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.
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.
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