Medical Electrical Equipment - Part 3-1: Essential Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment
|Publication Date:||1 July 1996|
|ICS Code (Radiographic equipment):||11.040.50|
This part of IEC 601 is a Particular Standard which specifies essential requirements for the performance of TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 3.1, hereinafter referred to as EQUIPMENT.
It applies to transcutaneous monitors intended for use with adults, children and neonates, and includes the use of these devices in foetal monitoring during birth.
It 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.