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SIST EN 13544-2:2003/kprA1:2009
01-april-2009
'LKDOQDRSUHPD]D]GUDYOMHQMHGHO &HYNHLQSULNOMXþNL
Respiratory therapy equipment - Part 2: Tubing and connectors
Atemtherapiegeräte - Teil 2: Schlauchsysteme und Verbindungsstücke
Equipement de thérapie respiratoire - Partie 2: Tubes et raccords
Ta slovenski standard je istoveten z: EN 13544-2:2002/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 13544-2:2003/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 13544-2:2003/kprA1:2009
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SIST EN 13544-2:2003/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 13544-2:2002
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.040.10
English Version
Respiratory therapy equipment - Part 2: Tubing and connectors
Equipement de thérapie respiratoire - Partie 2: Tubes et Atemtherapiegeräte - Teil 2: Schlauchsysteme und
raccords Verbindungsstücke
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 13544-2:2002. 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.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
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 13544-2:2002/prA1:2009: E
worldwide for CEN national Members.
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SIST EN 13544-2:2003/kprA1:2009
EN 13544-2:2002/prA1:2009 (E)
Contents Page
Foreword . 3
1 Modifications to Clause 2 . 4
2 Modification to 5.1 . 4
3 Modifications to Clause 6 . 4
4 Addition of Clauses 8 and 9 . 4
5 Modifications to Annex ZA . 5
2
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SIST EN 13544-2:2003/kprA1:2009
EN 13544-2:2002/prA1:2009 (E)
Foreword
This document (EN 13544-2:2002/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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of
this document.
3
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SIST EN 13544-2:2003/kprA1:2009
EN 13544-2:2002/prA1:2009 (E)
1 Modifications to Clause 2
Add the following references:
"EN 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability
EN 62366, Medical devices - Application of usability engineering to medical devices".
2 Modification to 5.1
Add the following:
"d) If phthalates are incorporated in parts of the medical devices coming directly or indirectly
into contact w
...