Addition:

This Particular Standard specifies requirements for the safety, including essential performance, of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT, as defined in 2.101 and hereinafter referred to as EQUIPMENT, whether this EQUIPMENT is stand alone or part of a system.

It applies to transcutaneous monitors used with adults, children and neonates, and it 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 (for example conjunctiva, mucosa).