Establishes particular requirements for the safety, including the essential performance of invasive blood pressure monitoring and measuring equipment.This particular standard takes into account Collateral Standard 60601-1-2:(1993) Electromagnetic compatibility and Collateral Standard 60601-1-4:(1996) Medical electrical equipment incorporating programmable electrical systems.A section on alarms has been included because alarms are necessary for monitoring equipment.
Applies to direct blood-pressure monitoring equipment. Establishes particular requirements for the safety of that equipment and the electrical safety requirements for catheter tip transducers. Does not apply to catheter tubing, catheter needles, luer locks, taps and taptables, etc.
IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.
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