SIST EN 13544-1:2007/kprA1:2009

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

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: Not Published
• Public Enquiry End Date: 19-May-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 27-Mar-2013
• Due Date: 01-Apr-2013
• Completion Date: 27-Mar-2013
• 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: EN 13544-1:2007/prA1 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components

Relations

• Amends: SIST EN 13544-1:2007 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 01-Apr-2009
• Consolidated By: SIST EN 13544-1:2007+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 18-Jan-2023
• Consolidated By: SIST EN 13544-1:2007+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 19-Jan-2023
• Consolidated By: SIST EN 13544-1:2007+A1:2009 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components
• Effective Date: 01-Oct-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13544-1:2007/kprA1:2009
01-april-2009
Dihalna oprema za zdravljenje - 1. del: Razprševalni sistemi in njihovi sestavni deli
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile
Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs
composants
Ta slovenski standard je istoveten z: EN 13544-1:2007/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 13544-1:2007/kprA1:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 13544-1:2007/kprA1:2009

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SIST EN 13544-1:2007/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 13544-1:2007
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.040.10

English Version
Respiratory therapy equipment - Part 1: Nebulizing systems and
their components
Matériel respiratoire thérapeutique - Partie 1: Systèmes de Atemtherapiegeräte - Teil 1: Verneblersysteme und deren
nébulisation et leurs composants Bauteile
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 215.
This draft amendment A1, if approved, will modify the European Standard EN 13544-1:2007. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13544-1:2007/prA1:2009: E
worldwide for CEN national Members.

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SIST EN 13544-1:2007/kprA1:2009
EN 13544-1:2007/prA1:2009 (E)
Contents Page
Foreword . 3
1  Modification to Clause 2 . 4
2  Modification to 4.1 . 4
3  Modification to 6.1 . 4
4  Modification to 6.8.2 . 5
5  Modification to Clause 48 . 5
6  Modification to Clause 54 . 5
7  Modification to Annex ZA . 6

2

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SIST EN 13544-1:2007/kprA1:2009
EN 13544-1:2007/prA1:2009 (E)
Foreword
This document (EN 13544-1:2007/prA1:2009) has been prepared by Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of
this document.
3

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SIST EN 13544-1:2007/kprA1:2009
EN 13544-1:2007/prA1:2009 (E)
1 Modification to Clause 2
In the title of reference EN 980, replace "Graphical symbols" with "Symbols".
In the title of reference EN 1041, replace "with" with "of".
In the title of reference EN 60601-1-2, replace "(IEC 60601-1-2:2001)" with
"(IEC 60601-1-2:2007, modified)".
Add the following references to Clause 2:
"EN 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic
safety and essential performance —
...