EN ISO 18777:2009
(Main)Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
ISO 18777:2005 specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision.
Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard.
Flüssigsauerstoffsysteme für medizinische Anwendungen - Besondere Anforderungen (ISO 18777:2005)
IEC 60601 1:1988, Abschnitt 1, gilt mit folgenden Ausnahmen:
Änderungen (am Ende von 1.1 ergänzen):
1.1
Diese Internationale Norm legt Anforderungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Flüssigsauerstoffsystemen fest, die als Versorgungsquelle für die Sauerstofftherapie verwendet werden. Diese Geräte bestehen üblicherweise aus einer tragbaren Einheit, die durch den oder mit dem Patienten während des Gebrauchs getragen wird, und dem zur Nachfüllung der tragbaren Einheit dienenden Gefäß. Diese Geräte werden vorwiegend bei der häuslichen Pflege und in Einrichtungen des Gesundheitswesens verwendet. Sie werden oft ohne Überwachung durch Fachpersonal verwendet.
Flüssigsauerstoffbehälter, die als Versorgungsquelle für Rohrleitungssysteme verwendet werden, fallen nicht in den Anwendungsbereich dieser Internationalen Norm.
Die Anforderungen dieser Internationalen Norm, die die Anforderungen von IEC 60601-1:1988 mit ihren Änderungen 1 (1991) und 2 (1995) ersetzen oder ändern, haben Vorrang gegenüber den entsprechenden allgemeinen Anforderungen.
1.4
Ergänzung:
ANMERKUNG Die Planung und Gestaltung von Produkten, die dieser Internationalen Norm entsprechen, kann im Lebensablauf des Produkts Auswirkungen auf die Umwelt haben. Umweltgesichtspunkte werden in Anhang BB behandelt. Zusätzliche Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.
Systèmes transportables d'oxygène liquide à usage médical - Exigences particulières (ISO 18777:2005)
L'ISO 18777:2005 spécifie les prescriptions de sécurité et de performance essentielles applicables aux systèmes transportables d'oxygène liquide utilisés comme source d'alimentation pour l'oxygénothérapie. Ces appareils se composent généralement d'une unité portative transportée par le patient ou avec celui-ci en cours d'utilisation et d'un récipient utilisé pour remplir l'unité portative. Ces appareils sont pour la plupart utilisés dans les applications de soins à domicile et dans les établissements de santé. Ces appareils sont souvent utilisés sans surveillance professionnelle.
Les cuves d'oxygène liquide utilisées comme source d'alimentation pour les systèmes de distribution d'oxygène sont exclues de la présente Norme internationale.
Prenosni sistemi tekočega kisika za medicinsko uporabo - Posebne zahteve (ISO 18777:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18777:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 18777:2005
3UHQRVQLVLVWHPLWHNRþHJDNLVLND]DPHGLFLQVNRXSRUDER3RVHEQH]DKWHYH ,62
Transportable liquid oxygen systems for medical use - Particular requirements (ISO
18777:2005)
Flüssigsauerstoffsysteme für medizinische Anwendungen - Besondere Anforderungen
(ISO 18777:2005)
Systèmes transportables d'oxygène liquide à usage médical - Exigences particulières
(ISO 18777:2005)
Ta slovenski standard je istoveten z: EN ISO 18777:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18777:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18777:2009
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SIST EN ISO 18777:2009
EUROPEAN STANDARD
EN ISO 18777
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.99 Supersedes EN ISO 18777:2005
English Version
Transportable liquid oxygen systems for medical use - Particular
requirements (ISO 18777:2005)
Systèmes transportables d'oxygène liquide à usage Flüssigsauerstoffsysteme für medizinische Anwendungen -
médical - Exigences particulières (ISO 18777:2005) Besondere Anforderungen (ISO 18777:2005)
This European Standard was approved by CEN on 24 February 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 Ref. No. EN ISO 18777:2009: E
worldwide for CEN national Members.
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 18777:2009
EN ISO 18777:2009 (E)
Foreword
The text of ISO 18777:2005 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 18777:2009 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 September 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18777:2005.
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 Directives.
For relationship with EC Directives, 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.
Endorseme
...
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