EN ISO 18778:2009

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

Publication date:   Feb 28, 2010

General information

99.60 Withdrawal effective   Oct 19, 2022

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 18778:2005

NOW

WITHDRAWN
EN ISO 18778:2009
99.60 Withdrawal effective
Oct 19, 2022

REVISED BY

PUBLISHED
EN ISO 18778:2022

Relations

Adopted from ISO 18778:2005 IDENTICAL