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ILNAS-EN ISO 18778:2009 Edition 04/2009
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
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  • 44.7 / copy
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Abstract

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.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 215 : Respiratory and anaesthetic equipment

Directives

93/42/EEC : Medical devices
2007/47/EC : Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Implementation

start of the vote on the project      date of ratification (dor)    21/03/2009
end of the vote on the project      date of anouncement (doa)    31/07/2009
start of the vote on the final project    20/11/2008   date of publication (dop)    31/10/2009
end of the vote on the final project    20/02/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions
ILNAS-EN ISO 18778:2022

Relations to older standards
ILNAS-EN ISO 18778:2005

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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