IEC 60601-2-34 Direct Blood Pressure Monitoring Equipment Testing
Medical electrical equipment – Part 2-34: the basic safety and essential performance of invasive blood pressure monitoring equipment
IEC 60601-2-34 Scope:
IEC 60601 2 34 and EN 60601 2 34 testing applies to basic safety and essential performance of invasive blood pressure monitoring equipment as defined in 201.3.63, hereinafter referred to as medical electronic equipment.
IEC 60601-2-34 testing does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the dome.
EN 60601-2-34 does not apply to non-invasive blood pressure monitoring equipment.
Keystone Compliance assists manufacturers with IEC 60601-2-34 and EN 60601-2-34 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-34 test lab needs.