SIST EN ISO 18779:2005
(Main)Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
This International Standard specifies requirements for the safety and essential performance of portable
devices that supply the flow of oxygen or oxygen mixtures during therapy (e.g. long term oxygen therapy,
analgesia). These devices1) are intended to conserve oxygen or oxygen mixtures by delivering these gases
intermittently on the patient's demand when used in home care applications. These devices are generally
used without continual professional supervision.
These devices are also used in health care facilities/institutions.
This International Standard covers two types of conserving devices (see 3.5 and 3.6): conserving devices
intended for continuous use and those not intended for continuous use.
This International Standard covers active devices only, e.g. pneumatically or electrically controlled devices,
and does not cover devices such as reservoir cannulas.
This International Standard also includes conserving devices which are part of a system, e.g. pressure
regulators, oxygen concentrators or liquid oxygen vessels.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the
corresponding general requirements.
Dosiersysteme für Sauerstoff und Sauerstoffgemische - Besondere Anforderungen (ISO 18779:2005)
IEC 60601 1:1988, Abschnitt 1, gilt mit folgenden Ausnahmen:
Änderung (am Ende von 1.1 ergänzen):
1.1
Diese Internationale Norm legt Anforderungen für die Sicherheit und die wesentlichen Leistungsmerkmale tragbarer Geräte fest, die zur Zufuhr von Sauerstoff und Sauerstoffgemischen während einer Therapie (z. B. Sauerstoff-Langzeitbehandlung, Analgesie) dienen. Diese Geräte ) sind dazu vorgesehen, Sauerstoff oder Sauerstoffgemische einzusparen, indem diese Gase mit Unterbrechungen auf die Anforderung des Patienten bei Verwendung im häuslichen Bereich abgegeben werden. Diese Geräte werden üblicherweise ohne ständige Überwachung durch Fachpersonal verwendet.
Diese Geräte werden auch in Gesundheitseinrichtungen verwendet.
Diese Internationale Norm behandelt zwei Arten von Spargeräten (siehe 3.5 und 3.6): Spargeräte für die ununterbrochene Anwendung und solche, die nicht für die ununterbrochene Anwendung vorgesehen sind.
Diese Internationale Norm gilt nur für aktive Geräte, z. B. pneumatisch oder elektrisch angetriebene Geräte, und nicht für solche Geräte wie Nasenbrillen mit Reservoiren.
Diese Internationale Norm gilt auch für Spargeräte, die Teil eines Systems sind, z. B. zusammen mit Druckminderern, Sauerstoff-Konzentratoren oder Behältern für Flüssigsauerstoff.
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.
Economiseurs médicaux d'oxygene et de mélanges oxygénés - Exigences particulieres (ISO 18779:2005)
L'ISO 18779:2005 spécifie les prescriptions essentielles de sécurité et de performance applicables aux appareils portatifs qui assurent le débit de gaz respirables durant le traitement (par exemple traitement par oxygène à long terme, analgésie).
Ces dispositifs sont destinés à économiser les gaz respirables en délivrant ces gaz de manière intermittente à la demande du patient lorsqu'ils sont utilisés dans des applications de soins à domicile. Ces appareils sont généralement utilisés sans surveillance continue d'un professionnel. Ces appareils sont également utilisés dans des établissements de santé.
L'ISO 18779:2005 couvre deux types de dispositifs: les économiseurs destinés à une utilisation continue ou ceux destinés à une utilisation non continue. Elle couvre les dispositifs actifs, par exemple les dispositifs à commande pneumatique ou électrique et ne couvre pas les dispositifs tels que les canules de réservoir.
L'ISO 18779:2005 inclut également les économiseurs qui font partie d'un système, par exemple les détendeurs, les concentrateurs d'oxygène ou les réservoirs d'oxygène liquide.
Medicinski pripomočki za shranjevanje kisika in kisikovih mešanic - Posebne zahteve (ISO 18779:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18779:2005
01-junij-2005
0HGLFLQVNLSULSRPRþNL]DVKUDQMHYDQMHNLVLNDLQNLVLNRYLKPHãDQLF3RVHEQH
]DKWHYH ,62
Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
(ISO 18779:2005)
Dosiersysteme für Sauerstoff und Sauerstoffgemische - Besondere Anforderungen (ISO
18779:2005)
Economiseurs médicaux d'oxygene et de mélanges oxygénés - Exigences particulieres
(ISO 18779:2005)
Ta slovenski standard je istoveten z: EN ISO 18779:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18779:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18779:2005
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SIST EN ISO 18779:2005
EUROPEAN STANDARD
EN ISO 18779
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 11.040.10
English version
Medical devices for conserving oxygen and oxygen mixtures -
Particular requirements (ISO 18779:2005)
Economiseurs médicaux d'oxygène et de mélanges Spargeräte für Sauerstoff und Sauerstoffgemische -
oxygénés - Exigences particulières (ISO 18779:2005) Besondere Anforderungen (ISO 18779:2005)
This European Standard was approved by CEN on 28 January 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18779:2005: E
worldwide for CEN national Members.
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SIST EN ISO 18779:2005
EN ISO 18779:2005 (E)
Foreword
This document (EN ISO 18779:2005) has been prepared by Technical Committee CEN/TC 215 "Respiratory
and anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical
Committee ISO/TC 121 "Anaesthetic and respiratory equipment”.
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 August 2005, and conflicting national standards shall be withdrawn
at the latest by August 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 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, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
2
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SIST EN ISO 18779:2005
EN ISO 18779:2005 (E)
ANNEX ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42 EEC Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42 EEC Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Direc
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