BAS EN ISO 18778:2010
Respiratory equipment - Infant monitors - Particular requirements
General Information
Status: Published
No. of pages: 32
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
93/42/EEC, Medical devices
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 18778:2009, identical
- ISO 18778:2005, identical