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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.