BS EN 60601-2-23 applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment and hereinafter referred to as medical electrical equipment, whether this medical electrical equipment is stand-alone or part of a system.
BS EN 60601-2-23 also applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.
Note:
BS EN 60601-2-23 does not apply to haemoglobin saturation oximeters or devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).
Who is BS EN 60601-2-23 - Basic safety and essential performance of transcutaneous for?
BS EN 60601-2-23 on basic safety and essential performance of transcutaneous partial pressure monitoring equipment are useful for:
BS EN 60601-2-23 concerns the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. The requirements of BS EN 60601-2-23 take priority over those of the general standard.
The aim of BS EN 60601-2-23 is to bring this standard up to date concerning the third edition of the general standard through reformatting and technical changes.
A “General guidance and rationale” for the more important requirements of this particular standard is included in BS EN 60601-2-23.
BS EN 60601-2-23 is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or because of developments in technology.
BS EN 60601-2-23:2015 supersedes BS EN 60601-2-23:2000 which has been withdrawn. BS EN 60601-2-23:2015 has been editorially revised.
EN 60601-2-23:2015
EN 61966-6:2006
IEC 60601-2-23:2011