EN ISO 27427:2023
(Main)Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
This document 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.
This document 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. This document does not specify the electrical requirements of electrically powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
This document does not apply to:
a) devices intended for nasal deposition;
b) devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices.
c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).
NOTE 2 ISO 20072 covers these devices.
NOTE 3 See Annex A for rationale.
Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO 27427:2023)
Dieses Dokument legt Anforderungen für die Prüfung der Sicherheit und Leistung von Mehrzweck-Verneblersystemen fest, die für die kontinuierliche oder atmungsaktivierte Ausgabe von Flüssigkeiten in Form von Aerosolen an Menschen durch das Atmungssystem vorgesehen sind.
Dieses Dokument schließt gasbetriebene Vernebler (die z. B. mit Kompressoren, Rohrleitungssystemen, 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. Dieses Dokument legt keine elektrischen Anforderungen an elektrisch betriebene Vernebler fest.
Dieses Dokument legt keine Mindestangaben für die Leistung von Verneblersystemen fest.
Dieses Dokument ist nicht anwendbar für:
a) Geräte, die für die nasale Ablagerung vorgesehen sind,
b) Geräte, die ausschließlich für die Erzeugung von Feuchte oder für die Hydration durch Bereitstellung von Wasser in Form von Aerosolen vorgesehen sind.
ANMERKUNG 1 Diese Geräte werden von ISO 80601 2 74 und ISO 20789 abgedeckt.
c) Vernebler für bestimmte Medikamente oder ihre Bauteile (z. B. Inhaliergeräte mit Dosierungen nach dem metrischen System, Flüssigkeits-Dosierinhaliergeräte, Trockenpulver-Inhaliergeräte).
ANMERKUNG 2 Diese Geräte werden von ISO 20072 abgedeckt.
ANMERKUNG 3 Siehe Anhang A für die Begründung.
Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et leurs composants (ISO 27427:2023)
Le présent document 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.
Le présent document inclut les nébuliseurs pneumatiques qui peuvent être alimentés, par exemple par compresseurs, par réseau de gaz médicaux, par bouteilles, etc. ainsi que les nébuliseurs électriques [par exemple les dispositifs à disque rotatif, ultrasoniques, à tamis vibrant (actif et passif) et à capillaire] ou les nébuliseurs manuels. Le présent document ne spécifie pas les exigences électriques pour les nébuliseurs électriques.
Le présent document ne spécifie pas de performance minimale pour les systèmes de nébulisation.
Le présent document ne s’applique pas aux:
a) dispositifs pour traitement nasal;
b) dispositifs uniquement destinés à assurer une humidification ou une hydratation en fournissant de l’eau sous forme d’aérosol.
NOTE 1 L’ISO 80601-2-74 et l’ISO 20789 couvrent ces dispositifs.
c) nébuliseurs spécifiques à des médicaments ou à leurs composants (par exemple aérosols doseurs, aérosols doseurs de liquide, inhalateurs à poudre sèche).
NOTE 2 L’ISO 20072 couvre ces dispositifs.
NOTE 3 Voir l’Annexe A pour les justifications.
Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO 27427:2023)
Ta dokument določa zahteve glede varnosti in preskušanje učinkovitosti razprševalnih sistemov za splošno uporabo, ki so namenjeni stalnemu ali z vdihavanjem aktiviranemu dovajanju tekočin v aerosolni obliki prek dihalnega sistema.
Ta dokument 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. Ta dokument ne določa električnih zahtev za električne nebulatorje.
Ta dokument ne določa minimalne učinkovitosti razprševalnih sistemov.
Ta dokument se ne uporablja za:
a) pripomočke, namenjene za nosno odmerjanje;
b) pripomočke, ki so namenjeni izključno zagotavljanju vlaženja ali hidracije z zagotavljanjem vode v obliki aerosola.
OPOMBA 1: Te pripomočke obravnavata standarda ISO 80601-2-74 in ISO 20789.
c) nebulatorje za določena zdravila ali njihove sestavne dele (npr. inhalatorji z odmerjenimi odmerki, inhalatorji z odmerjenimi tekočinami, inhalatorji s suhim prahom).
OPOMBA 2: Te pripomočke obravnava standard ISO 20072.
OPOMBA 3: Za osnovno utemeljitev glej dodatek A.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 27427:2023
01-oktober-2023
Nadomešča:
SIST EN ISO 27427:2019
Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO
27427:2023)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO
27427:2023)
Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO 27427:2023)
Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et leurs
composants (ISO 27427:2023)
Ta slovenski standard je istoveten z: EN ISO 27427:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 27427:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 27427:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 27427:2023
EN ISO 27427
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 27427:2019
English Version
Anaesthetic and respiratory equipment - Nebulizing
systems and components (ISO 27427:2023)
Matériel d'anesthésie et de réanimation respiratoire - Atemtherapiegeräte - Verneblersysteme und deren
Systèmes de nébulisation et leurs composants (ISO Bauteile (ISO 27427:2023)
27427:2023)
This European Standard was approved by CEN on 3 March 2023.
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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27427:2023 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 27427:2023
EN ISO 27427:2023 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 27427:2023
EN ISO 27427:2023 (E)
European foreword
This document (EN ISO 27427:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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 ISO 27427:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 27427:2023 has been approved by CEN as EN ISO 27427:2023 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 27427:2023
---------------------- Page: 6 ------
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.