EN 13544-1:2007+A1:2009

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• Status: Withdrawn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
• 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+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

Standards Content (Sample)

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



SIST EN 13544-1:2007+A1:2009



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



EN 13544-1:2007+A1:2009 (E) 2 Contents Page Foreword .5Introduction .61R) Scope .72Normative references .73Terms and definitions .94General requirements and general requirements for test . 104.1Modifications to Clause 3 of EN 60601-1:1990 . 104.2Clause 4 of EN 60601-1:1990 . 114.3Alternative type-test methods . 115Classification . 116Identification, marking and documents . 116.1Marking on the outside of equipment or equipment parts . 116.3Marking of controls and instruments . 126.4Symbols . 126.8.2Instructions for use . 126.8.3Technical description . 147Power input .
...