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CEN

EN 13544-1:2007+A1:2009

(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 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

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

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

General Information

Status
Withdrawn
Publication Date
18-Aug-2009
Withdrawal Date
17-Sep-2019
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
Completion Date
18-Sep-2019
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components

Relations

Merged From
EN 13544-1:2007/prA1 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Effective Date
19-Jan-2023
Merged From
EN 13544-1:2007 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Effective Date
19-Jan-2023
Replaced By
EN ISO 27427:2019 - Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)
Effective Date
26-Dec-2018

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EN 13544-1:2007+A1:2009EN 13544-1:2007+A1:2009
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dihalna oprema za zdravljenje - 1. del: Razprševalni sistemi in njihovi sestavni deliAtemtherapiegeräte - Teil 1: Verneblersysteme und deren BauteileMatériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composantsRespiratory therapy equipment - Part 1: Nebulizing systems and their components11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13544-1:2007+A1:2009SIST EN 13544-1:2007+A1:2009en,fr,de01-oktober-2009SIST EN 13544-1:2007+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13544-1:2007+A1
August 2009 ICS 11.040.10 Supersedes EN 13544-1:2007English Version
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composants
Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile This European Standard was approved by CEN on 22 March 2007 and includes Amendment 1 approved by CEN on 23 July 2009.
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 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 Management Centre has the same status as the official 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-1:2007+A1:2009: ESIST EN 13544-1:2007+A1:2009

Rationale . 24Annex B B (informative)
Diameters of the particles depositable fraction . 27Annex C C (normative)
Test methods for the aerosol output rate, the aerosol output and for particle sizing . 28CC.1Method of test for the aerosol output rate . 28CC.1.1Test conditions . 28CC.1.2R) Principle of test . 28CC.1.3Test equipment . 28SIST EN 13544-1:2007+A1:2009

Mass balance checks on cascade impactor tests . 36DD.1Aerosol output rate and aerosol output tests: . 36DD.2Particle sizing test . 36Annex E E (informative)
Environmental aspects . 37Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 39Bibliography . 43
...

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