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SIST EN 1782:2000/kprA1:2009
01-april-2009
6DSQLþQL HQGRWUDKHDOQL WXEXVLLQSULNOMXþNL
Tracheal tubes and connectors
Trachealtuben und Verbindungsstücke
Tubes trachéaux et raccords
Ta slovenski standard je istoveten z: EN 1782:1998/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 1782:2000/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 1782:2000/kprA1:2009
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SIST EN 1782:2000/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 1782:1998
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.040.10
English Version
Tracheal tubes and connectors
Tubes trachéaux et raccords Trachealtuben und 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 1782:1998. 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 1782:1998/prA1:2009: E
worldwide for CEN national Members.
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SIST EN 1782:2000/kprA1:2009
EN 1782:1998/prA1:2009 (E)
Contents Page
Foreword . 3
1 Modification to 4.3 . 4
2 Addition of subclauses 4.8 – 4.10 . 4
3 Modifications to Clause 7 . 4
4 Modifications to Annex ZA . 5
2
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SIST EN 1782:2000/kprA1:2009
EN 1782:1998/prA1:2009 (E)
Foreword
This document (EN 1782:1998/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.
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SIST EN 1782:2000/kprA1:2009
EN 1782:1998/prA1:2009 (E)
1 Modification to 4.3
Add the following to 4.3:
"If phthalates are incorporated in parts of the medical devices coming directly or indirectly into
contact with the patient the medical device shall be labelled accordingly.
NOTE 2 Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction."
Renumber the existing note as "Note 1".
2 Addition of subclauses 4.8 – 4.10
Insert the following new subclauses:
"4.8 Usability
The manufacturer shall address in a usability engineering process the risk resulting from poor
usability (see IEC 60601-1-6 and IEC 62366).
Check compliance by inspection of the usability engineering file.
4.9 Clinical evaluation
A clinical evaluation shall be performed and documented in the risk management file.
Check compliance by inspection of the risk management file.
4.10 Biophysical or modelling resea
...