EN ISO 5360:2007
(Main)Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
2007-02-09 Sent for assessment to consultant RV
2006-08-03 ON HOLD: Pending ISO publication.
2006-02-06 ON HOLD: The cancellation date for this CEN project is 9 February 2006, the CEN UAP would normally not be submitted to CMC until the subject ISO publication became available (see below) but in this case, immediate submission is necessary to prevent cancellation. The Secretariat of ISO/TC121/SC1 has proposed to ISO/CS that, instead of publishing the amendment to ISO 5360: 1993 (which is already the subject of Technical Corrigendum 1: 1998), ISO should publish a reprinted version that includes the texts of the corrigendum and the amendment. Until this decision has been finalized, the wording in the attached CEN endorsement notice allows for either possibility, but the CEN Annex ZA will need to be tailored to whichever publication results and therefore table ZA1 is not present yet. It is assumed the launch of the UAP will be deferred until the ISO publication is available, by which t
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2006)
Diese Internationale Norm legt Maße für substanzspezifische Füllsysteme zur Verwendung mit
substanzspezifischen Anästhesiemittelverdampfern fest.
Diese Internationale Norm legt keine Werkstoffe für die Konstruktion fest. Werkstoffe für diejenigen Teile des
substanzspezifischen Füllsystems, die mit flüssigem Anästhesiemittel in Berührung kommen, sollten
ausgewählt werden im Hinblick auf:
a) Toxizität;
b) Verträglichkeit mit Anästhesiemitteln;
c) Herabsetzung von Gesundheitsrisiken infolge von Substanzen, die aus dem Werkstoff herausgelöst
werden.
Aufgrund der besonderen Eigenschaften von Desfluran wurden die Maße für dieses Anästhesiemittel nicht in
dieser Internationalen Norm festgelegt.
ANMERKUNG Ausführungen von Anschlusssystemen werden unterstützt, die das Eingreifen der substanzspezifischen
Flaschenadapter in die Flasche nur dann zulassen, wenn der Flaschenkragen am richtigen Platz ist.
Evaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2006)
Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih anestetikov (ISO 5360:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5360:2008
01-april-2008
1DGRPHãþD
SIST EN 1280-1:2000
SIST EN 1280-1:2000/A1:2000
Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih
anestetikov (ISO 5360:2006)
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2006)
Evaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO
5360:2006)
Ta slovenski standard je istoveten z: EN ISO 5360:2007
ICS:
11.040.10
SIST EN ISO 5360:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 5360
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2007
ICS 11.040.10 Supersedes EN 1280-1:1997
English Version
Anaesthetic vaporizers - Agent-specific filling systems (ISO
5360:2006)
Evaporateurs d'anesthésie - Systèmes de remplissage Anästhesiemittelverdampfer - Substanzspezifische
spécifiques à l'agent (ISO 5360:2006) Füllsysteme (ISO 5360:2006)
This European Standard was approved by CEN on 19 November 2007.
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: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5360:2007: E
worldwide for CEN national Members.
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EN ISO 5360:2007 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices.4
2
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EN ISO 5360:2007 (E)
Foreword
The text of ISO 5360:2006 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 5360:2007 by Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2008, and conflicting national standards shall be withdrawn at
the latest by June 2008.
This document supersedes EN 1280-1:1997.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 5360:2006 has been approved by CEN as EN ISO 5360:2007 without any modifications.
3
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EN ISO 5360:2007 (E)
Annexe ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
...
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