EN 13544-1:2007

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

The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:
1.1   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.
NOTE   Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 “Humidifiers” (see 56.102).
This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI).

Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile

Der in EN 60601 1:1990, Abschnitt 1, angegebene Anwendungsbereich gilt mit der Ausnahme, dass 1.1 durch Folgendes zu ersetzen ist:
1.1   Diese Europäische Norm legt Anforderungen an Verneblersysteme fest, die dazu verwendet werden, über das Atemsystem Medikamente in Aerosolform an Menschen abzugeben.
Diese Europäische Norm schließt gasbetriebene Vernebler, die z. B. mit Kompressoren, Rohrleitungs¬systemen, Gasflaschen usw. betrieben werden, oder elektrische Vernebler (z. B. Ultraschall- und Membrangeräte) oder von Hand betriebene Vernebler ein.
ANMERKUNG   Anforderungen an Vernebler mit gleichzeitiger Anfeuchtungsfunktion sind in EN ISO 8185:1997 + AC:2002 Anfeuchter (siehe 56.102) festgelegt.
Diese Europäische Norm schließt keine Vernebler ein, die bereits mit einem speziellen Arzneimittel vorgefüllt sind (z. B. MDI, DPI).

Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composants

Le domaine d’application de l’Article 1 de l’EN 60601-1:1990 s’applique, à l’exception du 1.1 qui est remplacé par le texte suivant :
1.1   La présente Norme européenne spécifie les exigences relatives aux systèmes de nébulisation utilisés pour l’administration de médicaments aux personnes sous forme d’un aérosol via le système respiratoire.
Elle inclut les nébuliseurs à énergie pneumatique alimentés par compresseurs, par réseau de gaz médicaux, bouteilles, etc., à énergie électrique (par exemple dispositifs à ultrasons et membrane) ou les nébuliseurs manuels.
NOTE   Les exigences relatives aux nébuliseurs également utilisés comme humidificateurs sont spécifiées dans l’EN ISO 8185:1997 + AC: 2002 « Humidificateurs » (voir 56.102).
La présente Norme européenne ne s’applique pas aux nébuliseurs préchargés avec un produit pharmaceutique spécifique (par exemple MDI, DPI).

Dihalna oprema za zdravljenje - 1. del: Razprševalni sistemi in njihovi sestavni deli

General Information

• Status: Withdrawn
• Publication Date: 24-Apr-2007
• Withdrawal Date: 18-Aug-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 19-Aug-2009
• Completion Date: 19-Aug-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13544-1:2007 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components

Relations

• Replaces: EN 13544-1:2001/A1:2004 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 22-Dec-2008
• Replaces: EN 13544-1:2001/AC:2004 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 22-Dec-2008
• Replaces: EN 13544-1:2001 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 22-Dec-2008
• Merged Into: EN 13544-1:2007+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 19-Jan-2023
• Amended By: EN 13544-1:2007/prA1 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Respiratory therapy equipment - Part 1: Nebulizing systems and their componentsDihalna oprema za zdravljenje - 1. del: Razprševalni sistemi in njihovi sestavni deliMatériel respiratoire thérapeutique - Partie 1: Systemes de nébulisation et leurs composantsAtemtherapiegeräte - Teil 1: Verneblersysteme und deren BauteileTa slovenski standard je istoveten z:EN 13544-1:2007SIST EN 13544-1:2007en,fr,de11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SIST EN 13544-1:2002/AC:2005SIST EN 13544-1:2002/A1:2005SIST EN 13544-1:20021DGRPHãþDSLOVENSKI
STANDARDSIST EN 13544-1:200701-oktober-2007

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13544-1April 2007ICS 11.040.10Supersedes EN 13544-1:2001
English VersionRespiratory therapy equipment - Part 1: Nebulizing systems andtheir componentsMatériel respiratoire thérapeutique - Partie 1: Systèmes denébulisation et leurs composantsAtemtherapiegeräte - Teil 1: Verneblersysteme und derenBauteileThis European Standard was approved by CEN on 22 March 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13544-1:2007: E

Rationale.24 Annex B B (informative)
Diameters of the particles depositable fraction.27 Annex C C (normative)
Test methods for the aerosol output rate, the aerosol output and for particle sizing.28 CC.1 Method of test for the aerosol output rate.28 CC.1.1 Test conditions.28 CC.1.2 R) Principle of test.28 CC.1.3 Test equipment.28

Mass balance checks on cascade impactor tests.36 DD.1 Aerosol output rate and aerosol output tests:.36 DD.2 Particle sizing test.36 Annex E E (informative)
Environmental aspects.37 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices.39 Bibliography.41
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