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SIST EN 13544-1:2002

(Main)

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

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) or manually-powered nebulizers.
NOTE   Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 "Humidifiers".
This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application.

Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile

Der in Abschnitt 1 von EN 60601-1:1990 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 Beatmungssystem Medikamente in Aerosolform an Menschen abzugeben.
Diese Europäische Norm umfasst gasbetriebene Vernebler, die z. B. mit Kompressoren, Rohrleitungssystemen, Gasflaschen usw. betrieben werden, sowie elektrisch betriebene Vernebler (z. B. mit Ultraschall) oder von Hand betriebene Vernebler.
ANMERKUNG   Anforderungen an Vernebler mit gleichzeitiger Anfeuchtungsfunktion sind in EN ISO 8185 ¿Anfeuchter für medizinische Zwecke - Allgemeine Anforderungen an Anfeuchtungssysteme" festgelegt.
Diese Europäische Norm umfasst keine Vernebler, die bereits mit einem speziellen Arzneimittel vorgefüllt sind, und keine Vernebler, die zur allgemeinen Anwendung bestimmt sind.
.

Matériel respiratoire thérapeutique - Partie 1: Systemes 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 la délivrance des 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 ( ultrasonique, par exemple) ou les nébuliseurs manuels.
NOTE   Les exigences relatives aux nébuliseurs également utilisés comme humidificateurs sont spécifiées dans l'EN ISO 8185 « Humidificateurs ».
La présente Norme européenne ne traite pas des nébuliseurs préremplis avec un médicament spécifique et non destinés à des applications universelles.

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

General Information

Status
Withdrawn
Publication Date
30-Apr-2002
Withdrawal Date
22-Aug-2007
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
23-Aug-2007
Due Date
15-Sep-2007
Completion Date
23-Aug-2007
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 13544-1:2001 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components

Relations

Replaced By
SIST EN 13544-1:2007 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Effective Date
01-Oct-2007
Amended By
SIST EN 13544-1:2002/A1:2005 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Effective Date
22-Dec-2008
Corrected By
SIST EN 13544-1:2002/AC:2005 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Effective Date
22-Dec-2008
Parent
SIST EN 13544-2:2003 - Respiratory therapy equipment - Part 2: Tubing and connectors
Effective Date
22-Dec-2008

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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
...

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