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SRPS EN ISO 18778:2011

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

Jan 31, 2011
95.99   Withdrawal of Standard   Feb 28, 2023

General information

95.99     Feb 28, 2023

ISS

Z076

European Norm

11.040.10  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
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

Directive 2007/47/EC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 18778:2011
95.99 Withdrawal of Standard
Feb 28, 2023

REVISED BY

PUBLISHED
SRPS EN ISO 18778:2023

Related project

Adopted from EN ISO 18778:2009

Adopted from ISO 18778:2005 IDENTICAL