NEN-EN-ISO 18778:2003 Ontw. en

Zuigelingenmonitors - Speciale eisen

  • Deze norm is ingetrokken sinds 09-06-2005


Over deze norm

Status Ingetrokken
Aantal pagina's 33
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-10-2003
Taal Engels
This Standard refers to EN 60601-1:1990: Medical electrical equipment - Part 1: General requirements for safety with its amendments. For brevity Part 1 is referred to in this standard either as the General Standard or as the General requirements. The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following: These specific requirements for the safety and essential performance apply to monitors1) used to detect lifethreatening situations in children under three years of age. Devices are used in home care applications usually without continual professional supervision and in the clinical environment. This standard applies to stand-alone devices, multi-parameter monitors as well as to monitoring systems with regard to the physiological parameters specified by the manufacturer for the detection of life threatening situations. This standard applies also to the accessories e.g. probes and cables necessary to apply the monitor to the patient.


ICS-code 11.040.10
Nederlandse titel Zuigelingenmonitors - Speciale eisen
Engelse titel Infant monitors - Particular requirements
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



Ga naar winkelwagen