Devices are used for clinical and home care applications, very often without professional supervision. This standard applies to stand-alone devices, multi-parameter monitors as well as to monitoring systems with regard to the variables specified by the manufacturer for apnoea detection. This standard applies also to the accessories e.g. probes and cables necessary to apply the apnoea monitor to the patient.
Registration number (WIID)
21189
Scope
Devices are used for clinical and home care applications, very often without professional supervision. This standard applies to stand-alone devices, multi-parameter monitors as well as to monitoring systems with regard to the variables specified by the manufacturer for apnoea detection. This standard applies also to the accessories e.g. probes and cables necessary to apply the apnoea monitor to the patient.
