic safety . 6
4.6 Protection against inadvertent adjustments . 6
4.7 Usability . 6
5 Marking . 6
5.1 Symbols . 6
5.2 Marking on the device . 6
5.3 Labelling on the packaging or individual pack . 7
5.4 Instructions for use, inserts, and accompanying documents . 8
6 Construction requirements .11
6.1 Materials .11
6.2 Connectors .11
6.3 Rotary controls .13
7 Cleaning, sterilization, and disinfection .14
8 Biocompatibility .14
Annex A (informative) Rationale .15
Annex B (normative) Diameters of respirable fraction particles .19
Annex C (normative) Test methods for aerosol output and aerosol output rate .20
Annex D (normative) Test methods for particle sizing .23
Annex E (informative) Hazard identification for risk assessment .32
Annex F (informative) Classification of general purpose nebulizers .38
Annex G (informative) Environmental aspects .40
Annex AA (informative) Conformance to essential principles .42
Bibliography .46
ISO 27427:2013(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airways and related equipment.
This third edition cancels and replaces the second edition (ISO 27427:2010), of which it constitutes a
major revision.
iv © ISO 2013 – All rights reserved
ISO 27427:2013(E)
Introduction
Nebulizers are widely used to deliver drugs and vaccines in an aerosol form to humans through the
respiratory system. Nebulizers are also used for diagnostic purposes using radiois
...
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