EN 13544-1:2001

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 13544-1:2001SIST EN 13544-1:2002en11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SLOVENSKI
STANDARDSIST EN 13544-1:200201-maj-2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13544-1August 2001ICS 11.040.10English versionRespiratory therapy equipment - Part 1: Nebulizing systems andtheir componentsAtemtherapiegeräte - Teil 1: Verneblersysteme und derenBauteileThis European Standard was approved by CEN on 29 June 2001.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 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 Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13544-1:2001 E

Rationale.26Annex B B (informative)
Diameters of the particles depositable fraction.29Annex C C (normative)
Test methods for the aerosol output rate, the aerosol output and for particlesizing.30Annex D D (informative)
Method for characterisation of nebulizers with respect to droplet size usinglaser diffraction).39

Mass balance checks on cascade impactor tests.44Annex ZA (informative)
Clauses of this European Standard addressing Essential Requirements orother provisions of EU Directives.45Bibliography.48

1) This reference will be replaced, when EN 31201 is published, by reference to EN 31201 “Acoustics - Noise emitted bymachinery and equipment - Measurement of emission sound pressure levels at the work station and at other specifiedpositions - Engineering method in an essentially free field over a reflecting plane (ISO/DIS 11201:1993)”.

tests shall be repeated after the given number of cleaning and/or sterilization cycles.45 Pressure vessels and parts subject to pressureClause 45 of EN 60601-1:1990 applies except for the following modification:45.101The requirements of clause 45 do not apply to the nebulizer breathing system.
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