EN ISO 18778:2009
(Main)Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
ISO 18778:2005 specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.
ISO 18778:2005 also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. It does not apply to monitors intended for use in health care facilities/institutions.
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 werden1). 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, können 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)
L'ISO 18778:2005 spécifie les prescriptions essentielles de sécurité et de performance applicables aux moniteurs utilisés pour détecter des situations constituant un risque vital pour les enfants âgés de moins de trois ans. La présente Norme internationale s'applique aux dispositifs utilisés dans des applications de soins à domicile, généralement sans surveillance continue d'un professionnel.
L'ISO 18778:2005 s'applique également aux accessoires tels que les sondes et les câbles nécessaires pour placer le moniteur sur le patient. Elle ne s'applique pas aux moniteurs destinés à être utilisés dans des installations/établissements de soins.
Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 18778:2005
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 particulières (ISO 18778:2005)
Ta slovenski standard je istoveten z: EN ISO 18778:2009
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 18778
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 18778:2005
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 21 March 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 18778:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
The text of ISO 18778:2005 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
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 October 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 18778:2005.
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 Directive.
For relationship with EC Directive, 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 18778:2005 has been approved by CEN as a EN ISO 18778:2009 without any modification.
Annex ZA
(Informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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
New Approach Directive 93/42/EEC on 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 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.
Table ZA.1 – Correspondence between this International Standard and Directive 93/42/EEC
Medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
4 All
5 All
6 13, 13.2
6.1 7.5 (3rd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 12.1a) This relevant Essential
Requirement is not
addressed in this
European Standard.
6.1 d) 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this
European Standard
6.8.2aa) 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this
European Standard
6.8.2 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.6 (q)
This relevant Essential
Requirement is not
addressed in this
European Standard
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
- 6a) This relevant Essential
Requirement is not
addressed in this
European Standard
- 7.5 (1st paragraph)
This relevant Essential
Requirement is not fully
addressed in this
European Standard
48 7.5 (2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
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
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 18778
First edition
2005-02-15
Respiratory equipment — Infant
monitors — Particular requirements
Matériel respiratoire — Moniteurs pour enfants — Exigences
particulières
Reference number
ISO 18778:2005(E)
©
ISO 2005
ISO 18778:2005(E)
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ISO 18778:2005(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. 7
8 Basic safety categories . 7
9 Removable protective means . 8
10 Environmental conditions. 8
11 Not used. 8
12 Not used. 8
13 General. 8
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 9
16 Enclosures and protective covers . 9
17 Separation. 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous leakage currents and patient auxiliary currents . 9
20 Dielectric strength. 9
21 Mechanical strength . 9
22 Moving parts. 10
23 Surfaces, corners and edges. 10
24 Stability in normal use. 10
25 Expelled parts. 10
26 Vibration and noise. 10
27 Pneumatic and hydraulic power. 10
28 Suspended masses. 10
29 X-Radiation .
...
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