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)
ISO 18779:2005 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 devices 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.
ISO 18779:2005 covers two types of conserving devices: conserving devices intended for continuous use and those not intended for continuous use. It 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.
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'oxygène et de mélanges oxygénés - Exigences particulières (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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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.
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 Directive and associated
EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Medical devices
Clause(s)/Subclause(s) of this Essential Requirements (Ers) Qualifying remarks/Notes
International Standard of EU Directive 93/42/EEC
4 All
5 All
6 13, 13.2
6.1 13.1, 13.3, 13.4, 13.5
6.3 10.2, 10.3, 12.8, 12.9
6.8 13.1, 13.3, 13.4, 13.6
6.101 12.9
7 12.6
8 12.6
9 12.6
10.1 5
10.2 5
13 12.6
14 12.6
15 12.6
16 12.6, 12.7
17 12.6
18 12.6
19 12.6
20 12.6
21 12.7
22 12.7
23 12.7
24 12.7
25 12.7
26 12.7.2, 12.7.3
27 12.8
28 12.7
29 11
36 9.2, 12.5
38 13
39 9.2, 9.3, 12.6, 12.7
40 9.2, 9.3, 12.6, 12.7
41 9.2, 9.3, 12.6, 12.7
42 12.7
43 9.3, 12.7
44.3 7.6, 12.6
44.6 7.6, 12.6
44.7 8.1
44.8 7.1, 7.3, 7.5, 9.3
45 12.7
46 9, 10, 12.9
47 12.5
48 7.1, 7.5
49 9.2, 12.8
50 10
51 10, 12.8
52 12.1, 12.6, 12.7, 12.8
53 5
54 9
55 9
56 9
56.3 9.1
56.7 12.2
57 12.6, 12.7
58 12.6, 12.7
101.2.1 9.2, 12.8
101.2.3 12.8
101.2.4 12.8
101.2.6 12.8
101.2.7 12.2
101.2.8 9.3, 12.6, 12.8
101.3 12.3, 12.8
INTERNATIONAL ISO
STANDARD 18779
First edition
2005-02-15
Medical devices for conserving oxygen
and oxygen mixtures — Particular
requirements
Économiseurs médicaux d'oxygène et de mélanges oxygénés —
Exigences particulières
Reference number
ISO 18779:2005(E)
©
ISO 2005
ISO 18779:2005(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2005 – All rights reserved
ISO 18779:2005(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 3
5 Classification. 3
6 Identification, marking and documents. 3
7 Power input. 8
8 Basic safety categories . 8
9 Removable protective means . 8
10 Environmental conditions. 9
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 10
16 Enclosures and protective covers . 10
17 Separation. 10
18 Protective earthing, functional earthing and potential equalization . 10
19 Continuous leakage currents and patient auxiliary currents . 10
20 Dielectric strength. 10
21 Mechanical strength . 10
22 Moving parts. 11
23 Surfaces, corners and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
26 Vibration and noise. 11
27 Pneumatic and hydraulic power. 11
28 Suspended masses. 11
29 X-Radiation . 12
30 Alpha, beta, gamma, neutron radiation and other particle radiation. 12
31 Microwave radiation. 12
32 Light radiation (including lasers) . 12
33 Infrared radiation. 12
ISO 18779:2005(E)
34 Ultraviolet energy .12
35 Acoustical energy (including ultrasonics).12
36 Electromagnetic compatibility .12
37 Locations and basic requirements.12
38 Marking and accompanying documents.12
39 Common requirements for category AP and category APG equipment.12
40 Requirements and tests for category AP equipment, parts and components thereof.13
41 Requirements and tests for category APG equipment, parts and components th
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.