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CEN

EN ISO 18778:2005

(Main)

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

Devices are used for clinical and home care applications, very often without professional supervision. This standard applies to stand-alone devices, multi-parameter monitors as well as to monitoring systems with regard to the variables specified by the manufacturer for apnoea detection. This standard applies also to the accessories e.g. probes and cables necessary to apply the apnoea monitor to the patient.

Beatmungsgeräte - Überwachungsgeräte für Kleinkinder - Besondere Anforderungen (ISO 18778:2005)

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 Überwachungsgeräten fest, die zur Erkennung offenbar lebensbedrohlicher Ereignisse bei schlafenden oder ruhenden Kindern unter drei Jahren verwendet werden ). Diese Internationale Norm gilt für Geräte, die bei der häuslichen Pflege angewendet werden. Diese Überwachungsgeräte werden im Allgemeinen ohne ständige Überwachung durch Fachpersonal verwendet.
Diese Internationale Norm gilt auch für die Zusatzteile, z. B. Tastköpfe und Kabel, die zur Anlegung des Überwachungsgeräts am Patienten erforderlich sind.
Diese Internationale Norm gilt nicht für Überwachungsgeräte, die für die Verwendung in Einrichtungen des Gesundheitswesens vorgesehen sind.
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 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.

Matériel respiratoire - Moniteurs pour enfants - Exigences particulières (ISO 18778:2005)

Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)

General Information

Status
Withdrawn
Publication Date
14-Feb-2005
Withdrawal Date
14-Apr-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Apr-2009
Completion Date
15-Apr-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 18778:2005 - Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

Relations

Replaced By
EN ISO 18778:2009 - Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Effective Date
22-Apr-2009

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SLOVENSKI STANDARD
SIST EN ISO 18778:2005
01-junij-2005
Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Beatmungsgeräte - Überwachungsgeräte für Kleinkinder - Besondere Anforderungen
(ISO 18778:2005)
Matériel respiratoire - Moniteurs pour enfants - Exigences particulieres (ISO 18778:2005)
Ta slovenski standard je istoveten z: EN ISO 18778:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18778:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18778:2005

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SIST EN ISO 18778:2005
EUROPEAN STANDARD
EN ISO 18778
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 11.040.10
English version
Respiratory equipment - Infant monitors - Particular
requirements (ISO 18778:2005)
Matériel respiratoire - Moniteurs pour enfants - Exigences Beatmungsgeräte - Überwachungsgeräte für Kleinkinder -
particulières (ISO 18778:2005) Besondere Anforderungen (ISO 18778:2005)
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 18778:2005: E
worldwide for CEN national Members.

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SIST EN ISO 18778:2005
EN ISO 18778:2005 (E)




Foreword



This document (EN ISO 18778:2005) 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 18778:2005
EN ISO 18778:2005 (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 Directive and associated
EFTA regulations.
WARNING: Other requirements and oth
...

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