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IEC 60601-2-23 Transcutaneous Partial Pressure Monitoring Equipment Testing

Medical electrical equipment – Part 2-23: the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

IEC 60601-2-23 Scope:

IEC 60601 2 23 and EN 60601 2 23 testing applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment as defined in 201.3.63 and hereinafter referred to as medical electronic equipment, whether this medical electronic equipment is stand alone or part of a system.

IEC 60601-2-23 testing applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in fetal monitoring during birth. EN 60601-2-23 tests do not apply to hemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in IEC 60601-2-23 except in 7.2.13 and 8.4.1 of the general standard.

Keystone Compliance assists manufacturers with IEC 60601-2-23 and EN 60601-2-23 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-23 test lab needs.