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Specifies essential requirements for the performance of transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment. Applies to transcutaneous monitors intended for use with adults, children and neonates, and includes the use of these devices in foetal monitoring during birth. Does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin such as conjunctiva or mucosa.
Reģistrācijas numurs (WIID)
44345
Darbības sfēra
Specifies essential requirements for the performance of transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment. Applies to transcutaneous monitors intended for use with adults, children and neonates, and includes the use of these devices in foetal monitoring during birth. Does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin such as conjunctiva or mucosa.