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EVS-EN ISO 18778:2009

Respiratory equipment - Infant monitors - Particular requirements

General information
Withdrawn from 01.11.2022
Base Documents
ISO 18778:2005; EN ISO 18778:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
01.11.2022
Main
04.06.2009
Main
Main
EVS-EN ISO 18778:2005
This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) 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. This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. This International Standard does not apply to monitors intended for use in health care facilities/institutions. The requirements of this International Standard, which replace or modify the requirements of  IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements.
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