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.
Legislation related to this standard
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